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

Brio living Services

Resident Care Assistant: Part Time 10:30pm-7am Job at Brio living Services

 ...well-being, reimbursed 120 a year! Competitive Benefits for Part-Time Team Members Enjoy Vision, Mental Health Programs, Legal Plans...  ..., starting on the 1st of the month after 30 days of hire. Retirement Savings Plan Secure your future with employer contributions... 

Planet Fitness

Fitness Trainer Job at Planet Fitness

 ...401(k) ~ Employee discounts ~ Free uniforms ~ Wellness resources Job Summary The Fitness Trainer will be responsible for running the Planet Fitness group fitness program (****@*****.***). This includes assisting new members in the achievement of their fitness... 

LifeStance Health

Nurse Practitioner (PMHNP) Job at LifeStance Health

 ...team! We are actively looking to hire talented Psychiatric Nurse Practitioners in the area, who are passionate about patient care and...  ...offer Nurse Practitioners: Flexible work schedules. Telemedicine and in-person flexibility. Generous above market compensation... 

Southern Industries Home Improvements

Canvasser Job at Southern Industries Home Improvements

 ...Outside Marketing Representative(Canvasser)$35,000 to 55,000 PLUS UNCAPPED COMMISSIONS&BONUSES. Southern Industries Home Improvement is a proud family-owned company where our mission is to help homeowners achieve their home improvement dreams and needs for the last... 

New Castle Building Products

Outside Sales Representative Job at New Castle Building Products

 ...perfect fit for you! We are currently seeking a full time Outside Sales Representative to join our Brooklyn branch. In this role...  ...for the role: Residential / Commercial experience a plus(Roofing, Siding, Decking, Windows/Doors, Metal, Gutters) Road Sales;...