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  • Apply

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    Skills Alliance is currently partnered with a science driven analytics company that has a platform bringing analytics and computing technology together to create insights evaluating outcomes of medical treatments.
    The ideal candidate would need to be responsible for developing an understanding of the company’s technology and directing clients use of the platform to its fullest potential. This is someone that wants to be heavily involved with the day to day activities around the client and is comfortable engaging internally and externally in multiple avenues of communication.

    Responsibilities:
    -Work with clients to assist them in developing and delivering scientific results using the company’s platform
    -Consult with clients and colleagues to create and implement protocols for scientific use cases and scientific validation studies
    -Understand platform, and share knowledge with clients through multiple avenues of commutation (training seminars, 1:1 discussion, emails, etc.)

    Requirements:
    MPH, MS or PhD in epidemiology, health services research, health economics or a related field
    7+ years in an analytic area within a healthcare or medical organization
    Comfortable engaging customers in-person, on the phone, and in writing
    Ability to travel to customer sites

    For further details and a full job description please email or call me at 646-300-8377. All queries are treated confidentially.

  • Epidemiology

    $175000 - $250000 per annum
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    Share

    Skills Alliance is currently partnered with a science driven analytics company that has a platform bringing analytics and computing technology together to create insights evaluating outcomes of medical treatments.
    The ideal candidate would need to be responsible for developing an understanding of the company’s technology and directing clients use of the platform to its fullest potential. This is someone that wants to be heavily involved with the day to day activities around the client and is comfortable engaging internally and externally in multiple avenues of communication.

    Responsibilities:
    -Work with clients to assist them in developing and delivering scientific results using the company’s platform
    -Consult with clients and colleagues to create and implement protocols for scientific use cases and scientific validation studies
    -Understand platform, and share knowledge with clients through multiple avenues of commutation (training seminars, 1:1 discussion, emails, etc.)

    Requirements:
    MPH, MS or PhD in epidemiology, health services research, health economics or a related field
    7+ years in an analytic area within a healthcare or medical organization
    Comfortable engaging customers in-person, on the phone, and in writing
    Ability to travel to customer sites

    For further details and a full job description please email or call me at 646-300-8377. All queries are treated confidentially.

  • Quality assurance

    £30000 - £40000 per annum
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    Skills Alliance have partnered exclusively with rapidly expanding, very well-funded Biotech that develop and manufacture inhalation combination for the appointment of a Quality Assurance specialist in the South West.

    Company Overview
    Global leader in treating patients with airways diseases with multiple sites across the UK and Europe. After significant recent investment they are undergoing a restructuring and modernising of the
    EMEA Quality function and systems.

    Role Overview
    As QA officer you will be responsible for compliance to all relevant standards across pharmaceutical and medical devices (GMP, ISO 9001, ISO 13485) across both R&D and Commercially licensed products. As part of a large project to modernise and centralise their Quality Systems across multiple sites you will be responsible for maintaining and finding improvements to the existing QMS (Quality Management System). There will also be a significant involvement in the Operationally-focused QA responsibilities including BMR (Batch Manufacturing Record) review; internal auditing and documentation review. This role should appeal to those looking to expand on their Pharmaceutical QA experience with a broad role covering both R&D (IMP) and commercially licensed combination products and work with both systems and operational QA.

    Required Skills/Experience
    You will have previously worked in a QA role in a pharmaceutical setting, extensive knowledge of the GMP (Good Manufacturing Practice) standards. Ideally, you will also have experience working with Medical Devices and/or combination products but this is not essential. You will also have Quality Systems experience, ideally having a focus on improving or developing new systems.

    If you would like to be considered for this opportunity, please click APPLY to send a copy of your CV. For further details and a full job description, please call Bridget Matulyte on +44 (0) 207 220 6239. All inquiries are treated confidentially.

  • Quality assurance

    £30000 - £40000 per annum
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    Share

    Skills Alliance have partnered exclusively with rapidly expanding, very well-funded Biotech that develop and manufacture inhalation combination for the appointment of a Quality Assurance specialist in Cambridge.

    Company Overview
    Global leader in treating patients with airways diseases with multiple sites across the UK and Europe. After significant recent investment they are undergoing a restructuring and modernising of the
    EMEA Quality function and systems.

    Role Overview
    As QA officer you will be responsible for compliance to all relevant standards across pharmaceutical and medical devices (GMP, ISO 9001, ISO 13485) across both R&D and Commercially licensed products. As part of a large project to modernise and centralise their Quality Systems across multiple sites you will be responsible for maintaining and finding improvements to the existing QMS (Quality Management System). There will also be a significant involvement in the Operationally-focused QA responsibilities including BMR (Batch Manufacturing Record) review; internal auditing and documentation review. This role should appeal to those looking to expand on their Pharmaceutical QA experience with a broad role covering both R&D (IMP) and commercially licensed combination products and work with both systems and operational QA.

