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This position has overall responsibility for the successful initiation, planning, design, execution, monitoring, controlling and closure of a project/program. Primary responsibilities include ongoing project management of one or more departmental projects and or programs which may include but is not limited to Risk Evaluation & Mitigation Strategies (REMS) program commitments and department-wide initiatives by collaborating with key stakeholders, including but not limited to, Regulatory, PVE, Commercial, Medical Affairs, Legal, IT and external vendors. This position requires strong leadership, business partnering, and activity planning/sequencing and strategic influencing skills.
- Manager REMS PM, Standards & Collaborations within PVE
Specific Responsibilities and Skills for Position
- Utilizes strong operational and project management skills to manage the operational aspects of REMS programs at Gilead PVE
- Liaises with internal and external groups to maintain a high level of quality and consistency across cross-functional teams on best practices, industry standards
- Excellent interpersonal and communication skills, both written and oral
- Ability to effectively represent PVE on multidisciplinary teams
- The ability to provide direction to a team and to influence peers and team members appropriately including but not limited to delegate tasks to project teams or working group members to drive performance
- Ability to provide constructive feedback in a timely manner high-energy and fast paced environment
- Experience with managing vendors, partners including specialty pharmacies, external PMO’s highly preferred
Essential Job Duties and Functions
- Leads and manages PVE projects and REMS programs, taking responsibility for specific projects, with minimal direction from senior management
- Leads cross-functional projects and serve as a point of contact to other functions in the organization and outside the organization
- Manage ongoing REMS program commitments/ department-wide initiatives by collaborating with key stakeholders including but not limited to, Regulatory, PVE, Commercial, Medical Affairs, Legal, IT and external vendors
- May include task management of junior employees as required
- Responsible for internal and cross functional team representation and will lead cross functional projects as required including areas related to regulatory submissions for REMS programs per standard procedures
- Addresses identified issues escalated to management and coordinates for resolution
- Contribute to managing implementation related activities for REMS including but not limited to; website and print material verifications following FDA approval of an initial REMS or program modification to ensure compliance
- Ensures team compliance with internal processes to meet all applicable internal/external reporting requirements for PVE and REMS
- Oversees training and/or on-boarding activities, preparation and training materials for staff and vendors
- Assists with periodic training of REMS vendors and specialty pharmacies on AE reporting process and REMS-specific requirements.
- Understands and manages the execution of PVE Business Continuity processes, as applicable
- Ensure REMS vendors adequately perform their contractual activities
- Assists with strategic planning for development and/or revision of REMS process workflow and REMS related procedure documents.
- Provides support in internal and external audits and inspections
- Contributes to PVE S&C initiatives and goals as required
Manager/Project Management skills required:
- Comfortable as a Change Agent in a complex, dynamic environment
- Manages conflict resolution and has experience with risk management
- Excellence at resolving complex, interdependent activities into tasks and sub-tasks that is documented, monitored and controlled
- Works in partnership with project leaders to ensure timely, efficient, and effective moderation of meetings, and to ensure adequate progress on team activities between meetings
- Co-Chairs Project Team meetings and is responsible for coordinating moderately complex team operations and communications
- Directs project communications and ensures that all project customers are fully informed and knowledgeable of project activities and their status
- Organizes Project Management support for various functional areas on the Project, attends sub-team meetings as necessary; organizes ad hoc working groups
- Ensures that Development Plans optimize the integration of timing, scope and resources
- Represents the Project Team or Working Group team to the PVE Leadership or Program Steering Committee. Organizes preparation of moderately complex documents and/or procedures for review by the PVE Leadership or Program Steering Committee for projects within PVE
- 7+ years of relevant experience with BA/ BS
- 5+ years of relevant experience with MA/ MS
- A scientific background or experience in pharmacovigilance and/or REMS preferred.
Relevant experience consists of work in a scientific field or equivalent experience in association with R&D program teams and/or in cross-functional program management activities.
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For Current Gilead Employees and
Please log onto your Internal Career Site to apply for this job.