9568 Sr. Project Operations Manager
Responsibilities:
Support the Global Regulatory Policy Team in the following regulatory policy activities:
Review and inform on recently published global regulatory legislation and policies impacting development of treatments for rare diseases.
Provide project management support to the policy team in generation of comments on draft guidance’s.
Track Team memberships and involvement in policy trade associations and organizations.
Actively monitor and track policy meetings, track policy team activities and reports, track relevant policies and regulations.
Lead certain policy cross-functional meetings including minutes and action items.
Provide strategic logistical support for managing policy calendars and deliverables.
Develop and manage internal policy publications.
Develop and manage dashboards for policy team initiatives
Develop, track and manage regulatory conferences and inform internal stakeholders of such conferences.
Manage global policy deliverables, workload tracking, policy tracker, and SharePoint archival system.
Manage Trade Association List and Memberships including main contacts.
Responsibilities will also include a portion of time for any of the following:
Support the organization and project management of Expert Advisory Council (EAC) meetings, liaising with external experts, sharing material, project managing EACs.
Collaborate with WWRD Strategic Risk Management lead to plan EACs including cross functional meetings to coordinate content generation ahead of EACs.
Document EAC feedback/learnings and track mitigative actions against risks.
Support the management of WWRD Continuous Risk Management (CRM) platform across programs ensuring risks are identified and tracked.
Collaborate with Strategy, Scientific Collaborations and Policy (SSCP) Executive Coordinator to ensure appropriate contracts are in place to support vendors/services across SSCP, including for Strategic Risk Management and R&D Communications and Engagement.
Document project milestones/deliverables and report progress against team, department, and corporate goals.
Create and maintain project timelines for key activities and ensure that they are functional, consistent and integrated to reflect cross-functional dependencies.
Create and maintain program-specific risk assessment dashboards and management framework.
Manage SSCP meetings where projects will be discussed (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership may be required).
Provide project management support for cross functional meetings including program planning, key action items, and progress on deliverables.
Create and track progress on milestone program timelines and key deliverables across portfolio.
Assist in the development and documentation of processes and best practices across SSCP, including for Strategic Risk Management and R&D Communications and Engagement
Education:
Bachelor’s or Master’s degree in biology or other life sciences discipline.
Project Management Professional.
Experience:
At least 7 years’ experience in project or program management; a minimum of two years’ experience managing teams and team operations.
Pharma/biotech industry experience required, including at least 1 year in Regulatory Affairs and/or policy.
Experience with MS Office and MS Project Online, or similar scheduling software, required or proven skill at adapting to new software/technology.
Exposure to electronic document management system(s) (EDMS) and registration tracking systems helpful.
The candidate should possess the ability to work as part of an interdisciplinary team, have strong organizational skills, excellent interpersonal and communication (written and verbal) skills and understanding of biotech/pharmaceutical industry and nomenclature.
Strong attention to detail.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.