Senior Medical Writer (Medical)

TL;DR

Senior Medical Writer (Medical): Authoring high-quality clinical, safety, and regulatory documents for biotech and pharmaceutical organizations with an accent on regulatory submission requirements and FDA guidelines. Focus on producing complex deliverables like PBRER, IND, and NDA while mentoring junior writers and collaborating with cross-functional SMEs.

Location: United States. Remote working is supported, but hybrid work is encouraged for those within a short commute of company offices.

Company

hirify.global provides end-to-end consulting solutions to de-risk and accelerate drug and device programs for biotech, med device, and pharmaceutical organizations.

What you will do

• Author high-quality medical writing deliverables including protocols, study reports, IBs, and complex submission documents such as IND, NDA, BLA, and MAA.
• Supervise and mentor less experienced medical writers as necessary.
• Manage client expectations, lead project kickoff and comment review meetings, and oversee deliverable timelines.
• Collaborate with subject matter experts in clinical operations, data management, biostatistics, and regulatory affairs.
• Coordinate QC reviews of documents and maintain detailed audit trails of changes.
• Review statistical analysis plans and table/figure shells for content, grammar, and consistency.

Requirements

• Minimum 5 years of experience writing clinical or regulatory documents for CROs, pharmaceutical, or biotechnology companies.
• Advanced knowledge of clinical research principles and FDA regulations and guidelines.
• Bachelor’s degree or higher, preferably in a medical or scientific discipline.
• Expert word processing skills in MS Word, specifically with tables, graphs, and figures.
• English language proficiency and familiarity with American Medical Association (AMA) style.
• Strong project management skills and attention to detail.

Culture & Benefits

• Commitment to diversity, equity, and inclusion, encouraging an authentic and innovative workplace.
• Flexible work arrangements including remote support and hybrid options.
• Collaborative, entrepreneurial spirit within a safe and empowered professional space.
• Personalized recruitment process where all applications are reviewed by humans, not AI screening tools.