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

Toll Brothers

2026 Internship Program: Architecture Intern Job at Toll Brothers

Join an award-winning company! Who are we? Since 1967, Toll Brothers has been building luxury homes and communities in the best locations in the U.S. Today, were a Fortune 500 company operating in over 50 markets across more than 20 states. Were the countrys premier...

Curve Health

Travel Occupational Therapist (OT) Job at Curve Health

We are seeking a dedicated Travel Occupational Therapist (OT) to join our team in Torrington, WY, with a weekly pay of $2,320. Assess, plan, and implement therapeutic activities to improve clients' daily living and motor skills. Collaborate with healthcare teams to... 

Quality Talent Group

Workplace Mental Health Consultant (Temporary, Hybrid) Job at Quality Talent Group

 ...Our client, a digital mental health startup valued at $3.3 billion , is connecting providers with a network of over 10 million members...  ...Mental Health Consultants to join their platform and provide remote services. As our client expands rapidly, this is an excellent opportunity... 

Pyro Engineering, Inc.

Class C Driver Part Time CDL Hazmat Job Job at Pyro Engineering, Inc.

Class C Driver Part Time CDL Hazmat JobPick up Truck with Hazmat and from facility and deliver to job site. Stay at Hotel or off duty till evening then pick up Hazmat left over and return to facility.Pay: Varies $150 - $300 a daynone / part timeHow to apply for... 

Gpac

Bridge Construction Estimator Job at Gpac

Job Description: Estimator - Bridge/Structures Construction We are seeking a skilled and detail-oriented Bridge/Structures Construction...  ...to 15% Collaborative team environment and long-term project pipeline All inquiries are confidential - All qualified applicants...