A global CRO focused on delivering life-changing therapies with proven solutions from early phase to post-approval.

Global software company offering their cloud solution, LifeSphere®, for Drug Safety, Data & Analytics, Clinical Development, Regulatory Affairs and Medical AffairsManaged out-of-the-box Regulatory and EDMS platform training packages for customers and partnersAccomplishment:- Created a well-rounded, drug development-focused training program curriculum inclusive of software, system, and domain training, with the ability to be delivered based on the specific software package purchased

A global CRO with more than 21,000 employees offering end-to-end regulatory and clinical solutions for the biopharmaceutical and medical device industries.Partnered with Sales to develop bespoke operational strategies and solutions for customer engagements ranging from small biotech ad hoc consulting to large-scale Regulatory outsourcing for Top 10 Pharma with approval oversight. Served as Global SME for Regulatory Operations (RO), Information Management (RIM) and Publishing.Accomplishments:- Mediated $5M multi-year regulatory services contract with Top 20 Biopharmaceutical company to extend services and secure expansion to newly acquired companies- Optimized pricing tool for new EU CTR Readiness consulting program to establish accurate pricing and SME utilization estimates, including Regulatory, Pharmacovigilance and Training, to ensure clients' process documentation was completed in time for upcoming regulatory and ethics committee submissions to meet new regulation deadlines

A global CRO with more than 21,000 employees offering end-to-end regulatory and clinical solutions for the biopharmaceutical and medical device industries.Partnered with Sales to develop bespoke operational strategies and solutions for customer engagements ranging from small biotech ad hoc consulting to large-scale Regulatory outsourcing for Top 10 Pharma. Served as Global SME for Regulatory Operations (RO), Information Management (RIM) and Publishing.Accomplishments:-Negotiated $3.2M multi-year regulatory, pharmacovigilance, and medical writing contract with a small clinical-stage biopharmaceutical company-Participated in Parexel's Wisdom Circle, a year-long leadership development program for senior management-selected individuals

A global CRO with more than 21,000 employees offering end-to-end regulatory and clinical solutions for the biopharmaceutical and medical device industries.Contributed as SME to customer proposals and contracts with strategic Regulatory Operations (RO) and Information Management (RIM) solutions. Project managed publishing projects for US, Canadian and EU electronic applications and lifecycle submissionsAccomplishments:- Developed a pricing tool template, submission metrics data management tool, and standard proposal text for Regulatory Operations which decreased response time to client RFIs and RFPs- Nurtured client relationships to renew yearly lifecycle contracts and expand book of business

A global CRO with more than 21,000 employees offering end-to-end regulatory and clinical solutions for the biopharmaceutical and medical device industries.Project managed compilation of US, Canadian and EU electronic applications and lifecycle submissions. Document-level publishing.Accomplishments:- Led publishing project for small biotech's first original marketing applications for one product to US, Canada and EU with submission dates in the same month- Maintained governance model through regulatory changes and company acquisition

A global CRO with more than 21,000 employees offering end-to-end regulatory and clinical solutions for the biopharmaceutical and medical device industries. Project managed and compiled US IND and NDA applications and lifecycle submissions in paper, NeeS, and eCTD formats for assigned clients. Maintained project process documentation.Accomplishments:- Established a governance model for all regulatory services, inclusive of Standard Operating Procedures (SOPs), Work Instructions (WIs), and forms to ensure consistent project delivery - Completed Liquent Education Services course "Publishing with Liquent Insight Publisher"

Global pharmaceutical company with more than 80,000 employees focused on Oncology, BioPharmaceuticals and Rare DiseaseProject managed and compiled US IND and NDA applications and lifecycle submissions in paper, NeeS and eCTD formats for assigned productsAccomplishments:- Created innovative training matrix for Regulatory Operations-specific tasks for eCTD publishing to minimize changes required and shorten turn-around time to final updated documentation- Contributed to company-wide process for publishing eCTD formatted submissions- Key member of publishing team for company's first eCTD formatted application