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Technical writer

sunrise systems

New Brunswick, NJ

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JOB DETAILS
SALARY
$40–$42 Per Hour
SKILLS
Adjudication, Analytical Development, Best Practices, Biology, Biotech and Pharmaceutical, Clinical Practices/Protocols, Communication Skills, Computer Skills, Cross-Functional, Data Management, Detail Oriented, Document Management, Documentation, GPS (Global Positioning System), Logistics Management, Logistics Processes, Mentoring, Microsoft Excel, Microsoft Office, Microsoft SharePoint, Microsoft Word, Negotiation Skills, Organizational Skills, Presentation/Verbal Skills, Process Development, Process Improvement, Process Management, Product Development, Project Portfolio Management (PPM), Project/Program Management, Publications, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Staff Training, State Laws and Regulations, Team Lead/Manager, Technical Delivery, Technical Operations, Technical Writing, Time Management, Writing Skills
LOCATION
New Brunswick, NJ
POSTED
1 day ago
Job Title: Technical writer
Job ID: 26-002307
Location: New Brunswick, NJ/ Lawrenceville, NJ
Duration: 12 Months (possibility of extension)
Work Schedule: Mon-Fri 8 am-5 pm (50% onsite required)

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

The hourly rate for this position is between $40.00 - $42. 00 per hour.

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.

Contact:
Sunny Rajput | sunny.r@sunrisesys.com | URL: www.sunrisesys.com

About the Company

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sunrise systems

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 deep industry expertise, insights, and global resources, we have partnered with our clients to connect them with top professionals across several different industries.

We provide cost-effective Managed Staffing Solutions, Information Technology and Information Technology Consulting Services to several Fortune 500 companies and U.S. Government agencies. We provide our clients with flexible engagement models and customized products that are budget and time specific. Understanding the challenges that every business faces, we offer our services either on-site at the clients' site or from one of our globally distributed technology centers. Our onshore and offshore development capabilities ensure that we excel at meeting customer requirements every single time.

Our collective business experience spans over two and a half decades and ranges from:

  • Business, management, and technical fields
  • Information technology consulting and software solutions.
  • Providing strategic support for the development and long-term growth of new business ventures across several industries including but not limited to; accounting, banking, finance, and recruitment.
  • Motivating technology staff and establishing partnerships with Fortune 500 companies

Sunrise Systems has a vast range of competence in:

  • Design, development, and support of cloud-based solutions from simple to highly complexed
  • Database administration of multi-platform applications, complex databases, and web-based environments that include all aspects of installation, planning, maintenance, and monitoring.
  • Data processing and data migration
  • Application re-engineering and platform migration
  • Working with the Information Systems and end-user communities at all levels to resolve issues and establish consensus.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
1990
WEBSITE
http://www.sunrisesys.com/