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    Skills Alliance is exclusively collaborating with Takeda Pharmaceuticals to recruit multiple Validation Engineers specialized in CSV for Takeda’s production site in Lessines, Belgiun.

    The Validation Engineer performs qualification / validation activities linked to his/her part of the business (Computerized Systems Validation). He/She prepares and implements the validation documentation required to assure the proper development of a project. He/She manages deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

    Main responsibilities are:

    1) Prepare and implement the validation documentation required to assure the proper development of a project.

    2) Act as a validation representative for projects, with support of his/her Validation Supervisor: Define and implement all validation activities related to the project. Develop the Validation Plans: define validation methodology and approach in line with the Validation Supervisor. Provide validation expertise for the development of the project. Conduct the risk assessment related to the project. Review the URS, FS, DS and DR. Prepare the DQ. Review the commissioning protocols and reports to ensure leveraging into qualification. Prepare the IQ, OQ & PQ protocols. Assure requirements traceability throughout the whole project validation file (from URS to PQ). Organize and coordinate IQ, OQ & PQ validation activities with the different involved departments (on the ground, as required) Analyze, interpret, document and report the testing results. Ensure the follow-up and tracking of the validation activities. Update the validation documentation system. Assure feedback of status and issues to the Validation Supervisor.

    3) Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system.

    4) Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon.

    5) Support junior validation engineers as well as provide day to day guidance for the execution of Validation activities.

    6) Defend validation topics related to his/her projects during Regulatory Inspection and prepare validation parts of the submission file.

    7) Assuring the ability to meet the Department goals in respect to Quality, Finances, Fulfillment and EHS.

    Required profile:

    • Degree or equivalent in Engineering, Chemistry, Life Science, or other job related discipline
    • Minimum 2 years of experience in Validation/Quality systems Skills: Project management experience Excellent communication skills, fluent in French and good knowledge of English (written and spoken)
    • Familiar with Quality Management and GxP Regulations
    • Knowledge of Validation Methodologies Knowledge of Quality Systems, European and FDA regulations, cGMP, GDP
    • Knowledge of the manufacturing processes
    • Requires excellent analytical skills with systematic approaches to problem solving.
    • Must be able to break down complex problems and tasks into activities capable of being performed by personnel.
    • Sound industry knowledge, project proficiency, and autonomy expected.

    For this position, our client is offering relocation assistance for candidates coming from outside of Belgium and sponsorship for non-EU candidates speaking fluent French and meeting all criterias mentioned above.

    If you would like to receive more information about this position, please contact Khephren Mongongu +41 43 508 29 16 or click apply. We’re looking forward to receiving your application.

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    Skills Alliance has partnered exclusively with a world-leading pharma company to hire a Senior Director, Clinical Development for their Rheumatology portfolio. This newly created position will be a key contributor and lead the scientific side of studies and clinical submissions.

    Key Responsibilities:

    • Responsible for scientific reasoning, regulatory requirements, and development/commercial goals for clinical study design
    • Ensure appropriate data and evidence is generated to ascertain a product’s potential efficacy, safety and comparative effectiveness
    • Manage clinical development timelines to ensure trials run to schedule
    • Work cross-functionally with regulatory, clinical operations and other relevant functions
    • Manage and develop a team of direct reports
    • Serve as clinical point of contact for assigned products
    • Represent the function externally to deliver the clinical development strategy with external partners
    • Recognize opportunities for indications to be used for alternative patient populations and submissions
    • Contribute to clinical components of all relevant submission documents and respond to queries from regulatory authorities


    Preferred Qualifications and experience

    • PhD or PharmD degree (MD preferred)
    • Rheumatology experience in clinical drug development is essential
    • Strong familiarity with end-to-end clinical trial life cycle management
    • Complex project management experience
    • Accustomed to leading and working in global matrix structures
    • Excellent knowledge of clinical research methodology and biostatistics relating to clinical trial design
    • Previous direct people management is advantageous



    Skills Alliance is exclusively partnered with this innovative company. Please click APPLY or call Karina Sharipova at +44 (0) 207 220 6205 to receive further information, including a full job description.

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    Skills Alliance has partnered exclusively with a world-leading pharma company to hire a Director, Clinical Development for their Gastroenterology (GI) portfolio. The position will report into the VP, Clinical Development and is responsible for supporting assets in phase II and later development.

    Key Responsibilities

    • Responsible for progressing GI assets and supporting the design of phase II and III studies
    • Improving GI clinical studies using academic expertise and clinical trials experience
    • Work collaboratively in a matrix structure, providing support cross-functionally and leading the development plans of asset strategy

    • Recognize opportunities for indications to beused for alternative patient populations and submissions
    • Work cross-functionally with regulatory, clinical operations and other relevant functions
    • Provide medical expertise in relevant disease areas to support portfolio strategy

    Preferred Qualifications and Experience

    • MD (US Board Certification is strongly preferred)
    • Extensive experience in gastroenterology
    • Excellent knowledge of clinical research methodology and biostatistics relating to clinical trial design
    • Knowledge of clinical immunology would be advantageous
    • Accustomed to leading and working in global matrix structures
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    Skills Alliance has partnered exclusively with a world-leading pharma company to hire a Senior Director, Clinical Development to join their growing Nephrology team. This is a newly created position with responsibility for the clinical development strategy, focusing on their late stage chronic renal disease programme.

    Key Responsibilities

    • Lead progression of Nephrology assets through development and support creation of the Evidence Generation Plan
    • Manage clinical development plans and lead end-to-end strategy development
    • Working in a matrix structure and ensuring cross functional collaboration in developing clinical plans
    • Determine efficacy and drug benefits through evidence generation
    • Identify new potential indications for lead therapeutic assets
    • Engage with external stakeholders and partners when developing clinical development strategies
    • Assess risk and benefits of assets with accountability for study approval
    • Clinically contribute to submission documents and communicate with regulatory bodies
    • Identify areas of unmet patient need and changing medical strategy accordingly

    Preferred Qualifications and Experience

    • MD, PhD, or PharmD preferred
    • Extensive experience in renal drug development
    • Excellent knowledge of clinical research methodology and biostatistics relating to clinical trial design
    • Knowledge of FDA and ICH guidelines and requirements
    • Accustomed to leading and working in global matrix structures
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    Skills Alliance has partnered exclusively with a world-leading pharma company to hire a Director, Clinical Development for their Nephrology portfolio. The position will support the development of a pivotal late phase study and act as a key scientific contributor. The role is based in Upper Providence, PN.

    Key Responsibilities

    • Support Nephrology assets through development and manage the Evidence Generation Plan
    • Determine efficacy and drug benefits through evidence generation
    • Working in a matrix structure and ensuring cross functional collaboration in developing clinical plans with study counterparts
    • Represent the function externally to deliver the clinical development strategy with external partners
    • Recognize opportunities for indications to be used for alternative patient populations and submissions
    • Engage with external stakeholders and partners when developing clinical development strategies
    • Provide medical expertise and scientific understanding of relevant disease areas to support portfolio strategy and potential future therapeutic targets

    Preferred Qualifications and Experience

    • MD required
    • Understanding of Nephrology clinical drug development process and significant clinical research experience
    • Excellent scientific understanding of therapeutic targets
    • Extensive Knowledge of FDA and ICH guidelines and requirements
    • Knowledge of clinical research methodology and biostatistics relating to clinical trial design
    • Accustomed to leading and working in global matrix structures
  • Apply

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    Skills Alliance has partnered exclusively with a world-leading pharma company to hire a Director, Clinical Development for their Hepatology portfolio. The position will support the development of a pivotal late phase study and can be based in either Boston, MA; San Francisco, CA, Collegeville, PN or London, UK.

