Principal Medical Writer — Regulatory Strategy & Submissions

BioPhase Inc.; United States; Sur place; USD 140 000 - 200 000; Plein temps

Résumé du poste

BioPhase Inc. seeks a Principal Medical Writer to develop and coordinate clinical and regulatory documents across the product lifecycle, collaborating with cross‑functional teams to interpret data and produce accurate, submission‑ready content that moves through reviews and submissions.

The role requires leadership of writing projects, mentorship, and ensuring compliance with FDA/EMA/ICH guidelines. Must be located in the United States and aligned to West Coast hours; work arrangement to be

Qualifications

• Bachelor’s degree in a scientific or related field required; an advanced degree is preferred.
• 8+ years of medical writing experience in the pharmaceutical industry.
• Experience leading and writing clinical and regulatory documents across the development process.
• Extensive experience developing core regulatory documents such as CSRs, protocols, investigator brochures, INDs, and NDA/BLA components.
• Strong expertise with global regulatory standards and guidelines, including FDA, EMA, and ICH.
• Strong ability to interpret scientific data, prepare supporting tables or figures, and edit documents for accuracy and clarity.
• Excellent communication and organizational skills, with the ability to manage multiple projects and work effectively with cross-functional teams.

Responsabilités

• Develop and coordinate clinical and regulatory documents throughout the document lifecycle.
• Work cross-functionally to create clinical regulatory documents (CSRs, protocol writing, marketing applications).
• Help plan document timelines and coordinate input from contributors and reviewers.
• Lead discussions to align document content and key messages.
• Manage document review cycles and support timely resolution of comments.
• Review documents for accuracy, clarity, consistency, formatting, and quality (QC).
• Help address quality review findings and prepare documents for submission.
• Support responses to requests from regulatory agencies.
• Share writing guidance and provide mentorship to colleagues as needed.

Connaissances

Medical writing experience (8+ years)

Leadership in medical writing

Core regulatory docs

Regulatory standards (FDA/EMA/ICH)

Data interpretation & figures

Communication skills

Organizational skills

Formation

Bachelor’s degree in a scientific or related field

Advanced degree preferred

Description du poste

BioPhase Inc. seeks a Principal Medical Writer to develop and coordinate clinical and regulatory documents across the product lifecycle, collaborating with cross‑functional teams to interpret data and produce accurate, submission‑ready content that moves through reviews and submissions.

The role requires leadership of writing projects, mentorship, and ensuring compliance with FDA/EMA/ICH guidelines. Must be located in the United States and aligned to West Coast hours; work arrangement to be