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

Sands Chevrolet Glendale

Lot Attendant/Porter/Valet Job at Sands Chevrolet Glendale

 ...customer vehicles are moved into production efficiently in order to return them back in above average times. Responsibilities:* Park cars* Wash cars* Shuttle customers* Deliver parts* Sweep Customer areas/parking areaQualifications:* Candidate looking to grow... 

Optimal Health Chiropractic & Physical Therapy

Exercise Specialist/Rehab Aide Job at Optimal Health Chiropractic & Physical Therapy

Exercise Specialist Chiropractic & Physical Therapy Aide Optimal Health Chiropractic & Physical Therapy Egg Harbor Township, NJ (and Sewell, NJ opportunities) Turn Your Training Skills Into a Clinical Career Path Are you a personal trainer who loves movement...

Bestica

Backfill - Travel - Cath Lab Tech (746) - HCA Florida JFK MC - 7:00AM - 7:00PM Job at Bestica

 ...Unit Information: CV Services (74613) Cath Lab/ EP Lab CVT Facility: HCA FLORIDA JFK HOSPITAL Address: 5301 South Congress Avenue Floor: 2 Building: Main Cost Center: 74613 General Information Tell us about the unit(s): Number of Beds: 3 cath rooms and 4 ep rooms Number... 

Bank of America Corporation

Network Cyber Threat Defense Security Engineer Job at Bank of America Corporation

 ...opportunities to learn, grow, and make an impact. Join us! This is a Cyber Security role in Information Security with a focus on Network Security...  ...spear to ensure that customers have an uninterrupted network experience, by rapidly responding to security events, developing... 

Hugh Baby's BBQ & Burger Shop

Cashier Job at Hugh Baby's BBQ & Burger Shop

 ...and beyond, and seek out people who genuinely enjoy making people happy, and delivering exceptional guest experiences. Previous restaurant experience is always a plus, but never a must (were serious about training and development - so well teach you everything you...