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

SANINC

Inside Sales Job at SANINC

 ...Other: ~ Driven individual with the desire to learn and grow with the company ~2+ years metals sales experience is required ~ Sales experience within industrial distribution ~ Proven success of high-performance activity and growth of existing territory ~ Knowledge... 

Your SmartSource

Customer Experience / Partnership Specialist - Parentfile - Remote Job at Your SmartSource

 ...Customer Experience Partnership Specialist. We are a mission-driven startup that has built an online account to save everything important...  ...skills and be an efficient self- starter in working remotely. Compensation: $70K - $80K annual base salary DOE, for this... 

TAP Engineering

Mechanical Engineer Job at TAP Engineering

 ...Position: Mechanical Engineer Location: US MD, Columbia Category: Hardware Clearance Requirement: Active SECRET We are...  ...Mechanical Engineering or related field 15 years of relevant experience (internships, co-ops, or academic projects related to... 

Maximus

Red Hat Enterprise Linux (RHEL) Administrator Job at Maximus

 ...Description & Requirements Maximus is seeking an accomplished Red Hat Enterprise Linux Administrator to provide expertise in managing and optimizing assets for our federal client's critical operations. As a Red Hat Enterprise Linux Admin, you will be responsible for... 

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...