Head of Medical Affairs

Role Purpose

To manage the medical affairs department, in alignment with the organizational strategy and objectives as per Aspen code of compliance and industry standards.
To 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.
Travel required wherever necessary.

**Responsibilities**:

- 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 on 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 database 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 adhere 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
- Life sciences / (BSc in Chemistry/ Biology, etc.) or pharmacy degree
Preferable - Master 2 Sciences + anaesthesia-intensive care expertise or PHD Doctor of Pharmacy/ Doctor of Medicine(would be a plus)
- Minimum 5 years of experience in In Medical Affairs
- Minimum o