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

SGS Consulting

Procurement Analyst Job at SGS Consulting

 ...collection from contractors ~ Use internal systems (AS9 and Oracle) to process invoices and contracts ~ Troubleshoot invoicing errors/discrepancies with vendors. ~ Provide process improvement recommendations ~ Interface regularly with vendors and internal teams... 

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... 

Esferasoft Solutions Pvt. Ltd.

React Native Developer Job at Esferasoft Solutions Pvt. Ltd.

# Design, develop, and maintain mobile applications using React Native . # Build cross-platform apps (Android and iOS) ensuring responsiveness and scalability. # Integrate RESTful APIs and third-party libraries into mobile applications. # Write clean, efficient... 

Enclos

Chef de Partie Job at Enclos

 ...Chef de Partie for a Two-Michelin Star Fine Dining restaurant in Sonoma Enclos is a new fine dining restaurant located in downtown Sonoma. Helmed by Chef Brian Limoges (Atelier Crenn, Quince, Birdsong, Saison) the restaurant focuses on seasonally driven cuisine inspired... 

Aerotek

Electro-mechanical Assembler Job at Aerotek

**Electro-Mechanical Assembler****Shift:** 1st Shift 5am-3pm, 2nd Shift 3:30pm-2:15am Weekend Shift Friday-Sunday, 6:00 AM - 6:00 PM**Pay:** $21/hr**Join an award-winning manufacturer recognized as** **_Manufacturer of the Year_** **! We're looking for a detail-oriented...