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

N3NyQmhaQ2NOTENjWTVCN2dXVGNnanRWTnc9PQ==
  • 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

Uncommon Schools

Teacher Job at Uncommon Schools

 ...Description The Apprentice Teacher position provides a unique opportunity for talented individuals with limited or no teaching experience to explore the field of education and to gain hands-on practice and the training necessary to become a successful full-time... 

Unity Path Insurance

Office Assistant Job at Unity Path Insurance

 ...Job Title: Part-Time Office Assistant (Insurance Office) Location: Riverside Ca Hours: Part-Time (Flexible Hours, Approximately 2025 hrs/week) Compensation: Based on experience Job Overview: We are seeking a reliable and motivated Part-Time Office... 

Schneider

Owner-operator Port Drayage truck driver Job at Schneider

 ...that are drop-and-hook at no charge while operating under Schneiders authority. Get $190...  ...Minimum 6 months of Class A driving experience. Obtain a Transportation Worker Identification...  ...thats leasing or purchasing. Job Owner-Operator Schedule FULLTIME Sign... 

Komatsu

Senior Web Developer Job at Komatsu

 ..., 53204-2941 Req ID: 32337 Onsite or Remote: Hybrid Position Komatsu is an indispensable...  .... Job Overview Analyze, design, develop, test and deploy enterprise data...  ...interface applications with third party tools/web services. Effectively communicate with... 

ICON Strategic Solutions

Clinical Research Associate II - Early Development Job at ICON Strategic Solutions

 ...in the Quality Oversight Plan (QOP) document. Interfaces Primary/Other: Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials. Other Interfaces: Study Responsible...