Ten years experience in the pharmaceutical industry; presently lead scientific communications & publications for metabolism portfolio (including Galvus) on global medical affairs team.
Provide leadership therapeutically for the development of brand publication strategy both from an internal and external needs perspective. Retain primary responsibility on brand team for both strategic and operational elements of medical communications.
Responsibilities extend to other medical affairs functions including KOL management, local Phase IV study concept review and development, slide kit development, internal training, and a broad array of other medical communication deliverables.
Broad educational background includes scientific, public health and marketing training (BSc, MSPH, and MBA); excellent familiarity with scientific and marketing concepts
Medical Communication Leader01/2006 to CurrentNovartis PharmaceuticalsEast Hanover, NJ
Lead the strategy, development and execution of the global publication plan in alignment with global brand strategy for Galvus (DPP-4 inhibitor class oral diabetes drug) and pre-approved compounds to ensure timely publication and dissemination of key data via manuscripts, abstracts, posters, slide presentations, and other documents; oversee all project management tasks related to publications and planning process.
Provide expertise and support to Global Development and Medical Affairs, Regional Medical organizations and Country Pharmaceutical Organizations in the development of publications and other medical communication deliverables.
Identify synergies between different levels of the company (Global, Regional, and Country) and different functions (Medical Affairs, Commercial, Translation Medicine, Pre-clinical) to leverage data for maximal news flow.
Functional manager for 5 medical writers assigned to metabolism therapeutic area (Galvus and earlier stage compounds).
Chair the cross-functional global publication team.
Point of contact worldwide for scientific communication/publication support for regional and country level medical and marketing managers in nearly a hundred countries.
Contribute to the creation and adoption of best practices with regards to medical publication development.
Ensure evolving external regulatory, compliance and competitive environment is reflected in current publication process.
Manage cross-functional review of local Phase IV study concept sheets designed to support Galvus at the regional and country level.
Leverage opportunities to develop publications from these studies on a regional or worldwide level.
Launched KOL management software for Galvus in 2011; manage Galvus speaker bureau, liaise with country level medical managers to involve national level KOLs in global development and medical affairs activities.
Partner with commercial function and vendors to ensure timely dissemination of Galvus and competitor data through publication alerts, PR releases, brand website, etc.
Support development of plans for congress activities including abstract planning, congress reports, slide development, brand medical and marketing managers meeting.
Support development and/or review of slide decks for internal and external purposes.
Develop forecast, obtain approval and manage budget for approved brand scientific communication and publication plans; negotiate contracts and budgets with agencies and other vendors.
Senior Medical Writer01/2004 to 01/2006Novartis PharmaceuticalsEast Hanover, NJ
Authored clinical study reports, summary documents, and other documents for international drug registration for several key therapeutic areas including ophthalmology, dermatology, cardiovascular, gastroenterology and oncology.
Coordinated publication management support for US Ophthalmic Business Unit with inter-company international publication team and Key Opinion Leaders (KOL) to build awareness of new indications for Visudyne in the treatment of age-related macular degeneration.
Provided leadership/guidance on cross-functional project teams on a wide range of issues related to documentation preparation and the presentation of findings from clinical study trials.
Clinical Research Scientist01/2001 to 01/2004Forest LaboratoriesJersey City, NJ
Authored clinical study reports, summary documents, annual updates, and other document required for NDA and IND regulatory submissions within the CNS therapeutic area.
Supported commercialization activities for launch of novel Alzheimer's disease therapy (Namenda) for US market (e.g.
meeting abstracts, journal publications) including serving as an intermediary between clinical and marketing teams, agencies and KOL.
Collaborated with senior clinical staff in clinical data review, regulatory document review, agency management and medical affairs strategies.
Scientific Analyst01/1996 to 01/2000Jacob, Medinger&FinneganNew York, NY
Provided in-house scientific litigation support for product liability defense firm regarding medical and scientific issues impacting major product liability lawsuits.
Created up-to-date summary and analysis of scientific and marketplace information for clients' products using a wide variety of sources including general print media, peer-reviewed journals, and commercial databases.
Consultant01/1993 to 01/1996CanTox US IncBridgewater, NJ
Guided Fortune 500 clients in navigating regulatory requirements pertaining to food ingredients, pharmaceuticals, chemicals and consumer products.
Reviewed and summarized preclinical data in support of regulatory submissions by client companies (e.g.
white papers, publications).
MBA: Marketing Management2004Baruch College-CUNYNew York, NYMarketing Management
MSPH1993University of North CarolinaChapel Hill, NC
Master of Science: Public Health1990University of OttawaOttawa, ONPublic Health
2004 Beta Gamma Sigma Honor Society
2003 Direct Marketing Educational Foundation (DEMF) Echo Competition (2nd place nationally, Graduate Division)
2003 The Direct Marketing Club of New York Scholastic Merit Award