Senior Medical Writer II (Regulatory)
Company Overview
A well‑funded, rapidly growing biopharmaceutical company advancing a highly differentiated approach to drug discovery. Built on deep integration of biology, chemistry, engineering, and computational science, the organization is expanding a pipeline designed to translate complex science into meaningful clinical outcomes. The team is known for its rigor, collaboration, and long‑term investment in both science and people.
Role Overview
This role is designed for a medical writer who wants to do more than refine documents-you'll own them. You'll be a core contributor to how scientific and clinical data are translated into clear, compelling regulatory narratives that move programs forward.
Working closely with clinical, regulatory, and research teams, you'll have direct visibility into early and mid‑stage programs and play a key role in getting them ready for critical development milestones. Your work will directly influence how the science is understood by regulators and external stakeholders.
Key Responsibilities
- Independently author and deliver high‑quality clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, informed consent forms, and CTD components)
- Translate complex data into clear, scientifically sound narratives that support regulatory strategy and decision‑making
- Ensure all deliverables meet regulatory standards, internal quality expectations, and submission timelines
- Partner cross‑functionally with Clinical, Regulatory, and Research teams to align on messaging, data interpretation, and document strategy
Qualifications & Experience
- Advanced scientific degree (PhD, PharmD, MSc) or equivalent experience, with a strong foundation in life sciences
- Experience independently drafting clinical and/or regulatory documents within biotech or pharma
- Demonstrated strength in scientific storytelling, data interpretation, and attention to detail
- Ability to operate effectively in a collaborative, fast‑moving environment with evolving priorities
Compensation & Benefits
- Base salary: $145,000 - $165,000, plus bonus and equity
- Comprehensive medical, dental, and vision coverage with high employer contribution
- 401(k) with company match
- Generous PTO, company shutdown periods, and flexible time off
- Robust mental health, wellness, and parental leave support
- Onsite perks including subsidized meals when in the office
FAQs
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