Compliance Writer

Company: Big Sky Scientific
Location: Fairfield
Posted on: June 8, 2021

Job Description:

JOB DESCRIPTION To write and review high quality cGMP, OSHA-PSM, EPA-RMP, & NFPA documentation for submission to regulatory authorities. MAJOR ACTIVITIES 1. To author and review SOP documents 2. Liaison w/clinical trials and university research 3. Actively participate in planning of data analysis 4. Act as documentation consultant to ensure compliance of documentation to internal company standards and external regulatory guidelines MINIMUM REQUIREMENTS Minimum science degree or equivalent (chemical or mechanical engineering preferred) is required. Two or more years writing experience or other relevant food process industry experience combined with scientific and regulatory knowledge, plus strong knowledge of the compliance writing processes. Preferred. Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). Knowledge of process for and some experience in global registering of drugs (simple submissions). Excellent communication skills (written, verbal, presentations). JOB FUNCTIONS Compliance Research Data Analyst Science Other

Keywords: Big Sky Scientific, Billings , Compliance Writer, Other , Fairfield, Montana