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

vTech Solution

Cyber Security Specialist Job at vTech Solution

Job Summary: The Cyber Security Specialist will support and strengthen the overall cyber security posture through the implementation and...  ..., Information Security, or a related field, or equivalent experience. - At least 5 years of hands-on experience in IT security... 

University of Maryland Medical System

Patient Care Technician (PCT), PRN, Float Pool Job at University of Maryland Medical System

 ...mindful of voice and language in public. Self Management: # Reports to work appropriately groomed and in compliance with the Hospitals dress code. Wears identification badge at all times at chest level and facing outwards so identification is clearly visible. #... 

Brio living Services

Dietary Aide, Part Time 4pm - 7:30pm Job at Brio living Services

 ...Prioritize your health and well-being, reimbursed 120 a year! Retirement Savings Plan Secure your future with employer contributions...  ...of paid breaks during your shift. Schedule : Part time 12-16 hours per week | Evening Shift 4pm-7:30pm | Varies M-F |... 

CRH

Ground/Maintenance Person Job at CRH

 ...aggregate distribution network covers Florida, Southern Mississippi, South Carolina, and Alabama. Position Overview The Plant Maintenance position will be responsible for daily maintenance and repair of the plant as well as other miscellaneous work that needs to be... 

The Outreach Team

Community Canvasser Job at The Outreach Team

 ...Community Canvassers and Team Leaders - Fund LA Fire Now Hiring Immediately - $24-26/hr + bonuses Full-time & Part-time Los Angeles is growing, but our city budgets havent kept up with the needs of our Los Angeles Fire Department Firefighters, Paramedics, and...