Head of Medical Affairs, Australasia

TITLE:
Head of Medical Affairs, AustralAsia

Who we are:
Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction.

Position Summary:
The Head of Medical Affairs, AustralAsia (AuA) leads the Medical Affairs function by developing and executing medical affairs strategy and programs that support the AuA business. The Head of Medical Affairs, AuA, works with external and internal stakeholders to ensure delivery of key objectives and to fulfil the legal statutory duties of a Medical Affairs Lead in territories within Australasia (Australia, New Zealand, Malaysia, Taiwan, Hong Kong and any other countries as required).

The position reports to the VP of Medical Affairs (Most of World) with a dotted reporting line to the Head of AustralAsia and is a member of the AustralAsia Leadership Team. The position has 3 direct reports and is based in Macquarie Park, Sydney.

The Head of Medical Affairs, AuA will work closely with Indivior staff, in collaboration with the Medical Affairs team to train and educate the field teams of each territory within the Australian market, as well as to ensure compliance with required regulatory processes such as the TGA, Medicines Australia code of conduct, copy clearance, certification of sales representatives, study management, responding to medical information queries and pharmacovigilance.

The Head of Medical Affairs, AuA, ensures that the following activities are performed effectively for the AuA region:

- Provide medical education and support services to external addiction healthcare providers including education meetings, workshops and conduct advisory boards when needed.
- Generate new data from non-interventional phase IV and RWE studies and support investigator-initiated studies aligned with the Global and AuA strategies.
- Build and support a network of influential relationships in the treatment community to provide a supportive environment for expanding patient access within a framework of evidence based best practice.

Furthermore, the key responsibilities of the position include:

- Develop and execute the Medical Affairs strategy and plan in line with the organisations strategy.
- Provide regional input to ensure high professional and ethical standards in terms of various regulatory activities, clinical trials support, marketing support, and medical affairs including pharmacovigilance and information in accordance with standards of Good Pharmaceutical Medical Practice in certain markets.
- Lead the Medical Affairs function in AustralAsia markets either through a third party or Indivior infrastructure, ensuring that the business is compliant with local statutes and specifically that it meets any requirements stipulated by national regulatory authorities; and medical information services.
- Ensure compliance with MAH commitments and assist with the development and registration of NPDs or licensing agreements.
- Develop and provide the company, its customers, and the government, medical and technical information related to Indivior’s products.
- Provide, review and ensure medical activities (including promotional support, operational review and planning and clinical protocols) are implemented in alignment with product strategies, and in compliance with regulatory policies and guidelines.
- Coordinate activities surrounding issues with various governmental, regulatory, trade and professional agencies as and when they may arise such that a focused effort is put into issues to gain competitive advantage and where appropriate, raise the profile of Indivior products. This involves direct liaison with national regulatory/governmental bodies and academic or clinical opinion leader groups as required and to assist with medical and technical support as required.
- Develop strong relationships with key opinion leaders (KOLs) in therapeutic, regulatory, political, trade and professional arenas. This is especially the case in the addiction business which involves new and evolving regulation, laws, directives and guidelines in various markets.
- Work closely with external partners.
- Ensure suitable systems are in place to maintain the safety of patients.
- Help to distinguish Indivior as the leading addictions company and increase acceptance of the treatment of opioid dependence, it is essential that Indivior develops effective relationship networks and programs for consensus, education, intervention and dissemination of best practices.
- Working in conjunction with professional associations, KOLs and the Indivior cross functional teams to develop consensus on and deliver educational programs and training to external hea