Pharming Group N.V.

Medical Writer - Leiden

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Job

Active since 07-05-2018 Job category Science, research & development
Location Leiden Level Professional
Educational level Master / Post-Graduate / ... Employment type Fixed term contract with option...
Hours 40 Salary -

Pharming Group N.V. is committed to the development of innovative products for the treatment of unmet medical needs. We focus on the development and production of human therapeutic proteins to provide life-changing solutions to patients.

(Regulatory) Medical Writer
Based in: Leiden
fulltime position

Goal of the Job:

In collaboration with the Regulatory Affairs Department, Medical Affairs, Clinical Department, and Pharmacovigilance, create/compile documents that are required for regulatory submissions, based on applicable ICH, clinical, and (local) regulatory guidance and legislation.

Job description:
Writing/editing/compiling documents:

  • Compile, write, and edit medical writing deliverables for submission to regulatory agencies such as FDA and EMA, covering all phases of clinical research and post-approval medical activities. Deliverables include comprehensive clinical study protocols, clinical study reports, annual reports, PSURs, DSURs, educational materials, Policy 0043 and/or 0070 redacted documents, investigator brochures, risk/benefit analyses and integrated summaries from raw data
  • Serve as the medical writing representative on assigned project teams and support Pharming departments in the creation/writing of documents that will (eventually) be incorporated in regulatory submissions or that require specific English linguistic expertise
  • Stay up-to-date on relevant medical literature relevant for the Pharming product portfolio
  • Have knowledge of and communicate internally (updates in) regulations, standards, and ICH/GCP and GLP guidance
  • Champion the Pharming Style Guide and ensure document consistency throughout the company
  • Write scientific documents for a broader audience, including scientific liaisons, healthcare professionals, and pharmaceutical representatives; review promotional material

 

Other:

  • Participate in review of clinical study data
  • Assist in the development of publications, abstracts, and presentations

Job requirements:

Education:

  • Master’s Degree in (Bio)pharmaceutical Sciences, Biomedical Sciences, Biotechnology, Medical Biology, Medicine, or equivalent

Requirements/skills:

  • Ability to understand/process complicated scientific or medical information and write documents in a clear and concise manner
  • Experience in writing/compiling medical documents for regulatory submissions such as Clinical Study Protocols and Reports, Investigator Brochures, Clinical Overviews (M.2.5), Clinical Summaries (M.2.7) and Periodic Safety Update Reports (M.5.3.6)
  • Thorough understanding of FDA, EMA and ICH regulations and guidelines
  • Proficiency in Word, Excel, and PowerPoint
  • Familiarity with the principles of clinical research
  • Extensive knowledge of English grammar

Nice-to-have skills/experience:

  • Experience and/or knowledge of eCTD life-cycle management
  • Knowledge/experience with eDMS
  • General broad pharmaceutical background

Experience:

At least 2 years of relevant experience in a similar role.

Apply:

Please apply via our website www.pharming.com or www.pharminggroup.heeft-vacatures.nl

attn. Ms. Gabriëlle Smit.

For all recruitment agencies: don't call us, we call you!



 

More information
This listing is a full-time job

Job category Science, research & development
Industry / Industries Medical / Health
Region Netherlands
Keywords

Contact information

Name nienke van der Veer

Location

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