Job Description
Tasks & Responsibilities:
- Data Collection & Planning:
- Perform allied activities such as data collection for report planning.
- Develop strategies and lead kick-off meetings and round table discussions for comment resolution.
- Safety Report Writing:
- Write various safety reports (or parts of such reports) for global regulatory submissions.
- Types of reports include Annual Reports (IND and other), Periodic Safety Update Reports, Periodic Adverse Drug Experience Reports, Development Safety Update Reports, Risk Management Plans, and other documents.
- Take ownership of assigned deliverables and collaborate with internal/client stakeholders for required inputs.
- Perform quality reviews of safety reports prepared by junior or associate medical writers.
- Author or contribute to ad hoc reports, benefit-risk evaluation reports, and supporting documents for label updates.
- Common Technical Document Summaries:
- Write Common Technical Document Summaries, including Non-Clinical and Clinical Overviews, Clinical Summaries, and other regulatory documents as assigned.
- Medical Information Responses:
- Prepare medical information responses for healthcare professionals (HCPs).
- Signal Reports & Safety Issue Analysis:
- Author/contribute to signal reports (ad hoc & periodic) and safety issue analysis reports.
- Write subject narratives for adverse drug reactions and serious adverse events.
- Communication & Coordination:
- Communicate and coordinate internally and externally (with clients) to get required inputs.
- Label Creation & Updates:
- Participate in creating and updating labels, such as Core Data Sheets, USPI, centralized SPCs, and Med Guides.
- Literature Searches & Surveillance:
- Conduct literature searches for authoring various types of reports or routine surveillance activities.
- Review and propose updates to search strategies, and review articles selected by other medical writers/junior writers.
- Author literature abstracts/summaries and propose Company comments.
- Process Improvement:
- Implement and promote the use of consistent, efficient, and quality processes to meet timelines and deliverables.
- Ensure compliance of operations with governing regulatory requirements.
- Create and maintain a culture of high customer service.
- Additional Activities:
- Perform any additional activities as per the project requirements or manager’s discretion upon completion of relevant training.
- Execute all other duties as needed or assigned.
