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

Groundwork Coffee

Delivery Driver Job at Groundwork Coffee

 ...of delicious cold brew coffees. ABOUT YOU: Groundwork Delivery Drivers are responsible for delivering freshly roasted coffee to our...  ...hard, dream big, and impact the world. Pay Rate: $20.00/hour Schedule: Friday, Saturday, and Sunday Night shifts only... 

Commonwealth of Massachusetts

Policy analyst Job at Commonwealth of Massachusetts

 ...independently elected Members, each representing a district of approximately 43,000 people. Position Overview: Fiscal Policy Analysts work on a wide array of fiscal and budgetary matters that come before the House Ways and Means committee. Analysts partner with... 

Gpac

Search Consultant Job at Gpac

 ...become an industry leader and one of the largest and most successful executive search firms in the country, with over 350 search consultants. We do not require previous recruiting experience because we provide the proper training, tools, resources and support to reach your... 

Itaú Private Bank

Remote Customer Service Representative Work From Home Job at Itaú Private Bank

 ...looking for a friendly and reliable Remote Customer Service Representative to join our team. If you love helping people and enjoy working from home, this could be the perfect fit for you.In this role, youll be the first point of contact for our customers, answering their... 

Lorven technologies

Integration Release Manager - 100% remote Job at Lorven technologies

 ...Job Title: Integration Release Manager Location: Remote Job Type: Long-term contract Project description You will be lead and manage large technical projects, defining work strategies, aligning these with resources and desired client outcomes, and...