Job Description

POSITION SUMMARY

Medical Manager (Real World Evidence), Medical Review Services, supports Global Medical Affairs team and Global Medical Leads by performing medical review of promotional, and non promotional materials, specifically the materials citing real world evidence studies. This involves active internal and external stakeholder engagement to coordinate and perform review of these materials.

The Medical Manager will be part of a highly skilled and highly qualified team of reviewers driving excellence through application of sophisticated automation technology supporting reviews of materials.

POSITION RESPONSIBILITIES

Medical Review:

• Performs medical review of promotional and non promotional materials, as per applicable policies, to ensure:

• The claims are accurate, truthful, not misleading
• The references are adequate, and they fully support the relevant claims.
• Conducts reviews independently with minimal supervision, in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams in a timely manner of any definite or potential deviations.
• Supports review of promotional material/training materials for products other than assigned allocation based on bandwidth.
• Delivers assigned documents on or before deadline, alerting project teams in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
• Ensures delivery of all required activities are within expected timelines and on budget.
• Supports MRS team leads and team members in team expansion initiatives.

Stakeholder Management:

• Engages with Medical Leads, Marketing leads and agencies to ensure smooth workflow for reviews.
• Develops and sustains constructive relationship within customers and stakeholders.
• Leads the communication with different stakeholders and their departments for a coordinated structure of functions and workflow.

Tactical/ Operational

• Conducts quality control assessments of assigned deliverables as required
• Assist audit in relation to compliance of promotional/non promotional materials with applicable regulations, and company policies
• Faciliates creation of a robust feedback mechanism to ensure periodic inputs from stakeholders

Training & Oversight:

• Trains and mentors new team members for assigned review activities.
• Supports MRS Lead to ensure compliance to process guidance, collects feedbacks from stakeholders and ensures correct metrics are captured for the team..
• Supervises and reviews the work performed by the new associates in order to provide high quality and timely service.

EDUCATION AND EXPERIENCE

Education:

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

Qualification and experience:

• Medical graduates, PhDs & masters in life sciences with 3 years of experience is required
• 5 years of medical writing/review experience is preferred.

• Experience in collaborating with Global stakeholders and managing stringent timelines.
• Prior experience in RWE studies and/or epidemiology 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 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.
• Ability to critically evaluate analytic results against the literature, subject matter expert feedback or other reliable sources to ensure biological and medical credibility in alignment with cross-functional team strategy / priorities
• Strong experience in communicating in verbal and written
• 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.
• Software: 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.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Medical

Pfizer