Senior Medical Writer Job at Meet Life Sciences, San Rafael, CA

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  • Meet Life Sciences
  • San Rafael, CA

Job Description

Job Summary:

We are seeking a detail-oriented and experienced Senior Medical Writer to join our clinical development team on a contract basis. The ideal candidate will apply advanced writing and document management skills to produce high-quality clinical and regulatory documentation supporting global drug development. This role involves close collaboration with cross-functional teams and adherence to regulatory standards.

Responsibilities:

  • Draft and edit regulatory submission documents (e.g., CTDs, RtQs), clinical protocols, protocol amendments, informed consent forms, investigator brochures, and safety reports (PSURs, DSURs).
  • Manage the full document lifecycle including planning, drafting, review coordination, comment adjudication, and finalization.
  • Facilitate cross-functional meetings and maintain timelines to ensure timely document delivery.
  • Apply regulatory and company writing standards, including AMA, CBE, and Chicago Style guidelines.
  • Interpret and present clinical data in text and table formats using appropriate scientific language and referencing.
  • Collaborate effectively with teams across Clinical, Biostatistics, Regulatory, Medical Affairs, and other functions.

Qualifications:

  • Bachelor’s degree or higher, preferably in a life science or medical discipline.
  • Minimum of 6 years of medical writing experience in the pharmaceutical, biotech, or CRO industry.
  • Proven expertise in drafting clinical and regulatory documents, including protocols, clinical study reports, INDs, and BLA/NDA components.
  • Strong understanding of clinical research, regulatory requirements, and drug development lifecycle.
  • Familiarity with medical dictionaries (e.g., MedDRA, WHO Drug), biostatistics, and clinical coding practices.
  • Certification in medical writing or related training (e.g., AMWA, EMWA, DIA) is a plus.

Job Tags

Contract work,

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