Michael Deluca

Michael Deluca

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Executive Vice President of Global Medical Affairs and Medical Information at EVERSANA
Boston, Massachusetts, United States

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  • EVERSANA
    Executive Vice President Global Medical Affairs and Medical Information
    EVERSANA
    Apr 2024 - Current (2 years 5 months)
    • Oversee EVESANA's Global Medical Affairs and Medical Information business unit, which includes our Global Medical Information Contact Center and Medical Affairs services (including medical content development, medical review of promotional and non-promotional materials, digital medical affairs solutions, including medical portals and medical chatbots with conversational AI, etc.). • Manage multi-million Profit and Loss (P&L) and budget. • Develop and deliver Value & Quality driven solutions that are deep-seated in EVERSANA's cultural beliefs of Client Delight and being Patient Minded. Optimally support our clients throughout their products' life-cycle by providing high-quality service and customer engagement to support our clients most i
  • phactMI
    phactMI Board Member - Partnership Director
    phactMI
    Nov 2022 - Current (3 years 10 months)
  • EVERSANA
    Senior Vice President of Medical Affairs
    EVERSANA
    Apr 2021 - Apr 2024 (3 years 1 month)
    • Support the President Compliance Services Business Unit in 4 main areas of Business Strategy, Business Growth, Business Operations and Business Performance Management. Partner with President to understand current initiatives, create execution plans and monitor performance. Drive the entire P&L for Medical Affairs/Medical Information business globally. • Business Strategy: Actively participate in building and delivering the overall vision of EVERSANA’s Global Medical Affairs services. Proactively work internally and externally to uncover market unmet needs and building right solutions. Building the entire strategy for Medical Affairs line of services to create market differentiation and deliver enhanced value to our pharmaceutical/biotech
  • Esperion  The Lipid Management Company
    Head of Medical Information and Medical Communications
    Esperion The Lipid Management Company
    Mar 2021 - Apr 2021 (2 months)
    In addition to responsibilities listed below under Head of Medical Information: • Oversee the development and execution of strategic publication plan and scientific platform. • Oversee the development, management and execution of medical communications tactical plans, including the development of congress presentations and manuscript development. • Oversee the strategic and tactical execution of Investigator Initiated Studies (IIS) program. • Oversee the strategic and tactical execution of Independent Medical Education (IME) program. • Oversee the development, implementation, and maintenance of medical information and medical communications policies and standards for operational excellence. • Ensure databases and systems are in place to sup
  • Esperion  The Lipid Management Company
    Head of Medical Information
    Esperion The Lipid Management Company
    Sep 2019 - Apr 2021 (1 year 8 months)
    • Establish and oversee the operations of Esperion’s medical information contact center, systems, and procedures. This included evaluating and selecting contact center and systems vendors; establishing the avenues by which medical inquiries are received (phone, email, web request form, Veeva CRM, etc.); working collaboratively with pharmacovigilance and quality around adverse event and product complaint procedures; etc. • Oversee the development and implementation of medical information policies and standards for operational excellence of medical information. • Oversee the development and maintenance of all content needed for responses to unsolicited requests for medical information (e.g., Frequently Asked Questions (FAQs), Standard Respon
  • Alexion Pharmaceuticals Inc
    Sr. Director, Global Medical Information & Medical Review
    Alexion Pharmaceuticals Inc
    Jan 2019 - Sep 2019 (9 months)
    In addition to the responsibilities listed below under Director: • Establish and oversee the Strategic Operations function of Global Medical Information (GMI) and Medical Review department. • Establish Technology and Digital Strategy Steering Committee for Global Medical Communications and lead the development of technology and digital strategy roadmap. • Evaluate and establish new operating model for the development and maintenance of GMI response documents. • Assist in establishing Medical Review Committee (MRC) process for the cross-functional (medical, legal, regulatory) review and approval of medical affairs materials for use by field medical teams. Provide oversight of MRC operations. • Lead, train, mentor team of medical reviewers f
