Documentation Analyst

Documentation Analyst

BCforward is currently seeking a highly motivated Documentation Analyst - Remote

Job Title: Documentation Analyst

Location: Remote

Duration: 6+ Months

Work Schedule: Mon - Fri, Business Hours

Pay Rate: $36 - $39/ Hr. on W2.

Summary:

• 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:

• Manage document preparation of CMC regulatory submission documents to company's 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.

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.

Benefits:
BCforward offers all eligible employees a comprehensive benefits package including, but not limited to major medical, HSA, dental, vision, employer-provided group life, voluntary life insurance, short-term disability, long-term disability, and 401k.

About BCforward:
Founded in 1998 on the idea that industry leaders needed a professional service, and workforce management expert, to fuel the development and execution of core business and technology strategies, BCforward is a Black-owned firm providing unique solutions supporting value capture and digital product delivery needs for organizations around the world. Headquartered in Indianapolis, IN with an Offshore Development Center in Hyderabad, India, BCforward's 6,000 consultants support more than 225 clients globally.
BCforward champions the power of human potential to help companies transform, accelerate, and scale. Guided by our core values of People-Centric, Optimism, Excellence, Diversity, and Accountability, our professionals have helped our clients achieve their strategic goals for more than 25 years. Our strong culture and clear values have enabled BCforward to become a market leader and best in class place to work.
BCforward is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.
To learn more about how BCforward collects and uses personal information as part of the recruiting process, view our Privacy Notice and CCPA Addendum. As part of the recruitment process, we may ask for you to disclose and provide us with various categories of personal information, including identifiers, professional information, commercial information, education information, and other related information. BCforward will only use this information to complete the recruitment process.

Interested candidates please send resume in Word format Please reference job code 235976 when responding to this ad.

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