Associate Medical Manager - Global Medical Affairs International Services Team

Job Description

locations India - Mumbai India - Remote time type Full time posted on Posted 12 Days Ago job requisition id hidden_mobile MAIN REPONSIBILITIES / DUTIESResponsible for providing support to Global Medical Excellence & Innovation (GME&I), Global Technology & Engineering (GT&E), Worldwide Safety and Regulatory teams, specifically:
• Author high quality deliverables to support combination product post-production periodic review and activities associated with the maintenance phase of combination products.
• Coordinate/assemble information which may be sourced cross functionally.
• Perform literature searches in major databases (PubMed/EMBASE) followed by relevancy check and analysis of relevant data.
• Evaluate competitive landscape and on a periodic basis analyze changes to the state-of-the-art.
• Review the applicable processes, analyze and complete the following inputs:
  • Design Changes
  • Commitment Tracking (CT) Records
  • Competitor information
  • Corrective and Preventive Action (CAPA)
  • Supplier Corrective Action Request (SCAR)
  • Complaint Trends review by product with a deep-dive into Device Engineering Investigation data
  • Market Actions
• Perform Risk Management File reviews as part of Post-Production Combination product review.
The Associate Medical Manager supports and partners with cross functional stakeholders including GT&E, Quality, Safety, Regulatory, and Global Medical Affairs by:
• Providing support on assigned tasks for the combination products.
• Assessing document requirements, gauging document complexity, and identifying information gaps or other potential issues. In collaboration with the GT&E Lead, the author proposes or contributes to strategies to resolve any identified issues.
• Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
• To work collaboratively with team members and to align with agreed timelines. Effectively manage own time and workload.
• Deliver assigned documents on or before deadline, alerting project teams in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality.
REQUIRED SKILL SET Technical:
• Regulatory knowledge: Familiarity with global regulatory guidance especially:
  • International Conference on Harmonisation (ICH), Food and Drug Administration (FDA) and European Medicines Agency (EMA)
  • AAMI TIR105 Risk management guidance for combination products
  • ISO 13485:2016 Medical Devices-Quality Management Systems Requirements for Regulatory Purposes
  • US Food and Drug Administration (FDA) regulations published in 21 CFR part 820.30
  • ISO 14971:2019 Medical Devices-Application of Risk Management to Medical Devices
  • ISO/TR 24971:2020 Medical Devices-Guidance on the Application of ISO 14971
• Writing skills: Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively.
• Analytic skills: Utilize tools such as OvidSP and other bibliographic databases such as PubMed, Embase, and Biosis. Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them.
• 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.
• Software: Previous experience with software commonly used to present and analyze data and experience with searching academic databases. (Word, PowerPoint, Excel) is preferred.
Managerial:
• Reports directly to the Senior Medical Manager.
• Works closely with GT&E and Quality team colleagues at regional and global level.
Certifications: NAEducation:
• Graduate/Post-graduate/ Doctorate degree in life sciences/Pharmacy/Medical sciences/Biomedical Engineering or equivalent degrees.
Experience:
• Medical writing experience in the medical devices and/or combination products domain is mandatory.
• 3 years relevant experience for medical graduates and PhDs; 5 years relevant experience for science graduates/biomedical engineers. Minimum 3 years of experience in medical writing within an agency, CRO, Pharma / Biotech Company.
• Prior experience in using search tools, developing search strings and assessing search results is preferred.
Work Location Assignment: FlexiblePfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Medical #LI-PFE,

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