Director/Senior Director, Medical Writing

8+ years

Not Disclosed

Boston

10 Sept. 7, 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

Director/Senior Director, Medical Writing

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

About the Job:

Meet has partnered with a leading Boston-based biotech company specializing in oncology and immunology. With a robust development pipeline spanning from Phase 1 to Phase 3, they are seeking a highly skilled Director or Senior Director of Medical Writing to join their dynamic team.

Key Responsibilities:

Lead the creation and management of critical clinical and regulatory documents, including Investigator’s Brochures (IB), Clinical Study Reports (CSR), protocols, and IND/BLA/MAA submissions.
Oversee and manage medical writing vendors, determining which documents are authored in-house versus outsourced.
Build and develop a small in-house medical writing team as the company’s pipeline and business needs expand.

Key Qualifications:

Minimum of 8 years of experience in Medical Writing.
Required experience in oncology and NDA/BLA submissions.
Proven track record in managing both vendor and in-house teams effectively.
Advanced Degree (PhD, PharmD, MS) preferred.

Contact:

To learn more about this opportunity, please reach out to Ryan Moran at ✉: ryan.moran@peoplewithchemistry.com.

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Director/Senior Director, Medical Writing

Job Description

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