Skills

Communication Attention to detail Process Improvement Project Management

Job Specifications

Sunrise Systems Inc. is currently looking for Technical writer(CMC) at New Brunswick, NJ, Hybrid 50% with one of our top Pharma Client

Job Title: Technical writer(CMC)

Location: New Brunswick, NJ, Hybrid 50%

Duration: 12 months (High possibility of extension for right candidate depending on performance or budget)

Position Type: Hourly contract Position (W2 only)

Pay Rate: $40/Hr - $45/Hr

Job Description:

Work Schedule: Mon-Friday(normal business hours)

Summary

The Technical Writer will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO). This individual will be 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.
This 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-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 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.
Provide input and scientific oversight for content generation for Module 2.3 and 3.
Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections.
Ensures content clarity/ consistency in messaging across dossier.
Facilitate and manage the data verification process.
Assist with dossier creation and system compliance for regulatory submissions
Coordinate response authoring, review and data verification to queries from HA for submissions.
Track upcoming submissions and ongoing submission progress
Maintain submission content tracker for regulatory submissions and work with doc specialist/PM/ Reg CMC to update tracker.
Represent Tech Writing and Document management in cross-functional CMC teams as required.
Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions.
Collaborate with external suppliers as needed for CTD content and review.
Support and implement continuous process improvement ideas and initiatives.
Train others on procedures, systems access and best practices as appropriate.
Mentor and train employees on the document management process
Work independently under supervision and collaborate with other teams.

Competencies & Experiences

Required Bachelor's degree in Biology or related discipline with a minimum of 2 years' experience
Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; Cell therapy CMC experience required.
Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred.
Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery.
Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required.
Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication.
Experience in bio tech/pharma e2e product development required. Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
Take ownership of the section - formatting, language check, connections to other sections / tables.
Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy.

Travel: Occasionally to other local NJ sites for larger team meetings.(2-3 times a year)

Compensation:

Factors which may affect starting pay within this range may include [geography/market, skills, education, experience and other qualifications of the successful candidate].

Benefits:

Sunrise offers ACA compliant medical coverage/dental insurance/vision insurance to all employees. We also offer Sick time benefits as required per State regulations.

About the Company

Sunrise Systems was founded in 1990 with a clear vision to deliver world-class staffing service solutions in all labor categories, including IT consulting and solutions; all with the commitment to provide service that exceeds expectations and become the most trusted name in the industry. More than two and a half decades later, we pride ourselves on being at the forefront of the staffing industry. Combining our in-depth industry expertise, insights, and global resources, we've partnered with our clients to connect them with t... Know more