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

• Bachelors 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).