Sr Associate Regulatory Writing

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)