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

Cloud Analytics Technologies LLC

Python/ R Developer Job at Cloud Analytics Technologies LLC

 ...REQUIREMENTS: Experience with unit testing, release procedures, coding design and documentation...  ...Information Technology solutions using Python Responsible for documentation of the...  ...reviews and maintenance of internally developed applications, evaluation and performance... 

University of California, Irvine

Per Diem Hospital Assistant - Float Pool Orange and Irvine - Night Shift Job at University of California, Irvine

 ...its main campus, UCI Medical Center , a 459-bed, acute care hospital in in Orange, Calif., four hospitals and affiliated physicians...  ...As part of the UCI Health Enterprise Float Pool, the Nursing Assistant aids professional and technical nursing personnel primarily by... 

Akkodis

Senior Technical Writer Job at Akkodis

 ...Akkodis is seeking a Senior Technical Writer for a Contract with a client in Austin, TX. You will be responsible for creating clear...  .... Collaborate with cross-functional teams (Product Managers, UX Designers, Engineers, QA) to gather source material and define documentation... 

Brio living Services

Dietary Aide, Part Time 4pm - 7:30pm Job at Brio living Services

 ...Prioritize your health and well-being, reimbursed 120 a year! Retirement Savings Plan Secure your future with employer contributions...  ...of paid breaks during your shift. Schedule : Part time 12-16 hours per week | Evening Shift 4pm-7:30pm | Varies M-F |... 

EVERSANA

Pharmacy Technician Job at EVERSANA

 ...grounded in our cultural beliefs and serve more than 650 clients ranging from innovative biotech start-ups to established pharmaceutical companies. Our products, services and solutions help bring innovative therapies to market and support the patients who depend on them...