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Do Not Be Influenced by Others’ Negative Opinions of You
In-House
Attorney
Government / Public Law
Litigation - Whistleblower - CFTC
Min 5 yrs required
Associate Program Director, Commercial Regulatory Affairs (Advertising & Promotion) Duties: Provide cross-portfolio support for assigned CORA compliance and FE initiatives and day-to-day activities; leading cross-portfolio programs, projects and recurring activities. Manage departmental programs, projects and other deliverables in consultation with CORA senior staff members. Complete standard work with increasing levels of independence. Can be relied upon for sound project management and operational expertise. Effectively integrate regulatory risk/contest and business knowledge. Keep current in the areas of regulatory, healthcare compliance and ethics. Proactively identify and address compliance issues. Manage regular cross-functional interactions, projects and teams. Typically operate with a planning horizon of 3 - 12 months. CORA Compliance and Functional Excellence: Lead assigned CORA compliance and FE programs, projects and day-to-day activities under the guidance and direction of your manager or other senior staff members and effectively collaborate with cross-functional internal groups and any relevant external partners. Monitor PRCs and provide management oversight for various scenarios that require such oversight, e.g., Food and Drug Administration (FDA) audits, compliance violations, etc.. May serve as single point of contact (SPOC) to internal partners and stakeholders on CORA compliance and FE activities, with oversight from your manager or other senior staff members. Stay abreast of developments in therapeutic and disease areas, including the competitive landscape and other relevant commercial and development trends to ensure a fully current view of implications for Genentech products. Obtain and apply knowledge of Roche and regulatory guidelines, policies, procedures and best practices. Maintain current awareness of evolving Food and Drug Administration (FDA) opinions; including advisory letters, enforcement letters and policy issues. Drive consistent compliance and functional excellence across commercial regulatory activities, which may pertain to all therapeutic areas and/or cross-portfolio programs. Including consistently seeking, driving, defining and implementing opportunities to increase efficiency, quality of work and overall compliance across CORA functions and teams. Lead development of commercial regulatory compliance priorities and FE strategies, plans and goals. Lead development and implementation of processes, frameworks, documents, systems, tools and other resources to measure and ensure compliance and organizational excellence across multiple or all Genentech commercial regulatory activities. Lead coordination with other CORA staff and teams to ensure compliance priorities and goals are appropriately reflected in training, metrics and communications. Lead key initiatives and projects in FE, such as development of training programs, PRC analytics and reporting, etc. with guidance from manager or other senior staff members. As appropriate/applicable, support development of cross-functional regulatory strategies by providing commercial regulatory affairs expertise, insights, perspective and recommendations. Provide day-to-day guidance to other CORA team members supporting CORA compliance and FE programs, projects, initiatives and day-to-day activities. Keep internal partners and stakeholders abreast on primary CORA compliance and FE activities and status. Consult direct manager on all matters related to FDA communications, audits, POC presentations and compliance violations. As assigned, lead or otherwise participate in special projects.
Qualification and Experience
Qualifications: Bachelor's Degree (life sciences, law, public policy, marketing, business, education, or related discipline preferred). Graduate-level Degree strongly preferred (JD, MBA, MS, PharmD or other PhD, or related discipline). 5+ years’ work experience in regulatory, legal, compliance, policy, auditing, training, communications or related disciplines in the bio/pharma industry. Average experience for this role is 7-10 years. Knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as working knowledge of the legal and regulatory environment, as it relates to healthcare compliance in the bio/pharma industry (includes anti-kickback statutes, government fraud & abuse, off-label promotion, PhRMA Code, etc.).
Job ID: 3244310134
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