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

Baptist Memorial Hospital - Memphis

Nocturnist in Memphis, TN Job at Baptist Memorial Hospital - Memphis

 ...Block schedule Closed ICU with 24/7 intensivist support No procedures required APC support Admitter shift Dedicated nocturnist team Competitive compensation, sign on bonus, and relocation Paid professional liability insurance and tail Interested... 

Mondo

Junior Project Manager Job at Mondo

 ...Apply now: Junior Project Manager, Remote (U.S. only). The start date is ASAP for this 6-month W2 contract. Job Title: Junior Project Manager Location-Type: Remote (95 EST schedule) Start Date Is: ASAP Duration: 6-month W2 contract... 

Piedmont Healthcare Inc.

RN (Critical Care) - First Call Staffing, Internal Agency Job at Piedmont Healthcare Inc.

Overview: Work that works for you! Continue your nursing career by joining Piedmonts Travel Agency, First Call Staffing Solutions! We service most of our 28 hospitals across Georgia - Atlanta, McDonough, Fayetteville, Newnan, Columbus, Conyers, Covington, Monroe, Augusta... 

Monocraft Private Limited

CNC Operator Job at Monocraft Private Limited

# Operate CNC lathe/milling machines as per job requirements. # Read and interpret technical drawings and work instructions. # Perform machine setup, tool loading, and zero-point setting. # Measure and inspect components using vernier, micrometer, and gauges. #... 

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...