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

Tommy Bahama

Sales Associate Job at Tommy Bahama

 ...Please click here ( to review our Applicant Privacy Policy. LIVE THE ISLAND LIFE Tommy Bahama is more than just an island inspired brand, it's a lifestyle! Live the Island Life as an ambassador of our brand, representing the season's stylish trends. We look... 

Dr. Reddy’s Laboratories Ltd

Senior Pharmacovigilance & Medical Affairs Leader Job at Dr. Reddy’s Laboratories Ltd

A pharmaceutical company is seeking an exceptional leader to head Pharmacovigilance and Medical Affairs in Princeton, NJ. This role involves managing compliance, overseeing medical information services, and supporting strategic plans to enhance patient safety. Candidates... 

Serenity Mental Health Centers

Psychiatric Nurse Practitioner (PMHNP) Full Time Job at Serenity Mental Health Centers

 ...national network of Serenity providers and clinical leadership Annual provider retreats to exotic locations like Maui and the Bahamas The Role As a psychiatric nurse practitioner at Serenity, youll practice at the top of your license in a supportive, innovative... 

GQT Movies

Theater Manager Job at GQT Movies

 ...Theater Manager - Immediate Hiring Are you passionate about managing a theater and creating memorable experiences for audiences? Do you thrive while developing and working alongside a small team? We are looking for a highly skilled and dynamic Theater Manager to join... 

Providence Health and Services

Pharmacy Technician Job at Providence Health and Services

 ...California Fair Chance Act. Requsition ID: 398863 Company: Providence Jobs Job Category: Pharmacy Job Function:...  ...incentives, or bonus opportunities. PandoLogic. Category:Pharmaceutical, Keywords:Pharmacy Technician, Location:Veradale, WA-99037...