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

LM InternationalTchad

External Relations and Mobilization Officer Job at LM InternationalTchad

 ...External Relations and Mobilization Officer LM International -USA Join LM International as an External relations and mobilization officer (Trainee position), where you will Leverage a 6-month traineeship to build external relations and mobilize resources ensuring... 

A Igreja de Jesus Cristo dos Santos dos Últimos Dias

Project Coordinator Job at A Igreja de Jesus Cristo dos Santos dos Últimos Dias

View More Jobs Project Coordinator Salt Lake City, UT, United States (Hbrido) Trending...  ...Project Coordinator is responsible for working with researchers, departments, and areas...  ...week, with the option of working from home when there are not required in-person meetings... 

Black Bear Talent

Building and Grounds Maintenance Technician Job at Black Bear Talent

 ...Black Bear Talent is seeking a dependable and hands on Maintenance Technician for our client in Salem, VA to support the daily upkeep of buildings, grounds, and equipment for our client. This role focuses on general maintenance, basic repairs, and preventive care to... 

University of Pennsylvania

Head Women's Field Hockey Coach Job at University of Pennsylvania

 ...and we are proud to be among only 5% of U.S. universities in the top two Carnegie research classifications. Our faculty work with graduate...  ..., Grand Rapids, Detroit, Traverse City, wineries, beaches, golf and ski resorts, and many more - are within easy reach of the citys... 

TAP Engineering

Mechanical Engineer Job at TAP Engineering

 ...Position: Mechanical Engineer Location: US MD, Columbia Category: Hardware Clearance Requirement: Active SECRET We are...  ...Mechanical Engineering or related field 15 years of relevant experience (internships, co-ops, or academic projects related to...