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

Tax Resolution Plus

EA - Enrolled Agent Job at Tax Resolution Plus

 ...Our company is looking for a licensed Enrolled Agent whose primary role will be to represent services to individual & corporate clients before the IRS for the Fresh Start Programs in order to aid in there tax issues. The ideal candidate is a highly skilled tax professional... 

GreatAuPair LLC

Nanny Job at GreatAuPair LLC

The duties of this position will include:caring for 3 children school age. this will include taking and picking up the youngest, middle child from school (when needed)and bring to therapy and or other activities when planned. Meals will need to be prepared on work days ...

DSV - Global Transport and Logistics

International Supervisor Job at DSV - Global Transport and Logistics

 ...Read more at Location: USA - Dallas-Fort Worth Int Apt, Grapevine, Esters Blvd Division:Solutions Job Posting Title: International Supervisor Time Type: Full Time . DSV is an equal employment opportunity employer. Candidates are considered for employment... 

TRNurses

Healthcare Recruiter Job at TRNurses

 ...TrHealthNetwork (TrHN) () recruits allied health professionals for inpatient and outpatient healthcare facilities in Arizona, California, Delaware, Florida, Georgia, Pennsylvania, and Texas. We support candidates across a wide range of allied specialties by matching... 

Ansible Government Solutions

Emergency Department Physician Job at Ansible Government Solutions

 ...Overview Ansible Government Solutions, LLC (Ansible) is currently recruiting full-time and Locum Tenens, 1099 Emergency Physicians for service at the Jennifer Moreno VA Medical Center located at 3350 La Jolla Village Dr, San Diego, CA 92161. If you accept employment...