    Required Skills/Experience
    You will have previously worked in a QA role in a pharmaceutical setting, extensive knowledge of the GMP (Good Manufacturing Practice) standards. Ideally, you will also have experience working with Medical Devices and/or combination products but this is not essential. You will also have Quality Systems experience, ideally having a focus on improving or developing new systems.

    If you would like to be considered for this opportunity, please click APPLY to send a copy of your CV. For further details and a full job description, please call Bridget Matulyte on +44 (0) 207 220 6239. All inquiries are treated confidentially.

  • Pharmaceuticals

    $115000 - $130000 per annum
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    A Research and Development organization is currently looking for a Manager of Regulatory Affairs to join their team. The organization specializes in developing assets from pre-clinical research and transitioning the asset into the clinical trial setting. The organization’s focus is in a multitude of therapeutic areas including Oncology, Neurology, and more. This company serves as the R&D arm for their partner organization.

    The Manager of Regulatory Affairs would be joining a close-knit team to help facilitate the strategy and submissions of INDs. After having a successful IND, the company either hands off the asset to their partner company or sells the asset. With this process in place, the company focuses on developing as many assets as possible, giving the Manager the opportunity to file a minimum of 2 INDs a year. This is a great opportunity to diversify your experience and gain more submissions underneath your belt.

    The ideal candidate would have:
    -IND Submission Experience
    -3-5 Years of Regulatory Strategy Experience
    -M.S is Preferred

    Along with the very interesting nature of this role, the compensation package can be very lucrative as well.

    If you were interested in learning more about the opportunity, please submit a copy of CV for consideration.

  • Apply

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    An industry leader in Over The Counter space is seeking a senior leader within the supply chain team to join their organization. This company has diverse product portfolio including digestive care, oral care, pain relief, skin care, household cleaning, and more. Although this company has a diverse portfolio, they are still able to give attention to each product sufficiently to be leaders in each space. This gives any individual joining the organization the chance to diversify their experience and learn new projects. This organization has a global presence and gives the opportunity for the senior leader to expand upon their skillset.

    The Vice President of Supply Chain Operations would be joining a team of 11 individuals and reporting into the SVP of the business unit. The SVP maintains a laissez-faire model where he is a strategic leader and is looking for the VP to come in and help with the strategy and to execute the strategies discussed. This gives the VP a great breadth of responsibilities, including the negotiation contracts with CMOs and external vendors to help reduce costs for the organization and building new relationships to help facilitate the needs of the company. This is a very dynamic and all-encompassing role for any individual to step into.

    The ideal candidate would have:
    -7+ Years of supply chain experience in the OTC space
    -Worked in a Mid to Large Size organization ($1billion Market Cap)

    Along with the very interesting nature of this role, the compensation package can be very lucrative as well.

    If you were interested in learning more about the opportunity, please submit a copy of CV for consideration.

  • Manufacturing

    $70000 - $90000 per annum
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    Clinical manufacturing site transitioning to commercial, expanding shift patents and this is a great time for an Upstream Supervisor to join with a rapidly growing organization.

    I am urgently seeking Manufacturing Professionals, specialized in Upstream Operations, who would be interested in a leadership role as an Upstream Manufacturing Supervisor. This is a great opportunity offering career progression and permanent position with a leading, growing BioPharma company in New Jersey.

    Reporting into the Upstream Senior Manager the essential functions of the role will include meeting timelines, overseeing/mentoring a team of direct reports and Upstream Operations, SOPs, MBRs, Protocols, and other documentation.

    Ideal candidate must have previous leadership/supervisory experience and at least 5 years of Upstream, Aseptic, Biologics experience in the BioPharma industry.

  • HR and talent acquisition

    $90000 - $115000 per annum
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


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    This is an excellent opportunity to join one of the most exciting Brain Health Medical Technology companies who are growing extensively throughout the US.

    As the Head of Learning and Development, you will have the opportunity to build and spearhead the training program for up to 100 new hires across the next 12 months. This is a great opportunity to come into a company on the ground floor and really make an impact on the transition of new employees during a rapid growth period. The successful applicant will have the chance for this position to evolve into a HR Director function as well within the next 3-5 years.

    In this role, you will be responsible for working closely with senior management to create and implement the training program for new hires to ensure acquisition of company policies and procedures. You will also be responsible for ongoing training and the compiling of learning and development strategies related to specific departmental needs.

    You must have a minimum of a Bachelor’s degree and a minimum of 5 years of experience running a Learning and Development function. Having a background in the pharmaceutical or biotech industry would be looked at favorably.

