EPM is partnered with an innovative global biopharmaceutical company that is looking for a Senior Medical Writer to join their US team in the NJ/NY area.
Key responsibilities:
- Creating clinical and regulatory documents including protocols, CSRs, CSPs, IBs, ICFs, CTDs, RMPs, PIPs, INDs, NSAs, BLAs, MAAs and additional briefing documents for various regulatory authorities like FDA, EMA, ICH, GCP, etc
- Developing clinical trial protocols and development plans
- Working cross-functionally with various teams like clinical, regulatory, and medical affairs
- Participating in internal and external meetings surrounding strategy, industry trends, evolving guidelines, and timelines
A strong candidate for this role will bring:
- A PhD, PharmD, MD, or MSc
- A minimum of 3 years of direct medical writing experience in the biotech and/or pharmaceutical industry
- Prior experience with the above deliverables, documents, and submissions
- Experience working across various phases I-IV is a huge plus
- Experience in neurology is a plus
This position is looking for someone to come into the office and is open to candidates in the USA.
Apply now or reach out with questions!
