Documentation Analyst (Hybrid)

JOB DESCRIPTION:

This position involves compiling information from scientists, authoring chemistry, manufacturing, and controls (CMC) sections of regulatory documents, and performing data integrity checks to support the timely submissions of both investigational and marketing applications for small and large molecules. This position requires the knowledge of fundamental principles of organic chemistry, the critical evaluation of analytical data, and it is preferred to have experience in drug substance and/or drug product CMC development. Duration - 6 months (Possibility of extension for right candidate depending on performance).

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.

Job Type: Full-time

Pay: $30.00 - $35.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Health insurance
• Referral program

Schedule:

• 8 hour shift
• Day shift

Work Location: In person

Salary : $30 - $35