    The company is one of the most unique in the industry who have created an online assessment to find and diagnose early on-set of neuro-degenerative diseases. This test has engaged with and diagnosed with over 60K patients and counting!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

  • HR and talent acquisition

    $90000 - $115000 per annum
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    Share

    This is an excellent opportunity to join one of the most exciting Brain Health Medical Technology companies who are growing extensively throughout the US.

    As the Head of Learning and Development, you will have the opportunity to build and spearhead the training program for up to 100 new hires across the next 12 months. This is a great opportunity to come into a company on the ground floor and really make an impact on the transition of new employees during a rapid growth period. The successful applicant will have the chance for this position to evolve into a HR Director function as well within the next 3-5 years.

    In this role, you will be responsible for working closely with senior management to create and implement the training program for new hires to ensure acquisition of company policies and procedures. You will also be responsible for ongoing training and the compiling of learning and development strategies related to specific departmental needs.

    You must have a minimum of a Bachelor’s degree and a minimum of 5 years of experience running a Learning and Development function. Having a background in the pharmaceutical or biotech industry would be looked at favorably.

    The company is one of the most unique in the industry who have created an online assessment to find and diagnose early on-set of neuro-degenerative diseases. This test has engaged with and diagnosed with over 60K patients and counting!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

  • USA

    Pharmacovigilance

    $260000 - $290000 per annum
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    Before applying for this position you need to submit your online CV. Click the button below to continue.


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    This is an excellent opportunity to join a dynamic global specialty pharmaceutical company that are exponentially growing their team within the Greater Philadelphia area.

    As the Medical Director you will have the primary responsibility to provide medical expertise in the safety and risk assessment for the full drug development life cycle for a series of specialty products.

    Reporting directly into the VP of Pharmacovigilance, the successful applicant will have a unique opportunity to work with regulatory authorities as well as the Pharmacovigilance and Risk Management team to ensure safety data is evaluated on a medical basis. In this role, you will be responsible for the medical assessment, medical review, signal detection, and health hazard evaluation activities across a vast number of products throughout different therapeutic areas.

    You must have a Medical Degree and a minimum of 8 years of Pharmacovigilance and Drug Safety experience in a pharmaceutical setting. You must also be board certified or board eligible with a background as a practicing physician or worked directly with patients in clinical trials.

    The company is one of the most unique in the industry with a proven track record of success in the branded and generic pharmaceutical space both domestic and abroad. With several past product launches and more to come, this is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

  • USA

    Regulatory Affairs

    $160000 - $180000 per annum
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    Associate Director of Regulatory Affairs

    I have an exciting leadership opportunity within Regulatory Affairs for someone specialized in Regulatory Strategy and early and late stage drug development within the BioPharmaceutical Industry. This is a permanent position in the Greater Boston area, offering great benefits and salary, as well as an opportunity for advancement within a rapidly growing organization.

    Reporting into the VP of Regulatory Affairs, the essential functions of the role will be to oversee, develop and implement regulatory strategy, lead cross functional teams, and communicate appropriately with US FDA and global health authorities.

    Must have at least 5 to 7 years’ of progressive experience in regulatory affairs in the Biopharma Industry as well as early and late stage drug development experience. Must also have experience filing MAA and BLA’s, and preparing regulatory documents (IND, safety reports, IB’s, DSUR’s, briefing packages, and regulatory submissions). Must have experience with FDA regulations and EU, CTA requirements. Also must have experience directly interacting with the FDA and global health authorities. Experience with Biologics Drug Development is highly desired.Familiarity with eCTD or e-publishing is a plus.

  • USA

    Regulatory Affairs

    $180000 - $220000 per annum
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    Director of Regulatory Affairs

    I have an exciting leadership opportunity within Regulatory Affairs for someone specialized in Regulatory Strategy and early and late stage drug development within the BioPharmaceutical Industry. This is a permanent position in the Greater Boston area, offering great benefits and salary, as well as an opportunity for advancement within a rapidly growing organization.

    Reporting into the VP of Regulatory Affairs, the essential functions of the role will be to oversee, develop and implement regulatory strategy, lead cross functional teams, and communicate appropriately with US FDA and global health authorities.

    Must have at least 5 to 7 years’ of progressive experience in regulatory affairs in the Biopharma Industry as well as early and late stage drug development experience.Must also have experience filing MAA and BLA’s, and preparing regulatory documents (IND, safety reports, IB’s, DSUR’s, briefing packages, and regulatory submissions).Must have experience with FDA regulations and EU, CTA requirements.Also must have experience directly interacting with the FDA and global health authorities.Experience with Biologics Drug Development is highly desired.Familiarity with eCTD or e-publishing is a plus.

  • Quality assurance

    $140000 - $160000 per annum
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    This is an excellent opportunity to join one of the most exciting Medical Imaging companies in the Northeast with a robust pipeline of products in the cardiovascular space.

