What are the responsibilities and job description for the Documentation Analyst position at SOKOL GxP Services?
DUTIES AND RESPONSIBILITIES:
Author Chemistry, Manufacturing, and Controls (CMC) Sections
- Draft, review, and finalize CMC content for regulatory submissions.
Compile Scientific and Technical Information
- Gather and organize data from scientists and subject matter experts related to drug substance and drug product development.
Perform Data Integrity Checks
- Conduct thorough quality control reviews of analytical and manufacturing data to ensure completeness, accuracy, and compliance with regulatory standards.
Evaluate Analytical and Chemical Data
- Critically assess analytical methods and results using a solid understanding of organic and medicinal chemistry principles.
Collaborate with Cross-Functional Teams
- Work closely with R&D, Regulatory Affairs, Quality, and Manufacturing teams to align on document content, strategy, and timelines.
Support Regulatory Submissions
- Contribute to the timely preparation and submission of investigational and marketing applications by providing high-quality documentation.
Utilize Document Management Tools
- Use computer-assisted document preparation and management systems to draft, edit, and track regulatory documentation.
Ensure Regulatory Compliance
- Maintain consistency with regulatory guidelines and internal standards across all authored documents.
Manage Multiple Projects Simultaneously
- Prioritize and execute tasks across concurrent projects under tight deadlines, while maintaining accuracy and attention to detail.
Contribute to Process Improvements
- Identify areas for improving documentation processes and templates to enhance efficiency and compliance.
EDUCATION:
- Required B.S. in Chemistry. M.S. or Ph.D. in Organic or Medicinal Chemistry is strongly preferred
QUALIFICATIONS:
- The candidate should have excellent verbal and written communication skills and is expected to pay scrupulous attention to detail. This position requires constructive interactions with other members of a team to approach problem solving. Familiarity with computer-assisted document preparation tools is desirable.
- Regulatory Documentation and/or Authoring experience (not just formatting)
- Multitasking ability
- Strong communication -oral and written
- Pharmaceutical background
- Strong organic or Medicinal chemistry
WORKING CONDITIONS:
- This role may involve working in an office, laboratory, or manufacturing area.
- Must be able to work in gowning attire within a controlled environment for extended periods.
- Must demonstrate the ability to work safely with hazardous, radioactive, and biological materials and waste, ensuring safety both when working independently and with others.
- Must be able to lift up to 15 pounds as needed.
