The Medical Writing Operations Manager is a member of the Clinical Communications team within the global Medical Writing department. The role provides comprehensive, operational expertise in medical writing and vendor quality standards, partnering with internal and external groups to provide operational support and to ensure, compliance, and promote innovation in reporting deliverables. JOB RESPONSIBILITIES
QUALIFICATIONS / SKILLS
- Provide guidance to medical writing vendors and project teams on standard processes for preparing interventional, clinical study reports (CSRs), non-interventional study reports, safety narratives, and associated deliverables within scope of Clinical Communications. Guidance is based on understanding and knowledge of the underlying operational principles of applicable processes.
- Plan and manage project timelines to ensure that vendors complete deliverables within agreed-upon timelines. Identify, communicate, and resolve issues affecting project timelines.
- Manage routine vendor interactions, including preparation of work requests, procurement of access to internal systems, and monitoring of training compliance. Attend regular operational governance meetings with vendors. Assist management with forecasting by generating and/or reviewing reports from internal systems.
- Facilitate inspection readiness for processes in SOPs (Standard Operating Procedures)/Work instructions (WIs) used by Clinical Communications. Review documentation in trial master file and other systems associated with the CSR SOP. Respond to document requests before and during inspections. Assist management in the development of responses or corrective actions/preventive actions (CAPAs), as needed.
- Prepare CSR amendments and errata as needed.
- Supports and advances the implementation of process initiatives and technologic innovations to improve operational efficiency of business processes. Suggest moderately complex changes to improve operational efficiency.
- At minimum Bachelor degree or equivalent in medical-related field or life science. Post-graduate degree preferred.
- BS/BA +5 years, MS/MA +3 years of medical writing or vendor management experience in the pharmaceutical or biotech industry.
- A comprehensive understanding of the drug development process.
- Experience in vendor management and overseeing multiple deliverables at various stages across vendors.
- Advanced knowledge of ICH and other regulatory guidelines; demonstrated comprehensive ability to interpret and apply these guidelines.
- Ability to work independently, multi-task and work effectively under pressure; adapt to change as needed; can solve moderately complex problems and possess excellent project management and issue resolution skills.
- Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with program level colleagues.
- Ability to communicate with study and program level teams to set realistic timeline expectations.
- Demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues, appropriately.
- Knowledge of vendor processes, contracting, and best practices in outsourcing.
- Experience and working understanding of document management systems.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Position located at GPD site or remote work location. Primarily an office-based position involving computer work, attending meetings, making presentations, participating in global conference calls that accommodate time zones.
- Ability to professionally communicate both verbally and in writing in English. Can discuss clinical data succinctly and accurately with cross-functional lines, scientific staff from a range of disciplines, and all levels of management
- Some travel (~5%) across GPD sites for face to face meetings, if necessary. Depending on location may need to accommodate global teleconference calls across different time zones.
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