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

Global Wealth Management Ltd.

GWM recruitment ‏- Business Coordinator Job at Global Wealth Management Ltd.

GWM recruitment - Business Coordinator: Global Wealth Management Ltd. is an ethical, well...  ...E of 350,000 RMB. This is an excellent entry level position into the financial services...  ...progress and embark on a career as an International Financial Advisor. If you are ready for... 

One Source Technical

Director of Research & Development Job at One Source Technical

 ...Director of Research & Development Location : Western suburb of Chicago, IL Compensation : The compensation will be consist of a competitive base salary commensurate with experience plus bonus potential. Opportunity Summary : We are excited to be partnering... 

Momentus Field Service

Landscaper Job at Momentus Field Service

 ...Qualifications & Skills: Previous landscaping, groundskeeping, or related outdoor work experience preferred. Knowledge of horticulture, plant care, and seasonal maintenance techniques is an asset. Ability to operate and maintain landscaping tools and machinery... 

Sinch

AI Content & SEO Writer Job at Sinch

 ...Keep it Simple", and "Make it Happen". These values guide how we work and how we grow. The essence of the role We're looking for an...  ...leave and family planning support. WORK WHEREVER: Our flexible remote work offerings allow you to work wherever youre the most... 

Cardinal Pediatric Therapies

Registered Behavior Technician, RBT Job at Cardinal Pediatric Therapies

 ...area, where we're committed to empowering families and fostering growth in our community. Position Overview: As a Registered Behavior Technician (RBT) at our organization, you'll play a pivotal role in implementing individualized treatment plans designed to support...