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

Georgiabehavior

Entry-Level ABA Therapist — Flexible Hours & Training Job at Georgiabehavior

A leading healthcare organization is seeking an Entry-Level Behavior Technician in Brooklyn, NY. This role provides an opportunity to make a meaningful impact on the lives of children with Autism, offering competitive pay and flexible hours. No prior experience is required... 

YukonKuskokwim Health Corporation

Health Aide Assistant Job at YukonKuskokwim Health Corporation

 ...national origin, disability, protected veteran status and any other basis protected by law. Individuals with disabilities needing assistance in the recruitment process are encouraged to contact Human Resources directly. Under P.L. 93-638, preference is given to... 

Octans Group LLC

Python Developers Job at Octans Group LLC

 ...We are looking for Python Developers for long term projects in Washington State. MUST be local to Washington State - NO RELOCATION...  ...in a cloud environment. Required Skills: Strong experience in Python development and automation Platform Engineering... 

State of Indiana

Licensed Practical Nurse - LPN Job at State of Indiana

 ...coordinate the workflow on the unit and communicate problems to unit supervisors. Administer medications and treatments according to hospital policies and procedures. Developand implementnursing care plans for acute medical problems. Complete medication... 

RR Donnelley

Production Artist Job at RR Donnelley

 ...the integrity of the approved designs and themes. The Production Artist must thrive in a professional, fast-paced environment, juggling...  ...insurance coverages, plus parental leave, adoption assistance, tuition assistance and employer/partner discounts. #LI-LC4...