About the role:

Strategic oversight:

• Subject Matter Expert and single point of contact for Medical Review to enable lightspeed deliverables for Promotional & Medical-to-Medical review objectives for Medical.

• Identify strategic opportunities for in-country service and operations improvements that align with business priorities & building consensus among cross-functional teams and influence decision making.

• Gather and analyze in-country metrics focused on utilization and performance; develop compelling and insightful strategic recommendations for leadership and the country.

• Close partnership with CMAO categories and country partners to drive active engagement with key Medical and Marketing stakeholders.

• Leads process documentation and improvement as applicable.

Provision of Medical Expertise in Relation to Content of Materials

• To acquire and maintain in-depth scientific knowledge of Pfizer medicines within nominated therapy area(s) (including those in development) as well as the competitive landscape.

• To understand and advocate the appropriate use of medicines with the local health system.

Collaboration with Pfizer teams to Enable Streamlined Content Creation:

• Works with the nominated cross functional team(s) in-country and above-country to develop impactful and compliant promotional and non-promotional materials of value to healthcare professionals and patients. This includes for example:

• advising on marketing programmes other promotional activities and medical education

• providing support for revisions to prescribing information and implementation of risk management plans

• working with digital materials and digital technologies

• collaborating with Medical Affairs colleagues to understand therapy area and share pertinent issues with the relevant teams

• Provides specialist medical scientific and code/regulatory advice to teams during the development phase of materials/projects/activities to support streamlined creation of compliant content/activities that enable appropriate use of Pfizer medicines and successful implementation of materials initiatives and programmes for example:

• advising on and reviewing materials for submission to health authorities

• advising on and reviewing materials for package deals and materials for patient support programmes (eg Homecare)

• Works in collaboration with cross-functional team(s) on preparation and review of training materials for colleagues.

• Provides advice that will ensure that the highest ethical standards are upheld and that Pfizer always remains Pompliant with regulations.

• Provides clear feedback and suitable recommendations to enable the above.

Engages with category Medical and Marketing teams to ensure needs are met for both promotional medical-to-medical as well as corporate and social media materials in-country.

• Develops and sustains constructive continuous improvement focused relationship with leadership and stakeholders.

• Leads in-country communication with different stakeholders and their departments for a coordinated structure of functions and workflow.

• Supports for above-country activities that fall within scope of local regulation/code such as advisory boards symposia PAG donations market research.

• Works in collaboration with local stakeholders to support the local promotional and medical compliance strategies.

• Supports regulatory labelling and licence maintenance activities as .

• Manages local code/regulatory complaints and intracompany dialogue to the extent and advise on corrective and preventative actions.

Technical

• Act as super-user and change leader who provides in-country medical review and approval services in the designated electronic approval system (to support the appropriate use of Pfizer medicines and successful implementation of Pfizers materials initiatives and programmes in-country.

• Act as Final Country Signatory (FCS) where applicable.

• To independently perform fact-check scientific review and medical approval of promotional and medical materials and activities in line with local product label information country-specific code and regulatory requirements.

• To provide solution-focused feedback and recommendations to material owners that enable revisions to be made so that messages in materials ensure the appropriate use of Pfizer medicines and compliance with local code/regulations.

• To acquire and maintain scientific knowledge of Pfizer medicines within nominated therapy area(s) (including those in development) as well as of key competitors and national guidelines relevant to the country.

• High-level expertise about local regulations code and Pfizer policies relevant to creation and review and approval of materials as well as any additional guidance which may apply to the MR function.

• To work collaboratively with team members and core stakeholders (internal and external) and to the agreed timelines. Effectively manage own time and workload.

• Organize trainings on regulatory requirements and promotional material requirements for relevant colleagues

• Ensure handling of complaints related to promotional materials together with the Country Medical Director.

• Support local inspections/audit as defined by the local inspection action plan(s) and applicable local audit processes.

Service expansion:

• Operationalize transformative initiatives: Inception of applicable pilot activities of medical support services and drive them to business as usual with an enterprise mindset.

• Processes and workflows developed building efficiencies and value add for the stakeholders.

• Support in-country execution of opportunities against recommendations quickly and with flawless accuracy.

• Support in-countrycross-functional/country projects and manage BAU transition.

• Create and lead local operational processes and practices (as needed) that drive efficiencies for the MR and associated stakeholders.

• Partner with transformational teams across the organization to support the design and deliver innovation within the CMAO platform with emphasis on the in-country model.

ORGANIZATIONAL RELATIONSHIPS