What are the responsibilities and job description for the Documentation Analyst position at BCforward?
π Job Opening: Documentation Analyst
π Location: One Squibb Drive, New Brunswick, NJ 08903
π΅ Pay Rate: $41/hr
β±οΈ Schedule: Minimum 50% Onsite Required
πΉ Client: Pharma Industry
π§ͺ Job Description:
One of our client is seeking a Documentation Analyst to join their team in New Brunswick, NJ. In this role, you will be responsible for compiling scientific data, authoring Chemistry, Manufacturing, and Controls (CMC) sections of regulatory submissions, and ensuring data integrity. Your work will directly support timely submissions for both investigational and marketing applications involving small and large molecules.
This position is ideal for candidates with a strong background in organic or medicinal chemistry, and experience in CMC documentation within the pharmaceutical industry.
β Key Responsibilities:
- Compile technical data from scientists across departments.
- Author and review CMC sections of regulatory documents.
- Perform data integrity checks.
- Support regulatory submissions (INDs, NDAs, BLAs).
- Collaborate with cross-functional teams for documentation and problem-solving.
π Education & Qualifications:
- Required: B.S. in Chemistry
- Preferred: M.S. or Ph.D. in Organic or Medicinal Chemistry
- Experience in drug substance and/or drug product CMC development preferred.
π οΈ Skills & Experience:
- Proven regulatory documentation/authoring experience (beyond formatting)
- Solid background in organic or medicinal chemistry
- Experience with CMC processes in a pharma setting
- Strong attention to detail and organizational skills
- Excellent written and verbal communication
- Ability to multitask in a fast-paced environment
- Familiarity with computer-assisted documentation tools is a plus
Salary : $38 - $40