Summary
Overview
Work History
Education
Skills
Timeline
Generic

Loree A. Levine

Summary

Action-oriented Medical Affairs professional proficient at taking on new opportunities and tough challenges with sense of urgency, high energy and enthusiasm. Credited with achieving consistently top results through planning and prioritizing.

Overview

25
25
years of professional experience

Work History

Medical Science Liaison

Amarin Pharma Inc
Bridgewater, NJ
10.2022 - Current
  • Build partnerships with major academic institutions, academic key opinion leader (KOL) and external experts
  • Develop and maintain an advanced level of knowledge about pertinent studies, compounds, and diseases that facilitate peer-to-peer scientific exchange with leading cardiovascular thought leaders
  • Serve as a medical / scientific resource to external and internal partners, including clinical trial sites and Clinical Development & Operations organization
  • Develop and maintain a territory strategic and tactical plan to deliver on Medical Affairs (MA) strategic goals and objectives
  • Identify and report strategic and business relevant scientific / medical field insights
  • Develop internal training resources and slide decks

Director

Bridgewater, NJ
03.2017 - 10.2022
  • Executes the Company medical continuing medical education strategy through alignment with internal and external stakeholders, aligned with defined gaps
  • Executes Advisory Boards, CME programs and appropriate logistics related to Scientific Leader engagement for Regional Medical Teams partnering with Medical Managed Markets, Country Medical Directors, Medical Science Liaisons
  • Partnering with Regional Medical Heads, aligns Global Medical Education plan with regional education gaps ensuring execution is realizing the strategic intent to mitigate identified education gaps
  • Organizes cross-functional planning meetings on a recurrent basis with a focus on read out for major scientific congresses
  • Establishes a process to collect inputs and insights from Region / Country to inform updates to global dossiers on an annual or as needed basis through approval
  • Coordinates and executes Medical Advisory Board meetings partnering with Regional Medical Heads, Compliance, Regional Marketing colleagues
  • Organizes review meetings with Grants Committee and track budget for CME activities
  • Draft agreements and contracts for CME activities
  • Point of contact and lead interface with defined medical graphics/content companies
  • Partnering with Communications and other internal Medical stakeholders (MSLs
  • Managed Markets, etc.) to develop content (slides, animations, infographics, etc.) for scientific narrative on icosapent ethyl, uniqueness, mode of action, clinical evidence, and outcome data that are aligned with Global Medical Strategy
  • Helps to shepherd the content through approval process
  • Organizes FMV tiering process for global HCPs in conjunction with vendor
  • Establishes repository for documentation
  • Organizes review for sponsorships and non-educational congress activities for Europe
  • Ensuring Medical and Compliance review
  • Responsible for declaration of activities as necessary to French authorities
  • Meets weekly with Manager, Medical Affairs to assess grant workflow
  • Reviews and approves invoices for medical grants, sponsorships and other related activities
  • Reviews and circulates medical SRLs and FAQs for approval
  • Updates and routes departmental SOPs for review
  • Reviews and provides response to escalated medical inquiries as necessary
  • Attends bi-weekly publications meetings
  • Organizes IIT meetings for Europe and interfaces with legal for any needed contracts
  • Provides support for Support for creation of US and EU ad hoc HCP agreements

Hospital Pharmacist Per-diem

Holy Name Medical Center
Teaneck, NJ
01.2015 - 12.2020
  • Interaction with physicians and other healthcare professionals regarding patient drug therapy
  • Implemented therapeutic substitutions of antibiotics and other medications as well as automatic dosage adjustment of various antibiotics
  • Monitored patient profiles for drug allergies, drug-drug and drug-food interactions
  • Prepared intravenous piggybacks, large volume parenterals, chemotherapeutic agents, and total parenteral nutrition for adult and pediatric patients.

Medical Affairs Information Manager

Sandoz Inc
Princeton, NJ
05.2015 - 12.2015
  • Responsible for review rewrite and editing of pieces for Zarxio
  • Created non-promotional materials for field medical team use with healthcare professionals
  • Pieces included slide decks on an overview of biosimilars and Sandoz biosimilars in development
  • Leading team to author content and support creation and update of standard responses
  • Handling product inquiry escalations on assigned products
  • Implemented and built database with standard responses to support launched biosimilar products
  • Running monthly meetings to review content, discuss escalations, prioritizing the creation of future content, and interpreting medical insights
  • Provided training and education on identification and reporting of adverse events related to Sandoz products.

