Job Description

Responsible for providing support to Pfizer Biopharmaceuticals Group (PBG) Business Units (BUs) Global Medical Affairs team and Global Medical Leads, will have the following responsibilities:

Pre-Medical Review:

• Performs medical pre-review (reference check) of promotional, above brand 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.

• Manages end-to-end pre-medical review for assigned therapy area sales training materials and relevant materials by Patient Health and Impact (PHI).
• 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.
• Ensures the in-scope promotional, above brand and brand curriculum pieces are reviewed utilizing Automated Machine Learning outputs.
• Ensures the correct Bot commands are executed to enable efficiency in reviews.
• Supports scientific congresses through review of content and congress reports in GCMA.
• Supports review of promotional material/training materials for products other than assigned allocation covering other BUs as well as other therapeutic areas in same BU 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.

• Stakeholder Management:
• Engages with Medical Leads and Marketing leads to ensure smooth workflow for reference check of promotional and sales training materials.
• Develops and sustains constructive relationship within customers and stakeholders.

• Process Automation & Continuous Improvement:
• Drives efficiency and quality by ensuring review automation compliance in PMR automation BOT.
• Engages in the MRS Champion initiatives to enhance the process automation, communication, colleague engagement, training, and operational and quality efficiencies within MRS team.
• Identifies potential areas for process improvements and possible solutions, and communicates these to management.
• Assesses review requirements, gauges complexity, and identifies gaps or other potential issues in the process.

• Training & Oversight:
• Trains and mentors new team members for assigned review activities.
• Support Team Lead to collect feedback to train agencies on correct annotations.
• Supervises and reviews the work performed by the new associates in order to provide high quality and timely service.
• Leads the communication with different stakeholders and their departments for a coordinated structure of functions and workflow

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 medical content creation or promotional material review is preferred.
• Prior experience in conducting medical reviews or QC of regulatory documents is preferred.

Work Location Assignment: Flexible

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

Medical

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Pfizer