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

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... 

ATC Nassau County

Licensed Practical Nurse (LPN/LVN) Job at ATC Nassau County

Join Our Team as a Licensed Practical Nurse (LPN)! 500.00 Sign on BonusAre you a compassionate, dedicated LPN looking to make a difference in patient care? Rochester Hospital is seeking passionate Licensed Practical Nurses to join our growing healthcare team! All shifts... 

Your SmartSource

Customer Experience / Partnership Specialist - Parentfile - Remote Job at Your SmartSource

 ...Customer Experience Partnership Specialist. We are a mission-driven startup that has built an online account to save everything important...  ...skills and be an efficient self- starter in working remotely. Compensation: $70K - $80K annual base salary DOE, for this... 

Propio Language Services

Onsite Spanish Interpreter - Wenatchee, WA Job at Propio Language Services

 ...Founded in 1998 Propio Language Services provides critical interpreting and translation services that improve the quality of life with...  ...subject matter knowledge, as required for various clients, such as medical, legal, social services, etc. Requirements: ~ Submission... 

Benson Vacations

Bahamas Travel Review Specialist Job at Benson Vacations

 ...Job Posting: Bahamas Travel Review Specialist at Benson Vacations Job Description Benson Vacations, a leader in crafting unforgettable travel experiences, is excited to announce a new opening for a dedicated and enthusiastic Bahamas Travel Review Specialist. This...