Technical Writer role at Bristol Myers Squibb
Location: Warren, NJ (preferably); Manager open to hire at Princeton Pike or Summit West. M-F Business Hours. This is a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myers Squibb.
Job Description
This role is responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application. The role requires effective collaboration across technical functions to meet submission timelines. 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.
Primary Responsibilities
- Co-author scientific content for CTD Quality sections aligned with regulatory strategy for clinical, commercial, and lifecycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports.
- Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance with project timelines and CTD requirements and regulatory strategy.
- Provide input and scientific oversight for content generation for module 2.3 and 3.
- Review and adjudicate comments, facilitate comment resolution, and revise draft sections.
- Ensure content clarity/consistency in messaging across the dossier.
- Represent Tech Writing and document management in cross-functional CMC teams.
- Manage the logistical process and detailed timeline for scientific and regulatory content creation for clinical, commercial, and lifecycle CMC regulatory submissions and responses to health authority questions.
- Assist with dossier creation and system compliance for regulatory submissions.
- Coordinate with CMC matrix team leaders to ensure timely submissions.
- Support and implement continuous process improvement ideas and initiatives.
- Mentor and train employees on the technical writing processes.
- Collaborate with cross-functional teams to manage the logistics and timelines for scientific/regulatory content creation for regulatory submissions and responses to health authority questions.
- Must possess a thorough understanding of source documentation requirements for regulatory submissions and their correlation to the authoring process.
- Manage the logistical process and detailed timeline for authoring, review, and data verification of regulatory submissions.
- Collaborate with external suppliers as needed for CTD content and review.
- Review and adjudicate comments in collaboration with SMEs.
- Train others on procedures, systems access and best practices as appropriate.
- Work independently under supervision and in collaboration with other teams.
Qualifications
- Bachelor's degree or equivalent in a relevant discipline; minimum 2 years of experience (4-7 years for senior level).
- Cell therapy CMC experience required.
- Familiarity with eCTD structure for regulatory submissions; BLA experience strongly preferred.
- Outstanding verbal and written communication skills; strong attention to detail, planning, organizational and negotiating skills; demonstrated ability for timely delivery.
- Proficiency in Microsoft Office applications (Word, Excel, SharePoint, PPT).
- Experience with regulatory documentum software (CARA, eSub, etc) and compliance-ready standards for final publication preferred.
- Experience in biotech/pharma end-to-end product development; ability to work in a fast-paced, changing team environment and prioritize multiple tasks to meet filing deadlines.
Additional Information
- Starting hourly compensation range: $45 to 48.72/hr. Final compensation determined by employer of record (ASK Staffing, Inc.).
- Work arrangement and location details; contract assignment with ASK Consulting to Bristol Myers Squibb.
About ASK Consulting
ASK Consulting is an award-winning, woman-owned staffing and recruitment solutions provider with over three decades of industry experience. We specialize in connecting businesses with top-tier professionals across IT, healthcare, engineering, and more.
ASK Consulting provides comprehensive benefits including ACA-compliant health coverage, dental, vision, disability coverage, commuter benefits, a 401(k) plan, and paid leave as required by law.
Equal Opportunity Employer
ASK Consulting is an equal opportunity employer and does not discriminate based on race, religion, color, sex, national origin, age, sexual orientation, gender identity, genetic information, disability, veteran status, or any other classification protected by law.
California Applicant Notice
We comply with CPRA and relevant data privacy laws. Applicants may request details of data collection in an alternative format by contacting HR.