Urgent! Production - Documentation Analyst Job Opening In New Brunswick – Now Hiring Mindlance
Job Description:
o Documentation Analyst 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.
o 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:
o Manage the logistical process and detailed timeline for scientific and regulatory content creation for clinical and life-cycle CMC regulatory submissions and responses to health authority questions.
o Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, address any grammatical or formatting related comments.
o Facilitate and manage the data verification process.
o Assist with dossier creation and system compliance for regulatory submissions
o Track upcoming submissions and ongoing submission progress
o Represent Tech Writing and Document management in cross-functional CMC teams as required.
o Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions.
o Collaborate with external suppliers as needed for CTD content and review.
o Support and implement continuous process improvement ideas and initiatives.
o Train others on procedures, systems access and best practices as appropriate.
o Mentor and train employees on the document management process
o Work independently under supervision and collaborate with other teams.
• Competencies & Experiences
o Required Bachelor’s degree in Biology or related discipline with a minimum of + years experience
o Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; Cell therapy CMC experience required.
o Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred.
o Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery.
o Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required.
o Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication.
o Experience in bio tech/pharma ee product development required.
Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
o Take ownership of the section – formatting, language check, connections to other sections / tables.
o 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 times a year)
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Unlock Your Production Documentation Potential: Insight & Career Growth Guide
Real-time Production Documentation Jobs Trends in New Brunswick, United States (Graphical Representation)
Explore profound insights with Expertini's real-time, in-depth analysis, showcased through the graph below. This graph displays the job market trends for Production Documentation in New Brunswick, United States using a bar chart to represent the number of jobs available and a trend line to illustrate the trend over time. Specifically, the graph shows 18299 jobs in United States and 442 jobs in New Brunswick. This comprehensive analysis highlights market share and opportunities for professionals in Production Documentation roles. These dynamic trends provide a better understanding of the job market landscape in these regions.
Great news! Mindlance is currently hiring and seeking a Production Documentation Analyst to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Production Documentation Analyst Jobs New Brunswick.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at Mindlance adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Production Documentation Analyst Jobs United States varies, but the pay scale is rated "Standard" in New Brunswick. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
Key qualifications for Production Documentation Analyst typically include Business Operations Specialists and a list of qualifications and expertise as mentioned in the job specification. Be sure to check the specific job listing for detailed requirements and qualifications.
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