What are the responsibilities and job description for the Documentation Analyst position at Synectics Inc?
Job Description
Job Description
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.
Manage document preparation of CMC regulatory submission documents to 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.
Requirements :
Bachelor's degree in a relevant discipline with a minimum of 4 - 7 years relevant experience; OR
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.
This candidate is expected to have a good understanding of regulatory guidelines.
An understanding of CMC submission structure with respect to the different Modules (1,2,3) and respective section numbering within those modules.
Experienced in Word is required.
Benefits :
Healthcare Insurance : Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance : Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan : The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.
Technical Certification Bonus : Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.
Synectics is an equal opportunity employer.
