What are the responsibilities and job description for the Documentation Analyst - Remote / Telecommute position at Cynet Systems?
Job Description:
- This role will be responsible for managing the documentation activities for marketing applications and/or post-approval regulatory submissions for cell therapy brands.
- This role may also require the preparation of some CMC dossier elements of regulatory filings for marketing applications and/or post-approval regulatory submissions for cell therapy brands.
- This position regularly interfaces with experts in Manufacturing Sciences & Technology, Analytical Sciences, Quality and Regulatory departments.
- This role requires effective collaboration and communication across the internal CCTM team and external department matrix teams to deliver quality regulatory submissions on time.
- This candidate is expected to have a good understanding of regulatory guidelines.
- Manage document preparation of CMC regulatory submission documents to company standards and ensure final document compliance to ensure submission content meets formatting requirements.
- Manage the logistical process in the authoring system for CMC regulatory submissions.
- This process includes coordinating reviews in the review and authoring system, assisting in the triage of comments, scheduling/facilitating consensus meetings, distributing review comments to the matrix teams.
- Facilitate data verification to ensure accuracy of submission data following the internal standard operating procedure.
- Author CMC elements of regulatory filings with supervision.
- Participate on various cross-functional project teams, interact with technical subject matter experts, regulatory and other key partners both internal and external to the company as necessary.
- Bachelor’s degree in a relevant discipline with a minimum of 4 - 7 years relevant experience.
- Masters degree with 1-3 years relevant experience.
- Must possess the ability to work both independently and collaboratively in a team environment and communicate effectively in all teams.
- Must possess excellent time management and organizational skills and have the ability to navigate in electronic systems.
- Must possess working knowledge of regulatory CMC submissions, experience in Cell Therapy and CMC are a plus.
- Must be highly flexible, and able to manage multiple projects in fast-paced, changing environment, and deliver on deadlines.
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