NOLA Medical Lead - Specialty Care

MEDICAL:

• Ensures that 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.

• 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/or other direct reports. MSLs KPIs revision and follow up.

• Promotes the Development and maintenance of professional relationships among medical managers with KOLs and academic centers to be partners 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.

• Promote the personal development plan of his/her direct reports (MM, MSL).

• Collaborate with the medical affairs teams (regional lead and Scientific medical Expert) in the implementation of global / regional strategies.

• Key Opinion leader’s devolvement.

• Participate in POA and Pre-POA business meetings.

• Authoring of medical papers.

• Acts as speaker of scientific information related to the products as needed.

• Advisory Board and speaker training coordination.

• Periodic field work activities together with medical managers executing visits with physicians, KOL, associations and MSL coaching.

 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.

• 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 Regulatory Affairs in preparation of the Risk Management Plan along the conduct of all Post Authorization Safety Studies (PASS) conducted as a result of a commitment to the MoH as a condition of marketing approval.

• Review and assess the medical manager's leadership to publish the strategies for local clinical and epidemiological trials in adherence to Pfizer requirements.

• Participate and assess 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 medical team responsibility.

MARKETING Collaboration

• Ensures the full involvement of the medical team to provide scientific and medical inputs during the setup of new products, working together with Business Analytics and Insights area.

• Provides input, assessment and strategies to medical managers and MSLs to optimize the performance during product launch process, including medical team participationin Strategic Planning/New Product meetings.

• Promotes the close collaboration among medical managers and CBL/CPL providing medical and scientific knowledge to support the design of marketing campaigns and the development of Promotional Materials and/or activities of Pfizer products for the assigned therapeutic areas.

• Provides input and assessment reviewing the validation of scientific contents of the activities sponsored by Marketing and Customer Engagement Programs developed by medical managers together with the CBL/CPL.

• Facilitates and supports communication with Medical Associations, the Ministry of Health, and Academic Institutions for projects related to Medical and Marketing Areas, including Continuous Medical Education Programs.

• Supports the identification of new Key Opinion Leaders useful to develop material for scientific presentations of the portfolios entrusted.

• Evaluate and promote the adequate involvement of medical managers in the execution of trainings for each of their portfolio or products under medical team responsibility.

• Ensures and promote among medical managers the correct implementation of those medical aspects of scientific events (educational and/or promotional), in the process of selecting speakers, assuring ethics and scientific content (Communication management to Sales Force, Media, and Opinion Leaders) for Continuous Medical Education Programs.

• Maintains close communication with Regional Team members of Pfizer portfolios/products for the medical team assigned therapeutic areas, actively participating in teleconferences and in the annual meetings MM/PP (Medical leads/Medical Managers/Product Physician meetings).

• Provides input, feedback, and collaborates in Market Research activities, where medical is involved, as needed.

• Provides medical and scientific support to Corporate Affairs area in relation to public dissemination of Pfizer products for the assigned therapeutic areas.

• Actively participates in POA and Pre-POA business meetings and other medical trainings.

• 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 training with continuous focus on business needs.

REGULATORY

• Reviews the steps and information needed for product registration, including meetings with Regulatory Authorities, to support the Regulatory Affairs Department.

• Reviews, assesses and approves the Medical and Scientific information developed by medical managers that will be submitted to national, local, and private/government formularies and listings. As well as 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

• Review and Follow-up with the medical managers, any topic about Adverse Events (Spontaneous and/or within Clinical   Trials) reported to the Drug safety Unit that medical has supported or is aware of.

QUALITY STANDARDS

• Ensures that medical team is accomplished by winning the right way and owning Pfizer culture.

• Complies with Training Curricula.

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

• Manage and coach MSLs and/or other direct reports. MSLs KPIs revision and follow up.

Technical

·       Leadership, working team and group management abilities.

• Technically updated in local regulations

• Fluency in English (both written and spoken)

• Ability to prepare presentations and deliver public speeches

• Abilities in negotiation and effective communication among own team and related internal/external areas

• 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

Leadership:

• Maintain focus on performance, execution and effectiveness

• Contribute to an inclusive atmosphere

• Encourage open discussion and debate

• Handle change

• Develop his/her colleagues

• Alignment through Pfizer inclusive culture

• undefined

• Organizational:

  Integrity Innovation Respect for People Customer focus oriented Teamwork Leadership

• Functionality:

  ·       Leadership

  ·       Strategic thinking

  Analytical thinking Good planning and organization Judgment for decision-making Initiative Focus on business Set priorities Effective communication Teamwork Business and financial acumen Focus on results Sense of urgency Business travel

• Certifications:

  A minimum of 5 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. GCP training is a plus.

• Education

  ·       Medical knowledge in the assigned medical area of the products.

  ·       Medical degree required: preferably specialty

• Experience

  ·       Experience in project & budget administration and management.

  ·       People management

Work Location Assignment: Hybrid

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.

Medical