    Key Responsibilities

    • Progress Hepatology assets through development and support the Evidence Generation Plan
    • Determine efficacy and drug benefits through evidence generation
    • Working in a matrix structure and ensuring cross functional collaboration in developing clinical plans
    • Recognize opportunities for indications in alternative patient populations and submissions
    • Represent the function externally to deliver the clinical development strategy with external partners

    Preferred Qualifications and Experience

    • BSc in a Science related subject; MD, PhD or PharmD preferred
    • Experience in Hepatology clinical drug development
    • Excellent knowledge of clinical research methodology and biostatistics relating to clinical trial design
    • Extensive Knowledge of FDA and ICH guidelines and requirements
    • Accustomed to leading and working in global matrix structures

  • USA

    Competitive Pay
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    We are partnered with a forward thinking CRO in the Greater Seattle area in search of a Histology Technician. This company’s mission is to enhance human life through therapeutics, and they have a focus on animal welfare and the humane treatment of their animal models. This person will work on the preparation of quality tissue samples for histopathologic evaluation; identification of tissue samples for proper embedding orientation; microtomy skills; performance routine hematoxylin and eosin (H&E) staining procedures; knowledge of the use and maintenance of equipment used for the preparation of tissue samples and the ability to maintain a clean and orderly laboratory environment.

    Responsibilities

    • Maintain and document the use and maintenance of laboratory equipment
    • Microtomy daily
    • Performs paraffin tissue processing
    • Identifies required tissue sample orientation and performs paraffin embedding procedures
    • Uses microtomy skills in the preparation of routine (paraffin embedded) microscopic slides according to standard operating procedures and/or required by study protocols
    • Performs routine hematoxylin and eosin (H&E) staining as well as cover slipping microscopic slides

    • Requirements:
      Associate’s degree (AA), specializing in science, preferred
    • Work experience includes, but not limited to at least 1+ years laboratory experience and/or training HT (ASCP) eligible within one year of employment

    This position is moving quickly so do not hesitate to apply!

  • USA

    Competitive Pay + Benefits
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    We are partnered with a growing Companion Diagnostics in Seattle, working on state-of-the-art technology, and revolutionizing cancer diagnostics and monitoring through their novel approach to Next Generation Sequencing. Their goal is to bring this technology to as many cancer patients at possible.


    They are looking to grow the team with a Regulatory Manager who has experience with medical devices, as they are on their way to FDA approval.


    Role and Responsibilities:

    • Evaluate proposed products for product classification and regulatory pathway.
    • Assess regulatory intelligence in the development of regulatory strategies.
    • Develop and maintain Regulatory Strategy/Plan.
    • Develop regulatory procedures and SOPs and participates in implementation.
    • Manage submission activities for a variety of device regulatory approvals including CE mark, US premarket approvals (PMAs), US Premarket Notifications 510(k), post-approval reports, export certificates, establishment registrations, and device listings.
    • Review labeling and promotional material.


    Qualifications and Skills:

    • Bachelor’s degree.
    • At least 6 years of direct experience in the diagnostic industry, including a minimum of 5 years of Regulatory Affairs experience.
    • Experience in writing and preparing Regulatory Documents required.

    This position is moving quickly so do not hesitate to apply!

  • UK

    £50000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established Biopharma. Permanent Clinical Study Manager role based in West London and working in late phase.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for their Late Phase team to work on a wide variety of trials. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager or Junior Study Manager to join the team, this would be working on studies at the cutting edge of science. The candidate would need phase III or phase IV experience and be interested in observational studies.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work. They offer an excellent salary and package around GBP 50-65K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred partner for this Clinical Study Manager / Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • UK

    £50000 - £65000 per annum, excellent package
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    A very exciting opportunity to join an established Biopharma. Permanent Clinical Study Manager role based in West London and working in cell and gene therapy, specifically in Oncology.

    This World-class Biopharma work in a range of disease areas but are recruiting specifically for their Oncology team to work in Cell Therapy. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager or Junior Study Manager to join the team, this would be working on studies at the cutting edge of science. Oncology experience is required.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work. They offer an excellent salary and package around GBP 50-65K depending on experience + bonus + extensive benefits.

    Skills Alliance are the exclusive partner for this Clinical Study Manager / Clinical Trial Manager position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • UK

    £70000 - £80000 per annum, excellent package
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    A very exciting opportunity to join a growing Biopharma. Permanent Late Phase Associate Director / Program Manager role based in West London offering an excellent salary and package.

    This exciting and innovative Biopharma have many products on the market and a very strong pipeline. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Program Manager or Associate Director, this would be working on a variety of late phase phase studies. They require a substiantial clinical trial management background, line management and strong and recent non-interventional trials experience.

    This is a full-time and permanent position. It is office-based in West London with flexibility to work from home. They offer an excellent salary and package around GBP 75-90K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this Clinical Program Manager / AD position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • UK

    Rate on application
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    A multinational medical manufacturing company are recruiting for a Service Now Consultant III based in North West London for a 6 month (100% remote) contract. This role is an excellent opportunity for a driven individual to work within a large, complex Transformation Programme, leading the delivery of one of the key technology solutions.

    The Service Now Consultant will be responsible for working with a number key stakeholders and third parties to successfully deliver the changes to Service Now Platform. In addition to managing and executing the project level plans to achieve the overarching Programme delivery. The Incumbent will play a key role in understanding the status, risks and issues at the project level and then reporting this into the overall Programme.

    Requirements:

    • Proven experience (5 years+) project managing SaaS and PaaS solutions, with specific knowledge in architecting solutions for ServiceNow
    • Significant experience in the delivery of design documentation addressing business requirements and translating those requirements to application development teams
    • Knowledge of ServiceNow/ITIL modules, particularly HR case management and the use of that technology in a similar large corporate organisation
    • Experience in designing and implementing complex, multi-tier, multi-tenant, end-to-end solutions in a high availability environment.
    • Proven success on projects with large-scale deployments; understanding of application life-cycle management.
    • Ability to work globally, with management of remote and distributed project teams

    This role is a 6 month contract on an excellent hourly rate. Skills Alliance are the preferred supplier for this role. Please contact Gena Mazreku for more details on +44 207 220 6216 or click APPLY NOW.

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    A leading global Pharmaceutical company are currently recruiting for a Safety Evaluation and Risk Management – Pharmacovigilance manager based in London. The role sits in the pharma safety group which supports all aspects of the safety profile of the company’s medicine portfolio both in development and post marketing.

    In this role you will join a team engaged in early post marketing activities for one of the recently launched respiratory medicines. The pace is very dynamic with some opportunity to work flexibly across different projects.

