Senior Medical Writer Job at EPM Scientific, Jersey City, NJ

a1dyTy9mVkp1dXhwQWNpWjV4UkRObkwzT3c9PQ==
  • EPM Scientific
  • Jersey City, NJ

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

Oceaneering International

Tube Welder Job at Oceaneering International

 ...Company Profile Oceaneering is a global provider of engineered services and products, primarily to the offshore energy industry. We develop products and services for use throughout the lifecycle of an offshore oilfield, from drilling to decommissioning. We operate the... 

Jobot

Senior Quality Engineer Job at Jobot

 ...with opportunities to grow your career. Job Details Job Details: We are seeking a dynamic and experienced Senior Quality Engineer to join our team in the Energy industry. This role is integral to our mission of delivering top-tier, energy-efficient solutions... 

Good Samaritan Society

RN Case Manager, Home Health Job at Good Samaritan Society

 ...and sequencing of the clients care. Integration enhances patient/resident flow and interdisciplinary communication promotes early intervention. Seeks to evaluate outcomes based on an integration among established clinical, financial and utilization data. Functions in... 

Daybreaker LLC

Graphic Design Internship '25 Job at Daybreaker LLC

Daybreaker is looking to bring on a stellar Graphic Design Intern for the summer to join our powerhouse team that is rolling out amazing...  ...to growing the Daybreaker movement and creating unique experiences around the world you can consider these folks your new global... 

Haney Freightways

Hiring Class A OTR Company Drivers for SMALL Family Owned Company Job Job at Haney Freightways

Hiring Class A OTR Company Drivers for SMALL Family Owned Company JobRequirements:24 years old (Insurance requirement)Able to pass DOT Physical and Drug ScreenNo DUIs or felonies in last 3 yearsNo more than 4 moving violations in last 3 years or 2 in last 1...