  • Alexion Pharmaceuticals Inc
    Director, Global Medical Information, Metabolic Disorders
    Alexion Pharmaceuticals Inc
    May 2014 - Dec 2018 (4 years 8 months)
    - Serve as a global source and therapeutic expert to ensure content is scientifically accurate and medically relevant to guide clinical decision-making and serve patients and healthcare professionals. - Disseminate accurate and medically relevant scientific content to improve clinical decision-making globally. - Provide strategic planning in alignment with internal stakeholders (Global Medical Affairs, US and Global Commercial, Clinical Development) to ensure product launch preparedness in the global dissemination of medical information for metabolic disorder products. - Oversee the development, review and approval of medically accurate, up-to-date, and timely intellectual capital (e.g., medical information response documents, frequently as
  • Sunovion Pharmaceuticals Inc
    Director, Medical Information
    Sunovion Pharmaceuticals Inc
    Dec 2012 - May 2014 (1 year 6 months)
    • Responsible for many of the same objectives as detailed in Associate Director position below, plus the following. • Oversee and manage the budget for the Medical Information department. • Oversee the medical review team for the Latuda (lurasidone HCl) Promotional Material Review Committee (PMRC) process. • Provide oversight in developing policies, procedures, infrastructure, and training to improve efficiency and scalability for both Medical Information and Medical Affair processes. • Manage and provide oversight of Medical Information pre-launch and post launch planning for Latuda’s new indication for bipolar depression and new drug approval of eslicarbazepine acetate. • Assist in providing Medical Affairs support, including assisting in
  • Sunovion Pharmaceuticals Inc
    Associate Director, Medical Information
    Sunovion Pharmaceuticals Inc
    Jul 2010 - Dec 2012 (2 years 6 months)
    • Responsible for many of the same objectives as detailed in the Sr. Manager position below, plus the following. • Oversee and manage the pre-launch medical information initiatives for eslicarbazepine acetate, a product in late stage development for partial onset seizures. • Oversee and manage the pre- and post-launch medical information initiatives for Latuda (lurasidone HCl), a recently approved atypical antipsychotic. Initiatives include the creation of verbal scripts (Frequently Asked Questions – FAQs); creation of written response letters (Standard Response Letters – SRLs); training of call center; inclusion of Prescribing Information in Physicians’ Desk Reference Drug Information Service (www.PDR.net and mobilePDR); Epocrates Contact
  • Sunovion Pharmaceuticals Inc
    Sr. Medical Information Manager
    Sunovion Pharmaceuticals Inc
    Aug 2008 - Jul 2010 (2 years)
    • Responsible for managing the Respiratory & CNS divisions of the Medical Information Department [marketed products supported Xopenex (levalbuterol tartrate) Inhalation Solution, Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol, Brovana (arformoterol tartrate) Inhalation Solution, Alvesco (ciclesonide) Inhalation Aerosol, Omnaris (ciclesonide) Nasal Spray, and Lunesta (eszopiclone) Tablets; products in development eslicarbazepine acetate, lurasidone, ciclesonide HFA nasal spray) • Ensure that department meets its goals in turnaround time of medical inquiries and achieving its goals in customer satisfaction • Oversee the development of monthly and annual Medical Information metric reports • Develop and create the monthly Medical Inform
  • Thomson Reuters Healthcare  Physicians Desk Reference
    Strategic Marketing Manager
    Thomson Reuters Healthcare Physicians Desk Reference
    Jul 2007 - Jun 2008 (1 year)
    • Responsible for conducting competitive analysis of online, handheld, and print offerings of clinical/drug information providers. • Work closely with product management in the development of new products (e.g. PDR Drug Interactions Pocket Guide, PDR Brand/Generic Reference, PDRhealth.com). • Assist in the development of business cases for new products. • Identify opportunities, through partnerships, acquisitions, and internal development to give company competitive advantage for online, handheld, and print offerings. • Understand healthcare industry trends and the strengths and weaknesses of healthcare information providers. • Understand pharmaceutical industry trends and help sales identify potential opportunities. • Spokesperson for PDRh
  • Thomson Reuters Healthcare  Physicians Desk Reference
    Manager, Professional Services
    Thomson Reuters Healthcare Physicians Desk Reference
    Mar 2006 - Jul 2007 (1 year 5 months)
