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Medical Review Excellence Manager
Location: NLD - Capelle Ad Ijssel
About the role:
The Medical Review Excellence Manager will be a key member of the Medical Information and Review (MIR) Group by acting as partner to Medical Affairs and Marketing colleagues in the Netherlands. The MRE 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. 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 through cross-border collaboration that generates value for medical colleagues in the Netherlands.
Main 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 programs in-country.
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.
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.
Liaise with local health authority/regulatory agency as appliable.
Maintain oversight of, and where applicable, create, local policies, procedures and guidance relating to MRE.
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-country and cross-functional country projects and manage BAU transition.
Create local operational processes and practices (as needed) that drive efficiencies for MRE and associated stakeholders.
Partner with transformational teams across the organization to support the design and deliver innovation within the CMO 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 factor
About you:
Education:
Master’s level in life sciences/Pharmacy/Medical sciences or equivalent degrees.
Experience:
Preferred 4 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 interprets analyses and interprets routine medical and safety analyses without guidance from team members.
Language skills: High fluency in written English and Dutch and strong functional fluency in spoken English and Dutch.
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 the 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.
What do we offer?
Innovative company Pfizer has a pipeline full of innovative medicines for a variety of conditions. As a Pfizer colleague, you'll have the opportunity to maximize the impact of medicines for patients in a variety of ways. In short, you make a real difference.
Development opportunities We are always looking for top talent. We believe you will never stop learning and there will always be a new opportunity for your development. That is why we have broad opportunities in the Belux organization. There are regular opportunities for training or to gain experience in a different field or even advancement to an international position.
A culture where you can be yourself We are a large, international organization with people from all over the world. At Pfizer everyone should be able to be themselves, that's what we strive for and live by.
Work/life balance At Pfizer, we know that if you really want to make an impact on people's lives, it's important that your people are at their best. That's why we offer our colleagues good working conditions, such as an appropriate salary and opportunities to work from home. Working a lot of overtime is not the norm for us. We also believe that work and having fun should go hand in hand. That's why, for example, you can participate in all kinds of activities outside of work.
Are you interested?
Do you know enough and have you decided to respond? We are curious about you and invite you to submit your application via the apply button below. You don't have to worry about a deadline to respond. We keep looking until we have found the right candidate for this position.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
We kindly ask you to provide your application documents in English!
#LI-PFE
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Pfizer's aim is to provide equality of opportunity in the recruitment process by avoiding any bias or potential discrimination on any grounds including (but not limited to): sex, age, race, religion or belief, sexual orientation or disability. At Pfizer we are creating an organization and promoting a culture that respects each individual's unique character and life experiences and reflects the diversity of our society, customers and markets. We will achieve this through fostering and sustaining an environment in which every colleague feels valued and supported.
Disability Inclusion:
Onze missie is om de kracht van al onze mensen te ontwikkelen en ruimte te geven. We zijn trots om een inclusieve werkgever te zijn, die aan alle kandidaten met een beperking gelijke kansen biedt. We moedigen je aan om jezelf te zijn en dat met ons te delen, wetende dat wij ons best gaan doen om jouw sollicitatie en toekomstige carrière te ondersteunen. Jouw reis bij Pfizer begint hier!
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