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hace 7 meses
**MAIN REPONSIBILITIES / DUTIESMEDICAL**: -Ensures that category medical team provides support and the necessary medical and scientific information of Pfizer Biopharmaceutical Group products to internal and external customers assuring compliance with Corporate and Local Procedures and applicable regulations providing full support to our local medical objectives. Develop long-term relationships with a wide variety of key healthcare stakeholders and external customers to include Medical Groups and key opinion leaders in order to demonstrate clinical value of Pfizer's assets and ensures that medical team provides support and the necessary medical and scientific information of Pfizer Biopharmaceutical Group products
- Develop, in conjunction with team members, the therapeutic area medical strategy and an advanced perspective of the evolving clinical and healthcare landscape of the designated medical areas. Collaborate cross functionally with internal colleagues from Regulatory, Commercial, PIH and other cross functional areas to drive strategic direction for the brands within the therapeutic area, assuring compliance with Corporate and Local Procedures and applicable regulations
- Identifies, support and coordinate everything needed to collaborate with Drug Safety Unit, Global/Regional Therapeutic Areas and Regulatory Affairs in preparation of the Risk Management Plan of the products under medical team responsibility. Collaborates with Regulatory Affairs to review and assess the Local Language Document of the products under his/her responsibility
- Reviews, approve and asses medical managers in the whole process of the Clinical and Research Collaborations and Local and Regional Non
- Interventional / Interventional Studies (different from BE studies) as per the applicable Pfizer processes, and to the therapeutic area under medical managers' responsibility following major milestones and budget. Provide guidance and support to medical managers with regards to do´s and don'ts to commercial colleagues, be role model with regards to Compliance. Together or on behalf of medical managers, be the official spoke person with MD for their portfolio of products to healthcare authorities. Manage and coach MSLs and Medical Managers for the category. Promotes the Development and maintenance of professional relationships among medical managers with KOLs and academic centers to be partners in CME projects
- Manage Category Medical Affairs annual budget as planned. Develop the Category Medical Affairs annual local plan, aligned to brand objective(s), and coordinate derived tactics. Promote the personal development plan of his/her direct reports (MM, MSL)
- Collaborate and align with the regional medical affairs teams (regional lead and Scientific medical Expert) in the implementation of therapeutic area global / regional strategies. Key Opinion leaders devolvement
- Participate in POA and Pre-POA business meetings
- Authoring of medical papers. Acts as speaker of scientific information related to the products as need
- Advisory Board and speaker training coordination
- Maintains close communication with Regional and Global Team members of Pfizer portfolios/products for the medical team assigned therapeutic areas, actively participating in teleconferences and in the annual meetings MM (Medical leads/Medical Managers) and ensuring CAC medical voice. Actively participates in the approval, review and publish of medical papers where medical is involved authoring or reviewing contents. Strategically coordinates, develops and implements Advisory Boards and speaker trainings with continuous focus on business needs. Periodic field work activities together with medical managers executing visits with physicians, KOL, associations CLINICAL RESEARCH- Identify the scientific question and determine the need to conduct locally sponsored clinical trials (e.g., phase IV clinical trials, epidemiological, Pharmacoeconomics etc.) to support the strategies of the BU. - Indirectly responsible of the locally sponsored clinical trials, reviewing and approving proposed investigators, site identification, investigators coordination, and execute meetings and once the clinical trial is ongoing will continue assessing medical managers to have direct contact with investigators and the medical overview of the trial. Review and approve timelines and budget ensuring that the information related with the protocols is sustained in Pfizer Corporate Clinical Trials Registry systems and Finance, among others. Reviews, approve and execute together with medical managers and MSLs the management of the whole process of the Clinical and Research Collaborations and Local /Regional Non
- Interventional / Interventional Studies (different from BE studies) and compassionate access programs until their completion to assure adherence to Pfizer requirements and local regulations. As a team promotes the collaboration with Drug Safety Unit, Global/Regional Therapeutic Areas and R
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