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

Department of Consumer Affairs

Expert Reviewer Program Analyst Job at Department of Consumer Affairs

 ...maintenance of the Medical Board of California's (Board) Expert Reviewer Program. The incumbent independently provides the most complex...  ...be required to submit official sealed transcripts. Using the online application system as specified in the announcement is the... 

Integrity Placement Group

Licensed Crisis Screener Job at Integrity Placement Group

 ...Licensed Crisis Screener The Company : For over 60 years, our client has provided comprehensive behavioral health and family counseling services in Bay, Calhoun, Gulf, Holmes, Jackson, and Washington counties in the Florida Panhandle. They offer objective, professional... 

Sutter Health

Lactation Consultant Job at Sutter Health

 ...coordination, planning and management of patient and family education related to breastfeeding. Is accountable for providing lactation consultation and education services. Provides breastfeeding assistance, support and education to patients. Performs hands on lactation... 

Nesva Hotel New York City Vista

Room Attendant/Personal de Limpieza Job at Nesva Hotel New York City Vista

 ...cart throughout shift.Descripcin del puesto:Responsable de limpiar y preparar habitaciones y reas pblicas siguiendo los est...  ....Responsabilidades:~Preparar y mantener la carretilla de limpieza en orden.~Limpiar ventanas, puertas, paredes, closets, baos,... 

Athletes First

ATHLETES FIRST BRAND AMBASSADOR- University of Michigan Job at Athletes First

 ...are currently an active member in any of the above. Provide creative insight on planning that is specific to your campus...  ...ELIGIBILITY REQUIREMENTS: Must be actively enrolled at the University Must have a valid U.S. Driver's License Must be at least...