CMC Technical Writer (Pharmaceuticals)

CMC Technical Writer (Pharmaceuticals) 3.6 3.6 out of 5 stars New Brunswick, NJ 08901 $39

• $41 an hour
• Contract Dexian 641 reviews $39
• $41 an hour

• Contract Overview Job Title:

  Technical writer #BH-ID
• 1004167

Duration :

12 +

Months Location :

New Brunswick United States (On-site) Pay range : $39

• 41/hr on W2

Description:

Job Description

• The Technical Writer and Document Specialist (TW/DS) will sit within the Cell Therapy Development (CTD) Project and Portfolio Management Office (PMO).

This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for a late-stage clinical cell therapy program. 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. The successful candidate will work effectively in cross-functional project teams to accomplish company goals. o

Primary Responsibilities:

o 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. o Plan and facilitate submission kick-off for clinical regulatory submissions. o Manage the logistical process and detailed timeline for regulatory submissions. o Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy. o Provide input and scientific oversight for content generation for Module 2.3 and 3. o Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process. o Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections. o Ensure content clarity/ consistency in messaging across dossier. o Facilitate and manage the data verification process. o Assist with dossier creation and system compliance for regulatory submissions o Coordinate response authoring, review and data verification to queries from HA for submissions. Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. As one of the largest IT staffing companies and the 2nd largest minority-owned staffing company in the U.S., Dexian was formed in 2023 through the merger of DISYS and Signature Consultants. Combining the best elements of its core companies, Dexian's platform connects talent, technology, and organizations to produce game-changing results that help everyone achieve their ambitions and goals. Dexian's brands include Dexian DISYS, Dexian Signature Consultants, Dexian Government Solutions, Dexian Talent Development and Dexian IT Solutions.

Visit https:

//dexian.com/ to learn more. Dexian is an Equal Opportunity Employer that recruits and hires qualified candidates without regard to race, religion, sex, sexual orientation, gender identity, age, national origin, ancestry, citizenship, disability, or veteran status.

Pay:

$39.00

• $41.

00 per hour

Work Location:

In person