Medical Manager - Genitourinary Oncology

MAIN RESPONSIBILITIES / DUTIES

MEDICAL:

• 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.

• Collaborates with Drug Safety Unit, Global/Regional Therapeutic Areas and Regulatory Affairs in preparation of the Risk Management Plan of the products under her/his responsibility.

• Collaborates with Regulatory Affairs to review and assess the Local Language Document of the products under his/her responsibility

• Management of 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 his/her responsibility following major milestones and budget.

• Provide guidance with regards to do´s and don’ts to commercial colleagues, be role model with regards to Compliance.

·        Be the official spokesperson with MD for their portfolio of products to healthcare authorities.

• Supports MSLs coaching.

• Develop and maintain professional relationships with KOLs, Medical Societies and academic centers to partner in CME projects.

• Manage Medical Affairs annual budget as planned.

• Develop the Medical Affairs annual local plan, aligned to brand objective(s), and coordinate derived tactics.

• Assure Medical Affairs plan execution with the collaboration of the MSL.

 CLINICAL RESEARCH

• 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 MoHas 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.

MARKETING

• 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.

REGULATORY

• Reviews/validates and approves the updated Local Product Documents (LPDs) and Package Inserts of assigned products in accordance with the corporate information and with Local Regulatory requirements. 

• Supports the Regulatory Affairs Department during the process of product registration in the country, including preparation of meetings with the Regulatory Authorities.

• Prepares the Medical and Scientific information that will be submitted to national, local, and private/government for formularies and listings.

• Coordinates the preparation of Medical and Scientific dossier to include new therapeutic indications, formulations, and second and third brands together with the Regulatory Affairs and Medical information Departments, guaranteeing that the Product Information is consistent with the LPD (Local Product Document), International Product Information, Summary Product Characteristics, United States Product Information (USPI); as well as in adherence with the Pfizer SOPs and Local Regulations.

MEDICAL INFORMATION AND PHARMACOVIGILANCE

• Follow up with the Drug Safety Unit on any topic about Adverse Events (Spontaneous and/or within Clinical   Trials) that may require his/her medical support.

• Close interaction with Medical Information supporting dossiers and promotional material needs.

QUALITY STANDARDS

• Complies with the Training Curricula.

• Attend all the required training meetings according to established timelines.

• Knowledge and full participation on the Inspection Readiness Process and the applicable procedures before, during and after corporate audits or regulatory inspections.

REQUIRED SKILL SET

Technical

• 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)

Managerial

Leadership:

• Maintain focus on performance

• Contribute to an inclusive atmosphere

• Encourage open discussion and debate

• Handle change

• Develop his/her colleagues

• Alignment through Pfizer

Organizational:

• Integrity

• Innovation

• Respect for People

• Customers focus oriented

• Teamwork

• Leadership

• Performance

• Community

Functionality:

• Strategic thinking

• Analytical thinking

• Good planning and organization

• Judgment for decision-making

• Initiative

• Focus on business

• Set priorities

• Good communication

• Teamwork

• Leadership

• Focus on results

• Sense of urgency

• Business travel

Certifications

• A minimum of 3 years’ experience in positions within clinical practice or linked with medical affairs, R&D, medical-marketing, marketing, clinical research or medical direction, preferably within the pharmaceutical industry.

Education

• Medical knowledge in the assigned medical area of the products entrusted.

• Medical degree required: preferably specialty

Experience

• Experience in project & budget administration and management.

EEO (Equal Employment Opportunity) & Employment Eligibility 

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.