Medical Writer - Life Sciences III

Rahway, New Jersey, us
Company: Tech USA
Category: Arts, Design, Entertainment, Sports, and Media Occupations
Published on 2021-07-30 22:04:05

Description:




  • Scientific contributor and subject matter expert in preparation of selected regulatory clinical documentation.

  • Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects.

  • Participates as part of the medical writing team in cross-functional teams.

  • Demonstrates competence in writing, editing and reviewing of clinical study reports, investigator brochures, registration dossier modules, and other clinical regulatory documents in line with expectations.

  • Able to interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.

  • Manages medical writing projects including the design, planning, and preparation of clinical documentation in support of clinical development, trials, and sections of filings.

  • Works collaboratively with colleagues across functions to achieve results.

  • Solves problems associated with medical writing scope of work, seeking advice from management and others as needed, and exercising negotiation and communication skills with project team members. 



  • Requirements: 


  • Bachelor’s degree with 8+ years; or MS with 4+ years; or PhD with 3+ years of relevant career experience.

  • 3-8 years of experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry. Ability to prepare, with minimal supervision a subset of clinical regulatory documents (e.g., CSR, IB, clinical sections of IND/IMPD and CTD) according to company guidelines and international governmental regulations and to present clinical data objectively in a clear, concise format in keeping with industry guidelines.

  • Participate actively in medical writing and cross-functional project teams.

  • Technical expertise in Microsoft Office, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.

  • Excellent oral (including presentation) and written communication, and project management skills. Awareness of pharmaceutical industry needs beyond clinical development. 



  • Location 

    Rahway , NJ

    Minimum Experience (yrs): 

    3+

    Required Education: 

    Not Specified

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