    Key Responsibilities:

    • Provide high level scientific expertise in the safety evaluation and risk management of GSK medicines either in clinical development and/or the post-marketing.
    • Ensure that adverse event and other safety information is efficiently evaluated in order to meet global compliance and regulatory requirements, identify the need for product labelling updates and drive proactive implementation of risk management initiatives
    • Support the disease area or product area safety strategy at internal company cross functional meetings and may represent the company externally at meetings with regulatory authorities, outside consultants and other companies such as licensing partners
    • Participate in pharmacovigilance and risk management planning in the clinical matrix.
    • Plan and prioritize activities for designated products
    • Lead safety input into regulatory benefit-risk assessments and the preparation of Risk Management Plans
    • Deliver the clinical safety input into clinical development planning activities
    • May represent clinical safety on cross functional Clinical Matrix Teams and/or Project Teams.
    • Contribute to cross-functional ad hoc teams to address urgent and important product safety issues
    • Review and provide technical approval for investigator brochures, protocols, Informed consents, final study reports and external data monitoring committee charters.
    • May lead or participate in discussion at Global Safety Board for safety related findings.
    • Escalate safety signals appropriately as identified through the Safety Review Process

    Additional responsibilities in Signal Detection, Evaluation, Labelling and submissions

    • Requirements:
    • Prior experience in pharmacovigilance including aggregate reports and risk management activities.
    • Strong evaluation skills and analytical thinking
    • Medical writing skills
    • Sound knowledge of relevant pharmacovigilance regulations and methodologies applicable to safety evaluation and risk management activities
    • Track record of quality decision making, and problem resolution based on assessment of all relevant supporting and conflicting information/factors
    • Experience in managing complex tasks in a matrix team setting.
    • Degree in Biomedical or Health Care related specialty

    This role is based in London and comes with a competitive base salary + benefits package. Skills Alliance are the preferred supplier for this role. For more information or to apply please contact Ibraheem Idrissi on 0207 220 6204 or quick APPLY NOW!

  • €60 - €100 per hour
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    Skills Alliance are working with an innovative Medical Device company, currently within the Research & Development phase. As part of their growth they are seeking a Senior R&D engineer to join the business on an initial 6-month contract. You will be required to have experience with class IIb and III implantable medical device (catheter experience preferred).

    Responsibilities:

    – Prototyping of proposed designs

    – Development and documentation of manufacturing processes to support new designs

    – Contribute to compliance with Design Control regulations

    – Supporting and guiding the clinical team

    – Proficiency in SolidWorks and CAD experience

    Please contact: Shakir Hossain
    Email: shakir.hossain (at) skillsalliance.com
    Phone: + 44 (0) 207 220 6232

  • UK

    £40000 - £50000 per annum
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    Would you be interested in working with a leading global CRO company as a Quality Assurance Specialist in West Sussex? You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    This is an opportunity to be a part a growing team with an impressive clientele list. The rapid growth of the company is accompanied by excellent career progression opportunities.


    Responsibilities:

    • Maintain the company’s QMS in line with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)

    • Provide advice on the improvement of GCP and GMP compliant clinical trial systems

    • Manage SOPs

    • Coordinate audits and inspection visits

    Requirements:

    • 2+ years of relevant QA experience with clinical research

    • GCP knowledge

    • Bachelor’s Degree

    • Excellent interpersonal skills

    This Quality Assurance Specialist position comes with a competitive basic salary + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +44 (0) 20 3668 3961 OR click APPLY NOW.

  • UK

    £20000 - £27000 per annum
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    Quality Control Analyst

    This is a great opportunity to join a well-established Pharmaceutical firm, with an extremely strong culture and great opportunities for career progression.

    They are currently looking for a passionate QC Analyst to join their growing QC team and contribute to the development of a variety of medicines and healthcare products.


    Responsibilities:

    • Assisting with the Quality Control of raw materials

    • Working in accordance with prescribed guidelines

    • Working with different analytical techniques

    Requirements:

    • 1 year’s relevant experience in an analytical testing role

    • Experience working with HPLC and GC analysis

    • Excellent communication skills

    This is an office-based position based in Hertfordshire. It is a permanent role offering a competitive salary up to 25K, which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • UK

    £25000 - £35000 per annum
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    Microbiologist

    This is a great opportunity to join a European-based pharmaceutical company with global reach, currently recruiting for a Microbiologist position.

    You would be part of a well-established and well-known Pharma organisation and as the company grows, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the healthcare industry.


    Responsibilities:

    • Coordinate qualification and routine requalification in the sterile processes
    • Knowledge of sterile and aseptic technical processes
    • Developing analytical methods
    • Implementing CAPAs

    Requirements:

    • 3+ years of experience in leading investigations
    • HPLC, GMP, GLP knowledge
    • Bachelor’s Degree
    • Excellent interpersonal and communication skills

    This Microbiologist position is a permanent position and comes with a competitive basic salary. Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +44 (0) 20 3668 3961 OR click APPLY NOW.

  • UK

    £400 - £425 per day
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    Skills Alliance are recruiting on behalf of a major global pharmaceutical organisation, currently undertaking a significant functional transformation programme across shared service departments. They require 2 experienced P2P Business Analyst to join the existing structure, performing a key role supporting activities throughout the programme phases, ensure a successful system delivery and a clear and robust set of P2P processes for the EMEA system end users, approvers and offshore operating teams.

    Key Responsibilities:

    • Provide core Business Analysist support in the following P2P-related systems within SAP: Concur, Ariba, MDG / Supplier Master, SAP S/4 Hana (currently migrating to).
    • Managing expectations of a diverse stakeholder audience, which may include P2P system end users and/or requesters, approvers, managers, outsourced operation teams, or Finance and Procurement staff.
    • Provide clear information to the P2P functional and Master Data teams to support delivery objectives.
    • Co-ordinate effectively with the Finance and Procurement business, maintaining constant communication throughout the programme lifecycle.
    • Provide regular revisions to the P2P configuration guidelines until Cutover
    • Manage the development of the EMEA Business Roles permissions and transactions from both an Ariba and SAP perspectiveBusiness Analysis
    • Review and feedback on end user training documentation
    • Review and feedback on the set of detailed P2P SOP process manuals
    • Develop sub-processes and routines where gaps are observed, using Visio, Excel, Powerpoint and Word as appropriate.
    • Support the change management and communications teams by providing accurate process information
    • Create process related materials such as inputs to end user and supplier webcontent
    • Highlight business process issues, concerns, risks and gaps quickly and effectively
    • Support the P2P Regional Process Owner
    • User Acceptance Testing (UAT) support

    Required Skills & Experience:

    • Strong P2P process design and business analysis background.
    • Solid practical knowledge of P2P in Ariba, SAP AP and masterdata.
    • Ability to communicate with people at all levels.
    • Flexible approach to work with a focus on delivery to deadlines and high standards.
    • Good time management skills
    • Effective communication skills, both written and verbal
    • Able to work effectively in a team
    • Good analytical and reporting skills; able to turn data into meaningful information
    • Excellent attention to detail
    • Educated to a degree-level is desirable.

