Regulatory Writer

Regulatory Writer at Net2Source (N2S) Regulatory Writer at Net2Source (N2S) in Highland Park, New Jersey Posted in about 23 hours ago.

Type:

full-time

Job Description:

Net2Source Inc. is an award-winning total workforce solutions company recognized by Staffing Industry Analysts for our accelerated growth of 300% in the last 3 years with over 5500+ employees globally, with over 30+ locations in the US and global operations in 32 countries. We believe in providing staffing solutions to address the current talent gap

• Right Talent
• Right Time
• Right Place
• Right Price and acting as a Career Coach to our consultants.

Company:

One of Our Clients Job Description:

Job title: Regulatory Technical writer

Location:

New Brunswick, NJ 08903 (50% Onsite)

Duration:

12+ Months (Extendable)

Hours:

Mon-Fri 7am-4pm

EST Pay Rate:

$39.00

• 41.

95/hr on W2 2

Openings Must Haves:

1. Bachelor's degree required 2. Minimum of 2 year of experience in Technical Writing specifically for Regulatory CMC documentation within the pharmaceutical or biotechnology industry; Familiarity with eCTD structure, BLA regulatory submissions. 3. Strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery. 4. Proficiency in commonly used Microsoft Office applications (Word, Excel, Point, PPT) is required 5. Strong communication

• verbal and written 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.

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. 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. Ensure 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 submission 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 Bachelor's degree or equivalent in Biology or related discipline with a minimum of 2 years' experience (4-7 years for senior level). Familiarity and understanding of regulatory requirements and guidances 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, Point, 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 and GPS organization.

Travel:

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

Awards and Accolades:

America's Most Honored Businesses (Top 10%) Awarded by USPAAC for the Fastest Growing Business in the US 12th Fastest Growing Staffing Company in USA by Staffing industry Analysts in the US (2020, 2019, 2020) Fastest 50 by NJ Biz (2020, 2019, 2020)

INC 5000

Fastest growing for 8 consecutive years in a row (only 1.26% companies make it to this list) Top 100 by Dallas Business Journal (2020 and 2019) Proven Supplier of the Year by Workforce Logiq (2020 and 2019) 2019 Spirit of Alliance Award by Agile1 2018 Best of the Best Platinum Award by Agile1 2018 TechServe Alliance Excellence Awards Winner 2017 Best of the Best Gold Award by Agile1(Act1 Group)