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Documentation Analyst

unlimited holidays - extra holidays - extra parental leave - long remote period allowed
Remote: 
Full Remote
Contract: 
Full time
Experience: 
Mid-level (2-5 years)
Work from: 
United States

Offer summary

Qualifications:

Bachelor's degree or Master's degree, 3-5 years relevant experience or 1-2 years for Master's, Working knowledge of regulatory CMC submissions, Experience in Cell Therapy is a plus, Excellent organizational skills.

Key responsabilities:

  • Manage documentation activities for regulatory submissions
  • Coordinate reviews and facilitate consensus meetings
  • Ensure use of correct formatting for submissions
  • Participate in cross-functional project teams
  • Verify submission data accuracy
Aequor logo
Aequor Human Resources, Staffing & Recruiting SME https://www.aequor.com/
201 - 500 Employees
About Aequor
Since 1998, Aequor has provided exceptional workforce staffing services in multiple industries. Specializing in healthcare, we place nurses, therapists, allied professionals, physicians and medical technicians, as well as staff in the life sciences, technologies and schools. We believe in making a positive impact in the lives of those we serve by inspiring people and empowering growth both personally and professionally, which makes us better as individuals and as a company. We teach our team members to nurture positive and supportive relationships with our clients and candidates by nurturing positive and supportive relationships with each other—from the desk level to the C-suite. Year after year, Aequor is awarded for being one of the best places to work—for the candidates we place in assignments all over the country, and for our internal team, the Aequor Family. The vibrant culture of community and support that welcomes each new team member is the same culture that makes them want to stay. We understand that we’re better in collaboration rather than competition, so we build each other up, respect each other, and show up for one another. As a thriving healthcare staffing firm committed to investing in the resources and tools that ensure a remarkable experience for our clients, candidates and team members, Aequor’s personal approach connects the workforce needs of the industry with the right talent for the job.
See more Aequor offers

Job description

Job Description: Documentation Analyst

This position is REMOTE

Work Schedule: Mon - Fri, Business Hours

Based out of New Brunswick NJ

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 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.

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:

Bachelor's degree in a relevant discipline with a minimum of 3-5 years relevant experience. OR a Masters degree with 1-2 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.

Additional Job Requirements:

None

Required profile

Experience

Level of experience: Mid-level (2-5 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Hard Skills

Regulatory ComplianceData VerificationRegulatory CMCDocument ManagementCell TherapyProject Management

Other Skills

  • Communication
  • Collaboration
  • Time Management
  • Organizational Skills
  • Teamwork
Are you interested?

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