    Provide core Business Analysist support in the following P2P areas

    · Systems/processes

    o SAP Concur T&E

    o Ariba Sourcing, Contracts and Supplier SLP (Supplier Lifecycle Performance)

    o Ariba Guided Buying, Invoicing (Invoice Pro)

    o Ariba Network (Supplier Onboarding)

    o SAP MDG / Supplier Master

    o SAP S/4 Hana

    · Business Audience

    · Astellas end users and requesters

    · Astellas approvers and managers

    · Outsourced operation teams

    · Finance and Procurement

    · Functional and delivery Team support

    o Provide clear information to the P2P functional and Master Data teams to support delivery objectives.

    o Align closely with the Finance(FIN), Supply Chain(SCM), Integration and HR teams.

    o Co-ordinate effectively with the Finance (AP) and Procurement business, maintaining constant communication throughout the programme lifecycle.

    o Provide regular revisions to the P2P configuration ‘cookbook’ until Cutover

    o Work with the Apple Transition Leads (ATLs) and the Cutover leads to ensure that Cutover is adequately planned and prepared with appropriate actions delivered. E.g. Purchase Order ramp down and Supplier Master cleanse completed.

    o Manage the development of the Astellas EMEA Business Roles permissions and transactions from both an Ariba and SAP perspective

    · Business Analysis

    o Review and feedback on end user training documentation

    o Review and feedback on the set of detailed P2P SOP process manuals

    o Develop sub-processes and routines where gaps are observed, using Visio, Excel, Powerpoint and Word as appropriate.

    o Deliver appropriate SME related change actions as a result of the Change Impact Assessment(CIA)

    o Support the change management and communications teams by providing accurate process information

    o Create process related materials such as inputs to end user and supplier webcontent

    o Highlight business process issues, concerns, risks and gaps quickly and effectively

    o Support the P2P Regional Process Owner (RPO)

    · User Acceptance Testing (UAT) support

    o Support UAT Activities from script assessment to UAT tester support during the testing of 28 country configurations

    o Align closely with appropriate workstreams such as Finance and Supplier chain, to close blocking issues and support defect closure

    o Analyse and prioritise defects from a business impact perspective

    o Support subsequent DIL testing ( Day in the Life)

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    A leading pioneering software medical device company are currently on the market for a VP of Regulatory Affairs. With the company within its pivotal moment in its history and following the launch of a new program, the VP would overlook and be accountable for the overall Regulatory Affairs function.

    Responsibilities:

    • Provide strategic vision, expertise and leadership in the development of products and regulatory approval in the UK, Europe, US and then worldwide.
    • Responsibility for the company’s compliance with regulatory agencies and all applicable standards worldwide
    • Input as needed into the clinical studies required for Regulatory Approvals. Conversant in the key aspects and able to work with in-house and external experts in medical statistics, clinical study design, and data analysis.
    • Provide training and interpretation of FDA and other regulatory issues across the company more generally
    • Be responsible for the review and approval of promotional, advertising, and labelling items as and where necessary
    • Lead the Compliance to the Medical Device Directive (MDD) in the EU, FDA, and other regulatory agencies.

    Requirements:

    • Demonstrate significant regulatory experience and strategic thinking in novel situations.
    • Proven experience of achieving regulatory approvals for Software as a Medical device in the EU and USA.
    • A commercial focus in the application of regulatory requirements.
    • Outstanding communication skills, both verbal and written, and the ability to interface effectively with software engineering, operations, sales and marketing, and a wide range of other stakeholders
    • Bachelor’s or higher degree, preferably in life sciences, engineering, or business desirable

    The VP of Regulatory Affair is a permanent role offering a competitive salary and benefit package located in Cambridge.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi or for more details click APPLY NOW

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    I have a unique opportunity to join developing biotech focused on Cell therapy/Regenerative medicine as an Interim Associate Director of Clinical Operations.

    This is an office-based position (Due to COVID-19 Homebased)

    They are looking for this individual to be responsible for the overall coordination of the clinical team and monitoring of daily activities to ensure the successful completion of clinical trials. Exposure and participation in the planning, implementation, monitoring and management of clinical trials in compliance with applicable regulations, ICH–GCP Guidelines and SOPs.

    Additionally to supports overall management of the department in collaboration with senior management. Reports to the VP of Clinical Development.

    Experience required:
    ▪ 10+ year’s relevant experience in clinical operations.
    ▪ Considerable depth of experience in clinical study management, monitoring, and developing study-related documents.
    ▪ Management experience required – will be responsible for a team of 12.
    ▪ French-speaking

    I look forward to speaking with those interested.
    Please do call the number below
    +44 (0)2072206235

  • UK

    £65000 - £75000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Senior Clinical Trial Manager or Senior Clinical Study Manager role based in Hertfordshire offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Senior Study Manager, this would be working on interesting early phase studies. They require a strong clinical trial management background, ideally experience in early phase, complex TAs and ideally program level experience. It would be overseeing one of their two programs.

    This is a full-time and permanent position. It is office-based in Hertfordshire with flexibility to work from home. They offer an excellent salary and package around GBP 65-70K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this CPM / Senior CPM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • UK

    £50000 - £65000 per annum, Bonus + benefits
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    Great opportunity for a Study Manager or Senior Study Manager to join a niche Bitoech working in advanced therapies. This is a very varied role, it is permanent, full-time and office-based in West London.

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need an autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable.

    This is a permanent and full-time role. They would prefer people to be office-based in London. They offer an excellent salary + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • UK

    £65000 - £80000 per annum, Bonus + benefits
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    Great opportunity for a Senior Study Manager to join a niche Bitoech working in advanced therapies. This is a very varied role, it is permanent, full-time and office-based in West London.

    The role is with a niche company who are very innovative and have exciting science. They company are growing quickly and have advanced therapies trials in early stages across several indications. This would be working at the cutting edge of research.

    The position is a wide ranging one given the size of the team. They need a senior and autonomous Clinical Study Manager who is keen to work in both science and operations. Early phase project management expeirence would be preferable and ATMPs.

    This is a permanent and full-time role. They would prefer people to be office-based in London. They offer an excellent salary – up to £80K + bonus.

    Skills Alliance are the preferred supplier for this role. Please contact Mark Anderson for more details – +44 207 220 6209 or click apply now.

  • UK

    £55000 - £65000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Trial Manager or Clinical Study Manager role based in Hertfordshire AND/OR London offering an excellent salary and package.

    This exciting and innovative Biotech company are at early stages with trials working in advanced therapies. They will be expanding and will offer great long-term prospects. The company are looking for an experienced Study Manager, this would be working on interesting early phase studies. They require a strong clinical trial management background, ideally experience in early phase, complex TAs and ideally program level experience. It would be managing one of their two programs.

    This is a full-time and permanent position. It is office-based in Hertfordshire AND/OR London with flexibility to work from home. They offer an excellent salary and package around GBP 55-70K depending on experience + bonus + extensive benefits.

    Skills Alliance are the preferred supplier for this CPM / CTM position. For more details please call Mark Anderson on 0207 220 6209 or click apply now.

  • UK

    £55000 - £65000 per annum
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    Medical Device Quality Manager

    Would you be interested in working with a leading pharmaceutical company as a Medical Device Quality Manager based in West London?

