Sr. Medical Review Excellence Manager - Greece

The Senior Medical Review Excellence Manager will be a key member of the Medical Review Excellence (MRE) Group by acting as a partner to in-country Medical Affairs and Marketing colleagues. The Senior Medical Review Excellence Manager role aims to minimize compliance risks by ensuring review and approval of promotional and non-promotional marketing materials as well as Medical to Medical content in conformity with all applicable country law, regulation and industry code, undertaking Final Country Signatory (FCS) duties where applicable. As an active thought leader and medical processes partner, this role will also draw upon best practices to identify new ways of working and drive continuous improvement that generates value for medical colleagues in-country.
Strategic oversight

• Subject Matter Expert and single point of contact for Medical Review Excellence 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 MRE 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

• 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.
• 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 programs, 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 programs 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 programs (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 Compliant with regulations.
Provides clear feedback and suitable recommendations to enable the above.
Stakeholder Management

• 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 license maintenance activities as required.
• Manages local code/regulatory complaints and intracompany dialogue to the extent required 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 Pfizer's materials, initiatives, and programmes in-country.
• Act as Final Country Signatory (FCS) where applicable.
• Liaise with local health authority/regulatory agency as appliable.
• 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.
• 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.
• 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 MRE function.
• Lead/support creation and update of local policies, procedures and guidance as needed for MRE.
• Work collaboratively with team members and core stakeholders (internal and external) and to the agreed timelines. Effectively manage own time and workload.
• Lead 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.
• Develop processes and workflows to build efficiencies and value add for stakeholders.
• Support in-country execution of opportunities against recommendations quickly and with flawless accuracy.
• Support in-country and cross-functional country projects and manage BAU transition.
• Create and lead local operational processes and practices (as needed) that drive efficiencies for the MRE 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

• External - Content creation agencies, vendors and CoLab.
• Internal - Local/Regional/ Medical Leads Local/Regional Marketing Teams, Biopharma Ops, Country Medical Director and medical teams in-country, MRE platform and content factory.

Education:

• Master's level in Life Sciences/Pharmacy/Medical sciences or equivalent degrees.

Experience:

• Preferred 4 to 6 years relevant experience for medical graduates, PhDs & masters in life sciences.
• Preferred 3 years of experience in medical writing/review.
• Experience in collaborating with Global stakeholders and managing stringent timelines.
• Prior experience in medical content creation or promotional material review is preferred.
• Prior experience in conducting medical reviews or QC of regulatory documents is preferred.

Technical:

• Review/QC skills: Excellent review or QC skills. Experience in promotional/medical material review or content review would be an asset.
• Analytical skills: Proficiency in analyzing scientific claims and checking the same against the references. Familiarity with statistical/epidemiologic principles and concepts is desirable. Conducts and interpret analyses and interpret routine medical and safety analyses without guidance from team members.
• Language skills: High fluency in written English and Greek and strong functional fluency in spoken English.
• Personal skills: Ability to work independently with high accountability. Strong organizational skills and ability to prioritize multiple projects and meet deadlines. Solution driven and quality oriented.
• Interpersonal skills: Collaborative business acumen, team spirit and interest in cross-functional collaboration with local and global teams. Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy. Ability to work well with all levels and roles and to prioritize according to the needs.
• Regulatory knowledge: Interest in legal and regulatory aspects of promotional compliance. Familiarity with local regulation/code preferred. Familiarity with global regulatory guidance such as International Conference on Harmonization (ICH), Food and Drug Administration (FDA) is desirable but not essential.
• Software: Digital Affinity, sound user skills of IT-processes. Previous experience with software commonly used to present and analyze data (Word, PowerPoint, Excel) is preferred.
• Synthesize analyses of medical and scientific data into clearly written text without supervision.
• Understands medical concepts of the disease and the specific approach to treatment.
• Swift familiarization with different therapeutic areas and scientific content.

Work Location Assignment: Hybrid
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