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

Revel Staffing

Healthcare Recruiter Job at Revel Staffing

 ...A confidential healthcare organization is seeking an experienced Healthcare Recruiter to source, screen, and deliver high-quality clinical and administrative talent. This role requires strong relationship-building skills, deep knowledge of healthcare roles, and the ability... 

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... 

Sodexo

Dietitian Nutritionist II Job at Sodexo

 ...for Education in Nutrition and Dietetics (ACEND)Credentials Requirement:Meets eligibility requirements for Registered Dietitian Nutritionist (RD/RDN) by the Commission on Dietetic Registration (CDR) and will become registered within 120 days of hire. In some states and... 

Activate Talent

E-commerce Google Media Buyer ( Account Manager) Job at Activate Talent

 ...with innovative digital media buying and management solutions. We offer experience, strategy...  ...record in managing and optimizing Google Ads campaigns, with a deep understanding of Google...  ...with other digital advertising platforms (e.g., Facebook Ads, LinkedIn Ads) is a plus.... 

Menchie's Frozen Yogurt

Shift Leader/Assistant Manager Job at Menchie's Frozen Yogurt

 ...around the world, with stores in development throughout the U.S.A., Canada, Puerto Rico, England, South Africa, Kuwait, Bahrain, The Bahamas, Bangladesh, Guatemala, United Arab Emirates, Qatar, India, China, and Japan. Customize your own frozen yogurt treat and enjoy...