Associate Director

Bristol-Myers Squibb
Plainsboro, NJ
06.2005 - 01.2015
  • Responsible for: Leading team of regional MI specialists, medical writers and consultants to author content and support creation and update of worldwide medical content for Orencia, Nulojix, and other assigned brands
  • Conducting cost analyses and oversight of $1M budget for medical writers, interns, and consultants
  • TRECnet content management at the Global level for folders, components, and reference files
  • Ensure consistency of Global content with Regional content
  • Handling product inquiry escalations from all regions
  • Running monthly Worldwide Medical Content Team meetings to review content, discuss escalations, and prioritizing the creation of future content
  • Interpreting medical insights and analytics to support the creation of core content
  • Gathering, communicating, and ensuring availability of key data releases to all regions
  • Creating and communicating customer insights for all regions and for reporting to GMT lead
  • Contributing to development of Medical Brand Plans
  • Ensuring effective communication between WWMT and local Mi (including regional level) by serving as a team member for the WWMT
  • Support of international congresses for compounds in development
  • Liaising with Publication Operations leads to ensure timely availability of posters and oral presentations from congresses
  • Supporting global launches by providing insights, disease area training, and facilitating access to core content
  • Interfacing with global pharmacovigilance to address adverse event inquiries and reporting., Global Core Content & Knowledge Management Immunoscience/Neuroscience/Hemat-Oncology
  • Responsible for: Creation and update of global core content for Orencia, Nulojix, Abilify, clazakizumab, and elotuzumab
  • TRECnet content management at the Global level for folders, components, and reference files
  • Ensure consistency of Global content with Regional content
  • Handling product inquiry escalations from all regions
  • Running monthly Core Content Team meetings to review content, discuss escalations, and prioritizing the creation of future content
  • Interpreting medical insights and analytics to support the creation of core content
  • Gathering, communicating, and ensuring availability of key data releases to all regions
  • Creating and communicating customer insights for all regions and for reporting to GMT lead
  • Ensuring effective communication between GMT and local Mi (including regional level) by serving as a team member for the GMT
  • Support of international congresses for compounds in development
  • Liaising with Publication Operations leads to ensure timely availability of posters and oral presentations from congresses
  • Supporting global launches by providing insights, disease area training, and facilitating access to core content
  • Managing the medical writing activities of vendors and consultants
  • Mentoring fellow Global Core Content & Knowledge Management colleague
  • Contributing to development of Medical Brand Plans
  • Participating in ride-alongs with Field Medical to gain insight through face to face interactions with customers
  • Working on special project for digitalization of core content.

Risk Management/Manager

Safety
05.1998 - 12.2004
  • Provided oversight and strategic direction for the dissemination of practical and scientific knowledge on Organon USA Inc.’s products to both internal and external customers
  • Activities included interfacing with Regulatory, Legal, Marketing & Sales Departments, as well as with external health care professionals
  • Oversaw authoring of labeling and revisions for all US products for submission to FDA
  • Review promotional materials on US marketed products
  • Directed the activities of five Drug Information Specialists, one product complaint specialist, and three drug safety specialists
  • Managed budget $700K budget MI group
  • Performed annual performance appraisals
  • Conducted quarterly career development meetings with direct reports
  • Oversaw the collection and reporting of non-medical complaints
  • Coordinated review of current literature and maintain files of published articles about Organon products
  • Implemented computerized database for medical inquiries
  • Oversaw the collection and transfer of adverse events by Medical Information personnel
  • Acted as Manager of Drug Safety group in the absence of a Director to ensure appropriate collection, monitoring, processing, and distribution of the adverse event reports for investigational and marketed products as well as development and updating of policies and procedures
  • Assured team was meeting regulatory timelines for monitoring and reporting adverse events and pharmacovigilance activities
  • Trained Drug Safety group on departmental SOPs and therapeutic area knowledge
  • Developed risk management plan for marketed products that included comprehensive educational and distribution components
  • Developed objectives and coordinated activities for PharmD students rotating through Drug Information, Publications, Clinical Development, and Phase IV Trials
  • Coordinated risk evaluation management program activities, develop strategies and present findings at national sales meetings
  • Participated in FDA teleconferences
  • Provided educational support to Sales Training, Medical Advisors, RMLs, and Drug Safety
  • Directed educational activities for Medical Information booths at national meetings
  • Coordinated new business development, co-promotional and/or joint venture medical activities including review of clinical trial protocols for the pain management therapeutic area.

Associate Director, Interim, lead

Medical Content Immunoscience
  • Responsible for: Leading a team of 10 individuals including regional MI specialists, medical writers and consultants to author content to support multiple HCV compound launches in Japan, EU and US regions
  • Creation and delivery of HCV training materials to regional MI personnel and call center partners
  • Creation and update of global core content including standard responses and slide decks
  • TRECnet content management at the Global level for folders, components, and reference files
  • Ensure consistency of Global content with Regional content
  • Handling product inquiry escalations from all regions
  • Running monthly Core Content Team meetings to review content, discuss escalations, and prioritizing the creation of future content
  • Interpreting medical insights and analytics to support the creation of core content
  • Gathering, communicating, and ensuring availability of key data releases to all regions
  • Creating and communicating customer insights for all regions and for reporting to GMT lead
  • Ensuring effective communication between GMT and local Mi (including regional level) by serving as a team member for the GMT
  • Support of international congresses for compounds in development
  • Liaising with Publication Operations leads to ensure timely availability of posters and oral presentations from congresses
  • Managing the medical writing activities of vendors and consultants
  • Mentoring fellow Global Core Content & Knowledge Management colleague
  • Contributing to development of Medical Brand Plans.

