Senior Associate Regulatory Writing

Writes and edits non-complex regulatory documents (eg, simple clinical study report, investigator brochure, protocol, protocol amendments, Plain Language Protocol Synopsis, Plain Language Summary) and simple standalone documents (eg, informed consent forms and amendments)  

Participates in collaborative team activities for non-complex documents, including support to collect input from authors/reviewers  

Participates in the cross-functional document review process, comment triage, meeting attendance, and incorporation of feedback for development of subsequent drafts or for finalization 

Generates appropriate in-text tables and figures  

Manages the development of regulatory documents, ensuring compliance with guidelines and timelines; collaborate with Project Teams to track progress, facilitate reviews, and ensure documents meet regulatory standards for submission. 

Learns and uses organizationally required authoring tools and technology platforms 

Attends cross-functional meetings with other writers and departments, as appropriate, to share and gather information relevant for successful completion of their own and inter-dependent projects 

Documents in scope include, but are not limited to: Clinical Study Reports, Observational Research Study Reports, Plain Language Summaries, Investigator Brochures, local Risk Management Plans, non-complex Original Protocols/ Protocol Amendments, and ICFs. 

Understands and complies with SOPs, templates, best practices, policies, Regulatory Writing Style Guides