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

Homewell Care Services

Sales and Business Development Manager Job at Homewell Care Services

HomeWell Cares Services is a rapidly growing home care agency. We are looking for a motivated individual to be our Sales and Business Development Manager. We are offering a sign-on bonus to candidates with a home care sales background and established area contacts and... 

CalPortland

Quarry Utility (Cement) Job at CalPortland

 ...Job Summary The schedule is Friday - Monday, 4 days/10 hour shifts. The Quarry Utility position will operate all types of mobile and auxiliary equipment to load and move rock or other materials. Benefits At CalPortland, were proud to offer a comprehensive,... 

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... 

Canyon County

Maintenance Technician - Grounds Job at Canyon County

Description: at any time without notice. Canyon County is an Equal Opportunity Employer. Employment decisions related to recruitment and selection are made without regard to race, color, religion, sex, national origin, age, disability or genetics.

Contour Airlines

Flight Attendant - Charter Service - New York, NY Job at Contour Airlines

 ...our ongoing success. Summary of Essential Duties The Flight Attendant is responsible for ensuring the safety, comfort, and well-being...  ...record, and valid passport Authorized to work in the United States and able to travel in/out of the country Fluent in...