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:

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 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

Work at office, Local area,

Similar Jobs

Meanpug Digital

SEO Manager Job at Meanpug Digital

...requiring demonstrated expertise in Local SEO and Technical SEO. MeanPug Digital is... ...agency specializing in legal services marketing. We partner with law firms to deliver comprehensive... ...client communication and relationship management skills Experience presenting data-...

Brooksource

Data Analyst Job at Brooksource

...Data Analyst Contract (6 Months) | Contract-to-Perm Opportunity Overview We are looking for a Data Analyst to support a fast-paced, cross-functional team focused on operational reporting, dashboard development, and data-driven decision making. This role will...

NTT DATA, Inc.

Mainframe Vantage Developer Job at NTT DATA, Inc.

...us. If you want to be part of an inclusive, adaptable, and forward-thinking organization, apply now. We are currently seeking a Mainframe Vantage Developer to join our team in hyderabad, Telangana (IN-TG), India (IN). NLG Vantage Senior resource(8+ Years exp) on...

Flowers Foods

Model K/Pan-O-Mat Operator Job at Flowers Foods

...vacation, holidays, and parental leave Benefits may vary depending on your work location. Bringing Home the Dough Operates Model K machine, ensures that dough pieces are correct weight and size and flow into overhead correctly. Position requires demonstration...

Conway Institute of Music

Music Teacher Job at Conway Institute of Music

...Conway Institute of Music is one of our the fastest growing music schools in Arkansas and National Music School of the Year in 2017... ...and Saturday 9:00 a.m. to 6:00 p.m. Requirements: Music Teaching and/or performance experience. Individuals who are reliable,...

Technical Writer Job at TSR Consulting, New Brunswick, NJ

V3RBRjYvTUJMTFFLVVp3aHJWUlpJNkpGc1E9PQ==