    As the Associate Director of Quality Systems & Compliance, you will take on an operationally focused role overseeing the global compliance function from a GxP standpoint. This opportunity is offering a competitive package and the chance for rapid growth potential.

    The applicant will have a rare opportunity to lead the quality compliance team and ensure successful GxP execution of policies and procedures. This will include overseeing the self-inspection audit program as well as the Product Complaint process. In this role, you will also be responsible for managing the Field Action and Product Recall processes as well as guarantying all activities reach an inspection readiness state.

    You must have a minimum of a Bachelor’s degree in a life sciences field and a minimum of 7 years of working within quality assurance and GxP. You must also have strong experience within GCP and quality auditing. A background in both the pharmaceutical and medical device industries would be looked at extremely favorably.

    The company is one of the most unique in the industry with a proven track record of success both domestic and abroad in the medical imaging space. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

  • Regulatory Affairs

    £50000 - £55000 per annum
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    I am partnered exclusively with a clinical-stage biotech company who are currently developing innovative, next-generation T-Cell therapies and products. The role is based between West London and Hertfordshire.

    Responsibilities include being at the forefront of the end to end management process spent developing, launching, manufacturing and building up the product all the way up to the comercialisation of the product. This goal demands a high level of intergration across the entire company and end to end management, cross-functionality and coordination between departments.

    With a promising future pipeline and strong funding, this is an oppertunity to be a part of a innovative and cutting edge project helping to deliver effective treatments to cancer related illnesses and deseises.

    Required Skills

    • Previous background in cell/gene therapy would be beneficial.
    • An understanding or experience using Sigma or similar.
    • Experience planning and organising complex projects.
    • Experience in working for a biotech or pharma company.

    This is a permanent full time role.

    Salary starts between £50,000 and £55,000 per annum.

    If you are interested in discussing further then please don’t hesitate to contact me on the number below or click apply now!

    Oliver Nathan : 0207 220 6230

  • UK

    Quality assurance

    Competitive
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    Skills Alliance have partnered with this leading Global Pharmaceutical Company for the appointment of a Quality Systems Associate to be based on their site in Hertfordshire.

    This is an excellent opportunity to join a world-class company with a strong European presence and pipeline in multiple therapy areas including oncology. Working across all functions, the Quality Systems Associate will work in a team that ensure that all operations are carried out in compliance to the internal SOPs.

    As the Quality Systems Associate you will be responsible for the Product Quality Reviews (PQR); writing Quality Agreements and writing and approving SOPs (including coordination of existing ones). There is plenty of opportunity to develop and progress within this forward-thinking company on either their commercial manufacturing facility or the R&D facility.

    This is an office-based position in Hertfordshire offering a competitive salary and comprehensive benefits package.

    Please contact Alan Shina, from Skills Alliance, for more details on +44 203 663 3962 or click APPLY HERE

  • Quality assurance

    £40000 - £50000 per annum
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    Skills Alliance have partnered exclusively with an innovative immunotherapy Biotech that focuses on treating cancer patients for the appointment of a senior Quality Assurance Officer in the South East of the UK.

    Company Overview
    Biotech focusing on developing innovative immunotherapy treatments for cancer patients. With strong financial backing and industry-leading scientific founders this company are set to become the leader in this increasingly competitive field. The company is going through a massive expansion, opening new manufacturing sites in the UK and US.

    Role Overview
    As one of the first people in QA the Senior QA Specialist will help implement the Quality strategy and PQS as they approach the commercialisation of their pipeline. Providing broad exposure to almost all areas of QA (CAPAs/Deviations/Investigations/Validation/Auditing etc.) you will be responsible for ensuring adherence to GMP across the R&D and eventual commercial manufacturing sites. You will also get exposure to several key projects such as the build out of a new commercial manufacturing facility in the UK and will likely develop into a managerial role in quick succession. Building on existing experience with Aseptic manufacturing this role will also provide the opportunity to lead/mentor more junior team members. As the business grows and develops, there is potential to train to become a QP (Qualified Person).

    Required Skills/Experience
    Significant experience in a Quality Assurance role, adhering to GMP (Good Manufacturing Practice) standards with exposure to Aseptic manufacturing is essential. You will have experience in leading, mentoring or managing other team members and ideally will have exposure to Advanced Therapy Medicinal Products (ATMP) such as Cell, Gene or Stem Cell Therapy. Any experience of contributing to or hosting regulatory body inspections (MHRA, FDA, Envisa etc.) would be hugely beneficial.

    If you would like to be considered for this opportunity, please click APPLY to send a copy of your CV. For further details and a full job description, please call Bridget Matulyte on +44 (0) 207 220 6239. All inquiries are treated confidentially.

