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    A leading pharmaceutical company are recruiting for a Key Account Manager, covering South West England in Neurology. (Secondary Care)

    You would be responsible to sell niche pharmaceutical products to healthcare specialists, whilst always representing the company to high ethical principles.

    You will work with and report into your Regional Account Manager. You will create solid customer relationships assembled on your perception of their requirements and your capacity to demonstrate your integrity by filling those requirements.

    You will exhibit a high degree of knowledge within Neurology and utilize a variety of promotional strategies to successfully execute them. Contributing to the sales team and wider account teams you work within, whilst building and securing business strategies and conveying them successfully.

    The Key Account Manager role is field based. It’s a permanent role offering an excellent package with a competitive salary.

    Skills Alliance are the preferred supplier for this role. Please contact Warda Issa for more details on +44 203 823 4158.

  • UK

    £30 - £40 per hour
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    I am currently on a Regulatory Affairs Associate Position for a 12-month contract.

    My client is a global research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines in areas of unmet medical need.

    Location: Cambridge is the preferred location but would consider Stockley Park

    Essential Duties and Job Functions

    • Support post-marketing activities for the preparation of regulatory submissions for HIV medicinal products via the EU centralised procedure, which may include, but is not restricted to variations, PSURs/RMPs, responses to questions and renewals.

    • Preparation and/or coordination of regulatory labelling variation submissions

    • Assist in ensuring product packaging and associated information is updated and maintained in accordance with product licences in international territories including the review and provision of accurate labelling translations.

    • Support the preparation/ maintenance of clinical trial applications, ROW core dossiers and response to ROW questions.

    • Participate in regulatory HIV team meetings, product team meetings and departmental meetings.

    • Use and update regulatory information systems for planning, preparing, tracking and storing submissions to regulatory agencies.

    • Support the HIV Int RA team as required.

    Would this be a role of your interest?

    If so, please let me know. You can contact me via:
    Email: shakir.hossain (at) skillsalliance.com
    Phone: +44 (0) 207 220 6232
    LinkedIn: Shakir Hossain

  • 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

    £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

    £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 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 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 55-65K 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

    £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

    £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 55-65K 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.

  • USA

    Competitive Pay + Benefits
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    We are working with a Biopharma company in Seattle in search of a Director of Quality Control to add to their team full time, on-site. This company has a diverse pipeline focused on small molecule and protein therapeutics targeting CNS disorders and oncology. Let’s connect and set up a call to discuss!

    We are working with a Biopharma company in Seattle who are in search of a Director of Quality Control to add to their team full time, on-site. This is a stable and well-regarded company with a diverse pipeline focused on small molecule and protein therapeutics targeting CNS disorders and oncology. This person will lead Quality Control (QC) activities for clinical and commercial products, including management of in-process and release testing of GMP Biologics and small molecule products. Lead and manage QC staff including hiring, developing, evaluating and goal setting. Oversee GMP clinical and commercial stability planning, execution, data analysis and data trending in support of product expiry/shelf life determination.

    • Biologics/Large Molecule
    • Experience with Analytical Methods under QC
    • Experience with CMO
    • Worked in GMP

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

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    A leading European specialist pharmaceutical company are currently recruiting a Medical Device Expert located just outside of North West London.

    The Medical Device Expert would be responsible for activities requiring in-depth knowledge of regulations and regulatory requirements in relation to Medical Devices post CE approval, as well as assessments of Medical Devices and In-vitro Diagnostic and Active Implantable Medical Devices.

    Responsibilities:

    • Maintain up to date knowledge of relevant regulations, guidelines and industry standards, proactive communicate to internal stakeholders in writing and presentations to disseminate and discuss the interpretation and implementation
    • Provide expert advice and support to Brand Teams, cross functional Medical Device project team, and other area of the business, and communicate any changes required to Medical Devices RA Manager
    • Provide expert advice and support to due diligence activities as requested
    • Explore opportunities for continuous improvement to enhance business performance
    • Interrogate and sanity check audit preparation and participate in internal and external audits to ensure and sanity check successful re-certification of products.
    • Provide training of Medical Device cross functional project team members in Medical Device requirements as deemed relevant

    Requirements:

    • Focusses on improving efficiency to ensure cost effective utilisation of both internal and external resources, maintains a flexible and constructive outlook
    • Able to contribute to budget preparation and review
    • BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
    • Must have expertise in the development, certification and maintenance of medical device products
    • Clear communicator, sharing information to ensure successful partnering with internal and external stakeholders. Listens and responds effectively to others
    • Responds quickly and positively to customer needs, develops effective collaborative working relationships with customers/external partners

    This Medical Device Expert position is an office-based position with flexibility. It is a permanent role offering an attractive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

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    A Leading global full service CRO are currently recruiting for a Regulatory Affair Manager or Associate Director (ATMP / GMO) in their London offices.

