Lisa Grim Email & Phone Number

Coopersburg, Pa, Us

Paris, France, Fr

• Strategic innovator developing better methodologies for non-interventional Post-Authorization Safety Studies (PASS). Supporting internally led pharmacovigilance (PV) studies for Sanofi products (general medicines & specialty care) as required by market health authorities.• Study planning functional expert for the implementation of Veeva Vault Clinical Trial Management System.• Gig Project Manager for the corporate security insider risk program. Delivered gap analysis of the P&C talent acquisition clearance process that produced a RASCI matrix for US, Brazil, Canada, and Asian affiliates.• Communications Leader for the Cancer & Work US Affinity Group and member of the PSPV value creation communication campaign post approval culture collaborators.• Clinical Studies: KPI designer for CRO study deliverables. Delivered investigator meetings at ECTRIMS in Italy. Managed the study termination for an EU CRO working with Sanofi's Legal team and led transition to a new Global CRO. Led-post authorization safety studies planning, start up, close out and archiving projects.• Co-Author of a delivered Pharmacovigilance Acquisitions & Divestments Handbook.Skills utilized: Agile & Lean methodology, Adobe Pro, Veeva RIM & Clinical/eTMF, COUPA & SAP (finances), Smartsheet (reporting), Visio, M365, MS Forms (surveys) SharePoint, Teams, WeSpire (CSR), Viva Engage (comms), Canva (graphics), Copilot AI (content), outsourced events management, and translations services.

Paris, France, Fr

• Developed proposals for Opex & Capex budgets for R&D initiatives. Events manager collaborating with R&D leadership to deliver the Science Awards, town halls, open mic sessions, and the recognition program.• Delivered the first Sanofi R&D Integrations M&A Handbook, sponsored by the Head of R&D. Delivered data analytics proof of concept dashboard design for the Biological Samples Management program. Skills utilized: Agile methodology, SharePoint, Teams, COUPA & SAP (finances), OneTrust (data privacy), MS Project, Visio, M365, MS Forms (surveys), Camtasia Studio (videos), Adobe Pro, Rise Articulate.com (eLearning), Power BI (dashboards), internal events management, and outsourced multi-media agencies.

Paris, France, Fr

• Leader and Business Owner for framework (process, roles, and tools) of the Regulatory Data Analyst (RDA) function. Framework included receiving, tracking, investigating, analyzing, and resolving complex Regulatory issues and requests. Manager of Regulatory Data Analyst EU staff supplementals.

Paris, France, Fr

• Project leader for $3 million Business Intelligence (BI) cloud solution that automated planned, forecasted submission milestones and resource capacity that serviced 800 global end users. Core team member of the Horizon’s Program, reporting to R&D executive Steering Committee. Resource manager for Sanofi project staff, Cognizant, and Qlik Developers. eLearning designer and delivery manager for BI solution program serving users in English, German, French, Spanish, and Mandarin.• Delivered funding and ROI proposals to secure Opex and Capex budgets for GRA initiatives. Managed requests for proposals (RFPs), vendor selection process, co-authored master service agreements and work orders.• Proof of Concept leader for Veeva Vault RIM data model gap analyses. Managed the training and qualification of super users to wireframe 30 analytical reports using a Sanofi Qlik Sense development platform. Skills utilized: Waterfall, Lean & Agile methodologies, Adobe Pro, Qlik Sense, M365, SharePoint, AWS, Veeva RIM, OneTrust (data privacy), SurveyMonkey, COUPA & SAP (finances), MS Project, Jira, Documentum, HP App LCM, Smartsheet, Camtasia Studio (videos), Visio, travel services, and eLearning development services.

Ashburn, Virginia, Us

(Merger of Computer Science Corporation and Hewlett Packard Enterprise Services)• Services Director leading projects for commercial business process outsourcing services and regulatory submission management in eCTD format for 45 pharmaceutical and biopharma companies (Tier 1, 2 & 3) across Phases I, II, II and IV (market launch).• Product Owner for 300 commercialized medical writing templates, managing staff and maintaining guidelines. Designed a commercialized Regulatory Information Exchange (RIX) SharePoint Online client access platform. Project Manager for producing product launch kits with advertising agencies and directly training the company sales force.• Managed third-party suppliers used for clinical studies, pharmacovigilance ICSRs, and FAERS digital solution program, health authority communications, medical writing services, biostatistical consulting, and quality data management auditing for xEVMPD. Onboarded and maintained learnings for cross-functional teams in India, Philippines, China, EU, and US.• Managed RFPs, MSAs, work orders, engagement financials and sales conferences. Maintained partnerships with Sponsor business units (R&D leaders, Quality Management, Procurement, Legal reps, ITS/Digital leaders).• Participated as a voting member of Health Level Seven International (HL7) for RPS, SPL & IDMP and a member of the eTMF Reference Model working group.Skills utilized: Lean & Waterfall methodology, Adobe Creative Suite, Adobe Pro, eCTD Xpress, ISI Publisher, Writer, Toolbox and eCRF Track, Salesforce CRM, SAP (finances), MS Project, MS Office, SharePoint, Jira (s/w testing), Visio, First Doc R&D (Documentum), First Point R&D (SharePoint), and events management services.

Plymouth Meeting, Pa, Us

• Sales Director representing clinical study site feasibility services, site launch/site activation services, online investigator training services, CNS investigator rater training, patient recruitment services and safety reporting distribution solution for Ethics Committees and Institutional Review Boards. Clients were Roche and Pfizer.

Irvine, Ca, Us

• Sales Director and consultant representing Software as a Service (SaaS) clinical operations platform, study start-up portals, IRT (Interactive Response Technology) implementations, digital asset management (DAM) and labeling portfolio solutions. Member of the Microsoft Partner Network. Managed on & offshore software development validation resources and sales conferences. Clients were Novo Nordisk, Novartis, Bristol Myers Squibb, Biogen Idec, and Sandoz.

• Sales Account Manager and consultant with a yearly $5 million sales quota for commercial software and implementation services. Closed opportunities at 60%+ profit margins and multi-year agreements. Maintained client partnerships with Sponsor business units (R&D leaders, Quality Management, Procurement, Legal reps, ITS/Digital leaders). Managed RFPs, MSAs, work orders, engagement financials and sales conferences. Member of DIA EDM Reference Model Working Group and Microsoft Partner Network. Clients were Merck, Roche, Genentech, Amgen, Novartis, Jansen, and Sanofi.

Tel-Aviv, Il

• Project implementation leader and operations business owner of $3 million digital labeling submission and document management solution to accelerate commercial pharmaceutical drug approvals, integrated with Teva’s B2B supply chain model. Led the first outsourced drug submission in eCTD, eTMF, SPL, and PLR formats. Working group member of DIA EDM model, SPL, eTMF SIAC, Microsoft Partner Network and FCG FirstDoc client advisory board member.• (1996-2004) Design Specialist: Set up digital asset management processes for incoming Mergers & Acquisitions manufacturing package labeling. Delivered Teva USA’s first corporate identity manual, and style guide used for advertising and product labeling. Core team member for product launches (advertising & product labeling) for Teva brand generics and COPAXONE, Teva’s first BLA to treat relapsing forms of multiple sclerosis (MS) in adults.