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Work Background
Legal ShieldLegalShield & IDShield Independent Associate
Nov. 2024Berkeley Heights, New Jersey, United States
stay on course with Julie RigaHead of Business Development, Networking and Special Events
May. 2024
NovartisAssociate Director, Scientific Knowledge Design Lead
Jan. 2023 - May. 2024East Hanover, New Jersey, United States
NovartisAssociate Director of Scientific Communications US Oncology Melanoma/GI/GU and PROS
Oct. 2020 - Jan. 2023East Hanover, New Jersey, United States
NovartisAssociate Director of Scientific Communications US Oncology CML
Sep. 2019 - Oct. 2020East Hanover, New Jersey
NovartisSenior Manager, Clinical Disclosure Office
Jun. 2013 - Sep. 2019East Hanover, NJEnsure quality and compliant protocol registrations and results postings to global registries (ClinicalTrials.gov, EUdraCT registry, ENCePP, Novartis Clinical Trial Results, etc.) COMMUNICATIONS
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► Develop and maintain effective working relationships with global and country multidisciplinary leaders, such as Study Leads, MDs, Legal, and Business Development & Licensing. ► Address and resolve questions received from therapy areas and country registries. QUALITY
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►Interpret, discuss, and ensure appropriate trial data (i.e. protocol, CSR) is accurately represented as the trial registration and prepared result. ► Organize and conduct routine client training to drive quality, compliance, and organizational alignment to changing disclosure requirements. ► Remain current with global policies & regulations and operational application to ensure harmonization of Novartis transparency processes and standards. ► Drive delivery the most productive processes by continually ensuring best practices PROCESS IMPROVEMENT
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► Ensure all trial results comply by continually tracking projects that will be submitted for Health Authority approval. ► Identify barriers to alignment of processes, create implementation plans for execution, and obtain alignment within a franchise/business unit. ► Participate/lead the redesign and maintenance of SOPs and management of external & internal audits.
NovartisSenior Drug Supply Trial Manager
Oct. 2006 - Jun. 2013East Hanover, NJPerformed functional activities of Senior Trial Manager and performed project management activities from a clinical supplies perspective. COMMUNICATION
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► Participated on global project teams within various Franchise Teams: Oncology, Cardiovascular, Neuroscience, Infectious Disease, and Respiratory. ► Coordinated Oncology collaboration study with Celgene/Novartis since 2007. PROJECT MANAGMENT
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► Oversaw scheduling and timely delivery of bulk drug, label and packaging design, randomization, packaging, and distribution of clinical supplies. ► Challenged and coordinated supply chain deliverables. Verified key project milestones were met; negotiated and communicated supply plan timelines to internal and external partners. ► Proactively drove cross-functional activities. Worked line functions to manage complex projects. ► Led the planning, creation, and maintenance of project supply plans, based on study forecasts. PROCESS IMPROVEMENT
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► Performed supply forecast simulations, contributed to the study specifications for IVRS studies, and provided medication management for highly complex studies using IVRS. ► Led the work stream to create Governance Model for our new flat and lean structure within DSM. ► Participated in capacity, resource planning, and hiring committee.
NeighborCareFull Time Long Term Care Pharmacist
Jan. 2005 - Jan. 2006Filled and dispensed all pharmacy orders for Long Term Care facilities.
Jeiven Pharmaceutical Consulting, Inc.Senior Project Manager Consultant/Business Development Manager
Jan. 2004 - Jan. 2005Managed all clinical supply activities for clients for US and EU clinical trials. ►Liaised with all outside contractors to ensure timely delivery of clinical supplies in accordance with the study design and cGMP regulations. ►Kept up-to-date with all new regulations for clinical trials in the US and EU. ►Developed business through networking and industry conventions.
Aventis PharmaceuticalClinical Supplies Liaison- Senior Level
Jan. 2001 - Jan. 2003►Coordinated the preparation of investigational supplies for assigned projects. ►Prepared Microsoft Project plans for all assigned projects. ►Actively participated as Clinical Supplies representative on Project and CMC teams.
OrganonSupervisor/Coordinator - Investigational Supplies
Mar. 2000 - Sep. 2001New JerseyParticipated in Global clinical trial teams for various therapeutic areas and supported clinical packaging trouble-shooting activities. QUALITY / PROCESS IMPROVEMENT
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► Aided in the design and implementation of International Logistical Information Planning System. ► Coordinated sourcing, manufacturing, packaging, labeling, distribution, design and inventory control for investigational and comparison drug products for global clinical studies. ► Assisted in writing SOPs, packaging protocols, and other technical batch documentations. ► Monitored outside contract services for the manufacturing, packaging, and shipping of drug supply. STAFFING DEVELOPMENT
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► Supervised and coached five Investigational Supplies Coordinators plus one Admin Assistant. ► Provided training on protocol interpretation, optimal packaging design and investigational supplies operation for new associates as well as ongoing training for other employees. ► Managed job performance reviews; Developed team by recruiting and hiring qualified individuals. ► Handled planning, budgeting, and analysis of department.
MANAGED HEALTHCARE ASSOCIATES MHASenior Formulary Analyst - Pharmacist
Jan. 1999 - Jan. 2000Provided analytical services as part of a group purchasing organization for nursing home providers and acute care networks to target drugs that will maximize savings and profits.
CENTRAL FILL INCORPORATED CFI/NPALead Formulary Pharmacist
Jan. 1998 - Jan. 1999► Managed and trained pharmacists to maintain consistent productivity with high standard of quality. ► Implemented and aided in managing tactical and strategic projects to achieve marketing objectives. ► Researched certain drug classes for efficacious therapeutic conversions. ► Served as disease state pharmacist for 40+ patients with AIDS and Multiple Sclerosis.
CENTRAL FILL INCORPORATED CFI/NPAFormulary Pharmacist
Feb. 1997 - Aug. 1998Assisted in the development of a formulary department.
Monitored therapy and provided drug information to doctors, healthcare associates and patients.
VILLAGE MEDEX DRUGSRegistered Pharmacist/Pharmacy Intern
Jan. 1993 - Jan. 1997Supervised 10 - 15 employees; handled all employee relations: hiring, training and terminating.
Filled, processed, dispensed prescriptions for high volume store averaging 300 prescriptions daily.
Stay on Course LLC with Julie Riga
LegalShield & ID Shield
Berkeley Heights, New Jersey, United States
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