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

Georgiabehavior

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

A leading healthcare organization is seeking an Entry-Level Behavior Technician in Brooklyn, NY. This role provides an opportunity to make a meaningful impact on the lives of children with Autism, offering competitive pay and flexible hours. No prior experience is required... 

Brio living Services

Resident Care Assistant: Part Time 10:30pm-7am Job at Brio living Services

 ...well-being, reimbursed 120 a year! Competitive Benefits for Part-Time Team Members Enjoy Vision, Mental Health Programs, Legal Plans...  ..., starting on the 1st of the month after 30 days of hire. Retirement Savings Plan Secure your future with employer contributions... 

DLP Services

Ground Maintenance Supervisor Job at DLP Services

 ...POSITION TITLE: Ground Maintenance Supervisor Location: Charleston, South Carolina FLSA: Non - Exempt Hire Pay: DOE Classification : Full time SUMMARY: Performs a variety of grounds and floor maintenance tasks, including training, managing, and... 

DHD Consulting

(Entry-Level) General Affairs Associate Job at DHD Consulting

 ...early-career professionals with a background in Accounting or Business who are interested in developing their career in a fast-paced,...  ...and attention to detail Compensation & Benefits Competitive entry-level salary Health insurance and paid time off Opportunities... 

Eastern Industrial Supplies, Inc.

Industrial Sales Intern Job at Eastern Industrial Supplies, Inc.

 ...Summer Internship - Business Development / Industrial Sales Possible Locations: South Carolina - Greenville , Anderson, Spartanburg, Florence, Charleston, Aiken North Carolina - Charlotte, Greensboro, Durham Georgia - Augusta , Atlanta, LaGrange,...