    • Responsible for managing the Drug Information Specialists (pharmacists). • Work closely with product management, sales, project management, and operations for meeting client (pharmaceutical companies and clinicians) needs. • Work closely with solution managers (sales) to develop strategies and provide clinical knowledge to help prep solution managers for meetings with clients. • Involved in developing and reviewing clinical content for all print and electronic products (www.PDR.net, www.PDRhealth.com, Thomson Clinical Xpert, PDR Electronic Library). • Set the overall objectives for the professional services group and create/maintain the standard operating procedures/working instructions for all clinical content. • Work closely with pro
  • Boehringer Ingelheim Pharmaceuticals
    Manager, Drug Surveillance
    Boehringer Ingelheim Pharmaceuticals
    Nov 2005 - Mar 2006 (5 months)
    • Directly responsible for resolving day to day issues related to adverse event reports received from both marketed and investigational use. • Manage documentation, electronic storage, timely reporting and follow-up adverse event case reports at each step of the process. • Ensure the processing of adverse event reports in a timely fashion as specified by Federal Regulations and departmental SOPs. • Work with other departments to ensure consistent, accurate and timely reporting of adverse event information. • Participate in project team meetings and act as contact within Drug Surveillance regarding adverse event reporting procedures, coding issues, conventions and summary reports for therapeutic area. • Perform final review and resolves issu
  • Thomson Reuters Healthcare  Physicians Desk Reference
    Director, Clinical Services
    Thomson Reuters Healthcare Physicians Desk Reference
    Oct 2004 - Aug 2008 (3 years 11 months)
    • Responsible for managing the newly created Clinical Services department. • Oversee all clinical content, both print and electronic, for all PDR products. Includes trade/copy sales publications and customized publications for pharmaceutical companies. • Work closely with product development and upper management on strategy for individual products and business as a whole. • Provide clinical insight to product development, solution managers (sales reps), and upper management. • Stay current with trends in the healthcare industry, pharmaceutical industry, medical publishing, and medical communications. • Spokesperson for PDRhealth.com. • Create bi-monthly Strategic Marketing Newsletters for PDR sales and product management groups.
  • Thomson Reuters Healthcare  Physicians Desk Reference
    Drug Information Specialist
    Thomson Reuters Healthcare Physicians Desk Reference
    Oct 2004 - Nov 2005 (1 year 2 months)
    • Write and edit content for Physicians’ Desk Reference (PDR) publications and products. • Draft PDR Addendum letters and PDR Clinical Update letters. • Create front-matter and content of PDR Monthly Prescribing Guides and PDR Concise Prescribing Guides. • Database management of PDR Concise and Pharmacopoeia databases. • Develop content for PDR Pharmacopoeia and Red Book. • Develop and create content for new products and assist in the restructuring of current products. Examples include Hopkins ABX Guide, Physicians’ Desk Reference for Non-Prescription Drugs, and PDR Guide to Terrorism Response.
  • Pfizer Pharmaceuticals
    Regulatory Safety Associate
    Pfizer Pharmaceuticals
    Jun 2004 - Oct 2004 (5 months)
    • Contract Position • Document, data-base, and report adverse event cases. • Trained on ARISg, RSGT, WHO Drug, MedDRA.
  • T
    Staff Pharmacist
    The Prescription Counter
    May 2003 - Sep 2004 (1 year 5 months)
    • Fill new prescriptions and refill existing prescriptions via written and verbal prescriber orders. • Supervise technicians and interns. • Counsel patients on OTC and Rx drugs.
  • Walmart
    Staff Pharmacist/Pharmacy Manger
    Walmart
    Jun 2001 - May 2003 (2 years)
    • Fill new prescriptions and refill existing prescriptions via written and verbal prescriber orders. • Supervise technicians, interns, and the OTC manager. • Counsel patients on OTC and Rx drugs.
Education verified_user 0% verified
  • Northeastern University
    Master of Science In Regulatory Affairs, Regulatory Affairs
    Northeastern University
    Jan 2010 - Jan 2012 (2 years 1 month)
    Master of Science Regulatory Affairs
  • Seton Hall University
    MBA, MBA Pharmaceutical Management and Operations
    Seton Hall University
    Jan 2003 - Jan 2004 (1 year 1 month)
    MBA
  • University of Michigan
    PharmD, Pharmacy
    University of Michigan
    Jan 1997 - Jan 2001 (4 years 1 month)
    Pharmacy School
  • University of Maryland
    Pharmacy School Prerequisites
    University of Maryland
    Jan 1995 - Jan 1997 (2 years 1 month)
    Pharmacy School Prerequisites
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