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

Dal-Tile

Sustainability Environmental Engineer Job at Dal-Tile

 ...inspections as necessary. Develop and implement sustainability programs aimed at reducing environmental impact and promoting resource conservation. Identify opportunities for waste reduction, energy efficiency, and water conservation. Collaborate with cross-... 

Grapefruit Health

Travel Occupational Therapist (OT) Job at Grapefruit Health

Seeking a dedicated Travel Occupational Therapist (OT) in Pittsfield, MA, based in Worcester, MA. Responsibilities include evaluating clients' needs, developing personalized treatment plans, and providing therapy services in diverse settings. Assist patients in improving... 

Cardinal Health

Environment, Health & Safety Manager Job at Cardinal Health

 ...What Environment, Health & Safety (EHS) contributes to Cardinal Health The Cardinal Health Global Environment, Health & Safety (EHS...  ...knowledge of regulations and guidance promulgated by Federal and State OSHA and EPA, as well as workers compensation requirements Strong... 

Legacy House of Southern Hills

Entry-Level Dishwashing Assistant - Dishwasher Job at Legacy House of Southern Hills

 ...opportunity to contribute to a meaningful cause while gaining valuable experience? If you answered " YES!" to these questions, then Legacy...  ...of Southern Hills in Las Vegas, NV needs YOU as our next Entry-Level Dishwasher ! With competitive pay at $15.40 an hour and a... 

Dr. Howard Fuller Collegiate Academy

High School Social Studies Teacher Job at Dr. Howard Fuller Collegiate Academy

 ...relationships with students and families, and have a passion for social studies and education. Dr. Howard Fuller Collegiate Academys (HFCA...  ...as scholars capable of a lifetime of success. We seek teachers who are content experts and want the freedom to design lessons...