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

ONYX

UI/UX Designer Job at ONYX

Background in Art/Design with experience in consumer electronics projects; overseas product design experience preferred.Proven experience...  ...or a fully English-speaking work environment.Proficiency in UI/UX design tools and solid hand-drawing skills.Familiarity with E... 

Compass Group

FOOD TRANSPORTER/DELIVERY DRIVER (FULL TIME) Job at Compass Group

 ...Location: Lamar University We are hiring immediately for full time FOOD TRANSPORTER/DELIVERY DRIVER positions. Address : 211 Redbird Lane #10065, Beaumont, TX 77705. Note: online applications accepted only . Schedule : Full time schedule; days and... 

Modalways

Assistant Project Coordinator Job at Modalways

 ...About The Role Modalways is seeking a detail-oriented Assistant Project Coordinator to support the planning, coordination, and execution of technology projects. This role works closely with Project Managers and internal teams to help ensure projects are organized,... 

Stratos Solutions

Space Protection Engineer Job at Stratos Solutions

 ...Overview Stratos Solutions is seeking a highly skilledSpace Protection Engineerto provideSystems Engineering and Technical Advisory...  ...developcourses of actionto mitigate adversarial risks to space assets. Analyze and developtactics, techniques, and procedures (... 

Fanatics

Part-Time Retail Lead: Game Day Fan Experience Coach Job at Fanatics

 ...sales through operational excellence, supporting back of house operations, and providing training to ensure exemplary service on game days and during events. Applicants should have retail experience, strong communication skills, and the ability to work in a fast-paced...