    This is an opportunity to be a part a growing International Regulatory Affairs team with a strong career progression capability. They work in a range of area specialising in Oncology, Cardiology, Metabolic diseases and many more.

    Responsibilities:

    Project management focus to facilitate full global regulatory submissions, which will include:

    • Develop and review regulatory submission documents in support of clinical trials with a specific focus in providing Advanced Therapy Medicinal Products (ATMP)/ Genetically Modified Organisms (GMO) advice and dossier compilation;
    • Developing, tracking, compiling, and maintaining full regulatory applications including Paediatric Investigation Plans (PIPs), Orphan Designations, and Market Authorisation Applications (MAAs);
    • Maintaining timelines for full regulatory submissions;
    • Providing regulatory advice and guidance to Sponsors and other departments to ensure compliance with UK and European regulations and requirements;
    • Developing scientific and regulatory briefing documents for meetings with the EMA;
    • Interaction with EMA, MHRA, and other regulatory agencies;
    • Reviewing pertinent regulations and guidance to develop proactive solutions to regulatory issues and challenges.

    Requirements:

    • Bachelor’s degree and demonstrated regulatory affairs experience;
    • Knowledge of Advanced Therapy Medicinal Products (ATMP) is essential with Genetically Modified Organisms (GMO) experience being highly desirable;
    • Experience with EMA and other regulatory agencies is preferred;
    • Strong computer skills, project management skills, and a high attention to detail;
    • Strong communication skills (both written and oral);
    • Must be a team player with a global regulatory mind-set;
    • This position may require supervision of junior level staff.

    Travel: Less than 30%

    This Regulatory Affair Manager or Associate Director (ATMP / GMO) position is a permanent role offering a highly competitive salary + benefits.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi on 0207 220 6204 or click APPLY NOW

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    Would you be interested in working with a leading global CRO company as a Regulatory Affairs Associate 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 International Regulatory Affairs team with an impressive clientele list.. The rapid growth of the company is accompanied by excellent career progression opportunities

    Responsibilities:

    • Management, preparation, assembly and submissions of European:
    • Clinical Trial Authorisation Applications (CTAA) and amendments
    • Country-level Informed Consent and other patient facing documentation
      • Tracks, reports and files CTAA and amendment submissions / approval progress in electronic trial master files (eTMF) clinical trials management system (CTMS) or other applicable systems.
    • Maintains an awareness of the literature on cancer therapy, clinical trial design and conduct, Good Clinical Practice, and regulations and guidelines relating to the conduct of clinical trials produced by IECs and CA’s.

    Requirements:

    • 6 – 12 months of industry experience in a Regulatory environment
    • Science graduate

    This Regulatory Affair Senior Associate position comes with a competitive basic salary + benefits

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

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    A leading European specialist pharmaceutical company are currently recruiting a Regulatory Change Lead / Project Manager located just outside of North West London.

    The role requires a Regulatory change lead / Project manager to be responsible for the project management of assigned post approval regulatory activities. This includes; forming and leading the delivery team through the planning of assigned projects: ensuring that high quality documentation is prepared for regulatory submissions in partnership with our Regulatory Service Providers: liaising with relevant departments and third parties to ensure regulatory requirements for these submissions are met.

    Responsibilities:

    • Organise kick-off meetings as required for assigned projects, engaging the relevant team members to plan and implement the change
    • Prepare and agree plans for implementation of regulatory activities within agreed timelines for change control
    • Work in collaboration with the Regulatory Affairs Managers to understand and align with agreed product strategies
    • Ensure that high quality documentation is prepared for submission following current best practice standards and meeting requirement guidelines
    • Anticipate and resolve complex regulatory issues, engaging Regulatory Affairs Manager as required
    • Ensure any post approval commitments are logged and followed up on
    • Liaise with relevant internal departments and external contacts to ensure regulatory requirements are met and to proactively communicate with regulatory authorities where required in order to expedite approval of submissions

    Requirements:

    • Excellent verbal and written communication skills, proficient presenting complex projects in a relevant and meaningful way to others.
    • Good degree in a relevant life science subject or equivalent Project Management qualification with demonstrable experience working within the Pharmaceutical sector and in a regulatory environment.
    • Strong facilitation skills, with the ability to coordinate a multi-disciplinary team to deliver against agreed plans
    • Proven ability to project manage multiple small and large projects within the regulatory affairs environment

    This Regulatory Change Lead / Project manager position is an office-based position with flexibility. It is a permanent role offering an attractive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details on +44 (0) 207 220 6204 or click APPLY NOW

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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

  • 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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    Job
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    Share

    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

    £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

    £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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    Share

    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.

