(Sr.) Medical Review Manager Germany (m / f / d)

Pfizer; Berlin; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A global biopharmaceutical leader is seeking a Sr. Medical Review Manager in Berlin. You will provide strategic oversight for promotional materials, ensuring compliance and quality. The ideal candidate will possess a doctorate in life sciences with relevant experience in medical content and promotional review. Join the team to make a significant impact on health and lives worldwide.

Qualifikationen

• 4+ years of relevant experience in medical writing or review.
• Experience in collaborating with global stakeholders required.
• Prior experience in medical content creation or promotional review preferred.

Aufgaben

• Provide medical expertise and strategic oversight for promotional content.
• Collaborate with teams to develop compliant materials for healthcare professionals.
• Conduct reviews of promotional medical documents and materials.

Kenntnisse

Excellent review or QC skills

Proficiency in analyzing scientific claims

High fluency in written English and German

Strong organizational skills

Collaborative mindset

Ausbildung

Doctorate degree in life sciences, Pharmacy, or Medical Degree

Tools

Word

PowerPoint

Excel

Jobbeschreibung

Overview

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 :

Sr.) Medical Review Manager Germany (m / f / d)

Responsibilities

• 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 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.
• Provision of Medical Expertise in Relation to Content of Materials: Acquire and maintain in-depth scientific knowledge of Pfizer medicines within nominated therapy area(s) (including those in development) as well as the competitive landscape. Understand and advocate the appropriate use of medicines with the local health system.
• Collaboration with Pfizer teams to Enable Streamlined Content Creation: Works with the nominated cross functional team(s) in-country and above-country to develop impactful and compliant promotional and non-promotional materials of value to healthcare professionals and patients. This includes advising on marketing programmes other promotional activities and medical education, providing support for revisions to prescribing information and implementation of risk management plans, and working with digital materials and digital technologies. Collaborates with Medical Affairs colleagues to understand therapy area and share pertinent issues with the relevant teams.
• Provides specialist medical scientific and code / regulatory advice to teams during the development phase of materials / projects / activities to support streamlined creation of compliant content / activities that enable appropriate use of Pfizer medicines and successful implementation of materials initiatives and programmes. Advising on and reviewing materials for submission to health authorities; advising on and reviewing materials for package deals and materials for patient support programmes (eg Homecare).
• Works with cross-functional teams on preparation and review of training materials for colleagues. Provides feedback to ensure high ethical standards and Pfizer compliance. Engages with category Medical and Marketing teams to meet needs for promotional medical-to-medical as well as corporate and social media materials in-country. Develops constructive relationships with leadership and stakeholders. Leads in-country communication for coordinated structures of functions and workflow. Supports activities within local regulation / code such as advisory boards, symposia, PAG donations, market research. Supports regulatory labeling and license maintenance activities. Manages local code / regulatory complaints and advises on corrective and preventative actions.
• Technical: Act as super-user and change leader providing in-country medical review and approval services in the designated electronic approval system. Act as Final Country Signatory (FCS) where applicable. 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 are compliant. Acquire and maintain scientific knowledge of Pfizer medicines and of key competitors and national guidelines relevant to the country. High-level expertise about local regulations, code and Pfizer policies relevant to creation and review and approval of materials. Work collaboratively with team members to meet agreed timelines. Organize training on regulatory requirements and promotional material requirements for colleagues. Ensure handling of complaints related to promotional materials together with the Country Medical Director. Support local inspections / audit as defined by local plans.
• Service expansion: Operationalize transformative initiatives and pilot activities of medical support services and drive them to business as usual. Develop processes and workflows building efficiencies and value for stakeholders. Support in-country execution of opportunities quickly and accurately. Create and lead local operational processes and practices to drive efficiencies for the MR and stakeholders. Partner with transformational teams to 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, Local / Regional Marketing Teams, Biopharma Ops, Country Medical Director and medical teams in-country MR platform and content factory.

About You

• Doctorate degree in life sciences, Pharmacy or Medical Degree

Experience

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

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 against references. Familiarity with statistical / epidemiologic principles. Ability to conduct and interpret analyses without guidance.
• Language skills: High fluency in written English and German and strong functional fluency in spoken English.
• Personal skills: Ability to work independently with high accountability. Strong organizational skills. Solution driven and quality oriented. Collaborative mindset and effective influencing/negotiating skills.
• Regulatory knowledge: Interest in legal and regulatory aspects of promotional compliance. Familiarity with local regulations; global guidance such as ICH/FDA desirable but not essential.
• Software: Digital affinity; proficient with Word, PowerPoint, Excel; ability to use common data presentation and analysis tools.

Additional notes: Synthesize analyses of medical and scientific data into clearly written text. Understand medical concepts of diseases and treatments. Quick familiarization with different therapeutic areas. Pfizer’s commitment to breakthroughs that change patients’ lives.

Application & Diversity

Breakthroughs that change patients lives - Unser klares Unternehmensziel ist es Durchbrche zu erreichen die das Leben von PatienInnen verndern. 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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Employment Details:

• Employment Type : Full-Time
• Experience : years
• Vacancy : 1