Sr. Associate, Regulatory Writing 

• Writes and edits non-complex regulatory documents (eg, simple clinical study report, investigator brochure) and simple standalone documents (eg, informed consent forms)  

• 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 

Basic Qualifications  

• Bachelor’s degree 

• Minimum of 2 years of experience in preparing regulatory documents 

• Familiarity with clinical research and clinical regulatory documents 

• Knowledge of clinical study regulations, guidelines, and best practices 

Preferred Qualifications 

• Scientific or medical knowledge 

• Experience analyzing interpretating scientific data 

• Exposure to or working knowledge of basic statistical and medical communication principles 

• Demonstrated passion for writing (extra-curricular, scientific, etc.) 

• Strong oral and written communication skills, including ability to write scientific documents and summarize scientific data 

• Able to collaborate with others, and to build solid and positive relationships with cross‐functional team members 

• Able to work independently and problem solve  

• Attention to detail and accuracy 

• Organizational skills in time and project management; ability to manage more than one project simultaneously 

• Working knowledge of typical office applications (eg, Microsoft Office, SharePoint)