Senior consultant ATMP and biologics (REF7477Q)

Company: ProPharma Group MIS Limited
Location: Stockholm
Posted on: February 25, 2021

Job Description:

Senior consultant ATMP and biologics (REF7477Q)

• Full-time Company Description ProPharma Group is an industry leading, single source provider for regulatory compliance, pharmacovigilance, and medical information services across the full development lifecycle for pharmaceutical, biotechnology, and medical device companies. Operating around the world with offices in Australia, Canada, Germany, Japan, the Netherlands, Sweden, United Kingdom, and the United States, ProPharma Group's fully integrated service offerings will provide clients with a comprehensive suite of global support services that are required to be competitive in today's dynamic markets. We build successful long-term relationships with clients by providing leading industry knowledge, experience, and proven processes. Job Description In the role as a Senior consultant ATMP and biologics,--you will provide services to our clients spanning all aspects in the drug development field of ATMPs and biologics with a focus on the quality aspects of these products. Examples of these services include:
  • Providing expert advice in the quality and regulatory strategy of ATMPs and biologics.
  • Writing and reviewing documentation such as IMPDs, INDs, IBs and other documentation.
  • Defining and writing drug development and regulatory strategy plans.
  • Planning and reviewing quality (CMC) documentation for clinical trials and marketing applications.
  • Preparing and participating at national and EMA scientific advice.
  • Participating as subject matter expert in drug development teams. The drug development team in ProPharma Group is a cornerstone in the European regulatory affairs unit, providing strategical services important to--meet ProPharma Group's client needs. Qualifications Qualified candidates must have:
    • Academic degree in a life science field.
    • Minimum--5 years of experience of ATMPs and biologics in a relevant position within the pharmaceutical industry and/or government health agency.
    • Excellent communication skills (oral and written) in English.
    • Experience in medical writing, e.g. IMPD, quality documentation.
    • Being able to work independently.
    • Being able to transfer knowledge to others.
    • Act as a mentor for less experienced colleagues.
    • Being organized and pay attention to detail.
    • Being able to work on multiple projects, prioritize and meet project deadlines.
    • Good analytical, listening, and negotiation skills. Additional Information All candidates must be legally eligible to work in EU. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

Keywords: ProPharma Group MIS Limited, New England , Senior consultant ATMP and biologics (REF7477Q), Professions , Stockholm, Northeast