Job Description

Division
Legal
Department
Legal
Employment Type
Permanent
Job Purpose
Drive compliance program for global corporate, sales and marketing and manufacturing units ("Covered Units") of the company and legal strategy and administration of the areas as per business requirement. Provide legal assistance to address any compliance related contingencies that may arise during day-to-day business activities to ensure smooth and uninterrupted flow of business operations. Drive the legal strategy for generics - branded/unbranded, brand and 505(b)(2) business including promotional reviews. Administer, train, monitor and initiate remediation on the global compliance tool.
Accountabilities
1. Heatlhcare and Corporate Compliance
Establish healthcare and corporate compliance program
Provide timely, competent and practical advice and support regarding compliance.
Review and approval of global Cipla materials/communications to ensure compliance with applicable legal and regulatory requirements.
Liaise with internal stakeholders in all compliance related activities.
Establish compliance training on key legal aspects of the legal framework of the global federal/central state and local laws, auditing and monitoring programs, including support of enterprise risk management.
Facilitate compliance with state/region-specific legal requirements and local sales credentialing requirements
Ensure preparation and management of applicable state marketing/transparency reports
Develop or revise compliance policies, documents, deliverables and training
Oversee investigations and response to internal or external enforcement actions
Take full ownership for the tool-based total compliance program implementation and compliance certification for the Covered Units
Accountabilities
2. Business Development and Strategic Initiatives

• Support strategic initiatives as member of Senior Leadership Team
• Lead Government Affairs efforts, as and when required, in collaboration with various businesses/ functions
• Support evaluation of business development opportunities
• Support due diligence and integration activities
• Ensure proper and comprehensive execution of strategic and business development imperatives
• Collaborate on trademarks, copyrights, design, and patents prosecution, protection and estate management and assist on patent challenge initiatives.
• Provide advice on legal issues in M&A, high-value negotiations, BD&IL work, in coordination with the Global General Counsel

Accountabilities
3. Legal advice on US and other global markets branded, therapeutics, government business and other businesses and 505(b)(2) products, including promotional reviews

• Implement legal and litigation strategy, policies, procedures, and systems for the branded, therapeutics, Exelan and other businesses as required.
• Review promotional and educational materials, participate as a member of the promotional review committee (PRC), and provide legal advice and solutions to marketing, regulatory and medical teams on advertising and promotional materials and regulations - for the Branded, 505(b)(2) and Gx products (as applicable).
• Advice legal commercial businesses and operations in support of approved and pipeline products in the branded space, including working with Medical Affairs, Sales, Marketing, Market Access, Regulatory and others to ensure success.
• Draft, negotiate, review and advise on various agreements, including consulting agreements, master service agreements, supply agreements, distribution agreements, advisory agreements, market access-related agreements (including: PBM, Payer, and GPO agreements), wholesaler agreements, discount and rebate agreements
• Provide advice in relation to the company's interactions with HCPs and HCP consulting, HCP speaker programs and agreements.
• Provide legal guidance on patient support programs, and specialty pharmacy and HUB pharmacy collaborations.
• Enhancing legal understanding/capability of teams with training on key legal aspects of the legal framework of the US
• Provide legal, medical, regulatory requirements and review process for the branded business, including evaluating these aspects for various business models, structures, new/ amended laws, rules, and regulations to be followed

Accountabilities
4. Compliance to Trade Agreement Act (TAA) for the applicable business(es)

• TAA compliance for all businesses engaged as contractor with federal government to avoid potential legal issues and financial consequences and or fines under the False Claims Act (FCA).
• Due diligence for TAA compliance including identification of contracts subject to TAA, Product Origin Assessment etc.
• Maintain a record of all due diligence activities, including assessments, reviews, certifications, and written supplier certifications
• Conduct internal training to educate employees about TAA requirements and the importance of compliance.
• Engage with legal counsel experienced in government contracts and TAA compliance to ensure accurate interpretation and implementation of TAA regulations

Accountabilities
5. Drive corporate separateness across legal entities

• Ensure legal corporate separateness across various legal entities - Exelan, Cipla USA, Therapeutics and InvaGen etc.. Manage relevant compliances and legal advisory.
• Conduct internal training to educate employees about corporate separateness.
• Draft, negotiate, review and advise on various contracts, agreements, including pricing/GTN/ rebate etc., consulting agreements, master service agreements, supply agreements, distribution agreements, advisory agreements for various entities as per business requirements.

6. Other statutory license compliances

• Manage pharma distribution licenses across all entities
• Draft, negotiate, review and advise on various agreements related to distribution licenses

Education Qualification

• Baccalaureate level law degree in a relevant area from an accredited university required.
• 5+ years healthcare experience in the pharmaceutical or medical device industry & overall 15 years of PQE.
• Demonstrated knowledge and understanding of the required elements of compliance programs and applicable industry standards.
• Awareness of fraud and abuse laws and the Food, Drug and Cosmetic Act and an understanding of the roles and authority of government agencies and industry cooperative groups including global FDAs.
• Knowledge of people management including recruitment, hiring, progressive discipline process and coaching.
• Certification in Compliance & Ethics and Information Privacy from an accredited organization preferred

Relevant Work Experience

• Exceptional communication and collaboration skills, including presentation capabilities, interpersonal skills and conflict resolution.
• Action-oriented team player.
• Ability to work independently and with a high level of initiative.
• Ability to summarize and simplify complex information.
• Ability to maintain an independent and objective perspective while developing and maintaining a strong partnership with the client organization.
• Must be able to manage complex projects and multiple projects simultaneously.
• Demonstrated ability to adapt to and lead through changing competitive challenges and market dynamics.
• Displays a sense of urgency and commitment to achievement of objectives and commitment.

Competencies/Skills
Collaborate to Succeed
Innovate to Excel
Perform with Accountability
Lead with Empathy
Act with Agility
Strong Domain Knowledge
People Management
Job Location
Lower Parel
Shift Hours