Regulatory/ Technical Writer Intern posted in Regulatory
May 13th, 2018Company Tagline:
Cannabistry LabsCompany Website: Cannabistry LabsTwitter: Cannabistry LabsClick here to apply for this position. or Click here to view the full job listing.
The position reports directly to the Regulatory Manager. It is located at corporate headquarters in a first-tier Northern suburb of Chicago and is to be filled immediately. It is a key regulatory resource on the teams described above. This position is available immediately and can be full or part-time depending on availability and the internship policies at the participating academic institution. It will continue until at least December 2018.
This position is primarily focused on two areas:
Writing regulatory, operational and technical documents
Participation in cross-functional R&D teams.
The intern will assist and collaborate with the Cannabistry Labsí teams by executing the following:
Writing, editing, revising and submitting regulatory deliverables, including, but not limited to: Regulatory Briefs, Compliance Documents, Technical Documents, Label Content, Specifications, Brand Technical Manual (BTM), Standard Operating Procedures (SOPs), Training presentations and Stage-Gate regulatory documents.
Of these deliverables, the Brand Technical Manual (BTM) is the most important. The BTM is a comprehensive operational manual. It is the primary repository of all information needed for successful technology transfer to our licensees. It is the foundational document for the development and commercialization of our products. It includes product descriptions, regulatory information, detailed SOPS, quality and safety plans, finished product specifications and more.
To execute the writing of various documents, the intern will complete the following steps:
Review completed documents for existing products with the R&D team
Demonstrate understanding of the process used to create the documents
Develop a plan for the execution of assigned documents
Review plan with appropriate regulatory affairs personnel
Once plan is approved, begin writing assigned documents
Provide ongoing completed documents and progress reports for review and approval
Reports to the Director of Regulatory Affairs.
Cross-functional involvement with R&D and Commercialization teams.
Ensures compliance with all applicable State, Local and Federal regulations. Meets deadlines as required for deliverablesí execution.
Aligns and coordinates regulatory affairs documentation with Cannabistry Labsí intellectual property guidelines.
Assures quality control of regulatory documentation and submissions.
Actively collaborates with team members to develop documents that are consistent with Cannabistry Labsí unique business model.
Practices a continuous improvement mindset, monitors results and actively suggests ideas to meet unmet needs and improve outcomes across all areas.
Qualifications, Education and Experience
BA/BS in engineering, chemistry, food science or food safety; currently enrolled in a graduate program in food science or related technical area.
Basic awareness of safety and quality systems such as HACCP, FSMA, GMP, GFSI and ISO.
Some experience developing, writing and editing regulatory documents and compliance templates.
Able to adapt existing document systems to rapidly changing and often inconsistent regulatory environments.
Demonstrates high level of cross-functional communication and involvement.
Possesses a high level of project management ability and initiative.
Results-focused person who can work in a very fast-paced business environment.