Descripción de la oferta
Service expansion: Se valorarán las candidaturas que puedan aportar certificados oficiales de discapacidad.
Las únicas localizaciones disponibles para nuevos empleados serán Madrid, y Barcelona de forma excepcional para algunas funciones específicas.
Position Summary
The Medical Review Excellence Manager will be a key member of the Medical Review (MR) Group by acting as a key partner to in-country Medical Affairs and Marketing colleagues. The MR Manager role does medical and regulatory review 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. The role also includes the review of internal training materials. 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.
Position Responsibilities
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 MR 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.
Provides consultation for Marketing and Medical leads in support of compliant content creation as required.
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.
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.
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.
To maintain knowledge about local regulations, 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 and stakeholders.
Ensure handling of complaints related to promotional materials together with the Country Medical Director and local MR lead.
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 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.
Support international and national congresses to assure they comply with local regulations.
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, MR platform and content factory.
Education and Experience
Graduate/Post-graduate/PhD in life sciences.
Experience:
4+ years of experience.
At least 3 years of experience in medical writing or review within an agency, CRO, Pharma / Biotech.
Experience in collaborating with Global stakeholders and managing stringent timelines.
Prior experience in medical content creation or promotional material review.
Prior experience in conducting medical reviews or QC of regulatory documents.
Experience in any therapeutic area.
Technical Skills Requirements
Review/QC skills: Excellent review or QC skills. Experience in promotional/medical material review or content review would be an asset.
Regulatory knowledge: Interest in legal and regulatory aspects of promotional compliance. Familiarity with local regulation/code. Familarity with global regulatory guidance such as International Conference on Harmonization (ICH), European Federation of Pharmaceutical Industries and Associations (EFPIA), European Medicines Agency (EMA), and Agencia Española de Medicamentos y Productos Sanitarios (AEMPS).
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: Fluent in English and Spanish.
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 prioritize according to the needs.
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.
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing us to be as diverse as the patients and communities we serve. Together we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
#J-18808-Ljbffr
