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

Amrize

Quarry Manager Job at Amrize

 ...Quarry Manager Requisition ID: 15264 Location: Whitehall, PA, US, 18052 Pay Type: Salary Travel Requirement: % COMPANY OVERVIEW Amrize is building North America. From bridges and railways to data centers, schools, offices and homes, our solutions are... 

Merck

Chronic Care Specialty Sales Representative - Port Charlotte, FL Job at Merck

 ...including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from... 

HEOPS Inc

Transporter (Driver) Job at HEOPS Inc

 ...and active participation in performance improvement actions. Licensure / Certification Requirements a.Current valid Kentucky driver's license with good driving record b.Current CPR Certification Experience Required Knowledge, Skills and/or Abilities:... 

Freeport McMoRan

Diagnostic Electrician - Mine Maintenance Job at Freeport McMoRan

 ...What You Will Do Removal, repair and installation of electrical components, electrical systems, analysis and diagnosis, advanced...  ...non-routine repairs and construction Perform preventative maintenance including installation, repair and troubleshooting of industrical... 

State of Indiana

State Eligibility Consultant Job at State of Indiana

 ...preservation of families by emphasizing self-sufficiency and personal responsibility. Role Overview : The State Eligibility Consultant meets with clients, explains programs and benefits, and reviews applications for public assistance programs. You will determine...