Medical Review Excellence Manager (m/f/d)

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. In our Pfizer Corporation Austria we market over 100 products for the Austrian market and supervise 9 clinical studies in cooperation with Austrian institutes. As we continue to develop healthcare products and expand our business globally, we are consistently looking for new talents. Right now, we are seeking highly qualified candidates to fill the position:

Medical Review Excellence Manager (m/f/d)

You can look forward to:

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 Austria. 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 Austria.

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 factory.

You offer:

• Master’s level in life sciences/Pharmacy/Medical sciences or equivalent degrees.

• 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.

• 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 [applicable local language(s)] 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 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.

 
We offer:

• Attractive remuneration
• Corporate health management like „Pfizer in Balance“, vaccination programs, medical checkups, first-aid-trainings and more
• Staff restaurant with lunch allowance
• 24-hour-accident insurance for (non-)work related accidents in Austria
• Flexible working hours with Homeoffice-option
• Various career and development opportunities thanks to e.g. Growth Gigs and Mentoring
• Recognition for company anniversaries, monetary gifts for special occasions such as marriage or childbirth
• Social engagement as part of corporate volunteering

The salary depends on your educational background and expertise as well as your previous experiences but will at least amount to € 64.500 gross p.a. on a fulltime base.

Together we represent:

Breakthroughs that change patients' livesTM – At Pfizer we are a patient centric company, guided by our four values: Courage, Excellence, Equity and Joy. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Learn more about Pfizer as an employer via: www.pfizer.at

Convinced?

We are looking forward to your online application with all complete document (CV and Cover Letter - these as well as additional documents can be added and uploaded at the “Resume/CV” section of the “My Experience” page.) Apply today via www.pfizer.at/karriere.

Pfizer's aim is to provide equality of opportunity in the recruitment process by avoiding discrimination on the grounds of: sex, age, race, religion or belief, sexual orientation or disability. At Pfizer we are creating an organisation and promoting a culture that respects each individual's unique character and life experiences, and reflects the diversity of our customers and markets. We will achieve this through fostering and sustaining an environment in which every colleague feels valued and supported, thus enabling superior business results.

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