  • Quality assurance

    £30000 - £40000 per annum
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    Share

    Skills Alliance have partnered exclusively with rapidly expanding, very well-funded Biotech that develop and manufacture inhalation combination for the appointment of a Quality Assurance specialist in Cambridge.

    Company Overview
    Global leader in treating patients with airways diseases with multiple sites across the UK and Europe. After significant recent investment they are undergoing a restructuring and modernising of the
    EMEA Quality function and systems.

    Role Overview
    As QA officer you will be responsible for compliance to all relevant standards across pharmaceutical and medical devices (GMP, ISO 9001, ISO 13485) across both R&D and Commercially licensed products. As part of a large project to modernise and centralise their Quality Systems across multiple sites you will be responsible for maintaining and finding improvements to the existing QMS (Quality Management System). There will also be a significant involvement in the Operationally-focused QA responsibilities including BMR (Batch Manufacturing Record) review; internal auditing and documentation review. This role should appeal to those looking to expand on their Pharmaceutical QA experience with a broad role covering both R&D (IMP) and commercially licensed combination products and work with both systems and operational QA.

    Required Skills/Experience
    You will have previously worked in a QA role in a pharmaceutical setting, extensive knowledge of the GMP (Good Manufacturing Practice) standards. Ideally, you will also have experience working with Medical Devices and/or combination products but this is not essential. You will also have Quality Systems experience, ideally having a focus on improving or developing new systems.

    If you would like to be considered for this opportunity, please click APPLY to send a copy of your CV. For further details and a full job description, please call Bridget Matulyte on +44 (0) 207 220 6239. All inquiries are treated confidentially.

  • Quality assurance

    £30000 - £40000 per annum
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    Share

    Skills Alliance have partnered exclusively with rapidly expanding, very well-funded Biotech that develop and manufacture inhalation combination for the appointment of a Quality Assurance specialist in the South West.

    Company Overview
    Global leader in treating patients with airways diseases with multiple sites across the UK and Europe. After significant recent investment they are undergoing a restructuring and modernising of the
    EMEA Quality function and systems.

    Role Overview
    As QA officer you will be responsible for compliance to all relevant standards across pharmaceutical and medical devices (GMP, ISO 9001, ISO 13485) across both R&D and Commercially licensed products. As part of a large project to modernise and centralise their Quality Systems across multiple sites you will be responsible for maintaining and finding improvements to the existing QMS (Quality Management System). There will also be a significant involvement in the Operationally-focused QA responsibilities including BMR (Batch Manufacturing Record) review; internal auditing and documentation review. This role should appeal to those looking to expand on their Pharmaceutical QA experience with a broad role covering both R&D (IMP) and commercially licensed combination products and work with both systems and operational QA.

    Required Skills/Experience
    You will have previously worked in a QA role in a pharmaceutical setting, extensive knowledge of the GMP (Good Manufacturing Practice) standards. Ideally, you will also have experience working with Medical Devices and/or combination products but this is not essential. You will also have Quality Systems experience, ideally having a focus on improving or developing new systems.

    If you would like to be considered for this opportunity, please click APPLY to send a copy of your CV. For further details and a full job description, please call Bridget Matulyte on +44 (0) 207 220 6239. All inquiries are treated confidentially.

  • Medical affairs

    €90000 - €100000 per annum, bonus + company car
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    Medical Science Liaison (MSL) – North/North East Germany – Product launch

    I’m currently working with a client of mine who is a US start-up pharmaceutical company now looking to establish their European footprint.

    With this in mind, they are looking for build a team of MSLs across Europe so I’m keen to speak with any experienced MSLs based in the North of Germany who might be interested in hearing about this opportunity.

    You will be part of a brand new team of MSLs across Europe, and will be covering the North or North East of Germany.

    My client has a product which has already been launched in the US, and they are now looking to launch this product in Europe, hence the need for the MSLs. You will therefore have a lot of product launch responsibilities, for a product that has incredibly high demand amoong key opinion leaders (KOLs) and other healthcare professionals across the cardiovascular/cardiology therapeutic area.

    For this position, you need extensive MSL experience with product launch experience. You must be based in the North of Germany or currently covering the North/North East of Germany to be considered for this role.

    This is a great opportunity if you have extensive MSL experience to join a business that is growing as you will be able to really hone in on your experience to work autonomously within the company.

    For more information about this opportunity or any similar opportunities, please contact Chanel Hicken on 0044 (0)207 220 6206 or email your updated CV in word format to chanel.h.a4lgdx1gqdlw@skillsalliance.aptrack.co.

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    Skills Alliance are working with an international Bio Pharmaceutical company who are currently seeking a Health Economist on a 12 month contract to be based in West London/ Fully remotely if desired.

    This is an excellent opportunity for someone looking for a stable contract within a reputable Pharmaceutical organisation which is likely to extend annually for the right person.

    The role is for a Senior/ Health Economist to work across the company’s whole product pipeline.

