Summary
Overview
Work History
Education
Skills
Accomplishments
Languages
Custom
Timeline
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Virginia Manning

Virginia Manning

London

Summary

Accomplished professional with expertise in strategic planning, stakeholder management, and EMEA regulation. Demonstrated success in team leadership and risk mitigation, driving cross-functional management and process implementation. Adept at medical writing and editing, with a strong focus on program improvement. Committed to leveraging skills for continued career growth and impactful contributions to organisational objectives.

Overview

23
23
years of professional experience
6023
6023
years of post-secondary education

Work History

Program Manager

ROCHE PRODUCTS Ltd
01.2016 - Current
  • Leadership: EU Lead for authorised product
  • Global Filing Lead (multiple indications): initial MAAs, variations and line extensions and HA interactions
  • Lead strategist for paediatric programs in EU and rare disease strategies
  • Lead point of contact with EMA, PDCO and national authorities
  • Ensuring proactive management of cross-functional stakeholders, review committees and development teams
  • Engaged in proactive forecasting and provision of resource needs, including vendor and finance management
  • Oversight of CTR strategy
  • EU and Global Regulatory Compliance & Strategy: Served as EU Strategy Lead for clinical trials and medical devices (early and late-stage)
  • Lead communication for all EU28 country affiliates; key point of contact
  • Upskilled as IVDR and MDR point of contact
  • Process Mapping: Distributing global communications to provide project updates to Roche Leadership/Lifecycle teams
  • Business Growth: Strategically motivating individuals or teams with different interests/goals to reach consensus by highlighting program objectives and engaging
  • Lead recruiter for Program Management internship, coaching and mentoring
  • Global Business Process Owner for safety communication
  • Executed risk assessment strategies to mitigate potential project threats.
  • Facilitated training sessions for enhancing team skills and productivity.
  • Promoted culture of continuous improvement amongst team members through regular feedback sessions.

Senior Regulatory Documentation Scientist

ROCHE PRODUCTS Ltd
01.2012 - 01.2016
  • Medical Writing and Editing: Substantively wrote clinical documents, including eCTD Modules 2 and 5 for submission to agencies
  • Ensured high-quality documents and met program timelines by persuading key staff and other departments
  • Leader: UK Medical Editing team
  • Business Integration: Represented in senior stakeholder interactions relating to strategic decisions for programs and projects, enabling profit gains above target
  • Compliance: Ensured compliance with EMEA Policy requirements and consistency of external communications supporting business growth and strengthened information security
  • Prepared specifications for Regulatory work and served as liaison for project purposes
  • Authorizations Management: Obtained several global authorizations as leading participant in global filings for approval of pivotal drugs
  • Process Improvement: Improved accuracy, transparency, and compliance by actively contributing to best practices and continuous improvement within Regulatory teams, including engagement and team building

Program Manager

ROYAL COLLEGE OF GENERAL PRACTITIONERS
01.2011 - 01.2012
  • Process Enhancement: Facilitated operational activities by drafting and updating CIRC (Clinical Innovation and Research Centre) policy, guidelines and health modelling documents
  • Performance Achieving: Managed UK-based family and community health policies and research initiatives as well as national clinical audits
  • Ensured Program Sustainability: Fostered clear objectives and engagement by developing project timelines and implementing deliverables
  • RESULT: Maintained 100% accuracy

Program Manager, Cancer Genetics

MCGILL UNIVERSITY
01.2002 - 01.2011

Account Coordinator, Pharmaceuticals

FUSION MD COMMUNICATIONS
01.2007 - 01.2008

Education

MSc (Hons) - Medical Humanities

KING’S COLLEGE LONDON
London

BA (Hons) - English, minor Biology

CONCORDIA UNIVERSITY
Montreal
2007

High School Diploma - Honours

THE MASTERS SCHOOL
New York
06.2003

Skills

  • Strategic Planning
  • Stakeholder Management
  • EMEA Regulation
  • Team Leadership
  • Risk Mitigation
  • Cross-functional Management
  • Medical Writing and Editing
  • Process Implementation
  • Program Improvement

Accomplishments

  • Lead participant obtaining global approval for blockbuster drug and the most successful launch in Roche history.
  • Leadership of strategy meetings with European Medicines Agency (EMA) and other EU health authorities, negotiating and synthesising critical outcomes on behalf of Roche.
  • Lead communication strategy with EMA, including all manner of Regulatory procedures.
  • Implementation of global Regulation and Policy, including adaptive pathways resulting in simplified workflows and better results for a Regulatory sub-team.

Languages

English
Native
French
Advanced

Custom

Breastfeeding and Lactation Consultant (in training), 01/01/21, Present Vinyasa Power Yoga Teacher, 01/01/19, Present STEM Ambassador, 01/01/12, Present

Timeline

Program Manager

ROCHE PRODUCTS Ltd
01.2016 - Current

Senior Regulatory Documentation Scientist

ROCHE PRODUCTS Ltd
01.2012 - 01.2016

Program Manager

ROYAL COLLEGE OF GENERAL PRACTITIONERS
01.2011 - 01.2012

Account Coordinator, Pharmaceuticals

FUSION MD COMMUNICATIONS
01.2007 - 01.2008

Program Manager, Cancer Genetics

MCGILL UNIVERSITY
01.2002 - 01.2011

MSc (Hons) - Medical Humanities

KING’S COLLEGE LONDON

BA (Hons) - English, minor Biology

CONCORDIA UNIVERSITY

High School Diploma - Honours

THE MASTERS SCHOOL

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