Jonathan Warren Email & Phone Number

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Coordinated creation, storage, and fulfillment of printed promotional and non-promotional materials with internal stakeholders. Managed third party print and fulfillment vendors and systems.Lead all print and fulfillment activities for promotional materials, print production, inventory management, and materials distribution for over 100 unique materials.Managed and maintained existing inventory and fulfillment operations for successful commercial launch.Transitioned… Show more Coordinated creation, storage, and fulfillment of printed promotional and non-promotional materials with internal stakeholders. Managed third party print and fulfillment vendors and systems.Lead all print and fulfillment activities for promotional materials, print production, inventory management, and materials distribution for over 100 unique materials.Managed and maintained existing inventory and fulfillment operations for successful commercial launch.Transitioned print and fulfillment vendors resulting in new ordering system, transition of warehousing, and training for new vendor best practices.Collaborated with primary stakeholders in Marketing, Patient Services, Market Access, Patient Advocacy, Medical Affairs, and Peer to Peer marketing to ensure key print and fulfillment initiatives are supported with appropriate processes, tools, resources, and technology.Collaborated with the Information Systems team for Veeva CRM/Vault, OKTA, and Ordering System integrations for improved compliance and system security. Provided direction to stakeholders to ensure successful and timely material creation, delivery, and utilization for product launches, regional events, and field teams resulting in successful large and regional conferences.Developed key metrics for print and fulfillment activities; shared monthly with leadership and key stakeholders.Provided specific, actionable feedback to leadership regarding vendor performance and service concerns resulting in process improvements and cost savings.Collaborated with key stakeholders to manage annual budget, PO and invoicing processes for print and fulfillment vendors.Managed all print and print fulfillment for product launches.Trained all users on order fulfillment platform; developed key training tools for ongoing support.Developed procedures and training tools aligned to SOPs.Managed Medical Subscriptions for global use and integrated to existing systems for central access by Medical Affairs. Show less

Boston, Massachusetts, United States

Acted as a single point of contact for all MLR submissions, tracking, approvals, and reporting.Provided thorough quality checks of all materials submitted into the MLR process. Facilitated all MLR meetings taking into account timelines/prioritization for all projects and keeping a planning and prioritization tracker of future MLR projects. Collaborated cross functionally to prioritize materials for (M)MRC review for upcoming product launches. Capture… Show more Acted as a single point of contact for all MLR submissions, tracking, approvals, and reporting.Provided thorough quality checks of all materials submitted into the MLR process. Facilitated all MLR meetings taking into account timelines/prioritization for all projects and keeping a planning and prioritization tracker of future MLR projects. Collaborated cross functionally to prioritize materials for (M)MRC review for upcoming product launches. Capture changes/edits during MLR meetings.Routed and monitored promotional and non-promotional review materials, including initiating the re-reviews, in the content management system; ensuring the correct team reviewers are assigned. Collaborated with the reviewers, project originators, ad agencies, and leadership to resolve any questions or issues. Requested system access and training for new users. Delivered agendas in a timely fashion. Provided notification of release of materials to project originators and agencies. Monitored MLR specific inbox. Proactively provided recommendations for process, system, and resource optimizations.Provided ad hoc project coordination on Funding/Sponsorships development and maintenance, MRL/MSL onboarding and mentorship program, and systems implementation. Show less

Richmond, Virginia

Coordinated the review and evaluation for all branded and non-branded promotional materials. Subject matter expert to originate and investigate process deviations.Submitted advertising and promotional labeling materials to the US Food & Drug Administration for approved products through paper and NextGen portal. Helped implement Electronic Submission of Promotional Materials to the US Food & Drug Administration with Regulatory Operations team.Implemented process… Show more Coordinated the review and evaluation for all branded and non-branded promotional materials. Subject matter expert to originate and investigate process deviations.Submitted advertising and promotional labeling materials to the US Food & Drug Administration for approved products through paper and NextGen portal. Helped implement Electronic Submission of Promotional Materials to the US Food & Drug Administration with Regulatory Operations team.Implemented process improvements for the review and approval of promotional and non-promotional materials in a more timely and efficient manner.Automated Medical, Legal, and Regulatory Review meeting agenda using Visual Basic generating measurable time savings for all agendas.Established, monitored, and improved review timelines to meet project deadlines and product launches for promotional and non-promotional materials.Performed data analysis on document volume and life-cycle status for bi-weekly Executive Committee meeting. Documented outcomes of assessments. Performed final edits and quality checks of revised material and determined approval and use for ~1000 materialsProvided training on Veeva Vault PromoMats and MedComms to Global Indivior End Users in order to grant their software access for Promotional Review Committees and Medical Review Committees. Improved Standard Operating Procedure and all Work Instructions related to the Promotional Review Committee and completed Medical, Legal, and Regulatory Review of promotional and non-promotional material. Member of the Windows Update Feedback Pilot Team to help provide feedback on new Microsoft updates at varying stages before the updates are released to Global End Users. Show less

Charlottesville, Virginia Area

Liaison with Regulatory Authorities, Vendors, Investigative Sites, and others on behalf of the client. Provided clinical research safeguards by proxy for tasks related to regulatory requirements, GCP Guidelines, and the Code of Federal Regulations. Managed 110 Investigational Sites across 6 protocols with the support of CTM/SUL/CRA to maintain compliance with study timelines, the trial protocol, ICH/GCP, and applicable regulations.Resolved internal and external clinical issues… Show more Liaison with Regulatory Authorities, Vendors, Investigative Sites, and others on behalf of the client. Provided clinical research safeguards by proxy for tasks related to regulatory requirements, GCP Guidelines, and the Code of Federal Regulations. Managed 110 Investigational Sites across 6 protocols with the support of CTM/SUL/CRA to maintain compliance with study timelines, the trial protocol, ICH/GCP, and applicable regulations.Resolved internal and external clinical issues for client research projects managed by PRA and ensured the activities were accurately tracked within the designated trial management database. Reviewed and developed Informed Consent Form templates for 50+ Investigational Sites to meet Sponsor deliverables. Show less

Charlottesville, Virginia

Conducted research focused on Rotational Spectroscopy and identifications of unknown. Re-coded an old analysis program in Python from C++ to achieve higher efficiency and effectiveness. Designed, built, and diagnosed rotational spectrometer and vacuum system.

Charlottesville, Va

Instructed 22 student course on physical chemistry. Graded, advised, and supervised multiple classes in a large lab setting. Guided inquiry based academic lab for engineering students to provoke self motivation and higher understanding.

Fort Belvoir, Virginia

Designed and developed software in Python for use with light imaging sensor. Characterized lenses for use in highly sensitive camera systems. Performed basic computer maintenance and repair with LabVIEW based systems.

Silver Spring, Md

Aided supervisor and administrative officer in their work and research groups. Managed file storage and aided in the implementation and install of Microsoft SharePoint. Presented progress of work to supervisor and administrative officer.

As vending manager I would assign sections for the waitstaff to assist and decided inventory and sales strategy for vending staff.