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

CEDENT

Audit Supervisor - Global Corporate and Investment Banking (New York, NY) Job at CEDENT

 ...Job Description: This job is responsible for independently performing test work during highly complex audit activities for Lines of Business (LOBs). Key responsibilities include independently designing and executing audit tests, assessing issues for business impact and... 

Compass Group

Buffet Line Attendant Job at Compass Group

 ...title]] Pay Range : $15.00to$15.00 The American Airlines Center is a multi-purpose indoor arena located in downtown...  ...a highly motivated and customer-service-oriented Chef Table Attendant(Buffet Line Attendant) to join our Premium Clubs team. The ideal... 

SSP America

Line Cook Mad Town Gastropu Job at SSP America

 ...on a daily basis ~ Requisitioning and stocking of all required food, paper products, and condiments ~ Handles, stores, and rotates...  ...: ~1 year Restaurant type: Casual dining restaurant Fast casual restaurant Quick service & fast food restaurant Shift... 

Intelice Solutions, LLC

Service Desk - Tier 1 Support Engineer - Washington, DC Job at Intelice Solutions, LLC

 ...service desk, making them the first line of defense for incoming support requests. We are looking for dedicated individuals who know...  ...services rendered* Modification of configurations, utilities, software, hardware, etc. for workstations, servers, and network resources... 

Aramark

Housekeeper Part Time - Avantara Lake Zurich - EVS Job at Aramark

 ...Its time for a sweeping change to your career so that you can pursue what matters to you! At Aramark, making sure we provide clean...  ...vision, and work/life resources. Additional benefits may include retirement savings plans like 401(k) and paid days off such as parental...