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Medical Writer

4-8 years
$200,000/yr
10 Sept. 5, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Position: Director/Senior Director, Medical Writing

Location: Remote (EST preferred) or Hybrid in Boston, MA

About the Company:

We have partnered with an innovative biotech company based in Boston, MA, specializing in oncology and immunology. This organization boasts a robust development pipeline with programs spanning Phase 1 to Phase 3 trials. They are currently seeking a Director or Senior Director of Medical Writing to enhance their team.

Key Responsibilities:

  • Lead the creation and development of critical clinical and regulatory documents, including Investigator Brochures (IB), Clinical Study Reports (CSR), protocols, and IND/BLA/MAA submissions.
  • Act as an individual contributor while managing medical writing vendors, with the authority to determine which documents are created in-house versus outsourced.
  • Develop and expand a small in-house medical writing team in alignment with the company's growing pipeline and business needs.

Key Qualifications:

  • A minimum of 8 years of experience in medical writing.
  • Proven experience in oncology is essential.
  • Experience with NDA/BLA submissions is required.
  • Demonstrated expertise in managing both vendor and in-house writing teams.
  • Advanced degree (PhD, PharmD, MS) is highly preferred.

Interested in Learning More?

Please contact Ryan Moran at ✉: ryan.moran@peoplewithchemistry.com to explore this exciting opportunity further.

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