Senior Medical Writer Job at EPM Scientific, New Jersey

TkZzNi9oNG93aUVQSSs2NXRaVUtxRUNn
  • EPM Scientific
  • New Jersey

Job Description

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!

Job Tags

Similar Jobs

Kraft Heinz Company

Senior Scientist, R&D - Exports Job at Kraft Heinz Company

 ...All Posting Locations: Glenview, IL, US Job Functions: Research & Development Date Published: December 15, 2025 Ref#: R-98784 Remote, Hybrid or Onsite: Hybrid ABOUT THE ROLE Job Description Senior Scientist, R&D Exports Job Purpose... 

Challenge Unlimited Inc

Small Engine Mechanic Repair Job at Challenge Unlimited Inc

 ...meaningful work across all of our locations. We are looking for a Small Engine Mechanic to take care of our building and maintenance the...  ...the highest level of independence possible. I nspects, repairs, and prepares grounds maintenance equipment at the assigned site... 

ABB

Lace-Connecting Team Job at ABB

At ABB, we help industries outrun - leaner and cleaner. Here, progress is an expectation - for you, your team, and the world. As a global market leader, we'll give you what you need to make it happen. It won't always be easy, growing takes grit. But at ABB, you'll never... 

Wynn Las Vegas

Florist Job at Wynn Las Vegas

 ...Job Description The Florist is responsible for building, producing, installing and maintaining floral arrangements following the Wynn Floral Design Standard. The florist is responsible for the maintenance of fresh floral product and housekeeping of the department... 

NoGigiddy

Entry-Level Remote Sales Development Representative (20 - 27 per hour) Job at NoGigiddy

 ...NoGigiddy is seeking a motivated and energetic Entry-Level Remote Sales Development Representative (SDR) to join our remote team. In this role...  ...feedback, and service improvements. Collaboration: Work closely with internal teams, including sales, marketing, and...