Sr Associate Regulatory Writing

Career Category

Regulatory

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 and interpreting 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)

Locations

India - Hyderabad