We are seeking a Senior Manager Global Evidence Generation and Medical Operational Excellence (SMEGOE) to join our Medical Affairs organisation in London. Reporting to the Chief Medical Officer this global role will play a pivotal part in overseeing evidence generation activities and driving medical operational excellence across Theramex.
You will lead and manage the Global Scientific Review Committee (GSRC) and provide operational leadership across global medical planning repositories and medical meeting management. This position requires deep expertise in GCP GPP clinical research publication standards and strong organisational and communication skills to ensure compliance operational rigour and effective dissemination of scientific activities.
About you
You will bring:
An advanced degree (MD PhD PharmD or equivalent).
Experience in clinical research medical affairs or clinical trial management (including noninterventional studies and investigatorinitiated studies) within the pharmaceutical or biotech industry.
Expertise in Good Clinical Practice (GCP) and Good Publication Practice (GPP).
Global experience and comfort operating across multiple therapeutic areas (highly desirable).
Excellent project management capabilities with the ability to manage multiple priorities and stakeholders.
Strong communication and presentation skills with the ability to communicate complex scientific topics clearly.
Outstanding organisational skills with strong attention to detail and documentation accuracy.
Strong leadership collaboration skills and the ability to influence stakeholders at all levels.
A proactive and solutionoriented mindset with passion for scientific research and evidence generation.
Ability to work independently and as part of a global crossfunctional team in a fastpaced environment.
Willingness to travel occasionally for meetings conferences or studyrelated activities.
About the role
In this global position you will be responsible for:
Global Scientific Review Committee (GSRC) Leadership and Governance
Serve as the Chairperson of the GSRC ensuring effective leadership and smooth committee operations.
Review and evaluate:
Theramexsponsored noninterventional studies from affiliates and therapeutic area heads
PostAuthorisation Safety Studies (PASS)
InvestigatorInitiated Studies
Ensure submissions align with scientific merit regulatory standards and Theramex research priorities.
Meeting Management
Organise and lead regular GSRC meetings and other medical meetings.
Develop and distribute meeting agendas.
Prepare accurate and timely meeting minutes capturing decisions actions and followups.
Track and manage action items ensuring appropriate followup with stakeholders.
Documentation and Compliance
Ensure study proposals minutes correspondence and approvals are documented and stored in compliance with company and regulatory requirements.
Maintain a comprehensive organised system for evidence generation documentation.
Oversee compliance with GCP GPP and all relevant regulatory guidelines.
Publication Oversight
Lead preparation and review of publications (manuscripts abstracts posters).
Ensure all publications adhere to GPP and internal policies.
Collaborate crossfunctionally to support the publication strategy and timely dissemination of results.
Stakeholder Collaboration
Partner with global medical teams regulatory affairs pharmacovigilance and other stakeholders to maintain aligned evidence generation priorities.
Act as the main point of contact for affiliates and therapeutic area heads on evidence generation processes.
Facilitate efficient communication and decisionmaking across stakeholder groups.
Medical Operational Excellence
Lead global medical budget planning and monitoring.
Maintain and regularly update global medical repositories.
Organise global medical meetings and ensure operational consistency across teams.
What does our team say about life at Theramex
Theramex is committed to womens health and is making a huge positive impact to womens lives. I feel this daily in my interactions in the field. It fuels my passion to contribute as I can see feel and hear the impact in my area. How does it make me feel Empowered and proud!
Claire Holmes Womens Health Account Manager
Why Join Us
Be part of a dynamic team at Theramex where youll have the opportunity to make a significant impact on womens health. We offer:
A fastpaced environment with broad exposure where you can groweven beyond your current expertise.
A culture that supports learning celebrates success and recognises performance.
Opportunities for ambitious talented professionals who want to be part of our purposedriven journey.
Apply Now!
If youre passionate about making a difference and meet the qualifications wed love to hear from you. Apply today to join our team at Theramex.
We are Theramex, a global specialty pharmaceutical company solely committed to supporting the health needs of women through every stage of life.Wework closely with our partners, healthcare professionals, and patients to help women find the solution that may be right for them at the ti ... View more