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.
