Senior Medical Reviewer (Temporal 6M)

Pfizer; Madrid; Presencial; EUR 45.000 - 75.000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Senior Medical Reviewer to join their Medical Review Excellence Group. This role is pivotal in ensuring compliance and quality in promotional and medical content. You will collaborate with cross-functional teams, providing strategic oversight and driving process improvements. The ideal candidate will have a strong background in medical writing and regulatory compliance, with a passion for enhancing healthcare outcomes. Join a forward-thinking company dedicated to transforming lives through innovative therapies and a commitment to diversity and inclusion in the workplace.

Formación

• Experience in medical writing and regulatory review within Pharma/Biotech.
• Ability to collaborate with global stakeholders and manage timelines.

Responsabilidades

• Act as a Subject Matter Expert for Medical Review Excellence.
• Provide consultation for compliant content creation.
• Engage with Medical and Marketing teams for promotional materials.

Conocimientos

Medical Writing

Regulatory Compliance

Analytical Skills

Interpersonal Skills

Project Management

Educación

Bachelor's Degree in Life Sciences

Master's Degree in Life Sciences

PhD in Life Sciences

Descripción del empleo

Senior Medical Reviewer (Temporal 6M) page is loaded

Senior Medical Reviewer (Temporal 6M)

Apply locations Spain - Madrid time type Full time posted on Posted Yesterday job requisition id 4935300

The Senior Medical Excellence Reviewer will be a key member of the Medical Review Excellence (MRE) Group by acting as a key partner to in-country Medical Affairs and Marketing colleagues. The Senior Medical Excellence Reviewer 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. 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.

RESPONSIBILITIES

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.
• 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 MRE function.
· 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 MRE 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-country cross-functional/country projects and manage BAU transition.
• Create 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.
• Support international and national congresses to assure they comply with local regulations.

YOUR PROFILE

• Bachelor's Degree / Master's Degree / PhD in Life Sciences field.

• Previous experience in medical writing / medical review within an agency, CRO, Pharma / Biotech Company.
• Prior experience in medical content creation or promotional material review.
• Prior experience in conducting medical reviews or QC of regulatory documents.

• Ability to collaborate with Global stakeholders and managing stringent timelines.

• 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.
• High fluency in English.
• 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.
• Regulatory knowledge 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).

#LI-PFE

Purpose

Breakthroughs that change patients' lives... At Pfizer we are apatient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self.Let’s start the conversation!

Equal Employment Opportunity

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms – allowing for 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!

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.Medical

About Us

Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.