Technical Writer (New Brunswick) Job at TSR Consulting, New Brunswick, NJ

ZkZNaTZRR2l6U0lMc1N6QzlMWjlOMHJBVWc9PQ==
  • TSR Consulting
  • New Brunswick, NJ

Job Description

83415

***Local candidates to New Brunswick NJ ONLY please

TSR is a premier National U.S. Staffing company with over 50 years of staffing excellence.

Our client, a leading pharmaceutical company is hiring a Technical Writer for a 12+ months contracting assignment.

Must have skills:

  • Bachelors degree in Biology or related discipline with a minimum of 2 years experience
  • Minimum of 2 year of experience in Technical Writing specifically for Regulatory CMC documentation within the pharmaceutical or biotechnology industry
  • Familiarity with eCTD structure for regulatory submissions
  • Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required

Pay: $43-44/hour W2

Location: New Brunswick NJ

Responsibilities:

  • Will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy from early stage through registrational application
  • This role requires effective collaboration across technical functions to deliver on timelines for submissions
  • The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences across CTDO
  • Co-authors/ authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports
  • Plan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets
  • Manage the logistical process and detailed timeline for regulatory submissions
  • Partner with SMEs to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy

Job Tags

Part time, Work at office, Local area,

Similar Jobs

Balance Health

Podiatrist - Napa Job at Balance Health

 ...Balance Health is the nation's premier comprehensive lower-extremity focused Physician Practice. We provide leading podiatrists, orthopedic surgeons, and physical therapists with operational support so they can spend their time focused on growing their business and delivering... 

Ohio Staffing

Process Board Operator Job at Ohio Staffing

 ...Job Position Responsibilities Safely monitor, maintain, and operate all process equipment to efficiently meet the requirements stated in the Daily Operating Instructions, Key Operating Parameters, and Standard Operating Procedures. Maintain unit safety and housekeeping... 

Gemological Institute of America

On-Campus Bench Jeweler Instructor (Carlsbad) Job at Gemological Institute of America

 ...An educational organization in gemology located in Carlsbad, California is seeking an Associate Instructor for the Graduate Jeweler program. The role involves teaching students in jewelry manufacturing techniques and maintaining a supportive learning atmosphere. Ideal... 

Juniper Hotel Cupertino, Curio Collection by Hilton

Engineering Manager - Juniper Hotel Cupertino, A Curio Collection by Hilton Job at Juniper Hotel Cupertino, Curio Collection by Hilton

Juniper Hotel Cupertino, A Curio Collection by Hilton is looking for an Engineering Manager to join their elaborate team! With 224 rooms, our hotel is less than 20 minutes from Levi's Stadium and San Jose Airport and close to Saratogas great wineries. Join us and see... 

University Health

Coding Manager Job at University Health

 .../n/n EDUCATION/EXPERIENCE /n/n An associate degree or bachelor's Degree from an approved program for Health Information Management or a related field is preferred. Two years of experience managing/supervising health information management processes, coding and...