Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
- Sr. Medical Operations & Project Manager will be responsible for supporting the implementation of regional/global projects and on-going improvement of operational aspects of Medical Affairs programs (including relevant reportings and documentation of med/education events, advisory boards, scientific exchange meetings, budget control),
- This role also aims excellence in medical activities, and enhanced efficiency of Medical Capabilities within department.
- SMOPM will be responsible for large, multistakeholder involved projects like risk management plan, diagnostic services, global access to medicine , as well as medical Information process coordination, local policies and SOPs creation / update.
- Sr. Medical Operations & Project Manager will be directly reporting to medical director and will have close collaboration with associate medical directors , MSLs, team co-ordinators data entry specialist, regulatory&quality, customer operations, finance and sales forcewithin organization.
You will be responsible for:
Medical Operations & Excellence
- Support the Medical team in planning and execution of medical activity plans of Medical Affairs, including but not limited to ad boards, medical education events and symposia, scientific communication programs.
- Ensure that all the country needed policies and SOPs are in place, adapted and updated according to the corresponding Global documents and local regulations.
- Support Medical team in the preparation of audits and inspections, in the proper follow up of actions and implementation of CAPAs.
- Track and support the flawless execution of Medical Affairs Plans including budget control and follow-up
- Review and update Medical Affairs Plans follow-up regularly and report data within and above affiliate
- Address the requests from Global and International Medical Operations (not limited to country dashboards & investments)
- Support the onboarding of new Medical Affairs employees including training programs and keep proper evidence of training records
- Take part in Medical Affairs and Cross-Funcional team meetings
Risk Management & Patient Support Program Responsible
- Co-ordinate annual vendor agreement process and follow-up PR/PO processes with team coordinator and finance department
- Management of all risk management program workflow and monitor operational processes according to the approved KPIs, SOP and the valid agreement
- Ensuring team management and coordination within the scope of RMP.
- Organizing regular alignment meetings with RMP management team complying risk management plan SOPs.
- Following up physician and pharmacist consents within the scope of risk management program
- Controlling monthly expenses of RMP team with data entry specialist and finance team members.
- Working closely with customer operations department for controlled distribution
- Deliver relevant RMP trainings to Alexion team members as well as RMP team members/vendors
- Regular reconcilliation with regional and global patient support program responsibles
- Track PSP start/termination/revise processes and documentation with PV, regulatory and above affiliate responsibles
- Overview and lead preparation/approval from HA/distribution of materials with relevant parties
Diagnostic Service Responsible
- Management of Diagnostic Services, vendor, coordinating vendor agreement process
- Controlling and approving the diagnostic services invoices with Medical Data Entry Specialist and Finance Department
- Performing or coordinating audits and inspections regarding diagnostic services ( PV, services, financial, call center process, data privacy etc.)
- Preparing and updating SOPs regarding Diagnostic Services
- Coordination of Diagnostic Vendor’s providing kit and other necessary materials to laboratories in Turkey regarding PNH, aHUS, HPP and LAL-D
- Coordination of communication between Diagnostic Services vendor company and Alexion Turkey, including diagnostic testing problems of HCPs
- Lead project as single point of contact for relevant parties
Global Access to Medicine Responsible
- Coordination of GATM program with Global GATM department and HCPs
- Controlling shipment agreementsManagement of drug orders in GATM program
- Following up drug deliveries and related temperature data
- Periodic reporting of GATM process to health authority collaboration with Regulatory Affairs
- New GATM patient submission collaboration with Regulatory Affairs
- Coordinating agreement process with vendor for GATM program
- Submission for any new programs/updates to HA in collaboration with regulatory & quality department
- Provide regular forecasts to above affiliate parties and organize supply
Local Med-info Designee
- Serving as the point of contact for the Medical Information Contact Center (MICC)/Global Medical Information(GMI) for Turkey.
- Communicating in advance, as possible, to GMI/MICC any country-level regulatory (eg, product label update), legal or other specific information (eg, local congresses) that may have an impact on enquiry handling or customer service delivery.
- Ensuring all Alexion Turkey employees are trained on identifying and transmitting medical information enquiries; the training is documented; and records are maintained.
Responsible for reporting all pharmacovigilance events, product quality complaints and medical information requests within 24 hours as of awareness according to the local applicable procedures.
You will need to have:
- Pharmacist or medical doctor
- Experience in Pharmaceutical/Biotechnology industry (3-5 years)
- Proven Project Management experience, demonstrated ability to manage projects regarding diagnostic service or infrastructure, drug related risk management plan or similar projects preferred
- Demonstrated ability to manage multiple projects and competing priorities.
- Excellent multitasking and prioritization, collaboration, and communication skills to facilitate team discussions and drive optimal team performance.
- Proficient in developing reports for leadership oversight.
- Knowledge of local pharmaceutical regulations,SOPs of Alexion and ABAC rules.
- Solid background and experience in pharmaceutical quality system management (GxP)
- Computer skills,MS Office programs
- Admin and organizational skills
- Fluency in English both written and oral mandatory
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: www.alexion.com.
Alexion 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 accommodations@Alexion.com. Alexion participates in E-Verify.
AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you're interested in career opportunities with AstraZeneca, click here.
