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... 

Wilshire Law Firm

Cyber Security Engineer Job at Wilshire Law Firm

 ...Cyber Security Engineer Wilshire Law Firm is a distinguished, award-winning legal practice with over 18 years of experience, specializing in Personal Injury, Employee Rights, and Consumer Class Action lawsuits. We are dedicated to upholding the highest standards of... 

Georgiabehavior

Entry-Level ABA Therapist — Flexible Hours, Free Training Job at Georgiabehavior

A healthcare organization in New York City is seeking an Entry-Level ABA Therapist. This role offers competitive pay ranging from $20 - $30 per hour, flexible hours suited for students, and free training. The position involves providing ABA services to children with Autism... 

Pacer Group

Grounds Maintenance Job at Pacer Group

 ...Title - Grounds Maintenance Duration 5+ Months Shift Mon Fri (8:00 AM 5:00 PM) (Weekends as needed). Location - Hixson, TN 37343 Job Summary: ~ Responsible for the care, maintenance, and overall appearance of cemetery grounds, lawns, and... 

Senior Helpers - Seal Beach Los Alamitos

Hiring PCA/HCA Caregivers Job at Senior Helpers - Seal Beach Los Alamitos

 ...with non-medical care needs including normal aging challenges and hospital recovery* Provide transportation to appointments, grocery...  ...Must be on the California State Registry (or willing to sign up) - HCA* Willingness to learn new skills to better the lives of our clients...