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Summary
This expert consultant has extensive knowledge and experience working with pharmaceutical sponsor marketing and sales teams to develop and implement promotional strategies that comply with applicable regulations and guidance’s. He has over 12 years of sales effectiveness experience planning and implementing product promotional programs successfully using project management tools. He developed action and communication plans with matrix teams during organizational structure changes, e.g., company buyouts and/ or new product launch. This pharmaceutical sponsor marketing expert has extensive experience collaborating with promotional compliance team members and has chaired the steering committee that ensures products are handled/ managed per specifications outlined in the prescriber information sheet (PI). He has expert knowledge of and experience with 21 CFR Parts 11 electronic records, 201-205 Prescription Drug Marketing Act, Pharma Code, Anti-kickback statute, state and federal transparency reporting, and Sarbanes-Oxley.
Rocco has led projects to implement more compliant systems and training methods:
- Veeva
- Dendrite
- Websites and databases
Highlights
- Sales tool development to track visit messaging and Sunshine Act transparency data gathering and reporting
- Promotional content creator and collaborator with applicable functions such as corporate compliance and ethics, legal, manufacturing, distribution, corporate security, and digital marketing
- Compliance monitoring planning/ HR and sales reports /conduct investigations/ manage escalations/ corrective action and preventative actions (CAPA)
- Sample cold chain and ambient temperature product safety review/ batch forecast and distribution planning
- 20+ years in diagnostic
- spectrometry technologies
- Product recall/ FDA Letters
- HCP master database licensing and KOL expense tracking
- Co-promotion product program compliance collaborator and sales trainer
- FDA report management/ individual state reporting
- Validated System owner
- Developed testing approaches for developed requirements
- Records management
Relevant Accomplishments
- Acted as subject matter expert for product recalls and Healthcare Provider (HCP) prescriber status.
- Coordinated compliance and training for a project to align three sponsor sales organizations promoting new cold chain samples. Ensured sales practices to be consistent across over 5,000 sales
representatives. - Worked with promotional compliance teams to track and ensure messaging was consistent and aligned with pharmaceutical laws and guidance’s
- Developed training tools to ensure sales effectives and reduce regulatory impact by sales personnel.
- Planned for and managed change management activities for global projects.
- Developed and implemented direct to prescriber product programs for multiple therapeutic areas.
- Managed the conversion of paper documents to electronics eliminating the need for filing cabinets and paper printing and filing costs.
- Tracked Key Opinion Leaders (KOLs) approved for company promotional activities and tracked dollar spend activity based on state requirements.
- Established annual promotional event budgets and planning for promotional programs.
- Developed new sales tool system in Veeva.
- Optimized, tested and validated initial launch and Veeva tool re-iterations.
- Developed quality assessment of programs to ensure monitoring performance and detect issues for
correction; implementing corrective action plans when necessary. - Responsible for overall operation and administration of product FDA records ensuring that all duties were properly performed and applicable to PDMA regulations.
- Hired and maintained qualified personnel to monitor sales operations.
- Planned and developed policies and procedures.
Roles
- Sample Compliance Manager, Bristol Myers-Squib Co.
- Sr. Systems Analyst, Bristol Myers-Squib Co.
Request Expert / Similar Expert
Click “request expert” for a free initial screening call with this expert or a similar expert regarding your expert consulting needs
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