Head of Medical Affairs, EME

The ideal candidate will:

• Manage the medical affairs department in alignment with the organizational strategy and objectives as per the Aspen code of compliance and industry standards.
• Manage and oversee medical information, Promotional non promotional compliance and medical scientific support for the Aspen EME existing portfolio and input required for building a solid pipeline.
• To fulfill the role of Medical Operations Representative and medical signatory for Aspen UK.

Travel required wherever necessary
Job duties:

• Supervises quality, compliance and performance metrics related to medical information, medical compliance and Medical scientific engagement processes and communicates with key stake holders, where necessary.
• Create procedures to ensure compliance with global, EME regional and local regulations, ensure consistent standards and timely responses.
• Making sure that compliance with internal procedures, policies, codes, systems, and controls are up-to-date and effective.
• Support Quality Management by contributing to the policy developments and roll out associated with medical information, medical compliance, and medical scientific engagement.
• Oversee Medical affairs resourcing and forecasting to ensure that medical affairs function can meet KPI's in

compliance with regulatory requirements, internal policies, and processes.

• Ensure support and training is delivered to local team and remote team, where necessary.
• Provide departmental input on change controls raised by Aspen.
• Support medical information team in implementation, validation, and maintenance of medical information databases globally or relevant systems used to support medical information activities.
• Ensuring affiliates and service providers are trained in enquiry handling and compliance is monitored on an ongoing basis.
• Perform quality control activities across affiliates and service providers to ensure that medical information service is delivered in line with agreed process, policies, or contracts.
• Oversee Medical vendor (s) performance and audit external Medical Service provider in identifying any deficiencies in overall service delivery.
• Create, educate, and develop awareness on Aspen policies and Code of Marketing Practice
• Provide clinical and scientific input into the development of non-promotional and promotional materials.
• Approval and review of educational and promotional materials through Veeva Promomats or other identified platform as per Aspen policies and procedures, where requested.
• Ensure Aspen EME adheres to all regulatory standards and company policies associated with all promotional material.
• Develop and maintain working relationships with marketing and commercial colleagues and with key stakeholders in Aspen Pharma to enhance cross-functional teamwork and success.
• Develop expertise and scientific evaluation of assigned therapeutic areas to all local affiliate medical approvers.
• Support line manager in developing and maintaining the process for managing compliance monitoring process.

Support in maintaining risk register across all affiliate territories and report any critical risk to senior management.

• Co-developing and implementing customer facing interactions and have a primary liaison role to the medical and scientific community, responsible for engaging Customers, including HCPs, in non-promotional medical and scientific discussions regarding on-market and in-development, pipeline Aspen products, or on topics relating to disease states.
• Participate in the selection process to identify appropriately qualified experts the Company would wish to engage in collaborative efforts - such as potential research collaborations, or educational and advisory roles (Advisory Boards, Congresses, Symposia, etc.); while ensuring a high level of scientific or educational integrity in these collaborative efforts
• Support internal teams such as sales and marketing and members within the regional organization to develop scientific expertise through the delivery of scientific update presentations.
• Ensure a strong medical and scientific presence for Aspen portfolio in key markets by facilitation of educational initiatives, while supporting requests for medical and scientific information on products or areas of therapeutic interest to Aspen EME.
• Evaluate current, future potential therapeutic areas, clinical developments, and pipeline products to evaluate gap lists and provide potential pipeline portfolio.
• Assess and support Marketing and Business Development Team to evaluate all clinical, scientific data provided for pipeline BD potential products and evaluating data and engaging with HCP's to understand the need, scientific medical need and accordingly translate this to information supporting the decision-making process
• Act as a medical signatory in the approval process for promotional & non-promotional activities for the UK & Ireland.
• Provide clinical input to leverage the available data to optimize the development of promotional & non-promotional activities in UK.
• Ensure compliance with relevant Codes of Practice and avoid breaches of said Codes in UK e.g. PMCPA Code of Practice, Proprietary Association of Great Britain Code, Medicines Act, MHRA guidelines and Aspen SOPs. Maintain awareness of changes to all relevant Codes to ensure advice is updated accordingly.
• Certify UK materials in Veeva Promomats to ensure compliance from a medical perspective.
• Support the UK Marketing team in the development of promotional / educational campaigns.
• Support the development of local internal SOPs relating to compliance with the relevant Codes of Practice.

What We Look For In Candidates

• Educated to Doctorate Degree/ holds multiple Masters (i.e. PHD Doctor of Pharmacy/ Doctor of Medicine, medical practitioner or a pharmacist registered in the UK)
• Minimum of 5 years' experience in Medical Affairs
• 8years' or more in a Medical / Pharmaceutical industry role
• Ability to understand and interpret scientific data
• Previous experience in facilitator training
• Previous experience of working with voluntary codes such as EFPIA, ABPI, IPHA, etc
• Good understanding of the regulatory and legal environment as well as the auditing process.
• Experience in Medicine Affairs and compliance monitoring would be an added advantage.
• Familiar with MS Office package, Veeva Promomats or equivalent.

At Aspen, our culture is built on core values that drive our success and foster a supportive, innovative environment. We value Teamwork, where diverse perspectives and skills come together to enhance creativity and problem-solving. Innovation is at our core, as we continually seek better ways to achieve our goals and remain at the forefront of our industry. We demonstrate Commitment by exceeding expectations and building long-term relationships, while always striving for Excellence in everything we do. Our foundation of Integrity ensures that honesty, ethical behavior, and accountability guide our decisions. By proceeding with this job application, we understand that you share these values, and we look forward to reviewing your application and engaging with you further.