Associate Director

ImmunoScience Medical Information
  • For: Working with Scientific Communications director to develop and edit scientific manuscripts, abstracts, posters, oral presentations and other printed materials to support the clear scientific communication of BMS products in the ImmunoScience therapeutic area
  • Leading team to author and update the AMCP dossier
  • Providing medical review and guidance by analyzing and interpreting scientific data for professional, payer, and consumer promotional pieces
  • Leading kickoff team for Global Medical Information Project for Orencia
  • Mentoring fellow Medical Information colleagues and team members
  • Maintaining database of standard letters for ImmunoScience therapeutic area
  • Directing the activities of consultants and managers for ImmunoScience
  • Participant in recruitment for the fellowship program
  • Participating in special projects with Strategic Communications
  • Participating in ImmunoScience Medical Matrix team
  • Identifying and communicating inquiry trends and resulting unmet medical needs to Medical Matrix team
  • Contributing to development of Medical Brand Plans
  • Coordinating activities for PharmD students rotating through Medical Information
  • Training new ImmunmoScience Medical Information employees
  • Providing medical review for field communications, MSL and Sales Training materials, advisory board materials, and press releases
  • Directing activities for Medical Information booths at national meetings
  • Planning and maintaining budget for ImmunoScience Medical Information
  • Serving as Women’s Affinity Network tri-chair to oversee planning of educational Lunch and Learns on Women’s Health issues, coordinating networking events for internal employees and career panels with senior executives, participation in philanthropic volunteer opportunities (Dress for Success and Princeton Y Scholars) and promotion of internal BMS resources to employees
  • Coordinating Body of Knowledge Seminar on Organ Transplant for ImmunoScience therapeutic area.

Associate Director

Organon USA Inc
Roseland, NJ

Manager

  • Drug Information and Labeling
  • Managed the activities of four Drug Information Specialists
  • Performed annual performance appraisals
  • Conducted quarterly career development meeting with direct reports
  • Developed and supervised the maintenance of a computerized system of standardized responses, current literature, and information packages
  • Coordinated and reviewed product information correspondence to health care professionals
  • Insured the prompt, thorough, and accurate communication of product information concerning indications, dosages, stability and compatibility to all internal and external users
  • Served as medical liaison for new business development opportunities
  • Provided support to Sales Training Department as appropriate, and assisted in the development of marketing and educational materials
  • Coordinated package labeling revisions in conjunction with Regulatory, Legal, Marketing, and Packaging Development
  • Participated in training for Regional Medical Liaisons, Sales Representatives, and Customer Service Representatives
  • Responsible for providing practical and scientific knowledge on Organon Inc.’s products both to individuals within the company as well as to outsiders
  • Served as medical representative at product launches, national professional meetings, and national sales meetings.

Senior Drug Information and Labeling Specialist

  • Trained and mentored new DIS
  • Worked closely with Medical Advisors on special projects including competitive intelligence as requested
  • Received and handled product inquiries on products in the Fertility, Contraception, and Urology (Bladder Cancer) therapeutic areas
  • Authored and revised product labeling for Women’s Healthcare products.

Drug Information and Labeling Specialist

  • Received and handled product inquiries on products in the CNS therapeutic area
  • Maintained computerized system of standardized responses and information packages regarding most common product queries
  • Handled after-hours emergency calls on rotational basis secondary to Poison Control Center
  • Provided ad-hoc assistance on special issues pertaining to product inquiries with marketed products
  • Reviewed promotional materials and labeling on marketed products
  • Authored Package Inserts for NDAs as well as updated and revised Package Inserts according to FDA request.

Education

MBA - Pharmaceutical Marketing

St. Joseph’s University
05.2009

Master of Science Degree - Drug Information and Communications

Long Island University
05.2000

Bachelor of Science Degree - Pharmacy

St. John’s University
05.1988

Skills

  • Technical Skills:
  • Proficient in Microsoft Office Suite of applications, Medical Terminology, Medical Writing, Project Management, Leadership, Managing Cross-Functional Teams

Timeline

Medical Science Liaison

Amarin Pharma Inc
10.2022 - Current

Director

03.2017 - 10.2022

Medical Affairs Information Manager

Sandoz Inc
05.2015 - 12.2015

Hospital Pharmacist Per-diem

Holy Name Medical Center
01.2015 - 12.2020

Associate Director

Bristol-Myers Squibb
06.2005 - 01.2015

Risk Management/Manager

Safety
05.1998 - 12.2004

Associate Director, Interim, lead

Medical Content Immunoscience

Associate Director

ImmunoScience Medical Information

Associate Director

Organon USA Inc

Manager

Senior Drug Information and Labeling Specialist

Drug Information and Labeling Specialist

MBA - Pharmaceutical Marketing

St. Joseph’s University

Master of Science Degree - Drug Information and Communications

Long Island University

Bachelor of Science Degree - Pharmacy

St. John’s University

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Loree A. Levine