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    An exciting leading global Biopharmaceutical company are recruiting for a Regulatory Affairs Senior Manager/ Associate Director / Director position based in the Netherlands.

    This is an opportunity to be a part a growing International Regulatory Affairs team that are paving a new way to develop medications to deliver to patients across the globe. The rapid growth of the company is accompanied by excellent career progression opportunities.

    Responsibilities:

    • Manage/support the regulatory procedure/document preparation for MAA, post-approval activities (e.g. EU document request, CPP request, legalization, notarization etc.)
    • CRO management on regulatory submission and activities, if assigned
    • Communication with the partners for the timely support, if necessary
    • Review final labelling/artwork components for regulatory submissions/commercial purpose
    • Develop EU specific SOPs and manuals in line with EU regulation/guidance and internal process
    • Provide regulatory information, identifies opportunities, risks and mitigations associated with the regulatory strategies to the Global RA group in SB Headquarter
    • Review relevant regulatory documents to align with regulatory requirements
    • Liaison with EMA and/or local agency (if necessary) as a point of contact if requested
    • Act as a legal representative for clinical trial application in EU
    • Interpret and update the EU regulatory environment and regulatory intelligence

    Requirements:

    • At least 8 years of work experience in regulatory affairs
    • At least 4 years of work experience in EU regulatory affairs
    • Project management experience is preferred
    • A Bachelor’s degree in science or related fields

    This Regulatory Affair Senior Manager/ Associate Director / Director position comes with a highly competitive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi for more details at 0207 220 6204 or click APPLY NOW

  • UK

    Strong Competitive Salary + Excellent Bonus and Benefits
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    Share

    Skills Alliance is partnered with a global leading Medical Devices and Technologies company who are looking for an experienced Clinical Research Associate to join their exciting clinical division.

    You would be responsible for the oversight of clinical research conducted at investigational sites to ensure compliance with study protocols, SOPs, regulatory standards, and business policies. 2 Medical device trials in Pain and Cardiovascular studies would be the area of focus for this CRA.

    Most of the monitoring activities are done remotely, requiring little travel maybe once a week or month at times.

    Requirements for this role:

    • A minimum of 2 years of clinical monitoring experience as a CRA for medical device trials
    • Excellent CTMS experience due to the complexity of the client’s systems
    • Minimum of a Bachelors degree in a life science subject or another related discipline
    • Excellent communication skills, both written and oral

    This is a permanent position and fully field/home-based in the UK. Monitoring visits are mostly remote as mentioned.
    A full job description is available on request through Arturo Maldonado
    Alternatively, contact me on 0203 668 3963 for a confidential discussion on this and other opportunities

  • UK

    Up to £40,000 + Strong bonus + Extensive Benefits Package
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    My client is a leading global pharmaceutical company who is looking for a Senior TMF specialist to join their exciting team. This is an opportunity to join one of the leading players in the Neurology and Oncology field, being actively part of a highly dynamic clinical team.

    Key Responsibilities:

    • Monitor and maintain clinical trial documents and data for global scope trials across all clinical phases
    • Meeting and liaising with study teams from both the UK and the US
    • Quality Control (QC) of studies including starting the study, maintaining the QC and close out of the study
    • Liaising with the company vendor and their CRO, maintaining stakeholder management

    Key Requirements:

    • At least 4 years in the pharmaceutical industry, working within clinical development/operations
    • Strong experience with clinical document management (TMF,eTMF and QC required)
    • Excellent organisational and communication skills
    • Life Science degree to BSc level minimum

    Skills Alliance are the preferred supplier for this role. For more information please contact Arturo Maldonado on 02036683963 or alternatively click APPLY NOW.

  • UK

    Strong Competitive Salary + Car Allowance & Excellent Bonus and Benefits
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    My client is a leading global CRO that are looking for a Senior CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Strong independent monitoring experience as a CRA in a commercial setting (CRO or Pharma)
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, 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 55-65K 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.

