Medical writer

• Independently lead the preparation/update of complex aggregate safety reports across multiple product types
• Manage the distribution of final reports to stakeholders, including partners and health authorities
• Leads advanced safety signal detection and management for key products
• Collaborates with cross-functional teams to analyze complex safety data
• Provides strategic scientific expertise across therapeutic areas

Principal Medical Writer, Patient Safety

• Leads the preparation of complex scheduled and unscheduled aggregate safety reports across multiple product types and regulatory regions.
• Develops strategic approaches for challenging safety submissions.
• Reviews and approves high-complexity safety documents.
• Manages meeting logistics including scheduling, agenda drafting, and minute preparation.
• Designs and implements advanced signal detection plans tailored to specific product profiles.
• Leads signal detection for priority products by conducting expert-level analyses.
• Authors and reviews high-priority signal assessment reports and health authority response documents.
• Prepares and handles reviews of health authority response documents.
• Collaborates with cross-functional teams to ensure RMPs are scientifically robust and compliant.
• Demonstrates deep expertise in safety profiles across a wide range of therapeutic areas.

Senior Medical Writer, Patient Safety

• Leads or contributes to the preparation and compilation of aggregate safety reports.
• Reviews and finalizes safety documents for accuracy and compliance.
• Coordinates submissions to regulatory authorities.
• Conducts literature searches and systematic reviews.
• Identifies complex data discrepancies.
• Supports development of Risk Management Plans.
• Actively contributes to safety strategy discussions.
• Serves as primary client liaison for projects.
• Monitors KPIs and SLAs for assigned deliverables.
• Mentors junior team members by providing training.

Medical Writer – Patient Safety

• Leads or contributes independently to the preparation and compilation of both scheduled and ad-hoc aggregate safety reports.
• Independently performs signal detection activities by collecting and analyzing data from various sources.
• Manages client interactions effectively; handles routine queries independently while escalating complex issues.
• Applies knowledge of global regulatory requirements to ensure timely, high-quality deliverables through robust quality control.

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