Technical Writer Job at TSR Consulting Services, Inc., New Brunswick, NJ

cEdWbHFma2FBTitXcWthTWxWSm1ZQk5RalE9PQ==
  • TSR Consulting Services, Inc.
  • New Brunswick, NJ

Job Description

**Please only local candidates to New Brunswick NJ

83415

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:

  • Bachelor’s 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
  • 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

Work at office, Local area,

Similar Jobs

BlackRock Resources LLC

Construction Scheduler Job at BlackRock Resources LLC

 ...We are currently hiring a Construction Scheduler for our client in the Richmond, VA area. The position will pay an hourly rate, 1.5OT, per diem, MOB / DEBOB, health benefits, PTO, etc. Job Summary: In conjunction with Engineering, Procurement and Construction (... 

TPI Global Solutions

IT Sourcing & Contracts Manager Job at TPI Global Solutions

 ...Job Title: IT Sourcing & Contracts Manager Location: Westerville, OH (100% Onsite) Duration: 5+ month contact with high possibility...  ...requirements. Manage RFP responses for state and local government clients, supporting the Project Management Office (PMO) and internal... 

Medical Services of America

Speech Therapist Home Health Part-Time/PRN Job at Medical Services of America

 ...Empower Communication. Deliver Care Where It Counts. Speech Therapist Home Health | State College, PA (Centre County) Employment Type: Part-Time/PRN Pay Range: $45.00-$50.00 At Medi Home Health Agency , a division of Medical Services of America, Inc.... 

Exit 13

Waiter / Waitress Job at Exit 13

 ...and want to make 6 figures? Come Join one of the best new restaurants in the main line with a fun vibe! Searching for a HEAD WAITER OR WAITRESS. Must be able to lead and deliver and help lead our staff. We are looking for career minded servers, who are serious... 

Canadian Executive Search Group (USA) Inc / Division of Arro...

Field Service Technician Job at Canadian Executive Search Group (USA) Inc / Division of Arro...

 ...support continuous improvement initiatives Qualifications: ~ Associate degree (A.A.) or technical certification in a related field ~6 months to 1 year of hands-on experience in field service, machine installation, or technical support (or an equivalent combination...