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

Pacific First Aid Ltd.

Order Picker And Shipper Job at Pacific First Aid Ltd.

 ...team. We are located on 1170 Glen Dr. Our ideal candidate is self-driven, punctual, and reliable. Responsibilities Accurately pick and pack first aid products for customer orders. Prepare orders for shipment including boxing, labeling, and sealing. Generate... 

Martin Brower

Warehouse Order Selector Job at Martin Brower

Responsibilities: Walk-in Interviews Wednesdays 10:00AM-3:00PM!~$31.74/HR after 1 year ~Hourly Rate + $0.52/Min Uncapped Incentive ~Weekly Pay!~ We offer great benefits including health, vision and dental FREE after 3 years! Shifts Available: Must be able to... 

RLDatix

Staff Product Designer Job at RLDatix

 ...of a global effort of over 2,000 team members in making a difference in healthcareevery day. Were searching for a Staff Product Designer to join our Product & Design team, so that we can deepen our understanding of user needs and deliver elegant, intuitive experiences... 

Esri

Product Manager - Aviation Job at Esri

 ...Overview Join Esri and help shape the future of products, technologies, and workflows that connect customers with world-class airports and aviation mapping and analytics capabilities. These ArcGIS products and teams are at the heart of ever evolving applications of... 

ATS Automation

Mechanical-Electrical Installation Technician Job at ATS Automation

 ...life-saving innovations? Join Comecer, Inc. , a global leader in advanced isolation and automation solutions, as a Mechanical/Electrical Installation Technician and play a key role in installing high-tech equipment for pharmaceutical and radiopharmaceutical facilities...