Assignments

This position has overall responsibility for the development, negotiation and execution of group wide international commercial contracts and agreements. The two main objectives being that the agreements are both commercially viable and regulatory compliant across the relevant geographies.

• In accordance with Chief Commercial Officers’ guidelines, drafts, evaluates/reviews, negotiates and executes commercial contracts that impact multiple countries on behalf of the group (NDAs, Sales & Purchasing agreements, sub-contracts, consulting agreements, Licensing Agreements, Distribution Agreements, contracts with Government bodies, etc.);
• Acts as a point of contact for customers and internal departments on international contractual matters, ensuring timely review and approval/reconciliation of contract variations;
• Provides recommended commercial approach to contract negotiation and negotiates directly with customers/partners until consensus has been reached;
• Maintains library of contractual records and documentation of all standard and nonstandard contracts;
• Provides guidance on contract matters to project managers and other operational staff;
• Develops and implements procedures for contract management and administration in compliance with the Group policy and applicable national and international commercial legislation. Monitors compliance with established procedures;
• Liaises with Risk Management/Finance to coordinate contractual insurance requirements;
• Liaises with Finance to ensure legal input in broader financial requirements, including financial engineering, pricing, volume discount and bundling strategies and understanding/assessing the economic impact of terms and term options;
• Liaises with Marketing & Communication to ensure Group products and services are developed with adherence to contractual terms and conditions;
• Ensures that signed contracts are communicated to all relevant parties to provide contract visibility and awareness;
• Provides advice to management on contract interpretation to support implementation and any challenges to the contract or relationship issues;
• Monitors transaction compliance (milestones, deliverables, invoicing, etc.);
• Ensures contract close-out, extension or renewal;

Individual may have direct regulatory affairs knowledge or would be responsible for liaising with an individual with this expertise residing elsewhere in the organisation – either internally or externally.

• Evaluates International regulations, liaising with local partners – both internal and external - to understand specific country regulatory situations and take appropriate course of action.
• Develops relations with main regulatory bodies (direct or via consultants)
• Evaluates potential risks and opportunities of launch and marketing of products based on interpretation of local regulations. Anticipates impact of commercial decisions to launch and market products according to local regulations, providing advice to the group CCO and CEO, if required.
• Provides local management with support in dealing with changes in regulations.
• Ensures that the Group´s offer is fully compliant with existing regulations and where the position is unclear, summarises the Group’s position on the matter.

• 7 or more years’ work experience in legal, compliance, policy, auditing, training, communications or related disciplines in the Life Sciences / Healthcare industry;
• 2 or more years’ experience effectively leading design, development and execution of commercial contracts with independent healthcare companies;
• Demonstrated ability to work across countries to consult on local commercial/legal issues and support the local, as well as international group teams to ensure that these are satisfactorily resolved;
• Specific work experience in regulatory affairs, including advertising/promotional activities/compliance, desirable but not essential;
• Experience interacting with outside regulators or other authorities preferred;
• Will ideally demonstrate in-depth knowledge of the Life Sciences / Healthcare industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth knowledge of the legal and regulatory
  environment 
• Bachelors Degree required (life sciences, law, public policy, marketing, business, education, or related discipline preferred)
• Post Graduate-level Degree strongly preferred (JD, MBA, MS, PharmD or other PhD, or related discipline)