    Now onto a little about the opportunity itself; You would be joining a company with a strong EU presence and an impressive portfolio of devices currently in the pipeline. The role requires an experienced manager with a background in medical device quality systems to develop the quality function and liaise with other directors and board members to contribute in discussions around strategic growth with a focus on bringing innovative products to the healthcare system.

    Responsibilities:

    • Acting as a leader of global quality to ensure MDQMS are up to date
    • Coordinating all the processes related to the Medical Device quality system
    • Performing audits in line with ISO 13485
    • Opportunity to support the wider Quality function

    Requirements:

    • Experience at managerial level
    • Experience within medical device auditing
    • An engineering degree or equivalent
    • Strong analytical and communication skills

    This Medical Device Quality Manager role is an office-based position in London. It is a permanent role offering an attractive package, which can be discussed further on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • UK

    £30000 - £40000 per annum
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    Would you be interested in working with a leading global CRO company as a Quality Assurance Specialist in West Sussex? You would be joining a company with a strong global presence and an impressive portfolio of clientele currently in the pipeline.

    This is an opportunity to be a part a growing team with an impressive clientele list. The rapid growth of the company is accompanied by excellent career progression opportunities.


    Responsibilities:

    • Maintain the company’s QMS in line with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP)

    • Provide advice on the improvement of GCP and GMP compliant clinical trial systems

    • Manage SOPs

    • Coordinate audits and inspection visit

    Requirements:

    • 2+ years of relevant QA experience with clinical research

    • GCP knowledge

    • Bachelor’s Degree

    • Excellent interpersonal skills

      This Quality Assurance Specialist position comes with a competitive basic salary + benefits.

      Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +44 (0) 20 3668 3961 OR click APPLY NOW.

  • €80000 - €100000 per annum
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    Our client, medical device company that manufactures and distributes ventilation equipment for patients with respiratory diseases, is looking for a new addition to the team as a Team Leader – Manufacturing. Its solutions include cuff pressure control, volumetric capnography, pulse oximetry, transpulmonary pressure management, ventilation cockpit user interface, adaptive support ventilation, and protective ventilation tool.

    Tasks:

    • Head of the production department of sensors in personnel, organizational and technical terms as well as preparation of the operational planning of the employees together with the technical leader
    • Personnel management including recruitment, maintenance, promotion and adoption
    • Process owner in the manufacture of sensors and their components
    • Deriving and recording production key figures (KPI), evaluating and introducing new production technologies and driving automation solutions
    • Leadership or participation in quality and cost optimization
    • Leadership or participation in initiatives from the production strategy
    • Leadership or participation in the change process
    • Leadership or participation in task forces in quality problems
    • Contact person for audits within the sensor production

    Conditions:

    • Basic technical training, for example as an electronics engineer, electrician, mechanic, automation engineer or chemical laboratory assistant
    • Technical training to become a process specialist or in the field of mechanical engineering, software, chemistry or system technology (FH / TS)
    • Management and / or project manager experience
    • High level of social skills and a hands-on mentality (assertiveness, action orientation and determination)
    • Several years of professional experience in process development is an advantage
    • Very good knowledge of German, knowledge of English an advantage
    • Independent, structured and practice-oriented way of working as well as analytical thinking

    Please get in touch with Irina Bouras + 41 (0) 435 08 28 23 or click apply. We’re looking forward to receiving your application.

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    Skills Alliance are partnered with a global pharmaceutical organisation currently undertaking an exciting transformation programme across their entire professional services department. As part of this initiative, major changes are being implemented across the existing IT/IS infrastructure. They are seeking an outstanding Service Delivery Manager with experience across managing a broad range of commercial / CRM applications, within the life sciences sector (pharmaceutical, biotechnology or medical devices). This will be an initial 6 month contract, based at the EMEA HQ in Surrey. Remote/Flexible working is supported.

    Primary objective:
    Objective of the role: Implement a Global Service Delivery model for all Commercial Applications, such as Veeva CRM.

    Key Responsibilites/Deliverables:

    • Lead resolution for high priority incidents
    • Vendor relationship management for Global Commercial Applications and related services
    • Application management for Cvent and E-Pricing, and other applications as required
    • Standardise L1, L2 and L3 services, including change/release processes, service catalogues and KPI reporting
    • Implement standard service introduction for new applications, projects and services
    • Close alignment with partner IS teams, in particular infrastructure, service delivery and vendor management
    • Drive process excellence, continuous improvement, vendor governance and return on investment
    • Ensure alignment with global strategic supplier strategy and service management tools, such as ServiceNow.

    Required experience:

    • A strong track record as a Service Delivery Manager for commerical application implementations. These commercial applications can be wide-ranging – some may include CRM systems such as Veeva or Salesforce, or Azure for cloud computing.
    • Private sector, global company experience across either the pharmaceutical, biotechnology or medical device industries.
    • Experience with deploying applications that will directly impact on the service provided to professionals in the healthcare industry.
    • Ability to manage stakeholders both internally on a cross-functional basis (into IS, Finance, Procurement etc) but also externally with key customers on changing systems processes or policies.

    Should this role be of interest to you, please don’t hesitate to apply or contact the recruiter Jim Bellicoso directly on jim.bellicoso@skillsalliance.com.

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    Skills Alliance are partnering a global pharmaceutical company on an extensive SAP transformation programme across EMEA, US and APAC operations. As part of this initiative, they are seeking three Finance Business Analysts to join the organisation over a 12 month contract period.

    Job Purpose:
    The Business Analyst supports the rollout of the EMEA S/4 release for 28 countries as part of the core Finance team. The programme is developing regionally standardised processes and improving the performance of the organisation to meet the process and system related programme objectives.

    Key Responsibilities:

    • Support the testing of activities though User Acceptance Testing and further testing cycles
    • Be a point of contact for data conversion
    • Support training activities
    • Change impact assessment and operational readiness
    • Assist in defining and communicating cutover activities
    • Develop internal relationships across the business. In particular affiliate and HQ employees across EMEA, generally in Finance or Procurement departments.
    • Building external relationships with Vendors, Customers, BPO or other external consultants.

    Required Experience:

    • At least two years experience with an EMEA affiliate preferably in a support function
    • Deep knowledge of financial systems is essential, SAP is preferable
    • Proven experience in complex process improvements and project delivery, formal qualification is an advantage
    • Proven experience in managing changes to financial systems, SAP is preferable
    • Change management experience
    • Deep knowledge of process improvement methodology, formal qualification is preferable
    • Experience of working across multiple sites and nationalities
    • MS Excel ability to an intermediate level

    Desirable Experience (but not required:

    • Pharmaceutical industry experience is an advantage
    • Shared services experience is an advantage
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    A Leading global Pharmaceutical company are recruiting for a Senior Manager Global Quality Operations in Hertfordshire.

    This is a unique opportunity to improve the company’s quality systems, inspection management, regulatory intelligence activities and many more.

