Allstar Technologies
Medical and Regulatory - WW and US Medical Communications Manager
Allstar Technologies, Trenton, New Jersey, United States,
Medical and Regulatory - WW and US Medical Communications Manager
Position Summary The primary responsibility for the WW/US Medical Communications Manager is the development and execution of a comprehensive, globally aligned strategic WW/US medical publications and content plans to support the effective communication of data and launch for safe and effective use of Client medicines. Develop and update WW/US medical content per clinical development program, publications, data presentations, congress activity, MI inquiry trends, global communication platform, product safety reports and treatment landscape.
Key Responsibilities Primary accountabilities of the Medical Communications Manager include: • 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, and are used to appropriately communicate with healthcare providers and customers involved in healthcare or evidence-based healthcare decisions • Lead development of medical communications and ensure timely journal submissions, publications, congress presentations, and deliver internal and external scientific content • Understands and complies with established good publication practices (GPP3, ICMJE, and Client processes) to execute the publication plan • Manages and prioritizes multiple projects, provides solutions to complex problems, and delivers complete and accurate information within deadlines • Assists with the communication of the Oncology strategy related to healthcare providers, payers, access influencers, and healthcare decision makers • Serve as a subject matter expert to Client internal audiences related to communication landscape, HCP preferences, publication and scientific content planning, data disclosure / dissemination, and represent Client scientific communications to external investigators, key authors and journal editors • Manages development of content deliverables, such as reactive materials for field medical and field HEOR use, including core slide decks, training materials, FAQs, and backgrounders to address specific unsolicited health care provider and payer requests for health economic or outcomes research (HEOR) information • Maintains awareness of current industry practices that pertain to Medical Communications and Access Scientific 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 • Ensure effective rollout and communication occurs, feedback loops are implemented, and continuous improvement opportunities are identified for content development • Develops, maintains and enhances a high level of knowledge in the respective therapeutic area(s) to provide high quality medical communication support • Manage vendor agency partnership to drive planning and execution of publication and content deliverables
Qualifications & Experience •Required: o PharmD, MD, PhD or equivalent o Minimum of 3-4 years of Pharmaceutical/Healthcare industry experience with a focus on medical communications o Ability to manage various projects, solve problems, deliver on commitments, and work with multidisciplinary teams. o Demonstrated ability to lead strategically, drive performance, build alignment, inform, negotiate and collaborate o Experience leading cross-functional, cross-cultural project teams, and collaborating across matrix, multiple markets and global geographies o Experience leading medical communications across all phases of drug development and commercialization o Ability to analyze and interpret trial data •Preferred: o Experience in solid tumor oncology o In-depth knowledge of Good Publication Practices and guidance (GPP, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices and scientific data communication o Understanding of clinical trial design and execution, statistical methods and clinical trial data reporting requirements o Working knowledge of Microsoft suite of applications, and familiar with publication management tool (DataVision)
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Position Summary The primary responsibility for the WW/US Medical Communications Manager is the development and execution of a comprehensive, globally aligned strategic WW/US medical publications and content plans to support the effective communication of data and launch for safe and effective use of Client medicines. Develop and update WW/US medical content per clinical development program, publications, data presentations, congress activity, MI inquiry trends, global communication platform, product safety reports and treatment landscape.
Key Responsibilities Primary accountabilities of the Medical Communications Manager include: • 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, and are used to appropriately communicate with healthcare providers and customers involved in healthcare or evidence-based healthcare decisions • Lead development of medical communications and ensure timely journal submissions, publications, congress presentations, and deliver internal and external scientific content • Understands and complies with established good publication practices (GPP3, ICMJE, and Client processes) to execute the publication plan • Manages and prioritizes multiple projects, provides solutions to complex problems, and delivers complete and accurate information within deadlines • Assists with the communication of the Oncology strategy related to healthcare providers, payers, access influencers, and healthcare decision makers • Serve as a subject matter expert to Client internal audiences related to communication landscape, HCP preferences, publication and scientific content planning, data disclosure / dissemination, and represent Client scientific communications to external investigators, key authors and journal editors • Manages development of content deliverables, such as reactive materials for field medical and field HEOR use, including core slide decks, training materials, FAQs, and backgrounders to address specific unsolicited health care provider and payer requests for health economic or outcomes research (HEOR) information • Maintains awareness of current industry practices that pertain to Medical Communications and Access Scientific 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 • Ensure effective rollout and communication occurs, feedback loops are implemented, and continuous improvement opportunities are identified for content development • Develops, maintains and enhances a high level of knowledge in the respective therapeutic area(s) to provide high quality medical communication support • Manage vendor agency partnership to drive planning and execution of publication and content deliverables
Qualifications & Experience •Required: o PharmD, MD, PhD or equivalent o Minimum of 3-4 years of Pharmaceutical/Healthcare industry experience with a focus on medical communications o Ability to manage various projects, solve problems, deliver on commitments, and work with multidisciplinary teams. o Demonstrated ability to lead strategically, drive performance, build alignment, inform, negotiate and collaborate o Experience leading cross-functional, cross-cultural project teams, and collaborating across matrix, multiple markets and global geographies o Experience leading medical communications across all phases of drug development and commercialization o Ability to analyze and interpret trial data •Preferred: o Experience in solid tumor oncology o In-depth knowledge of Good Publication Practices and guidance (GPP, ICMJE), Sunshine Act, Pharma Code of Conduct, and other guidance related to post-marketing practices and scientific data communication o Understanding of clinical trial design and execution, statistical methods and clinical trial data reporting requirements o Working knowledge of Microsoft suite of applications, and familiar with publication management tool (DataVision)
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