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

Nuclear Care Partners

Registered Nurse - Dialysis Job at Nuclear Care Partners

 ...Registered Nurse (RN) | Dialysis -- Westminster, CO Overview At Nuclear Care Partners, we provide in-home nursing care to individuals impacted by their work in the Department of Energy or Nuclear Energy programs. As a Registered Nurse (RN), you will make a meaningful... 

Chick-fil-A

Senior Kitchen Leader Job at Chick-fil-A

 ...guest walks away feeling highly satisfied with the quality of their food while also maintaining the highest level of food safety....  ...organized kitchen. Participating Operationally in a high volume, fast paced restaurant. Assist in training of new team members. Act... 

Heartland Community Church

Finance Job at Heartland Community Church

 ...Purpose: To provide day-to-day finance tasks including accounts payable, accounts receivable, and finance management responsibilities....  ...and reporting weekly online, check and cash donations. Prepare bank deposits using weekly offering count sheets from volunteer... 

Openwork

Nutritionist (Baytown Area) Job at Openwork

 ...Nutritionist Make a Community-Wide Impact Full-Time | Harris County Baytown Area Step into a career where your passion for nutrition directly transforms lives. Openwork is excited to partner with Harris County to hire a dedicated Nutritionist serving the... 

Humana

Senior Clinical Recruiter Job at Humana

 ...put health first The Senior Clinical Recruiter plays a critical role in driving talent...  ...technical approach for project components, and work is performed without direction. Exercises...  ...WAH Internet Statement To ensure Home or Hybrid Home/Office employees' ability...