Medical Director (JAPAC)

Executive recruitment company Monroe Consulting Group Malaysia is recruiting on behalf of a leading provider of pharmaceutical services globally. Our distinguished client is looking for an ambitious and experienced professional to join the team as a Medical Director.

The role will be responsible for managing the medical function across JAPAC and providing medical expertise to both unlicensed and licensed business. The Medical Director must develop and perform the necessary processes to ensure compliant management of medical information to regulatory agencies and business partners within the designated region (JAPAC) in accordance with medical regulations and contractual agreements. Is responsible for ensuring the implementation of necessary processes to ensure compliance with regional regulations and global standards. This person will report to the Senior VP, JAPAC and will be based in Selangor, Malaysia.

Job Responsibilities:

Medical Operations

• Ensure the review and Sign-off of marketing materials for all commercial products in full compliance with country specific code of practice.
• Support the Medical Information team with the production and update of standard responses and assist in the answering of ad hoc queries.
• Support the pharmacovigilance team in ensuring compliance with all pharmacovigilance obligations.
• Proactively identifies needs from a medical perspective; takes ownership, and makes things happen.
• Follow all relevant Standard Operating Procedures, for Quality, regulatory, legal and ethical requirements. Where necessary documents are developed medical processes in SOPs.
• Manage the divisional budget as and where appropriate.

Medical Strategy

• Input into regional BD plans and targets to ensure effective identification of potential assets.
• Input into all regional / divisional plans where required and appropriate.
• Support due diligence teams for asset/business acquisitions where required.
• Provide medical direction to the strategy for the unlicensed and licensed portfolios Medical Expertise – how MI, PV, MA etc interact with each other.
• Be recognized as the medical expert within JAPAC and provide broad medical expertise and advice to the business in relation to the company’s medical activities and products.
• Establish trusted relationships with KOLs and run Advisory Boards.
• Advise on the appropriate medical operations for clinical and medical affairs programmes.
• Apply physician experience to the individual product plans for each of the key regional products to educate internal teams on place in therapy.
• Apply medical expertise to construction of training and educational initiatives in support of each of the key regional products.
• Provide medical input and direction to constructing an effective review of relevant therapy areas and competitive 'early warning' system.

People Management & Development

• Effectively manage the team through sound leadership, guidance and open communication.
• Ensure the team meet established KPIs, with the measurement and results clearly communicated with the team on a regular basis.
• Address performance issues as and when they arise and recognise good performance.
• Ensure staffing, skill and performance levels are adequate to achieve the set business requirements.
• Identify training and development needs for team and work with the Human Resources to design individualised personal development plans as and when required. Ensure Development Plans are recorded in Clear Review and review quarterly.
• Reinforce skills taught in training courses through one-to-one coaching and evaluating performance following training events.
• Ensure that performance conversations are conducted for the team in accordance with our Performance Management System (Clear Review) ensuring regular feedback is given throughout the year.
• Encourage team to use Peakon and use the system to identify areas for improvement and implement actions to achieve sustainable results, thereby striving for a healthy culture.
• Ensure every team member can work in a safe and health work environment.

Personal Development

• Maintain an awareness of changes to worldwide regulations and trends as it pertains to medical matters. Determine how any changes impact Group companies and ensure that senior management are made aware of any potential changes in regulations, trends or medical practices.
• Have in place appropriate forums or regular attendance at established meetings to ensure sufficient working knowledge of all the businesses and up to date initiatives.
• Continue to develop own talents and strengths and address any areas of self-development.
• Keep up to date with, implement and/or cascade new/changes to legislation pertaining to the regulation of medicines access in the region.
• Active communication with a range of national and international regulatory, policy and related bodies and institutions with regards to medicines access.
• Involvement in cross functional technical and regulatory networks, both relating to pharmaceutical legislation and local GVP rules and guidance.
• Attendance at relevant conferences and meetings.
• Develop and maintain effective business relationships with Group colleagues.
• Participate fully in the Company’s Personal Performance and Development process.
• Undertake training and development relevant to the job.

Knowledge and Compliance

• Understanding the regulatory-, healthcare-, pharmaceutical- & reimbursement environments in Asia Pacific region.
• Maintain up-to-date knowledge of the company’s standard operating procedures and policies and ensure compliance at all time.
• Comply with the company Pharmacovigilance requirements as per training.
• Ensure that duties are carried out in adherence to GCP regulations.
• Ensure every team member has the opportunity to work in a safe and health work environment.
• Contributes to a Quality-focused mindset; Quality is everyone’s responsibility.

Administration

• Ensure filing and documentation is up-to-date and in compliance with standard processes and formats.
• Complete required reports within designated timeframes (e.g. expenses, product samples etc.).
• Participate in meetings as needed.
• Liaise with management and staff to ensure projects are conducted efficiently.
• Communicate with staff & management using proper channels.

Additional Duties

The list of duties is not intended to be exhaustive but gives a general indication of the tasks involved. It is the nature of the Company that tasks and responsibilities are in many circumstances unpredictable and varied. All employees are therefore expected to work in a flexible way when the occasion arises and acknowledge that tasks not specifically covered in their job profile are not excluded.

Job Requirements:

• Essential to hold a bachelor’s degree in medicine or pharmacy and a Completion of Certificate of Training (CCT) in Pharmaceutical Medicine (Specialist Qualification) (or other national equivalent).
• Extensive experience of the global Pharmaceutical Industry.
• Demonstrated success in a senior leadership role.
• Broad experience in different therapeutic areas; knowledge of oncology, haematology, oncology support, anti-infective and rare/orphan disease areas.
• Adaptable and comfortable working in new therapeutic areas.
• Experience of interacting with the major Regulatory Agencies and in reviewing and authoring regulatory documents.