Job Description

Job Title: Documentation Analyst

Location: Remote

Duration: 06 Months

Pay Rate: $35 to 41.80/ hr. on W2

Work Schedule: Mon - Fri, Business Hours

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.

Job Description:

• Author independently CMC elements of regulatory filings.
• Provide technical writing expertise to ensure CMC submissions meet regulatory requirements and health authority expectations.
• Develop authoring plans and strategic approaches to filings with cross-functional teams.
• Carry out integrated review process for documents and lead the finalization of drafts for next phase review.
• Manage document preparation of CMC regulatory submission documents to client 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.
• 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.

Education and Experience Required:

• Bachelors degree in a relevant discipline with a minimum of 4 - 7 years relevant experience. OR a 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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