Helen Milton Email & Phone Number

Chiswick, England, United Kingdom

Amersham, England, United Kingdom

I work as a parttime CrossFit coach covering adhoc classes where needed and foundation sessions for new athletes

United Kingdom

Provided operational oversight of the onboarding of a new client for a Real-World Evidence Global Expanded Access Program, leveraging cross-functional collaboration and timeline tracking using Jira. Actively contributed to EU Expanded Access Programs and supported the enhancement of internal processes and strategies within the Expanded Access Program team.Key Achievements:• Facilitated the initial onboarding of a new Real-World Evidence program for a major client, including protocol and informed consent form review to ensure alignment. Served as the primary liaison between the client and internal teams.• Provided operational oversight by setting up and managing detailed timelines in Jira, ensuring all deadlines were realistic and achievable.• Developed and implemented a Risk Register in line with the company’s Quality Management Standard Operating Procedures, collaborating with key internal stakeholders to maintain project integrity throughout its lifecycle.• Identified and addressed potential operational challenges through collaboration with internal and external stakeholders.• Oversaw and managed all operational aspects of an additional Expanded Access Program, ensuring effective communication and seamless coordination among stakeholders.

Oversee a diverse portfolio of global projects with a primary focus on Managed Access Programs, using a wealth of expertise in line management and cross-functional collaboration. •Facilitated seamless collaboration between sponsors, investigators and regulatory bodies during the life cycle projects, ensuring meticulous oversight of all study-related activities and exceeding stakeholder expectations for communications and transparency•Empowered a team of functional leads by effectively delegating amendment responsibilities, fostering ownership & improving team-wide efficiency •Developed & implemented comprehensive amendment management plans, minimizing project delays and mitigating compliance risks associated with protocol changes•Foster regular communication with functional leads to gain holistic oversight of project-related activities. Demonstrate strong project leadership, clearly delineating responsibilities to optimize collaboration across functions•Ensure project-level financial stewardship through understanding of contracts, resource alignment to budget, effective management of OOS work, and proactive participation in the contract modification process. Results to date are meeting budget expectations and saving a client money•Identified quality issues through risk identification and implemented issue resolution at project level, collaborating with the QA team in addressing quality issues•Adhere to PPD SOPs while incorporating client-specific procedures within the established governance model. Ensure timely reporting of all quality issues and potential serious breaches, meeting established timelines•Ensure full oversight of the project team's compliance with organizational policies, SOPs, ICH-GCP, regulatory requirements, and project-specific mandates•Spearhead contract updates, including timeline extensions, collaborating closely with commercial finance on updated budget proposals•Contribute actively to a variety of bid defence meetings

London, United Kingdom

Facilitated the operational oversight of several Global Early Access Programs across Gastrointestinal, Rare Genetics and Hematology and Neuroscience Therapeutic Areas resulting in all projects meeting planned milestones and within budgetEnsured effective vendor management by tracking all milestones and targets set. Implemented a more streamline communication process by establishing expectations in the management of all projects and ensuring these were met at regular intervals which resulted in providing the framework for the start of a governance framework to be implementedProvided expertise and operational guidance on internal requirements on the development and implementation of ethical, agile and sustainable early access programs and initiatives resulting in the wider knowledge of the benefits of early access programs over other types of studies Facilitated Global cross-functional collaboration resulting in improved communications across patient access teams, regulatory, supply chain, finance, ethics and compliance and legal.Directed budget management by tracking agreed spend across programs, monitored mid-year commitment and tracked monthly accruals in line with actual spend resulting in projects meeting forecasted budgets.Acted at the Subject Matter Expert for early access programs including Post Trial Access, Compassionate Use, Unregistered Product Access across the company in response to requests or identified needs for the wider company enabling wider knowledge of the variety of different types of access pathwaysImproved the reporting of metrics for the Pharmacovigilance System Master File (PSMF), Periodic Safety Update Report (PSUR), and Periodic Benefit-Risk Evaluation Report (PBRER) in the context of early access programs, ensuring maximum accuracy by implementing a streamlined communication pathway for each project

London, Greater London, United Kingdom

Assessed, rated the seriousness and processed incoming adverse events for all Baxalta/Shire productsSourced all follow up informationManaged the pharmacovigilance cases for the Nordic and Baltic countries, UK, Ireland and MaltaReconciliation of all market research and patient support programs, clinical trials and distributors for reporting into the regulatory authoritiesSubmitted cases to the MHRA, SE-MPA and HPRA authorities through ARGUSPerformed literature searches to prevent duplicated submissionsCompleted all drug safety training for internal and external staff and companiesWorked with Global Drug Safety to Implement PV wording in all Safety Data Exchange Agreements (SDEA) agreements and keeping wording up to date through company integration

Stockholm, Sweden

Assessed, rated the seriousness and processed incoming adverse events for all Baxalta/Shire productsSourced all follow up informationManaged the pharmacovigilance cases for the Nordic and Baltic countries, UK, Ireland and MaltaRe-conciliated all Market Research and Patient Support Programs, Clinical Trials and distributors for reporting into the regulatory authoritiesSubmitted cases to the MHRA, SE-MPA and HPRA authorities through ARGUSPerformed literature searches to prevent duplicated submissionsCommunicated with the SE-MPA regarding complianceCompleted all drug safety training for internal and external staff and companiesImplemented PV wording in all Safety Data Exchange Agreements (SDEA) agreements

Compton, Berkshire, England

Processed incoming adverse events for all Baxter products within the required timeframes Assessed all adverse events received and sourced follow up informationFrontline customer contact for pharmacovigilance enquires Attended cross functional meetings for periodic reviews of all adverse events and prepare listings of open cases for review and document action taken Maintained the documentation system for all adverse event reporting, workload allocation sheet, training records and submissions of adverse events Reported cases to the regulatory authorities where required

Various

All nursing duties, including but not limited to: working in the operating theatre on a wide range of operations, minor and major surgery, laboratory workI provided support across all branches across North West London. Including running of sole branch practices where required, collecting and submitting the finance sheets and takings for each branch

Maidenhead, Berkshire

Provided primary technical support for pharmacovigilance reporting and customer medical complaints for all European customers, evaluating the nature of the inquiry/complaint and providing technical knowledge of the product and resolution where possible

I managed a team of veterinary surgeons, nurses and administration staff

Uxbridge

All nursing duties, including but not limited to: working in the operating theatre on a wide range of operations including minor and major surgery, as well as laboratory work.

Provided technical advice for all medical information inquires from veterinary practices and the general public including collection and reporting of adverse events)

Hammersmith, London

Provided telephone support in the delivery of two key programs, one to the owners of dogs that were administered the Non Steroidal Anti-Inflammatory drug Metacam and the otherproviding nutritional advice and personal support to individuals taking the anti-obesity medication Xenical

Led and supported a team of four which included maximising sales of advertising space within a number of publicationsEssential skills required were the ability to work as part of a team, meet tight deadlines, negotiate costs, exceed sales targets and close a sale

Veterinary Nursing, Veterinary/Animal Health Technology/Technician And Veterinary Assistant

Veterinary Nursing, Veterinary/Animal Health Technology/Technician And Veterinary Assistant