    Responsibilities:

    • Pharmacovigilance Audits – Implement & maintain the global pharmacovigilance risk-based strategy for audit and risk assessment activities

    • Plan, supervise, conduct, and support internal and external GxP audits

    • Maintain a tracking tool for audits, findings and corrective and preventive actions

    • Quality System

    • Ensure continuous improvement and enhancement of the Quality System by supporting global metrics generation and ‘lessons learned from audit/ inspection’

    • Cover GxP related Functional Areas, specifically thus related to GCP, GVP, GMP and CSV.

    • Collaborate with the respective Functional Area Heads/representatives

    • Ensure SOPs/ WPs are compliant with applicable requirements and regulations

    • Support the preparation for GxP inspections

    • Support the responses to Regulatory Authorities

    • Regulatory Intelligence – Maintain an overview over the relevant regulatory requirements and state-of-the-art knowledge of development in the professional regulatory environment to be able to provide guidance for timely adaptation of the company’s procedures.

    Requirements:

    • Degree in natural science or equivalent number of years’ experience

    • Experience in Pharmacovigilance auditing (Qualification as an auditor preferred)

    • Several years of clinical/industry/Regulatory Authority or otherwise relevant experience, preferably including Quality Management for Pharmacovigilance or Clinical Development or Computer System Validation

    • Expert knowledge/experience in relevant regulations and guidance documents, e.g., in the area of Pharmacovigilance, Clinical Development, Medical Device, IMP management, Regulatory Affairs and Pharmacovigilance

    • Experience in Monitoring, Quality Assurance and/or Good Clinical Practices

    • Exposure to inspections

    This Senior Manager Global Quality Operations position is an office-based position. It Is a permanent role offering a competitive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details at
    0203 668 3961 or click APPLY NOW

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    Skills Alliance are currently partnered with a Global Specialist CNS Pharmaceutical company who is increasing their Manufacturing and as a result searching for an experienced QP to join their team.


    Key Responsibilities

    • Qualified Person as defined in Article 51 of 2001/83/EC
    • Responsible for ensuring that all medicinal products are manufactured to the requirements of EU GMP
    • MHRA and FDA Inspections
    • Lead internal/external quality audits

    Requirements

    • Knowledge of EU GMP, regulations and guidelines.
    • Managing QMS Systems
    • Experience in sterile and non-sterile dosage forms
    • BSc degree in Life Sciences.

    This Qualified Person position is a permanent position and comes with a competitive salary + benefits. Skills Alliance are the preferred supplier for this role. Please contact Stephanie Khalife for more details on +44 (0) 20 7220 6230 OR click APPLY NOW.

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    Skills Alliance is currently partnered with the leading global biotech company based in the central part of the Switzerland. For this purpose, our client is looking for a Medical Project Coordinator EMEA to join their team on a permanent basis.

    JOB TItle: Medical Project Coordinator EMEA

    You will be a key member of EMEA Medical Team and responsible for supporting strategy & planning for medical activities. You will work closely with a multitude of cross-functional partners including Preclinical, Clinical, Sales, and Marketing to ensure full organizational alignment with Medical. You are primarily responsible for supporting the development and execution of Medical Commercial strategies and tactics. Builds and maintains collaborative partnerships with internal colleagues. Collaborates as a member of the Medical team in the development of overall medical strategy and execution of projects.

    Essential Duties & Responsibilities:

    • Responsible for logistical support and organization before and during national and international congresses
    • Provide project management support for implementation databases/systems
    • Provide project management and administrative support
    • Manage the KOL engagement plan in collaboration with R&D, Medical & Field Medical colleagues
    • Provides logistical support for advisory boards, and other meetings (internal and external)
    • Prepare training documents/binders, other correspondence and documents as needed
    • Prepare PowerPoint slides as needed
    • Schedule appointments/meetings
    • Monitor and manage the impact on program planning and execution of new developments in the medical environments
    • Support successful execution of advisory board plans
    • Travel is a required component of this job. Candidates should be willing to travel up to 25% of the time including weekends


    Required Skills & Competencies:

    • Ability to work independently and in a collaborative team environment
    • Willingness to take on multiple tasks simultaneously and perform at high levels
    • The incumbent should excel in all phases of project management (program initiation to launch); be detail-oriented; have strong written and verbal communication skills and be a self-starter who takes initiative
    • Excellent oral and written communication skills
    • Detailed oriented and works with a high degree of accuracy
    • Highly organized and flexible
    • Must be self-directed and able to complete projects with limited supervision
    • Highly ethical and manage confidential and sensitive information
    • Gets energized by hard work and by making a difference for patients suffering from brain cancer
    • Solid working knowledge of Microsoft office (word, excel, PowerPoint) and Outlook
    • Comfortable with occasional after­hours and weekends availability
    • Comfortable with travel to national and international meetings if necessary
    • Language requirements: English and preferably German, any other language a plus


    Qualifications:

    • Bachelor’s degree or equivalent work experience required
    • Advanced scientific degree such as Pharm D, or PhD is a plus
    • Work experience in healthcare industry marketing
    • Oncology and/or Device experience preferred

    If interested, or you know someone who would be interested please apply directly here or contact Heena Verma via phone: +41 44 798 2410


  • USA

    Competitive Pay + Benefits
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    We are partnered with a leading Medical Technology company who specializes in ADHD research and treatment and are revolutionizing ADHD diagnostics. A small Swedish based company who is looking to challenge misconceptions about the condition; what it is, how it affects people and how it should be treated. This is a great opportunity to work for a company with a great passion for what they do and are making strides in an often-overlooked space. They are looking to add a Clinical Advisor to their team in the U.S. on a remote basis with travel.

    • Master’s Level

    • Licensed or License eligible in Mental or Behavioral Health

    • 1 year of clinical experience in diagnosis and assessment of mental health disorders

    • Active & Valid Driver’s License – Clean Driving Record

    They are looking to move quickly on this role – so do not hesitate to apply!

  • USA

    Competitive Pay + Benefits
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    We are partnered with an innovative Biotech company in the Bay area who is looking to add a Project Coordinator / Manager to their team. Looking for someone with a scientific background who is interested in project management.

    This company is on the cutting edge of gene and cell therapy and are passionate about helping patients with untreatable diseases. They have a prominent leadership team who have been pioneers in this space for years. This is an exciting time to join a company who is in a niche space and looking to grow!

    • Scientific background
    • Project coordination or management experience
    • Microsoft office suite
    • Smartsheet experience

    This position is moving quickly do not hesitate to apply!

  • UK

    £50000 - £70000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London (Euston). The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £50-60K depending on experience + full benefits package.

    Skills Alliance are retained to fill this position. Please contact Mark Anderson for more details +44 207 220 6209.

  • UK

    £60000 - £80000 per annum, Excellent package
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    Skills Alliance are retained on a unique opportunity with an innovative not-for-profit organisation.

    The company specialises in vaccine development to combat epidemic outbreaks such as Coronavirus and Ebola, they are a global partnership of government, civil society, philanthropic and Pharma organisations. They have a unique approach and will have a direct impact on global epidemics in the coming years. With this goal in mind, they are looking to build out the organisation and are looking for high calibre candidates who want to make a difference.