    Essential experience:

    • Evidence Based methods such as SLRs
    • Project Management
    • Execution of Global Health Economics
    • Working with NMAs and supporting HTA submission

    Desirable experience:

    • Biotech industry background

    If interested, please click apply and attach a copy of your up to date CV.

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    Skills Alliance are working with an international Bio Pharmaceutical company who are currently seeking a Brand Manager on a 12 month contract to be based in North London.

    This is a brilliant opportunity for someone looking to work for a Global Pharmaceutical organisation in a specialist therapeutic area.

    The role is for a Senior Brand Manager with experience in Oncology.

    Essential experience:
    -At least 3 years Brand Manager experience
    -Relevant experience in Oncology
    -Project leadership and experience with strategy leadership
    -Bachelor’s Degree in Science pharmacy/medical science related subject

    Desirable Experience:
    -Proven track record of Excellent interpersonal and Communication skills

    If interested, please click apply and send an up to date CV.

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    Skills Alliance are working with an international Pharmaceutical company who are currently seeking a Market Access Manager on a 12 month contract to be based in Luton.

    This is an exciting opportunity for someone looking to work within a Global Pharmaceuticals Company, whilst initiating market access for new products.

    The role is for a Senior Market Access and Pricing Manager to work across a wide range of therapy areas.

    Essential experience:
    -Uk National Market Access
    -Pricing and Reimbursement
    -Project management
    -Degree educated with an understanding of NHS decision processes

    Desirable experience:
    – Background in HTAs
    – Background in Oncology, Cardiovascular & Immunology

    If interested, please click apply and send an up to date CV.

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    The Job Description:

    • Participate in a multi-disciplinary team to establish regulatory strategies to identify and communicate potential risks associated with strategy scenarios;
    • Support the preparation, review, and submission of regulatory submissions as appropriate, (i.e. including marketing applications, clinical trial applications, amendments, variations, responses to Agency questions, meeting requests, briefing packages, annual reports, periodic safety reports). Coordinate preparation and review of responses to Agency questions;
    • Manage communication to Health Authorities and internal stakeholders verbally and written;
    • Ensure consistency/completeness/accuracy, and adherence to regulations and applicable guidelines for regulatory submissions;
    • Manage review tracking systems for regulatory documents and promotional materials;
    • Enter data into Regulatory Database;
    • Provide in-depth reviews of protocols, reports, presentations and documents;
    • Manage timelines to ensure approvals are timely and development objectives are met;
    • Review and interpret recent product approvals, current regulatory guidance documents, and recent public Advisory Committee proceedings to support regulatory strategy and submissions;
    • Provide risk assessments and recommendations for various regulatory scenarios;
    • Participate in the electronic review and quality verification of regulatory submissions.

    Essential and Desirable Criteria:

    • Regulatory experience in the pharmaceutical and/or biotech industry;
    • Experience with HA and/or EMA regulatory procedures ie: Regulatory Submissions;
    • Demonstrated understanding and strategic application of regulations and guidelines for drug development;
    • Excellent English verbal and written communication skills;
    • Ability to work within a team environment or individually with limited supervision, high attention to detail, ability to set priorities to meet timelines and to motivate and influence others;
    • Exceptional interpersonal skills with the ability to work individually or within a multi-disciplinary team with external partners and regulators;
    • Some international travel may be required.

    Contact info:

    Phone: +44(0)207 220 6232

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    Skills Alliance are working with an emerging medical device company, based in London, who are currently seeking a Key Account Manager on a 12 month contract.

    This is a fast-growing Company who are in the process of expanding there Commercial team. The role represents a brilliant opportunity for someone who has a keen interest in sales and is interested by Medical devices, within the respiratory field.

    The role is for an experienced Key Account Manager who will cover the South East London, Kent and Essex region.

    Essential experience:
    -Medical Sales background
    -Selling at CCG level
    -Maintaining successful relationships with key customers
    -Achieving regionals sales and profit Targets
    -Science Degree or equivalent

    Desired experience:
    -Respiratory background
    -Previous experience selling in South East Territory

    If interested, please click apply and send an up to date CV.

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    Skills Alliance are working with an emerging medical device company, based in London, who are currently seeking a Key Account Manager on a 12 month contract.

    This is a fast-growing Company who are in the process of expanding there Commercial team. The role represents a brilliant opportunity for someone who has a keen interest in sales and is interested by Medical devices, within the respiratory field.

    The role is for an experienced Key Account Manager who will cover the South East London, Kent and Essex region.

    Essential experience:
    -Medical Sales background
    -Selling at CCG level
    -Maintaining successful relationships with key customers
    -Achieving regionals sales and profit Targets
    -Science Degree or equivalent

    Desired experience:
    -Respiratory background
    -Previous experience selling in South East Territory

    If interested, please click apply and send an up to date CV.

