Regulatory & Medical Affairs - Manager

apartmentRangam Consultants Inc. placeTrenton calendar_month 

The primary responsibility for the Market Medical Communications Consultant is the development and execution of a comprehensive, globally aligned strategic market medical publications and content plans to support the effective communication of data and launch for safe and effective use of client medicines across the Markets.

  • Develop and update (from WW content ) local market medical content per clinical development program, publications, data presentations, congress activity, MI inquiry trends, global communication platform, product safety reports and treatment landscape.
  • Collaborate with cross-functional stakeholders (WW Pub content leads, Country Medical Directors (CMD), Disease Area Heads/Specialists (DAH/DAS) to identify pertinent data and solicit functional expertise when needed to ensure medical content and publications are developed with a high degree of medical integrity, accuracy and clinical relevance.
  • Lead through close partnership with WW Pubs/Content leads, Contact Center leads, and local Market Medical team in the development of medical content.
  • Work with cross-functional teams on a worldwide level to ensure consistent messaging and communication of medical information and key messages.
  • Support the global standardization of Medical content to streamline creation, distribution and curation of content while eliminating redundancies in resource utilization and deliverables.
  • Analyzes and interprets scientific data to update or develop comprehensive, balanced, credible and
accurate documents that comply with applicable laws, regulations, guidance and client policies and procedures.
  • Determines extent of global content available for use in the market including self-service, and ensures local customization or de novo content generation needs are met with quality and speed.
  • Collaborates closely with the Medical Capabilities Customer Engagement & Contact Center, to inform on new content deliverables and consult on training/messaging for new scientific data.
  • Develop Medical Contact Center training on disease state, product overview and relevant market events to ensure Contact Center’s readiness to address customer inquiries.
  • Works effectively as a member of the Medical Matrix Market Team and other core Medical teams by contributing to development of the Medical Brand Plan, communicating insights and trends from WW Medical, WW Pubs/Content and Field Medical and contributing to the identification and delivery of publications and content to address local Market unmet medical needs.
  • Translates medical strategies and objectives into actionable publication and content (medical communication) plans for the markets (ensures local customization or de novo publications and content generation needs are met with quality and speed); plans that are comprehensive (representing all functions with ongoing data generation) and globally aligned.
  • Ensure effective rollout and communication occurs, feedback loops are implemented, and continuous improvement opportunities are identified for content development
  • Act as a scientific expert to drive and support the market Publication activities in the respective therapeutic area (s) collaborating with the Market Publication Manager/Lead and Medical team, WW Pubs/ Content Team
  • Develops, maintains and enhances a high level of knowledge in the respective therapeutic area(s) to provide high quality medical communication support.

Job Requirements:

  • PhD, PharmD, MD, vet (or specifically qualified natural scientists of biology/human biology), with minimum of 1-2 years of experience in clinical practice, pharmaceutical industry or medical communications agency.
  • Expert clinical, pharmacological and pharmaceutical knowledge and thorough understanding of medical terminology in local language and English, as well as of the function, activities and processes of Medical Information.
  • Knowledge and experience in disease areas and treatment options with scientific expertise in Oncology, preferred.
  • Experience responding to unsolicited inquiries from health care professionals by collecting, analyzing, interpreting and providing specific clinical/scientific data that is requestor-focused.
  • Expertise across all aspects of scientific publication strategy, planning and execution during all phases of drug development and commercialization process (investigational, registration, pre & post-launch and marketed), desirable
  • Understands the needs of health care professionals and demonstrates an understanding of pharmaceutical industry regulations.
  • Demonstrated ability to manage various projects, solve problems, deliver on commitments, and work with multidisciplinary teams.
  • Proficiency in basic computer programs.
  • Excellent scientific/medical written and verbal communication skills in local language and English required
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