Acquis is a consulting firm specializing in strategy and implementation. We help ambitious organizations solve business challenges efficiently. I support clients across clinical development, clinical operations, and medical affairs with business activities such as clinical trial design and protocol development, regulatory agency response, KOL/KEE mapping, advisory board presentations, investor presentations, asset program management, and operational excellence.

Government pricing reconciliation support

Project Management: Led projects through full lifecycle, managed timeline and action items for team and external stakeholders, drove client meetings, developed executive reports, and conducted quality review of deliverables.Data Analytics: Spearheaded dashboard development to track compliance program effectiveness and assess metrics against industry benchmarking. Designed surveys and analyzed cross-functional responses in order to reprioritize risk activities based on business needs.Auditing: Managed internal audit of Corporate Compliance Program to assess effectiveness. Managed audit of Clinical Research Organizations to assess performance against contractional requirements. Independently conducted records reviews of field sales expenses to identify non-compliance with internal protocols. Trained and supervised 20 employees during remediation of expense records against client's transparency reporting system to ensure accurate reporting.Monitoring: Managed US Field Force Monitoring Programs for multiple clients annually to observe the appropriateness of field interactions with healthcare professionals. Designed annual monitoring plans and observation form templates to identify improper conduct. Led all client calls to provide a feedback loop on findings. Provided training to all monitoring teams.Transactions Reviews: Designed testing criteria to identify compliance risk for business processes including: incentive compensation, fee-for-service arrangements, and medical information requests. Produced recommendations based on testing results to resolve findings and mitigate risk of reoccurrence.Gap Assessments/Systems Reviews: Guided narrative interviews with stakeholders and evaluated documentation to recommend process improvements for review areas. Drove consensus amongst C-Suite and staff to effectively implement process improvements by enhancing policies, SOPs, and Work Instructions.

Monitoring: SME of live monitoring, including speaker programs (both disease state and branded product presentations) and field rides (with commercial, medical, and reimbursement field personnel) to ensure compliance with internal protocol and regulatory requirements. Led annual and ad hoc training for all monitoring engagements to ensure consistency of methodology.Independent Review Organization (IRO) and Corporate Integrity Agreement (CIA) Readiness: Conducted systems and transactions/encounters reviews, and developed associated reports for IRO, Mock IRO, or CIA Readiness engagements for pharmaceutical, biotech, and medical device companies under or with impending CIAs. Evaluated review areas including, but not limited to: monitoring programs, promotional and non-promotional materials review, investigator sponsored studies, fee-for-service arrangements, publications, incentive compensation, patient assistance programs, and coding advice. Reported observations and developed recommendations that made compliance relevant and were aligned with clients' strategic priorities and desired culture.Policy and Standard Operating Procedure (SOP) Development: Authored Global and US policies and SOPs for various Compliance, Marketing, Commercial, and Medical Affairs business activities to instruct company-wide personnel on functional responsibilities, appropriate interactions, and process steps. Practice Development:> Steered internal initiatives for proposal development, thought leadership, whitepapers, and conference presentation materials> New York Office Social Events Lead from 2013 – 2016: Managed team of five cross-functional members with the objective to build an inclusive culture by curating office-wide social and wellness events> Case and culture-fit interviews for life sciences candidates

Independent Review Organization (IRO) and Corporate Integrity Agreement (CIA) Readiness: Lead Analyst on IRO for medical device subsidiary of Fortune 50 Company under a CIA for off-label use in a clinical trail. Evaluated policies, processes, and procedures to develop Systems Review Report and performed assessments of clinical trial patient information to develop Transactions Review ReportFair Market Value: Led development of FMV evaluation of payments to HCPs for consulting services, including the documentation of FMV methodology and creation of rate cardsGovernment Pricing Reconciliation: AMP, BP, and Non-FAMP calculationsAggregate Spend: Systems testing including development of UAT scripts Practice Development:> Developed CIA summaries to identify trends over the decade and provide recommendations for CIA Readiness> Delivered on-boarding and business etiquette training for new consultant hires