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)