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

Care Options for Kids

Licensed Practical Nurse (LPN) Job at Care Options for Kids

 ...a little differently. There's no revolving door of patients or hospital setting chaos blinking call lights, scurrying doctors, and wards...  ...for Licensed Practical Nurses (LPNs) Valid Delaware LPN License or Multistate License Physical within one year PPD or TB... 

Menchie's Frozen Yogurt

Shift Leader/Assistant Manager Job at Menchie's Frozen Yogurt

 ...around the world, with stores in development throughout the U.S.A., Canada, Puerto Rico, England, South Africa, Kuwait, Bahrain, The Bahamas, Bangladesh, Guatemala, United Arab Emirates, Qatar, India, China, and Japan. Customize your own frozen yogurt treat and enjoy... 

Enclos

Chef de Partie Job at Enclos

 ...Chef de Partie for a Two-Michelin Star Fine Dining restaurant in Sonoma Enclos is a new fine dining restaurant located in downtown Sonoma. Helmed by Chef Brian Limoges (Atelier Crenn, Quince, Birdsong, Saison) the restaurant focuses on seasonally driven cuisine inspired... 

Mondo

Junior Project Manager Job at Mondo

 ...Apply now: Junior Project Manager, Remote (U.S. only). The start date is ASAP for this 6-month W2 contract. Job Title: Junior Project Manager Location-Type: Remote (95 EST schedule) Start Date Is: ASAP Duration: 6-month W2 contract... 

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...