Strategic Operations Lead, Global Medical Information and Medical Review
hace 4 semanas
This is what you will do:
The Director, Strategic Operations Lead, Medical Information and Medical Review (GMI-MR) is responsible for providing business and operations strategy partnership for global medical information and medical review. This individual will manage all Global Medical Information & Review operations, including governance of global contact and call centers, other vendors, ensuring audit and inspection readiness and providing oversight of all Standard Operating Procedures (SOPs), Working Practice Documents (WPDs), Budgeting, and Training Materials. This person will also be responsible for identifying and implementing operational efficiencies and ensuring systems/databases support efficient workflows, and metrics inform strategic growth and resource allocation. As Strategic Operations Lead, this individual will have a pivotal role in defining the digital strategy roadmap for GMI-MR in close partnership with Global Medical Affairs.
You will be responsible for:
Overseeing the Strategic Operations function of Global Medical Information and Medical Review (GMI-MR) department ensuring continual improvement and Operational Excellence of Medical Information and Medical Review process and between therapeutic areas. Creating quarterly and annual metrics to broadly educate on key deliverables and turn-around times, inform strategic growth and determine appropriate resource allocation. Driving departmental annual budgeting planning process, tracking and reporting monthly accruals / forecasts, and ensure spend is within 5% of Annual Operating Plan (AOP). Managing a global internal team as well as vendors, ensuring audit and inspection readiness and providing oversight of all Standard Operating Procedures (SOPs), Working Practice Documents (WPDs), oversight of metrics and insight reporting, and training materials, modules and/or curriculums related to GMI-MR. Providing oversight of Medical Review by contributing to process improvements, providing guidance, and collaborating with cross-functional leaders, and serving as a point of contact for process escalations Oversight of Medical Material Review [MMR] Operations, vendor management, departmental project management, budget planning, customer insights and KPI reporting. Provide on-site operational support for Medical Information booth at Tier 1 European Congresses Oversight of all GMI-MR technology, systems, and databases (including global medical information database and call center). Evaluating, establishing and maintaining the operating model and global style guide for the development and maintenance of GMI response documents. Managing development and oversight for all GMI-MR training materials, including development of all applicable training modules, curriculums and maintenance of departmental training matrix. Achieving and maintaining compliance with all applicable regulatory, legal and operational rules and procedures by ensuring that all plans and activities for and on behalf of Alexion are carried out with the best industry practices and the highest ethical standards. The employee carries out this role in accordance with departmental SOPs, corporate policy and other legal and regulatory requirements.You will need to have:
Advanced degree or commensurate experience in health sciences, business administration, or project management with 7+ years of experience in the biopharmaceutical industry preferably in Medical Affairs, Medical Information, or Medical Communications Demonstrated people management experience (3-5 years) and ability to develop staff. Experienced in contracting, finance and approvals, and performance management. Demonstrated strong project management skills (5 years) and proven ability to execute on small and large projects via direct reports or via a matrixed environment. Experience in developing work practice documents, SOPs and effective training materials Vendor management and budget oversight experience Highly detail-oriented and proven ability to collaborate cross-functionally. Excellent written and verbal communication skills Self-motivated to drive for results, with strong organizational and planning skills. Highly proficient with Microsoft Office Suite Ability to travel to meetings / conferences (predominantly in Europe) as required, varied by quarter but approximately 15% of the time. The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:
PharmD, MD or PhD with operational experience PMP certification Extensive experience working with medical information or medical communication systems / databases (e.g., Veeva) Medical information / medical communication experience globally. Understands drug development, health authority regulations, reporting requirements for pharmacovigilance events and product complaints, and best practices for handling medical information requests both US and internationally. Experience working in medical, legal, and regulatory (MLR) review committee for the review and approval of promotional and non-promotional materials. Experience leading medical information initiatives for a product launch. Training or past experience in assigned therapeutic area(s) or rare-disease, nephrology, hematology, oncology, neurology, enzyme-replacement therapies. Demonstrated project management skills. People management experienceDate Posted
05-Apr-2024Closing Date
30-Jul-2024Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact . Alexion participates in E-Verify.
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