Medical Review Manager

Main Responsibilities:

• Responsible for providing support to Medical Review Excellence team, within Chief Medical Affairs Office (CMAO) specifically
• Performs medical review of promotional and sales training materials including but not limited to Health Care Professional (HCP) promotional aids, Web/Social, training material, advertisements, consumer promotions, conventions/ meetings etc to ensure:
• The claims are accurate, truthful, not misleading and aligned with Core Claims, Common Technical and/or other regulatory documents.
• The references are adequate, and they fully support the relevant claims.
• The claims are consistent with the specified reference label used.
• Collaborates with Medical Leads and Marketing leads for coordinating reviews of promotional, sales training and medical to medical materials.
• Provides training and mentoring to new team members for assigned review activities.
• Develop and sustain constructive relationships within customers and stakeholders
• Identify potential areas for process improvements and possible solutions, and communicate these to management
• Conduct pre-medical review of assigned therapy area sales training materials and relevant materials by PHI (Patient Health and Impact).
• Assess review requirements, gauging complexity, and identifying gaps or other potential issues.
• Collaborate with Marketing/Commercial/Medical Leads to manage correct allocations of reviews.
• Communicating with different stakeholders and their departments for a coordinated structure of functions and workflow.
• Ensure assigned reviews are conducted in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams in a timely manner of any definite or potential deviations.
• Technical:
• Review/QC skills: Excellent review or QC skills. Experience in promotional 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 written English and strong functional fluency in spoken English.
• Personal skills: Strong organizational skills and ability to prioritize multiple projects and meet deadlines.
• Interpersonal skills: 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 in cross-functional, global teams. Ability to mentor more junior colleagues and external vendors.
• Regulatory knowledge: Familiarity with global regulatory guidance especially International Conference on Harmonization (ICH), Food and Drug Administration (FDA) and European Medical Agencies (EMA) relevant to clinical and safety aspects.
• Software: Previous experience with software commonly used to present and analyze data and experience with searching academic databases. (Word, PowerPoint, Excel) is required.
• 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.
• Managerial
• Reports directly to the Senior Medical Manager
• Works closely with Global/US Medical Affairs Leads and commercial leads.
• Certifications: NA
  Education:
• Graduate/Post-graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees.
• Experience:
• 3 to 4 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 within an agency, CRO, Pharma / Biotech Company.
• Experience in collaborating with Global stakeholders and managing stringent timelines.
• Prior experience in conducting medical reviews or QC of regulatory documents is preferred.

Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Medical