    The R&D Project Manager will facilitate the successful delivery of several vaccine R&D projects associated with the organisation’s mission. Responsible to proactively manage all elements of each project – monitoring, scope, timelines, risk, budget and quality. They require previous R&D project management experience, ideally managing projects from pre-clinical to commercialisation. Cross-functional PM experience is required and experience of overseeing vaccine projects would be a bonus.

    This is a full-time and permanent position to be based at their offices in Central London (near Euston). The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £60-80K depending on experience + full benefits package.

  • UK

    £350 - £400 per day
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    Skills Alliance are partnering a global pharmaceutical organisation on an extensive transformation programme across various shared service functions within their business. The programme is upgrading a wide range of processes and systems across finance, procurement, supply chain and HR, amongst others. As part of this programme, they require O2C (order-to-cash) Business Analysts to join the team on a 12 month contract assignment.

    Job purpose:

    The role will perform a key function in performing business analyst activities throughout the programme phases and to not only support a successful system delivery but ensure a clear and robust set of O2C processes for our EMEA end users, approvers and offshore operating teams.

    Key Deliverables/Responsibilities:

    Functional and delivery Team support:

    • Provide clear information to the O2C functional and Master Data teams to support delivery objectives;
    • Align closely with the Finance, Supply Chain, Business Services, Data, Affiliates & Integration;
    • Co-ordinate effectively with the Finance (AR), QA, Finance & Logistics Managers, maintaining constant communication throughout the programme lifecycle;
    • Provide regular revisions to the O2C configuration ‘cookbook’ until Cutover;
    • Work with programme transition leads and the Cutover leads to ensure that Cutover is adequately planned and prepared with appropriate actions delivered. E.g. Purchase Order ramp down and Supplier Master cleanse completed;
    • Create the Business Role model by affiliate type. Manage the development of EMEA business roles permissions and transactions.

    Business Analysis:

    • Review and feedback on end user training documentation
    • Review and feedback on the set of detailed O2C SOP process manuals
    • Develop sub-processes and routines where gaps are observed, using Visio, Excel, Powerpoint and Word as appropriate.
    • Deliver appropriate SME related change actions as a result of the Change Impact Assessment
    • Support the change management and communications teams by providing accurate process information
    • Create process related materials such as inputs to end user material
    • Highlight business process issues, concerns, risks and gaps quickly and effectively
    • Support the O2C Regional Process Owner
    • Input into DOA and SOD recommendations
    • Effective regular reporting

    User Acceptance Testing (UAT) support:

    • Support UAT Activities from script assessment to UAT tester support during the testing of 28 country configurations
    • Align closely with appropriate workstreams such as Finance and Supplier chain, to close blocking issues and support defect closure
    • Analyse and prioritise defects from a business impact perspective

    Required experience:

    • Strong O2C process design experience and business analyst background.
    • Solid practical knowledge of O2C in SAP SD and masterdata is required.
    • Ability to work cross-functionally across a complex business structure, managing stakeholders with a wide range of expectations from projects affected by your work.
    • Able to work both autonomously or collaboratively as a team.
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    Our client is very innovative and dynamic biopharmaceutical company based in Basel area. They are looking for an experienced Laboratory Technician in Clinical Manufacturing to join their team in a position of Senior Laboratory Technician Clinical Manufacturing Unit for Solids

    Business Area: Pharmaceutical Development – GMP Clinical Manufacturing Units

    Responsibilities :

    • Formulation, manufacturing process development and Clinical Trial Material supply from early to late stage development.
      • Manufacturing of development batches including scale up from small to pilot scale
      • Manufacturing and supply of clinical batches according to cGMP for phase I to III clinical studies.
      • Clean operational areas and equipment according to SOPs
      • Development plan proposal, protocol writing in collaboration with the responsible Formulation Development Manager
      • Support in issuing master batch records, preliminarily development reports
      • SOPs writing and maintenance
    • Support internal and external Quality inspections
    • Collaboration with other disciplines such as Preformulation and Preclinical Galenics, Project Management, Quality Assurance, compliance team, Quality Control and Clinical Trial Supply to ensure that operations are planned in an efficient manner.
    • Purchase and management of facility consumables
    • Manage manufacturing related change controls, deviations, CAPAs
    • Support supervision of unit installations and follow-up on safety regulations with Health & Safety department


    Requirements :

    • Bachelor degree in a relevant field with at least 5 years of experience in drug product formulation development / clinical trial material manufacturing field (production system, Formulation development processes, QbD approaches or cGMP Drug product manufacturing and control)
    • Excellent communication and team working skills
    • Be able to work closely with different stakeholders in a matrix environment
    • Well-developed planning and organization skills
    • Fluent in English (German or French an advantage)

    For more information please contact Maja Vidovic:

    M: 0041 22 518 82 49

  • UK

    £30000 - £40000 per annum
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    Quality Systems Associate

    This is a great opportunity to join a global, mid-sized leading pharmaceutical company, currently recruiting for a Quality Systems Associate.

    You would be part of a global, well-established and well-known Pharma organisation, which specialises in neurology and oncology. As the company expands, you will have the capability to progress within your career, as well as contributing towards reaching the company’s vision within the healthcare industry.

    Responsibilities:

    • To support QMS Indicator reports

    • To coordinate GMP training

    • To support improvements to TrackWise processes and systems

    • To support the Deviation System

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Good technical and analytical judgment

    • Ability to maintain a professional behaviour

    • Excellent communicator

    This is an office-based position based in North London. It is a permanent role offering a competitive salary between 30K-40k, depending on experience.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • UK

    £30000 - £40000 per annum
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    Quality Specialist


    This is a great opportunity to join a successful and rapidly growing pharmaceutical company, currently recruiting for a Quality Specialist.

    If you are looking for a more challenging role within a well-funded pharma company that will give you the opportunity to progress, this is it! As the company expands, you will have the capability to progress within your career, as well as contributing towards making a difference within the healthcare industry.

    Responsibilities:

    • To support Quality Operations in the warehouse

    • To review pharmaceutical product batch files

    • To provide QA support

    • To monitor Complaints, CAPA, Deviation and Change Control

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Previous experience working in a GMP environment

    • Enthusiastic and highly motivated

    • Excellent communicator

    This is an office-based position in Essex. It is a temporary 12-month contract role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • UK

    £30000 - £40000 per annum
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    Quality Specialist


    This is a great opportunity to join a successful and rapidly growing pharmaceutical company, currently recruiting for a Quality Specialist.

    If you are looking for a more challenging role within a well-funded pharma company that will give you the opportunity to progress, this is it! As the company expands, you will have the capability to progress within your career, as well as contributing towards making a difference within the healthcare industry.

    Responsibilities:

    • To support Quality Operations in the warehouse

    • To review pharmaceutical product batch files

    • To provide QA support

    • To monitor Complaints, CAPA, Deviation and Change Control

    Requirements:

    • Excellent IT skills and experience working with Quality Systems

    • Previous experience working in a GMP environment

    • Enthusiastic and highly motivated

    • Excellent communicator

    This is an office-based position in Essex. It is a temporary 12-month contract role offering a competitive salary which can be discussed on the application.

    Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +4402036683961 or click APPLY NOW.

  • UK

    £30000 - £40000 per annum
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    This is a great opportunity to join a pharmaceutical company with global reach, currently recruiting for a QC Analyst position.