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    A global pharmaceutical company are currently sourcing for a fully home based Senior Regulatory Project Manager. This is an opportunity to be a part a growing International Regulatory Affairs team with a strong career progression capability.

    The company focusses in the research of chronic endocrine conditions which are dedicated to developing high quality hormone therapies.

    Responsibilities:

    • Support the Head of Regulatory in devising and developing the Company’s regulatory strategies for all development projects, manufacturing improvements, and the continued registration and licensing for all established products when applicable, including lifecycle management.
    • Act as a point of contact for all regulatory interactions with relevant agencies, including, but not limited to, application for and maintenance of clinical trial/investigational new drug applications, preparing all pre- and post- meeting strategies, and responses and life cycle management.
    • Support the Company at regulatory meetings with the Food and Drug Administration, European Medicines Agency, and other global regulatory agencies as required.
    • Preparation of registration dossiers and submission of Marketing Authorisation Applications (MAAs) / New Drug Applications in line with regulatory authority requirements; and interaction with all licensing partners, and designated vendors such as Contract Research Organisations and others where applicable, to facilitate the submissions of MAAs in their territories.

    Requirements:

    • Education in Bachelors of Biomedical sciences or other relevant discipline.
    • At least 4-10 years’ experience in pharmaceutical regulatory affairs, including with both clinical trial and marketing authorisation applications.
    • Experience working in both project teams and independently, and to timetables/deadlines
    • Excellent communication skills, both oral and written.
    • Experience with electronic Common Technical Document submissions including monitoring publishing activities
    • Experience with both Centralised EU MAA and US FDA NDA and IND regulatory procedures.

    This Regulatory Affair Senior Project Manager is fully home-based permanent role offering a competitive salary and benefit package.

    Skills Alliance are the preferred supplier for this role. Please contact Ibraheem Idrissi on 0207 220 6204 for more details or click APPLY NOW

  • UK

    £65000 - £80000 per annum, car allowance + bonus
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    Medical Final Signatory Manager – BRAND NEW ROLE, EU Wide Responsibility

    One of our clients are building out their European medical affairs team and are looking for an experienced final signatory professional to join the business to take on Final Signatory responsibilities across the business.

    Our client are a mid-sized pharmaceutical company, globally renowned for their work across most CNS and oncology and are due to launch a CNS product within the next 18 – 24 months. With this in mind, they require a dedicated final signatory professional to join the team to review anad examine both promtional and non-promotional materials across their European products/portfolios.

    For this position, our client are looking for either GMC or GPhC registered medics or pharmacists with final signatory experience.

    As part of this role, you will be working closely with the Head of Medical to ensure positive outcomes are achieved across the business and working on medical remediation across the European business.

    For more information about this position or any similar opportunities, please contact Chanel Hicken 0207 220 6206.

  • 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.

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    I am currently partnered with an innovative medical device company specialising in Class III devices. My client is experiencing a large amount of growth at this moment in time and is looking to expand their Quality Team and are seeking a freelance/contract/consultant Quality Engineer specialising in setting up the QMS.

    The device itself focuses on human behavioural changes and monitors various functions within the body.

    Rate: €100 – €140 p/h
    Start Date: ASAP
    Contract Length: 6 months
    Hours: 1 FTE
    Location: Heidelberg

    Roles and responsibilities:

    · Provide oversight of current and evolving Medical Device regulatory requirements to ensure the MDQMS remains current.

    · Maintain up to date knowledge of laws and regulations, keeping abreast of recent changes relating to medical device standards, practices and regulations

    · Report to senior management through management review on the performance of the Medical Device quality management system and any need for improvement using KPIs

    · Maintain awareness of customer requirements throughout the organization and ensure these are supported by the MDQMS.

    · Ensure those processes needed for the Medical Device quality management system are established, implemented and maintained

    · Ensure systems in place to maintain the MDQMS

    · Development of globally harmonised processes for critical Medical Device business processes

    · Development and maintenance of the QMS that meets Regulatory and business expectations for Medical Devices.

