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Senior international medical review manager

Walton (West Yorkshire)
Manager
Posted: 7h ago
Offer description

The Senior International Medical Review Manager is responsible for the medical review of international created promotional and non-promotional content and supports review of country content as needed. The role aims to minimize compliance risks by ensuring accurate review in conformity with all applicable criteria including Pfizer policies and procedures as well as relevant countries’ laws, regulations and industry codes to ensure quality and compliance. As a review processes partner, this role builds on medical review experience and draws upon best practices to support the implementation of new ways of working and drive continuous improvement that generates value for cross functional partners. Strategy Assist with strategic activities to advance the vision and goals of Medical Review (MR). Assist with the optimization of the regional MR strategic and operational initiatives, in alignment with cross functional partners. Provide consultation and solution-focused input to cross-functional partners and assist with compliant content creation and seamless review. Provide assistance to international MR operations with implementation of initiatives related to MR process and workflow optimizations as required. Operations and Stakeholder Management Perform fact-check, scientific review and medical approval of promotional and non-promotional materials and activities in line with pre-determined criteria, local product label information, country-specific code and regulatory requirements as required. 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. Medical Review Subject Matter Expert, and superuser of the designated electronic approval system, that enables lightspeed review deliverables for Promotional & Medical. Routinely identifies, shares, and implements best practices, ensuring consistency and compliance with relevant policies, processes, procedures and guidance across the international markets. Maintain knowledge about relevant 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. Support training in regulatory requirements and promotional material requirements for relevant colleagues and stakeholders as applicable. Close partnership with team members and stakeholders such as International Medical and Commercial content teams, global MR leadership and country partners to drive active engagement with key stakeholders and reviews within the agreed timelines. Support local inspections/audit as defined by the inspection action plan(s) and applicable local audit processes (if applicable). Support handling of complaints and quality events related (if applicable). Qualifications Masters degree in a life science/healthcare field. Strong experience in medical review, medical writing, review within an agency or CRO. Attention to detail and high fluency in English and at least one additional language, preferably Spanish or German. Demonstrated understanding of and interest in regulations governing promotional compliance. Project management experience and demonstrated ability to handle multiple tasks/projects and respond to tight timelines. Ability to work in a high-paced environment, flexible and adaptive mindset to changes in internal and external environment, project scope and direction. Experience managing projects with team members in multiple locations. Experience with operating effectively across multiple functions in a heavily matrix organization and ability to engage to influence outcomes. Strong decision-making, communication and interpersonal skills, in verbal and written English, and ability to influence without authority. Non-standard work schedule, travel or environment requirements May be required to work occasional public holidays. May be required to work hours outside of the normal local working hours. Occasional International travel 10%. Work Location Assignment: Hybrid Purpose Breakthroughs that change patients' lives At Pfizer we are a patient 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 is committed to celebrating this, in all its forms – 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 Confident We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here! Medical

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