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

Interco

Paid Internship - Business Development Intern (Spring '26) Job at Interco

 ...This internship is open to Local Students only As a matter of company policy, Interco does not sponsor employment visas or hire from out of the USA nor does the company sponsorcandidates who do not currently reside within the USAwithout an existing H-1B visa.... 

Hermes

Floor Director, Maison, Maison Madison Flagship Job at Hermes

 ...balanced attention to all teams and floors. This position is responsible for achievement of Floor Group Mtier Sales volume, and...  .... At Herms, our actions for sustainable development and corporate social responsibility are founded in values passed down by generations... 

University of Louisville

Events Specialist III - UofL Health Job at University of Louisville

 ...: The University of Louisville is seeking to hire an Events Specialist III in the department of Philanthropy & Alumni Engagement (PAE). The Events Specialist III for UofL Health will oversee efforts for fundraising and engagement events for UofL Health, and work to build... 

Stateline Family YMCA

Wellness Coach Job at Stateline Family YMCA

Wellness Center Pay Range $13.24-$14.47 Part Time evening shifts 5pm-9pm.10+ hours per week with potential to increase hours. Our Wellness Attendants provide a safe and positive experience for all members. Be present and approachable if members need assistance...

Osborn Family Health Center

Outreach Worker Job at Osborn Family Health Center

Job Summary: The Outreach Worker promotes the services and mission of Osborn Family Health Center through community engagement activities. Specialized Skills: Experience and understanding of community culture, and health needs is important. Excellent interpersonal and group...