- Report Writing: Author various safety reports for global regulatory submissions, including Annual Reports, Periodic Safety Update Reports, Development Safety Update Reports, Risk Management Plans, and other documents.
- Quality Review: Perform quality reviews of safety reports prepared by junior or associate medical writers.
- Technical Documents: Write Common Technical Document Summaries, including Non-Clinical and Clinical Overviews and Clinical Summaries.
- Medical Information: Prepare medical information responses for healthcare professionals.
- Signal Reports: Author/contribute to signal reports and safety issue analysis reports.
- Narratives: Write subject narratives for adverse drug reactions and serious adverse events.
- Communication: Facilitate internal and external (client) communication and coordination for required inputs.
- Label Updates: Participate in creating and updating labels, including Core Data Sheets, USPI, centralized SPCs, and Med Guides.
- Literature Searches: Conduct literature searches for authoring reports and routine surveillance activities. Review and propose updates to search strategies.
- Quality Processes: Implement and promote use of consistent, efficient, and quality processes to meet timelines and deliverables according to requirements and standard operating procedures.
- Compliance: Ensure compliance with governing regulatory requirements.
- Customer Service: Create, maintain, and assume accountability for a culture of high customer service.
- Additional Activities: Perform any additional activities as per the project requirement or manager’s discretion on completion of relevant training.
Qualifications:
- Relevant experience in writing safety reports and regulatory documents.
- Strong organizational and project management skills.
- Excellent written and verbal communication skills.
- Ability to work collaboratively in a team environment.
- Proficiency in literature search and review methodologies.
- Knowledge of global regulatory requirements and guidelines.