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    A Global CRO company is recruiting for a CRA II or Senior Clinical Research Associate position to be based in Spain.

    This is an opportunity to join a world-class company that are expanding a lot in Europe at the moment and will continue to do so over the next few years. As they expand there will be excellent opportunities for progression and development.

    You would be responsible for overseeing the monitoring activities in Spain. They require an experienced CRA looking for development opportunities or Senior CRA with strong experience in Hematology. Additional experience in Oncology and IBD would would be a plus.

    This Senior Clinical Research Associate role based in Madrid. It is a permanent role offering competitive salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Maria Matei for more details on +44 203 948 5999.

  • Junior project manager

    $115000 - $125000 per annum
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    This is an excellent opportunity to join a dynamic global specialty pharmaceutical company that are exponentially growing their team within the Greater Philadelphia area.

    As the Drug Safety Manager, you will be primarily responsible for the management of Individual Case Safety Report processing for branded and generic products. The successful applicant will have the exciting opportunity to manage a small team of Drug Safety Associates to ensure case processing activities are being executed properly.

    In this role, you will be responsible for guaranteeing safety reporting and case processing are accurately meeting regulatory guidelines and company processes by managing team day to day operations. You will also be responsible for assisting in the development of safety processes and case processing guidelines. Monitoring case processing workflow and adverse event information to input into the safety database will be an important aspect to this role as well.

    You must have a Bachelor’s Degree in a life sciences discipline and a minimum of 8 years of Pharmacovigilance and/or Drug Safety experience in a pharmaceutical setting. Having an advanced degree as well as past management experience would be looked at favorably.

    The company is one of the most unique in the industry with a proven track record of success in the branded and generic pharmaceutical space both domestic and abroad. With recent successful Phase 3 results, this is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

  • Regulatory Affairs

    $140000 - $180000 per annum
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    I have an exciting Regulatory Strategy opportunity in New Jersey with a BioPharmaceutical Company noted for their positive and supportive work culture and environment, for someone specialized in Injectables and/or Combination Products in the Biopharmaceutical Industry.

    Reporting into the VP of Regulatory Affairs the essential function will include but is not limited to supporting and assisting the Vice President with regulatory strategy and product development, compliance and review of regulatory documents, compilation of regulatory dossiers (IND, NDA), and acting as point of contact when collaborating with regulatory authorities.

    Ideal Candidate will be coming from previous experience with Combination Products/and or Injectables, at least 5 years of Regulatory Strategy and submissions experience (IND, NDA, etc.), US FDA experience, strong working knowledge and understanding of regulatory regulations and guidelines, and strong writing and communication skills.

  • Regulatory Affairs

    $140000 - $180000 per annum
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    I have an exciting Regulatory Strategy opportunity in New Jersey with a BioPharmaceutical Company noted for their positive and supportive work culture and environment, for someone specialized in Injectables and/or Combination Products in the Biopharmaceutical Industry.

    Reporting into the VP of Regulatory Affairs the essential function will include but is not limited to supporting and assisting the Vice President with regulatory strategy and product development, compliance and review of regulatory documents, compilation of regulatory dossiers (IND, NDA), and acting as point of contact when collaborating with regulatory authorities.

    Ideal Candidate will be coming from previous experience with Combination Products/and or Injectables, at least 5 years of Regulatory Strategy and submissions experience (IND, NDA, etc.), US FDA experience, strong working knowledge and understanding of regulatory regulations and guidelines, and strong writing and communication skills.

  • Accounting & finance

    $130000 - $160000 per annum
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    This is an excellent opportunity to join one of the most exciting Biopharmaceutical investment setups in the Tri-State area with a robust pipeline of investigational products across a vast amount of different therapeutic areas.

    This is a rare chance to join a highly skilled team assessing acquisitions through their venture capitalist structure. The successful applicant will have the opportunity to take the lead from a broad payroll perspective for a small to mid-sized organization who are rapidly growing and increasing their headcount.

    As Director of Payroll, you will be responsible to manage the full payroll lifecycle operations including but limited to the preparation, distribution, processing, and reporting of employee payroll compensation. You will have the opportunity to also act as the equity administrator managing all operations associated with the employee equity compensation plans.

    You must have a minimum of a Bachelor’s Degree and a minimum of 8 years of overseeing payroll operations for large and/or growing organizations. You must also have experience working within equity administration. A CPP or CEP certification as well as a background within the pharmaceutical industry would be looked at favorably.

    The company is one of the most unique in the industry with a proven track record of success in the biopharmaceutical space. This is the right time to be joining this truly innovative team!

    If you are interested in more information on this role and further detail on the job description, please reach out to me at 646-300-8349.

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    An exciting small Medical Devices company is recruiting for a Senior Clinical Research Associate position to be based in Germany.

