Manager, GMA, Strategic Planning
Edison-New Brunswick Metro Area, NJ
Collaborate with Medical Affairs disease teams to coordinate timing, development, and approval of Medical Affairs tactical plans and aligned budgets.
In partnership with disease teams, attend meetings with Corporate Medical Affairs to review progress to publication plans and business reviews
Manage the identification and compilation of Medical Affairs key departmental goals and track monthly, quarterly, and annual performance against goals.
Strategize with Head, Medical Affairs Strategic Planning and Medical Affairs Disease Leads to prepare for governance committee and decision board meetings and communicate outcomes as appropriate (including scheduling and tracking of agenda items, supporting presentation development, tracking of completion of action items)
In tandem with the Global Disease Teams, review/update Open Data Questions (ODQs) for each disease area and lead the operationalized endorsement.
With each Therapeutic Area Global Disease Team, establish annual Tactical Plans and lead the operationalized endorsement.
Identify and develop content for external use at Global Medical Affairs receptions
Manage external vendors to ensure compliant attendance and established 3rd party involvement for Global Medical Affairs Receptions
Development of relevant content for Scientific Directors meetings and Global Medical Affairs Leadership Team meetings
Partner with Medical Affairs Team to track investigator-initiated trials against open ODQs.
Partner with Clinical Research and Development and Medical Affairs teams globally to develop/update dashboards to track MASTs, including study opening, study enrollment, data clean-up, study closure, and reporting of results
Collaborate with Corporate Medical Affairs to develop/update dashboards for IIT studies to track study approval, study opening, study enrollment, study completion
Coordinate cross-functional project review meetings and prepare progress reports as required
Liaise with MAST vendors to ensure Service Level Agreements are adhered to and Quality assessments are communicated
Processes and Systems
Work with key stakeholders to identify best practices across Medical Affairs Functions globally and identify areas of improvement
Participate in the development of planning tools, templates, processes to support Medical Affairs.
Maintain team website(s) and support maintenance of Medical Affairs portal
Partner with Head, Global Medical Affairs Strategic Planning, Corporate Medical Affairs and IT to evaluate hardware and software packages for Global and US Medical Affairs
Upon annual renewal, receive and review SOPs to approve for GMA DL/SD appointment in LMS
Point of contact for company-wide and CR&D process development initiatives
Lead annual ad board planning, guidance, and compliance within the archive system
Lead/support Medical Affairs special projects as required.
Project Management Team Oversight
Oversee and lead the GMA project management team and provide proper support to ensure that the project managers are equipped to fulfill their day-to-day responsibilities
Through the project management team, develop, align, and implement tools and processes to ensure harmonization and synergy of GMA team deliverables.
Bachelor s degree with a minimum 6-8 yrs Pharma experience / 4 years Project management experience or equivalent; MS/ MBA 4 years Pharma experience / 2 year project management experience or equivalent.
Strong project management skills
Strong analytical and planning skills
Fosters team work and is able to build constructive relationships with team members
Capable of managing meetings within a multicultural and cross functional environment
Demonstrated ability to work independently and with others within and across functions/teams
Ability to adapt behavior to situation
Ability to influence outcomes without direct authority
Ability to hold oneself and others accountable for commitments in a productive, collaborative and assertive manner
Possesses good conflict resolution/critical thinking skills
Excellent written and verbal communication skills
Knowledge of project budgeting process including financial planning/expenditures
Computer and systems literate; strong knowledge of MS Office, including Word, Excel, PowerPoint, and Outlook
Experience in planning systems and project management tools (e.g. MS project)
Ability to navigate through data warehouse/repository systems