    · Design, development and continuous review of the MDQMS to ensure its continues to meet business and regulatory expectations

    If this is a role of your interest, please contact:

    email: shakir.hossain (at) skillsalliance.com
    phone: +44 (0) 207 220 6232
    LinkedIn: Shakir Hossain

  • UK

    £35000 - £40000 per annum, Excellent Bonus + Extensive Benefits Package
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    Skills Alliance is partnered exclusively with a leading biopharmaceutical company in Central London who are looking for a Senior Clinical Trials Associate (CTA) to join their exciting Clinical Operations team in the UK.
    This client is a pioneer and leader in advanced treatments in the Hepatology space and treating life-threatening Liver Disease conditions. You would be reporting directly to the Director of Clinical Operations and helping support and execute the clinical trials from start-up through execution and the preparation of study reports and regulatory filings.

    Key Requirements:

    • Minimum of 2 years’ experience as a CTA/CRA in pharmaceutical, biotechnology or CRO environment.
    • Competency in ICH-GCP and a strong interest in clinical research
    • Bachelor’s degree, nursing qualification, or equivalent, in a biomedical, life science or related field of study.

    This is a fantastic opportunity to join a leading organisation in the biopharmaceutical space and expand your clinical research career. This company offers excellent progression routes into clinical monitoring or project and study management.

    A full job description is available on request along with further package details. Please send your CV in word format to Arturo Maldonado or call 0203 668 3963 for more information.

  • UK

    £50000 - £60000 per annum, Strong Bonus and Extensive Benefits Package
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    A leading Biopharma in London are hiring for a Clinical Project Manager to join and manage trials in their exciting late-phase unit. The role would be working and managing trials in this area across a variety of different therapeutic areas and working on their vast and extensive pipeline.

    Key Responsibilities:

    • 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.
    • Manages aspects of assigned international post-authorisation studies within designated program budgets and timelines.
    • Contributes to development and maintenance of study budgets.
    • Contributes to development of RFPs and participate in 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 the organisation’s late phase operational team and cross- functional staff internationally as required.

    Key Requirements:

    • The role would require someone with a project management background that has experience working on non-interventional studies (NIS) as well as late phase trials from phase III and IV.
    • Therapeutic area isn’t a specific requirement, but the management of trials in NIS is essential.
    • Working on PASS studies; Investigator lead trials or Compassionate Use Trials would also be a strong advantage
    • Knowledge of post-marketing requirements and different types of post-authorisation safety and efficacy studies.

    Skills Alliance are the preffered suppliers for this role. A full job description is available on request. For more information please contact Arturo Maldonado on +44 203 668 3963 or alternatively click APPLY.

    Please note if you do not recieve a response within 72 hours then unfortunately you have be unsuccessful on this ocassion.

  • UK

    Strong Competitive Salary + Car Allowance & Excellent Bonus and Benefits
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    My client is a leading global CRO that are looking for a Senior CRA to join them onsite exclusively for one of their strategical pharmaceutical partners. You would be working on trials from a pharma sponsor who is one of the largest and best-known organizations in the world!

    This is a great opportunity for CRAs to develop their career in clinical research within a CRO dedicated to a single sponsor.
    You would have the opportunity to work on challenging studies as part of international projects across a range of therapeutic areas and clinical phases.

    The role would involve all aspects of clinical monitoring, and you should be qualified to conduct these monitoring activities.

    Key Facts:

    • Permanent position
    • Full-time
    • Home-based
    • Regional monitoring

    Key Requirements:

    • Strong independent monitoring experience as a CRA in a commercial setting (CRO or Pharma)
    • Excellent understanding of ICH-GCP and guidelines
    • Degree in Life science, pharmacy or related field
    • Proficiency in Microsoft package

    Skills Alliance are the preferred suppliers for this role. A full job spec is available on request. Please contact Arturo Maldonado for more information on 0203 668 3963. Alternatively, click APPLY NOW

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    I am working with a Global Pharmaceutical company who work on researching, developing, manufacturing and marketing of innovative products. They are currently looking for a QA Compliance Specialist to join their UK team to contribute to the maintenance of the quality system in order to ensure that QA and Regulatory compliance activities are fully adequate.

