Director of Medical Affairs for launch Brands

About Norgine

Norgine is a leading European specialist pharmaceutical company that has been bringing transformative medicines to patients for over a century. Our commitment to transforming people’s lives drives everything we do and our European experience, fully integrated infrastructure and exceptional partnership approach enables us to quickly apply creative solutions to bring life-changing medicines to patients that they may not otherwise be able to access. Norgine is proud to have helped 22 million patients around the world in 2020 and generated €448 million in net product sales, a growth of 7% over 2019.

Norgine has a direct presence in 12 European countries, as well as Australia and New Zealand. We also have a strong global network of partnerships in non-Norgine markets. We are a flexible and fully integrated pharmaceutical business, with manufacturing (Hengoed, Wales and Dreux, France), third party supply networks and significant product development capabilities, in addition to our sales and marketing infrastructure. This enables us to acquire, develop and commercialise specialist and innovative products that make a real difference to the lives of patients around the world.

In 2012, Norgine established Norgine Ventures, a complementary business which supports innovative healthcare companies through the provision of debt-like financing in Europe and the US. For more information, please visit www.norgineventures.com.

NORGINE and the sail logo are trademarks of the Norgine group of companies.

MAIN PURPOSE:

Provide Medical leadership and governance in developing launch products strategy and execution with Medical Affairs teams in the operating territories for Norgine .Strategic support, for all Business Unit Launch Projects and any other relevant support to personnel for all Norgine Group Companies.Proven ability to work Xfunctionally both at a Global and Local level.

KEY RESPONSIBILITIES & ACCOUNTABILITIES:

Since this is a Global role,acting generally on behalf of all Norgine legal entities including without limitation, inspections/audits etc.

• Provide leadership, direction and co-ordination of medical affairs strategy, systems and outputs for implementation and adoption by central and affiliate based medical affairs staff, including new product integration, provision of medical information, scientific training, medical writing and copy approval.

• Interface with Clinical Development, Central Medical Affairs, Regulatory Affairs, Global Commercial, other Business units and Affiliates to ensure co-ordination of approach across products and central platforms for country utilisation.

• Oversee systems and activities for compliance with GxP and relevant internal/external codes and legislation for promotional and non-promotional activities including transparency declarations.

• Ensure provision of Educational Supervision and Educational Supervisor training for Pharmaceutical Medicine Speciality Training.

• Lead Norgine’s Patient Engagement activities, and identify and maintain links with opinion leaders and clinical centres that would support strategic direction for the therapeutic areas of interest to Norgine.

• Act as a confident and credible ambassador of the company, leading and driving medical strategy discussions at partnering meetings with external companies and at relevant Governance meetings as required.

• Provide strategic medical advice and support to any function, as required.

MAIN TASKS

• Provision of technical Medical expertise as required for specific activities for medicinal products and devices e.g. provision of medical support for the QPPV if required, authorisation of Regulatory documentation and final signatory of Global Copy Approval Process, due diligence activities and medical aspects of post marketing surveillance & risk management activity.

• Senior signatory for copy approval; change control.

• Medical review of safety evaluations, regulatory submissions and responses, labelling changes as required.

• Escalate issues to appropriate governance bodies.

• Forge strong links and effective working relationships with internal stakeholders and externally as appropriate.

• First and second line management activities and oversight
  • Management of budget within agreed targets
  • Oversight of Quality activities, including Quality Events, CAPA & audit/inspection activities

Requirements

SKILLS & KNOWLEDGE

• Experienced pharmaceutical (medical affairs) physician with a proven track record in xfunctional working and product strategy

• Significant judgement and advanced problem solving skills, including crisis management. Ability to manage issues without all information being available.

• Possesses emotional intelligence and diplomacy to operate at senior levels within Norgine and represent Norgine externally.

• Experience in working with early launch markets and early access programmes

Qualifications

• Medical qualification and UK (or equivalent) Registration
• Membership of Faculty of Pharmaceutical Physicians (desirable)

Skills and knowledge should be maintained through appropriate ongoing education.