drjobs Medical Review Manager Germany (m/w/d)

Medical Review Manager Germany (m/w/d)

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Job Location drjobs

Berlin - Germany

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

A career at Pfizer offers opportunity ownership and impact.

All over the world Pfizer colleagues work together to positively impact health for everyone everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer a global leader in the biopharmaceutical industry is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Right now we are seeking highly qualified candidates to fill the position:

Medical Review Manager Germany (m/w/d)

About the role:

The Medical Review (MR) Manager will be a key member of the the Medical Information & Review (MI&R) Group by acting as a key partner to in-country Medical Affairs and Marketing colleagues. The MR 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 that generates value for medical colleagues in-country.

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 .

  • 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 Pfizers 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

  • 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-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.

ORGANIZATIONAL RELATIONSHIPS

External Content creation agencies vendors and CoLab

Internal Local/Regional/ Medical Leads Medical Teams in-country Local/Regional Marketing Teams MQG FCS MR platform and content factory.

EDUCATION AND EXPERIENCE

Graduate/Post-graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees.

Experience:

  • 4 to 6 years relevant experience for medical graduates PhDs & masters in life sciences/ more than 6 years relevant experience for science graduates.

  • Minimum 3 years of experience in medical writing/review within an agency CRO Pharma / Biotech Company.

  • 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.

  • Experience in vaccines therapeutic area would be an advantage.

TECHNICAL SKILLS REQUIREMENTS

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 interpret analyses and interpret routine medical and safety analyses without guidance from team members.

Language skills: High fluency in English and German

  • 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. Familarity with global regulatory guidance such as 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

Breakthroughsthatchangepatientslives- Unser klares Unternehmensziel ist es Durchbrche zu erreichen die das Leben vonPatienInnenverndern. Sie sind der Sinn unseres Tuns. Wenn Sie Teil dieser Vision sein wollen und die gleiche Leidenschaft teilen ist Pfizer der ideale Ort um eine Karriere zu beginnen oder um eine erfolgreich fortzusetzen.

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Manager

Employment Type

Full-Time

Company Industry

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