Pfizer Life Sciences Medical Review Job Opening – Apply Online

Pfizer Life Sciences Medical Review Job Opening – Apply Online

Pfizer Life Sciences Medical Review Job Opening – Apply Online. Medical Review Specialist Job For BSc / MSc Candidates at Pfizer Pharmaceutical company, Mumbai, India. Interested candidates check out the details for Clinical Review Specialist Job below and Apply Online

Job title: Associate Medical Manager, Medical Review Services (MRS)

Job Location:

• Mumbai, India
• Remote, India

Job id: 4892334

Job Type: Full time

JOB DESCRIPTION:

POSITION SUMMARY

Associate Medical Manager, Medical Review Services supports Global Medical Affairs team and Global Medical Leads by performing medical pre-review (reference check) of promotional, above brand materials, as well as sales training material. This involves active internal and external stakeholder engagement to coordinate and perform pre-review of materials.

The Pfizer Biopharmaceuticals Group (PBG) Business Units (BUs) (global and US) like Hospital, Oncology, Internal Medicine, Rare Diseases, Vaccines and Inflammation and Immunology are in scope for MRS reviews. The Associate Medical Managers 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

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.
• Leads the communication with different stakeholders and their departments for a coordinated structure of functions and workflow.

EDUCATION AND EXPERIENCE

Education:

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

Experience:

• 2 to 3 years relevant experience for medical graduates, PhDs & masters in life sciences/ more than 6 years relevant experience for science graduates.
• Minimum 2 year of 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 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.
• 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.

APPLY ONLINE 

Clinical Review Specialist Job For BSc / MSc Candidates at Pfizer. Here are five Possible interview questions along with their answers :

Question 1: Can you describe your experience in conducting medical pre-reviews of promotional and sales training materials? How do you ensure accuracy and alignment with regulatory guidelines? Answer: In my previous role, I had the responsibility of conducting medical pre-reviews for various promotional and sales training materials. I ensured accuracy and alignment with regulatory guidelines by thoroughly checking claims for accuracy, truthfulness, and non-misleading nature. I also verified that references provided fully supported the claims and that the claims were consistent with the specified reference label. I followed internal SOPs and external regulatory guidance throughout the review process to maintain compliance. Additionally, I utilized Automated Machine Learning outputs and correct Bot commands to streamline and enhance the efficiency of the review process.

Question 2: Can you provide an example of a time when you had to manage a project with tight timelines and multiple deliverables? How did you ensure all activities were completed on schedule? Answer: In my previous role, there was a situation where we had to review a set of promotional materials for an upcoming product launch within a short timeframe. To ensure timely completion, I first prioritized the materials based on their importance and urgency. I collaborated closely with the Medical Leads and Marketing leads to establish a clear workflow and allocate tasks. I also communicated with my team to set expectations and deadlines, ensuring everyone was aligned. Additionally, I utilized my organizational skills to manage multiple projects simultaneously and monitored progress closely. This proactive approach allowed us to deliver all required activities on or before the deadline.

Question 3: Could you share an experience where you effectively engaged with stakeholders, both internally and externally, to coordinate and execute the medical review process? Answer: In a previous role, I was tasked with coordinating the medical review of promotional materials for a global product launch. I engaged with Medical Leads, Marketing leads, and cross-functional teams to establish a structured workflow for the reference check process. I maintained open and regular communication with stakeholders to provide updates, gather necessary information, and address any concerns. By nurturing positive relationships and fostering effective communication, we were able to streamline the review process, ensure smooth collaboration, and maintain the quality of materials within the required timelines.

Question 4: How do you approach conducting medical reviews for materials that cover therapy areas and products outside of your assigned allocation? Answer: When reviewing materials for therapy areas and products outside of my assigned allocation, I ensure a comprehensive understanding of the relevant therapeutic concepts and medical information. I leverage my familiarity with global regulatory guidelines, including ICH, FDA, and EMA, to ensure that the claims and references meet regulatory standards. Additionally, I draw on my experience in medical content creation and promotional material review to critically assess the accuracy and alignment of the content. Through effective analysis and collaboration with stakeholders, I ensure that the reviewed materials adhere to the same high standards as my assigned allocation.

Question 5: Could you describe your approach to mentoring junior colleagues and external vendors in the medical review process? Answer: Mentoring junior colleagues and external vendors is a collaborative process that requires effective communication and guidance. I approach this by first understanding their knowledge and experience levels. I then provide clear explanations of the medical review process, including regulatory requirements and internal SOPs. I encourage open dialogue and create a supportive environment where they can ask questions and seek clarifications. I also share practical examples and case studies to illustrate best practices and potential challenges. By fostering a learning-oriented approach and offering constructive feedback, I help them develop their review skills and contribute effectively to the team’s success.

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