Jenny Craver

Director, Medical Writing @ Biogen

About

Medical writing director with 15+ years of experience delivering regulatory and clinical documents that drive successful global submissions. I specialize in high‑complexity programs across oncology, nephrology, CNS, and infectious diseases, with a track record of producing clear, concise, and strategically aligned documents under tight timelines. My expertise includes protocols, CSRs, investigator’s brochures, briefing documents, and Module 2 summaries. I’m also a recognized expert in protocol and template development, creating scalable frameworks that improve consistency, efficiency, and regulatory compliance.

Country

United States

City

Raleigh

Industry

Research

Skill

Global Regulatory Compliance, Electronic Common Technical Document (eCTD), Regulatory Compliance, Coaching & Mentoring, Regulatory Submissions, Regulatory Affairs, Mentoring, Electronic Document Management System (EDMS), Project Planning, Good Clinical Practice (GCP), Writing, Regulatory Submissions (NDA/BLA/MAA IND/CTA eCTD), Protocols/Amendment/CSRs/IBs/Module 2 documents, Onocology/CNS/Nephrology/Infectious Disease, Phase 1 through 3 documents

Experience

Director, Medical Writing

Biogen

2025-11 - Present · 11 mos

• Lead medical writing strategy and execution across complex development and marketed programs at the portfolio level • Provide direct oversight of medical writing program leads and manage issue resolution across cross-functional teams and external partners • Represent Medical Writing in governance, regulatory, and partner-facing meetings • Drive departmental strategy, process consistency, and adherence to SOPs across programs • Align project prioritization and ensure high-quality, submission-ready deliverables across functional areas

Associate Director, Medical Writing

Taiho Oncology, Inc.

2025-2 - 2025-11 · 10 mos

• Led development of regulatory and clinical documents with consistent messaging and compliance with global regulatory standards • Partnered with Clinical Development, Regulatory Affairs, and Biostatistics to deliver submissions on time • Mentored junior writers and contributed to best practice initiatives

Principal Medical Writer

Kowa Pharmaceuticals America, Inc.

2024-5 - 2025-3 · 11 mos

• Directed medical writing deliverables across multiple programs, including timelines, resources, and messaging strategy • Led modernization of templates and implementation of lean writing processes, improving efficiency and regulatory alignment

Director / Associate Director / Manager, Medical Writing

Pfizer-US

2019-4 - 2024-5 · 5 yrs 2 mos

• Led development of medical writing deliverables across Phase 1–3 programs • Authored and oversaw protocols, CSRs, IBs, and regulatory briefing documents for global submissions • Managed and mentored in-house writers, ensuring consistent quality and adherence to standards • Owned protocol template strategy, incorporating regulatory updates and SME feedback

Senior Medical Writer

Planet Pharma

2018-1 - 2024-5 · 6 yrs 5 mos

Authored protocols, CSRs, IBs, and patient narratives across CNS and infectious disease programs Supported early-phase clinical development and data messaging strategies

Senior Medical Writer

PRA Group, PAREXEL, EXECUPHARM

2013-1 - 2018-1 · 5 yrs 1 mo

Developed protocols, CSRs, and amendments across oncology, CNS, and infectious disease programs Collaborated with cross-functional teams to ensure regulatory compliance and scientific accuracy Mentored junior writers and conducted QC reviews

Medical Writer

Early Career: Medical Writing (CROs & Freelance)

2006-1 - 2012-1 · 6 yrs 1 mo

Built foundation in regulatory writing, including protocols, CSRs, IBs, and narratives Managed narrative writing teams and contributed to large-scale projects