Life Sciences Senior Regulatory Compliance Officer
- Senior-level (Director or Senior Director) Life Sciences Regulatory Compliance Officer role based in either North America, Europe or India.Responsible for developing and leading the strategic regulatory compliance program for Cognizant Life Sciences in order to meet the stringent global regulatory requirements pertinent to the company's service and software product lines of business.In addition to a strong R&D/pharma/Contract Research Organisation (CRO)/life science compliance background and experience working with new and emerging technology paradigms, the candidate must possess project and portfolio management skills and the ability to work at a senior level with Client compliance and operations business stakeholders.The candidate should be a strategic-thinking, compliance 'all rounder' and a natural team player who has demonstrated their capacity to succeed in collaborative work scenarios involving other risk, privacy, legal, compliance, and operation professionals.
- Life Sciences business domains: lines of business include (but shall not be limited to) CRO and CRO component services, and Life Sciences' Software Products and Platforms, Business Process Outsourcing (BPO) and Business Process as a Service (BPaaS). Laws and Regulations (including but not limited to): GxPs, 21 CFR Part 11/Annex 11, medical device, data privacy and HIPAA as these pertain to the EU, UK, US, Japan and other global country Agencies and Authorities.
- Develops, implements and manages regulatory compliance program as required for some or all of Life Sciences CRO and CRO component services (BPO, BPaaS, PaaS, SaaS delivery models); Life Sciences Products and Platforms lines of business and other tools used in support of regulated activities.Provides thorough oversight, internal advisory/consulting and monitoring/reporting activities to ensure compliance with all applicable global regulations.Works with executive and senior management on strategic and operational planning activities to ensure compliance with applicable global regulations, and managing compliance risk to lowest levels.Interfaces with compliance professionals across Cognizant domains to ensure that Life Sciences lines of business conform to applicable laws and regulations globally as well as to all Cognizant Corporate Compliance standards, policies, and practices.Assesses and manages regulatory risk across all Life Sciences lines of business.Manages the Life Sciences implementation of new laws and regulations affecting regulated activities and products. Reviews the Company’s Life Sciences operations for adherence to compliant policies and procedures.Interprets and communicates pending and adopted legislation and regulations to the appropriate departments and groups in the Company.Manages a set of compliance risk metrics derived from an effective mixture of internal auditing, self-reporting, and monitors the analysis of compliance metrics to determine appropriate escalations to senior management.Determines when and how to recommend the reporting of issues/instances of noncompliance with applicable global regulations as these relate to Cognizant activities.Establishes and maintains processes and procedures to ensure earliest possible detection and remediation of instances of regulatory non-compliance, including proper reporting, documentation, and tracking of deviations or potential deviations as appropriate or required.Coordinates and collaborates with Life Sciences management, business delivery and development teams to ensure awareness of regulations and regulatory expectations relevant to Life Sciences lines of business.Develops, periodically reviews and updates Standards of Conduct to ensure continuing currency and relevance in providing compliance guidance to management and line personnel.Provides regulatory compliance oversight for all Cognizant Life Sciences lines of business.Participate as Subject Matter Expert in the creation and delivery of appropriate training and business materials relating to regulatory and compliance.
- Delivery Process and Methods.Work as a Senior member of the Regulatory Compliance Office team and take responsibility for the following activities:Developing Compliance policies and procedures,
- Monitoring and auditing to ensure guidelines and standards are being followed,Initiating and manage appropriate operational compliance projects,Reporting on status of compliance activities to senior leadership,Self-identification (self-reporting and self-audits) and the subsequent implementation of corrective actions,
- The Senior Life Sciences Regulatory Compliance Officer will report to the Life Sciences Chief Compliance Officer.
- Bachelor’s Degree in political science, law, business, scientific, computer science or related field is required; Graduate Degree in political science, law, business or scientific field is highly desirable and preferred.
- One of the following certifications (e.g., SQA, RAC, SCDM, CHC, CCEP, and CIPP/US) is highly desirable.
- Significant, direct experience in regulatory compliance and/or government regulatory affairs roles as well as experience in a pharmaceutical-related or CRO environment is required, with relevant global and country-specific compliance and operational compliance experience.
- Deep regulatory and procedural knowledge of some or all of the following: cGMP, GCP, GLP (ICH), 21 CFR Part 11/Annex 11 (EU) and Medical Device regulations and related guidance.Understanding of IEEE GAMP guidance for development of systems and software for the pharmaceutical and medical device industries.Significant familiarity with HIPAA privacy and security regulations and GDPR as applied to life sciences and clinical research data collected at clinical sites globallyHighly developed analytical, communication, critical-thinking and problem-solving skills.Ability to interpret legislation and regulations, implement policies and procedures effectivelyAbility to be a motivator with visionary ability and capacity to implement new ideas in a positive and supportive manner.Interpersonal skills including the ability to listen actively and responsively, delegate responsibilities appropriately and facilitate effective and successful relationships within a matrix management structureEffective and persuasive negotiation skills in order to achieve effective regulatory, legal and operational compliance objectivesSelf-starter with the ability to work independently in a fast-paced and flexible corporate environmentStrong team player with strong collaboration and project/portfolio management skills. Ability to work seamlessly with other members of extremely collegial and supportive business team and organization
- Knowledge of how legislative and regulatory processes work, ability to research laws, regulations as needed.Ability to collaborate with Corporate Compliance and Legal, when appropriate (e.g., when Conflicts of Interests occur)
- Experienced and skilled in management within a cross-functional, cross-culturalorganisation and in a client/service provider business setting.Ability and willingness to travel internationally as required by the role.Candidate may choose to work fully or partially from their home (with the prior agreement of the line manager).
Cognizant (NASDAQ-100: CTSH) is one of the world's leading professional services companies, transforming clients' business, operating and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant is ranked 230 on the Fortune 500 and is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com or follow us @Cognizant.
This job was originally posted as www.cwjobs.co.uk/job/76059498