    You would be part of a well-established and well-known Pharma organisation, which specialises in the treatment of addiction and critical care. As the company grows, you will have the capability to progress within your career, as well as contributing towards reaching the companies vision within the healthcare industry.


    Responsibilities:

    • Carrying out analysis of finished products and stability batches

    • Working alongside the technical team

    • Developing analytical methods

    • Working according to GMP standards

    Requirements:

    • 2+ years of relevant experience

    • HPLC, GMP, GLP knowledge

    • Bachelor’s Degree

    • Excellent interpersonal and communication skills

    This Quality Control Analyst position is a permanent position and comes with a competitive basic salary. Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +44 (0) 20 3668 3961 OR click APPLY NOW.

  • UK

    £30000 - £38000 per annum
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    This is a great opportunity to join a European-based pharmaceutical company with global reach, currently recruiting for a QA Team Leader.

    You would be part of a well-established and well-known Pharma organisation, and as the company expands their manufacturing plans, you will have the capability to progress within your career, as well as contribute towards reaching the companies targets and vision.


    Responsibilities:

    • Oversee the quality of the entire product journey
    • Working alongside the Quality Systems Department
    • Generating the departmental KPIs as required by the business
    • Ensure that all staff members are trained and aware of the importance of GMP guidelines


    Requirements:

    • Previous managerial experience/ leading a team
    • Prior experience working with GMP and GDP standards
    • Previous managerial experience
    • Experience with regulatory GMDP audits
    • Excellent interpersonal and leadership skills


    This QA Team Leader position is a permanent position and comes with a competitive basic salary. Skills Alliance are the preferred supplier for this role. Please contact Anais Croitoru for more details on +44 (0) 20 3668 3961 OR click APPLY NOW.

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    A rare contract position has arisen to join the Clinical Operations team based in our International Headquarters as a Contract Clinical Trial Manager to be responsible for the management of post-authorisation studies and Investigator Sponsored Research across different therapeutic areas.

    Provide support and oversight of Investigator Sponsored Trials including Fair Market Value and feasibility assessment, contract milestone advice, tracking and publication follow-up as required.

    Role Responsibilities
    • Manages aspects of assigned international post-authorisation studies within designated program budgets and timelines.
    • Contributes to the development and maintenance of study budgets.
    • Contributes to the development of RFPs and participate in the selection of CROs/vendors.
    • Manages CROs/vendors for assigned post-authorisation studies.
    • Communicates project status and issues and ensure project team goals are met.
    • Contributes to the writing and coordinates review of relevant documents including protocols, informed consents, case report forms, monitoring plans and clinical study reports.
    • Maintains study timelines and communicates adjustments where necessary.
    • Develops good working relationships with Gilead US late phase operational team and cross-functional staff internationally as required.
    • May participate in the preparation of interim/final clinical study reports.
    • May contribute to the development of abstracts, presentations, and manuscripts.
    • Keep study status in Clinical Trial Management System up to date for assigned studies.
    • Under supervision, may participate in or lead departmental strategic initiatives.
    • Conduct study feasibility in conjunction with internal Medical Affairs and Clinical Operations staff and/or external collaborators or CROs.
    • Participate in CRO calls as necessary.
    • Conducts Monitoring/co-monitoring as required.
    • Contributes to Clinical Operations International team activities & initiatives.
    • May serve as a resource for others within the company for clinical trials management expertise.
    • Under general supervision, is able to examine functional issues from an organizational perspective.
    • Works with Clinical Program Managers to manage the European component of global post-authorisation studies and/or the entire process of an EU post-authorisation study, with the ability to identify issues and adapt to changes.
    • Interacts with cross-functional teams internally and externally to ensure study progress.
    • Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.

    Experience, knowledge and skills:
    • Typically requires a BSc in a relevant scientific discipline and relevant clinical experience in the pharmaceutical or health care industry or equivalent.
    • Previous experience in the management of Phase IV and Non-Interventional studies essential.
    • Experience in the review and oversight of Investigator Sponsored Trials desirable.
    • Knowledge of post-marketing requirements and different types of post-authorisation safety and efficacy studies.
    • Must be able to generally understand, interpret, and explain protocol requirements to others.
    • Good knowledge and understanding of ICH GCP, GVP, FDA and EMEA regulations and guidelines applicable to post-authorization studies.
    • Must be able to prioritize multiple tasks.
    • Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
    • Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
    • Excellent teamwork, communication, decision-making and organizational skills are required.

    If this role is for you call me on 07788260835, I look forward to speaking with you.

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    Description:

    The Health Economics Senior Manager develops and leads a Global Health Economics (GHE) value-evidence strategy for either a pipeline asset or Marketed Product in oncology.

    Responsibilities include:

    1. Integrates with a global research team and program to support the asset, as well as with individual regional and local business units, in alignment with the strategy, tracks and executes the GHE plan and delivers against goals.

    2. Coordinates product and project activities.

    3. Has budget responsibility and may immediately, or over time direct and develop staff.

    4. Develops strategy and selection of Patient Reported Outcomes (PROs) for interventional trials and observational studies. Develops FDA briefing documents for PRO label discussions.

    5. Develops core economic models with vendors or Amgen internal center of excellence. Works with Amgen international affiliates to adapt core economic models for regional use

    6. Designs existing data studies, develops or approves research project plans, and oversees execution.

    7. Develops and communicates the Global Value Dossier (GVD) and final value propositions and validates that the regional dossiers

    8. Designs or approves GHE-related aspects such as statistical analysis plan (SAP) of observational studies and interventional trials and consults on study execution.

    9. Develops and oversees/conducts relevant meta-analysis, PRO, systematic review, utility measurement or other outcomes research study as determined by product evidence generation plans/strategy

    10. Helps design product evidence generation strategy and communicate plans to cross functions teams

    11. Serves as the GHE representative for the Global Publication Team and coordinates with affiliates and Regional HE on publication plan

    12. Prepares GHE publications for dissemination.

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    Our client is very innovative and dynamic biopharmaceutical company based in Basel area. They are looking for an experienced Senior Legal Counsel, who will be responsible for providing legal advice and draft as well negotiate documents on a wide variety of topics. This includes particularly the legal managing of the following job responsibilities:

    Job Responsibilities

    • Business development contracts (e,g. licensing contracts)
    • Human resources matter
    • Procurement contracts
    • Clinical development projects
    • Marketing contracts
    • Compliance matters
    • The function reports into the Group General Counsel


    Candidate’s Requirements

    • A well-seasoned person with bar admission in Switzerland
    • At least 7 years of post-qualification experience in the pharmaceutical industry
    • Generalist with experience in licensing contracts for pharmaceutical compounds and products, clinical development processes and contracts
    • Understanding of relevant compliance regulations like FCPA, false claims act, etc. as well as anti-trust laws
    • Deep understanding of the laws of Switzerland as well as a broad understanding of other jurisdictions (common law countries)
    • Excellent language skills (orally and in writing) in German and English
    • Pronounced hands-on work attitude combined with a distinctive high willingness to provide high-quality services to customers on a short time

    For more information please contact Maja Vidovic:

    M: 0041 22 518 82 49