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

GreatAuPair LLC

Nanny Job at GreatAuPair LLC

Get hired for Jessica's nanny Job in Royse City, TX. Nanny needed for teacher.. Find nanny care work in Royse City.

Bath Iron Works

Classified Area Escort - 2nd Shift Job at Bath Iron Works

 ...Responsibilities for this Position Classified Area Escort - 2nd Shift US-ME-Bath Req ID: 2026-4987 Type: Regular Full-Time Remaining Positions: 1 Post End Date: 1/21/2026 Category: Other Salary Grade: A Shift: 2nd Overview The Classified... 

Cabela's

Apparel Processor (Part Time) Job at Cabela's

 ...Demonstrates exceptional customer service and ensures a pleasant shopping experience for all guests. 5% ALL OTHER DUTIES AS ASSIGNED...  ...Savings Paid holidays Paid vacation Bass Pro Cares Fund And more! Bass Pro Shops is an equal opportunity... 

New York University Abu Dhabi

Research Scientist in the Center for Water Research - Dr. Nidal Hilal Job at New York University Abu Dhabi

 ...New York University: NYU - Global: Abu Dhabi: AD_Research Centers Location Abu Dhabi, United Arab Emirates Open Date...  ...Abu Dhabi, seeks to recruit a research scientist to work on the development of membrane desalination to treat water from the Arabian Gulf... 

Advanced Private Police

Armed Security Officer Job at Advanced Private Police

 ...Armed Security Officer -PT/On-Call Looking for people with attention to detail, people skills, courage, and judgment to fill some upcoming roles in the Milwaukee area. Requirements: Ability to Read/Write/Speak English at a high school graduate level....