Senior Medical Writer Job at EPM Scientific, Jersey City, NJ

cm5WVHVUcmNiTDUyTWJGQlVtUkZQUmUyRGc9PQ==
  • EPM Scientific
  • Jersey City, NJ

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

________________________________________________________

Onsite Training Manager Job at ________________________________________________________

 ...Position Overview: In collaboration with key stakeholders, the Training Manager is responsible for leading the continuing development of training programs for the Contact Center located across the US. This includes the ability to manage and lead a team of Trainers... 

Get It - Executive

Outbound Call Center Rep - DIALER Job at Get It - Executive

Are you a great communicator who enjoys speaking with people? We're looking for part-time Call Center Representatives to join our fast-paced, goal-oriented team! No prior experience? No problem! Training is provided, and entry-level applicants are encouraged to apply.... 

On Board Experiential

Assistant Controller Job at On Board Experiential

 ...regulations and compliance reporting. They should also have experience managing payroll and streamlining the accounting processes. This person...  ...to accounts receivable, accounts payable, payroll, purchasing, cash management, revenue recognition accruals, reconciliations, and... 

Mohawk Valley Health System

Recreational Therapist Job at Mohawk Valley Health System

 ...Job Summary The Recreational Therapist will organize and implement daily therapeutic activities which include individual, group and...  ...Recreation Director or designee. Core Job Responsibilities Assist in planning, developing, organizing, implementing, evaluating and... 

FedEx

Tractor Trailer Driver - RTD-4 Job at FedEx

Job Duties Drives tractor-trailer vehicle to designated locations and operate mechanized loading/unloading equipment. Performs other...  ...and in a safe manner. Must obtain & maintain valid commercial driver's license (CDL) & a hazardous materials endorsement (HME) for type...