    Responsibilities of the role will fall into three different categories:

    Quality Assurance

    • Develop and maintain the quality management system to assure compliance with GMP and GDP
    • Plan, implement and perform internal quality audits
    • Monitor and report on product non-conformities
    • Manage and maintain systems for change control, deviation and CAPA
    • Manage and maintain a system for product complaint handling ensuring timely completion and reporting. If necessary, assist in any product recall
    • Collect, collate and compile data for periodic product quality reviews, including preparation of reports
    • Assist in conducting external/supplier audits as required
    • Review batch release documentation and coordinate correction of any errors
    • Assist in maintaining the system for document control, so that the current local and regional SOP systems are managed both in hard copy and electronically
    • Maintain documentation archiving systems
    • Prepare and maintain GMP documentation such as standard operating procedures
    • Conduct training sessions on QA systems as required
    • Contribute to Global Quality goals, projects and initiatives
    • Processing of Product Returns forms including usage decision

    Quality Control

    • Provide support in the planning and scheduling of laboratory testing
    • Initiate follow-up action on out of specification materials
    • Liaise with contractors and the laboratory on sample quantities and sampling frequency
    • Ensure stability testing is performed in accordance with the requirements of the marketing authorisations

    Regulatory

    • Provide support and advice relating to the manufacturing and technical content of the Company’s product licences and submissions
    • Ensure that the requirements and conditions of the Company’s product licences and submissions are reflected in the manufacturing, technical, and testing processes and procedures.

    Please submit your CV if you are interested in finding out more about the role.

  • 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

    £50000 - £70000 per annum, Excellent package
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    Share

    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 (near Euston). The role can also be based in Oslo, Norway. They will offer a very competitive salary – circa £60-70K 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.

  • USA

    competitive pay + comprehensive benefits
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    Title: Clinical Molecular Technician

    Location: Kirkland, WA

    We are currently working alongside a groundbreaking next generation sequencing technology company, who are looking to bring the power of NGS to help patients around the world. Enhancing the capabilities of any DNA sequencing platform, their patented biochemistry & bioinformatics will revolutionize cancer diagnostics and monitoring.

    They are currently looking for a Clinical Molecular Technician to join their dynamic work environment. Specifically, they are looking for someone who has experience working in a CLIA lab with human genomics and has at least one year of hands on experience.

    Responsibilities/Requirements

    • Familiarity with CLIA, HIPAA, and OSHA regulations
    • Experience with one or more of the following: PCR and qPCR, Next-generation sequencing library preparation and instrument runs
    • Perform complex molecular-based procedures with a high degree of quality and in accordance with established protocols.
    • Maintain complete documentation for all steps of the processes as outlined in SOPs
    • Analyze and interpret patient results

    We are moving quickly on this role, so please don’t hesitate to apply. Please also feel free to reach out directly to sarah.r.a4lgdx1gv23m@skillsalliance.aptrack.co

  • USA

    Competitive Pay + Benefits
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    We are partnered with a commercial-stage pharmaceutical company who is focused on designing and developing novel countermeasures to prevent and treat serious diseases with an emphasis on biological warfare. Their belief is to provide solutions to unmet needs. A stable company who is rapidly growing after their FDA approval and looking to continue to grow their pipeline. They are in search of a Regulatory Affairs Manager to join their team in Corvallis, OR and to lead NDA submissions and post marketing commitments.

    • Regulatory submittal experience. INDs, NDAs etc
    • 5-7 years’ experience in a pharma setting
    • Regulatory strategy

    The position is moving quickly, so do not hesitate to apply!

  • USA

    competitive pay + comprehensive benefits
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    Title: Director of National Sales

    Location: Remote

    We are working with a pharmaceutical company focused on animal health. This company creates, manufactures and sells specialized medications to improve the lives of animals and those who have them. Moreover, they are derived of a team who is passionate about animal health and focused on bettering the lives of animals!

    They are currently looking for a Director of National Sales to work alongside the VP of Sales and Marketing and create strategic vision, metrics, targets, and ensure they are met. The ideal candidate will have managed both inside and outside sales teams and of course has a passion for animals and pets.

    Responsibilities/Requirements

    • 5-10 years of Sales Management or selling experience with progressive leadership responsibilities
    • 8-10 years of total experience with documented success in business to business or business to veterinarian sales preferred
    • Build and retain a highly effective team; bring strong leadership with clear communication, transparent expectations, and clear accountabilities; be a coach and mentor to the team.
    • Execute strategies and tactics in close collaboration with Commercial Operations, Product Management, and Marketing colleagues through effective analysis of available data, conducting account analysis and considering market information and trends.
    • Continuously monitor field activities and regularly visit and work with direct reports or other team members, helping to ensure goals and objectives will be met in a customer-focused, sustainable and scalable manner.

    We are moving quickly on this role, so please don’t hesitate to apply. Please also feel free to reach out directly to sarah.r.a4lgdx1gv23o@skillsalliance.aptrack.co