Together with the cross functional team identify and discuss the scientific question and determine the need to conduct locally sponsored clinical trials (e.g., phase IV clinical trials, epidemiological, Pharmacoeconomics, RWE etc.) to support the strategies of the assigned Pfizer products.
Responsible of the locally sponsored clinical trials, proposing investigators, site identification, coordinates investigators´ meeting and once the clinical trial is ongoing will continue to have direct contact with investigators and the medical overview of the trial. Manage timelines and budget ensuring that information related to the protocols is sustained in Pfizer Corporate Clinical Trials Registry systems.
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.
Collaborates with Drug Safety Unit, Global/Regional Therapeutic Areas and Regulatory Affairs in preparation of the Risk Management Plan along with the conduct of all Post Authorization Safety Studies (PASS) conducted because of a commitment to the MoH as a condition of marketing approval.
Lead the publication strategies of local clinical and epidemiological trials in adherence to the Pfizer requirements.
Participate before, during, and after audits and inspections when required and during the implementation of the Corrective Action/Preventive Action (CAPA) of the clinical studies under his or her responsibility.
Full involvement in providing scientific and medical inputs during the setup of new products, working together with Business Analytics and Insights area.
Collaborates during product launch process, including his/her participation in Strategic Planning/New Product meetings.
Collaborates with CBL/CPL in designing marketing campaigns, providing medical and scientific knowledge during the development of Promotional Materials and/or activities of Pfizer products for the assigned therapeutic area.
Reviews and validates scientific contents of the activities sponsored by Marketing and Customer Engagement Programs together with the CBL/CPL.
Maintains close communication with Medical Associations, Ministry of Health and Academic Institutions for projects regarding Medical and Marketing Areas, including Continuous Medical Education Programs.
Develops with Key Opinion Leaders material for scientific presentations of the products entrusted.
Collaborate in the training of their portfolio of products under their responsibility.
Coordinates Medical aspects of scientific events (educational and/or promotional), selecting speakers and assuring ethics and scientific content (Communication management to Sales Force, Media, and Opinion Leaders) for Continuous Medical Education Programs.
Train the trainers and their commercial colleagues on product and disease knowledge of their portfolio of products. Validate training materials.
Maintains close communicationwith Regional Team members of Pfizer products for the assigned therapeutic area, actively participating in teleconferences and in the annual meetings of MM/PP (Medical Managers/Product Physician meeting).
Provides input, feedback, and collaborates in Market Research activities as needed.
Provides medical and scientific support to the Corporate Affairs area in relation to public dissemination of Pfizer products for the assigned therapeutic area.
Actively participates in POA and Pre-POA business meetings and other medical training.
Actively participates in authoring or reviewing medical papers.
Strategically coordinates, develops and implements Advisory Boards and speaker training with continuous focus on business needs.
Periodic field work activities /visits with physicians now in separate sessions from Sales Representatives.
Technically updated in local regulations
Fluency in English (both written and spoken)
Ability to prepare presentations and deliver public speeches
Ability to teach and train
Abilities in negotiation and effective communication
Excellent abilities in strategic and interpersonal influence
Knowledge of scientific, ethical, regulatory and legal aspects which allow the conduction of research trials in human beings
Handle computer software, specifically Microsoft Office, internet and other basic electronic tools
Business and Financial acumen (budget management)
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