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

HIMMELS ARCHITECHTURAL DOOR & HARDWARE

Assistant Project Manager Job at HIMMELS ARCHITECHTURAL DOOR & HARDWARE

 ...opening experts, not simply a construction material supplier. Our family owned and operated company is currently seeking an Assistant Project Manager to join our Nashville, TN. team! The Project Management Team is the backbone of our growing business. This position... 

Your SmartSource

Customer Experience / Partnership Specialist - Parentfile - Remote Job at Your SmartSource

 ...Customer Experience Partnership Specialist. We are a mission-driven startup that has built an online account to save everything important...  ...skills and be an efficient self- starter in working remotely. Compensation: $70K - $80K annual base salary DOE, for this... 

Macpower CNC Machines Limited

QC Engineer Job at Macpower CNC Machines Limited

# Conduct quality inspections of raw materials, in-process products, and finished goods. # Perform material and product testing...  ...Assist in quality audits and internal inspections. # Recommend process improvements to enhance product quality and efficiency.... 

Xaloy

CNC Mill Setup and Production Machinist (3-5 Axis) Job at Xaloy

 ...Are You Our Next CNC Mill Setup and Production Machinist? Where: Austintown, OH When: MonThu, 10-hour off-shift with flexible start between 3:00 PM and 9:00 PM Questions to Consider Can you interpret complex blueprints and technical drawings without missing... 

Curve Health

Travel Occupational Therapist (OT) Job at Curve Health

We are seeking a dedicated Travel Occupational Therapist (OT) to join our team in Torrington, WY, with a weekly pay of $2,320. Assess, plan, and implement therapeutic activities to improve clients' daily living and motor skills. Collaborate with healthcare teams to...