Full-Time Principal Medical Writer
Deciphera Pharmaceuticals is hiring a remote Full-Time Principal Medical Writer. The career level for this job opening is Experienced and is accepting Waltham, MA based applicants remotely. Read complete job description before applying.
Deciphera Pharmaceuticals
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The Medical Writing team is seeking a Principal Medical Writer to be the lead writer across programs/submissions. This role involves independently writing and managing clinical study-related documents, including protocols, Investigator's brochures, and clinical study reports. The individual will lead cross-functional teams in the development of regulatory submission documents.
What You’ll Do:
- Medical Writing lead for one or more clinical programs.
- Author and manage the preparation of clinical documents.
- Drive document strategies in a collaborative way with subject matter experts.
- Incorporate process improvements that align with R&D needs.
- Plan and coordinate work with in-house Medical Writer team and outside CROs
- Mentor junior members of the team.
- Perform reviews of medical writing deliverables.
Requirements:
- PhD or equivalent plus 5+ years of experience or Bachelors/Masters plus 10+ years of experience.
- Expert knowledge of preparing high-quality clinical and regulatory documents.
- Submission experience across ICH regions (NDA, NDS, MAA, IND).
- Strong organizational/prioritization skills.
- Proficiency with eCTD templates, Smart Sheet, MS Office, Veeva Vault.
- Oncology, immunology, and/or neurology experience is highly preferred.