    This is a good opportunity to join a growing company that is expanding a lot in Europe at the moment and will continue to do so over the next few years. As they expand there will be excellent opportunities for progression and development as well as being involved in the decision-making process and close proximity to management.

    You would be responsible for overseeing the monitoring activities in Germany. They require an experienced CRA looking for development opportunities or Senior CRA with strong experience in the medical device area.

    This Senior Clinical Research Associate role is a home-based position in Germany with flexibility. It is a permanent role offering competitive salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Maria Matei for more details on +44 203 948 5999.

  • Clinical research

    £65000 - £75000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Project Manager or Senior Clinical Project 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.

  • Clinical Operations

    £55000 - £65000 per annum, bonus + benefits
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    A very rare opportunity for an experienced (Senior) Study Manager or (Senior) Trial Manager to join an exciting niche start-up Biopharma, this position is permanent and office-based in London.

    This position is with a small and niche Biotech and will offer very exciting long-term prospects. This is quite a unique opportunity to join the company at early stages so there will be a lot of exposure. They work in exciting and innovative therapy areas.

    The Senior Clinical Trial Manager role is a great opportunity for Study Manager to work in a wide ranging study management role, including program oversight, line management and working on a cross-functional basis. They require a strong project management management experience from Pharma or CRO. This would be working on early phase trials.

    This is a permanent and full-time position. It is office-based in London offering around GBP 55-65K depending on experience + bonus + benefits.

    Skills Alliance are the preferred supplier for this role, please contact Mark Anderson for more details – +44 207 220 6209 or click APPLY NOW!

  • Clinical Operations

    £60000 - £70000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Project 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 a strong clinical trial management background, ideally experience in early phase, complex TAs and overseeing CROs and vendors.

    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 60-70K depending on experience + bonus + extensive benefits.

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

  • Clinical Operations

    £55000 - £70000 per annum, excellent package
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    A very exciting opportunity to join a fast growing Biotech. Permanent Clinical Study Manager or Senior Clinical Study Manager role based in 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 to join the team, this would be working on interesting early phase studies.

    This is a full-time and permanent position. It is office-based in London with flexibility to work from home. They offer an excellent salary and package around GBP 55-75K depending on experience + bonus + extensive benefits.

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

    Key words: Clinical Study Manager / Clinical Trial Manager / Global Study Manager / Senior Study Manager / Senior Clinical Study Manager / Pharma / Biopharma / Biotech / Berkshire / London / Hertfordshire / Buckinghamshire / England / UK / permanent / Surrey / advanced therapies / gene therapy / cell therapy / ATMP

  • Clinical research

    £22000 - £27000 per annum, benefits
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    A growing patient recruitment company is seeking an ambitious individual to join their growing and dynamic team. My client partners with a wide range of Pharmaceutical clients to oversee patient recruitment for a variety of clinical trials. They specifically work in Alzheimer’s and have shown to cut recruitment time and spend by over 50%.

    You will be responsible for reaching out to new prospective research in order to conduct studies. Ideally you would have worked in an outbound telephone role, reaching out to new prospective clients. You will also have the opportunity to work on complex studies whilst staying close to the projects and key decision makes.

    Responsibilities:

    • Telephone outreach to prospective research sites
    • Coordinating studies along with project team
    • Conducting face to face meetings

    Experience required:

    • BSc or MSc in scientific discipline
    • Experience working in a telephone-based environment
    • Alzheimer’s a bonus or experience in other complex therapy areas
    • Knowledge of Plymouth and surrounding areas


    Please contact Troy Neenan on 02072206237 or click apply.

  • UK

    Clinical Operations

    Competitive
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    A mid-sized CRO is currently seeking an experienced Contracts Manager to build their own department within the company. You will be responsible for overseeing all contracts and proposals whilst also taking on line management responsibilities. You will also have the opportunity to work closely with Directors.

    Responsibilities:

    • Lead and develop contracts and proposals for assigned studies
    • Manage a small team whilst working closely with the Director
    • Contribute to the company’s strategic vision


    Experience required:

    • Experience working on contract and proposals within a CRO
    • Previous Line management or mentoring of junior staff
    • Life science degree or equivalent

    For more info call Troy Neenan on 02072206237

  • UK

    Junior project manager

    Competitive
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    An exciting Pharma company is recruiting for a New Product Development Manager to join their team based around London area.

    This is a great opportunity to join a great company with an exciting pipeline and continuous growth. As they expand there will be excellent opportunities for progression and development.

    You would be responsible of overseeing the product development from early-stages to commercialisation.
    The role is an office position based around the London area. It is a permanent role offering competitive salary and package.

    Skills Alliance are the preferred supplier for this role. Please contact Maria Matei for more details on +44 203 948 5999.