Program Director - Commercial Regulatory Affairs
Program Director is the core individual contributor position for Commercial Regulatory Affairs (CORA) Review. Incumbents in this position:
Lead Program Review Committees (PRCs) independently Demonstrate mastery of the review committee process and regulatory technical knowledge Are the decision-makers for the PRCs in their designated therapeutic or business area assignments; independently leading cross-functional PRCs and modeling strong facilitation and decision- making skills Represent Genentech in official FDA communications and sign-off on 2253s Manage other departmental programs, projects and other deliverables with limited guidance from their managers Require limited direction to complete standard and non-standard work Can be relied upon for sound regulatory guidance and apply a strategic approach to problem-solving Effectively integrate regulatory, legal and commercial context and business knowledge to address complex problems Keep current in the areas of regulatory, healthcare compliance and ethics Proactively identify and address compliance issues Regularly lead cross-functional interactions, projects and teams Typically operate with a planning horizon of 6 - 12 months Example Duties and Responsibilities PRC Leadership:
Lead/chair PRCs and effectively collaborate with cross-functional internal groups and external advertising agencies; acting as the decision-maker for PRCs in the assigned therapeutic or business area Monitor PRCs and provide management oversight for various scenarios that require such oversight, e.g., Food and Drug Administration (FDA) communications, audits, POC presentations, compliance violations, etc. Represent Genentech in official FDA communications and sign-off on 2253s Act as a primary Roche liaison to the FDA on relevant CORA activities Stay abreast of developments in therapeutic and disease areas, including the competitive landscape and other relevant commercial and development trends and dynamics to ensure a fully current view of implications for Genentech products Support development of therapeutic-area strategy for CORA, conducting and summarizing product- specific analysis as requested Obtain and apply in-depth knowledge of Roche and regulatory guidelines, policies, procedures and best practices Maintain current awareness of evolving FDA opinions; including advisory letters, enforcement letters and policy issues. Communicate significant changes or other relevant matters to internal partners and stakeholders Collaborate with commercial leadership to influence marketing strategies, implementation and promotion objectives Facilitate the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from the FDA and Roche policies Provide regulatory input on commercial concepts and draft materials Develop and implement effective strategies for FDA marketing, advertising and communications submissions Develop and deliver initial correspondence with the FDA and manage interpretation of FDA comments. Oversee and guide follow-on correspondence, such as resubmissions Actively represent commercial regulatory for Core Data Sheet (CDS) and U.S. product label development Support development of the cross-functional regulatory strategy for each product or portfolio assignment by providing commercial regulatory affairs expertise, insights, perspective and recommendations Provide oversight and decision-making leadership to junior CORA staff as well as day-to- day guidance to other CORA team members supporting the same PRCs or other assignments Keep internal partners and stakeholders abreast on primary PRC/CORA activities and status Consult direct manager on all matters related to FDA communications, audits, POC presentations and compliance violations Other:
As appropriate, participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products As assigned, lead or otherwise participate in special projects and act as a standing or ad hoc member of other teams Competencies successful candidates will demonstrate the following competencies critical to this position:
Strategic Agility - Articulates wise, long-term objectives and strategies. Links his/her responsibilities with the mission of the whole organization. Regularly updates plans to reflect changing circumstances. Focuses on activities that provide the most value. Decision Making - Understands the broad context for decisions and reflects that context in how decisions are made. Makes good decisions even in the face of ambiguous circumstances or contradictory requirements. Able to manage divergent perspectives and to deliver difficult or unwelcome information in a constructive and productive manner. Gathers information necessary to make decisions. Thinks through problems clearly and logically. Is decisive; doesn't procrastinate on decisions. Expresses regulatory position and rationale clearly and fluently. Encourages direct and open discussions about important issues - eliminating churn and driving towards clarity. Inspiring and Influencing - Fosters an exchange of ideas and support amongst colleagues. Is good at promoting an idea or vision:
persuading. Works effectively with other people over whom he or she has no direct authority. Understands what motivates other people to perform at their best Technical and Business Expertise - Has a firm grasp of internal and external conditions affecting the organization. Applies emerging knowledge and trends in one's area of expertise to improve results. Builds strong relationships with key customers. Contributes expertise to help colleagues within and beyond his or her area.
Qualifications:
Bachelors 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) Experience 7 or more years' work experience in regulatory, legal, compliance, policy, auditing, training, communications or related disciplines in the bio/pharma industry Regulatory advertising and promotion experience strongly preferred Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth 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.) Additional Skills
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
Lead Program Review Committees (PRCs) independently Demonstrate mastery of the review committee process and regulatory technical knowledge Are the decision-makers for the PRCs in their designated therapeutic or business area assignments; independently leading cross-functional PRCs and modeling strong facilitation and decision- making skills Represent Genentech in official FDA communications and sign-off on 2253s Manage other departmental programs, projects and other deliverables with limited guidance from their managers Require limited direction to complete standard and non-standard work Can be relied upon for sound regulatory guidance and apply a strategic approach to problem-solving Effectively integrate regulatory, legal and commercial context and business knowledge to address complex problems Keep current in the areas of regulatory, healthcare compliance and ethics Proactively identify and address compliance issues Regularly lead cross-functional interactions, projects and teams Typically operate with a planning horizon of 6 - 12 months Example Duties and Responsibilities PRC Leadership:
Lead/chair PRCs and effectively collaborate with cross-functional internal groups and external advertising agencies; acting as the decision-maker for PRCs in the assigned therapeutic or business area Monitor PRCs and provide management oversight for various scenarios that require such oversight, e.g., Food and Drug Administration (FDA) communications, audits, POC presentations, compliance violations, etc. Represent Genentech in official FDA communications and sign-off on 2253s Act as a primary Roche liaison to the FDA on relevant CORA activities Stay abreast of developments in therapeutic and disease areas, including the competitive landscape and other relevant commercial and development trends and dynamics to ensure a fully current view of implications for Genentech products Support development of therapeutic-area strategy for CORA, conducting and summarizing product- specific analysis as requested Obtain and apply in-depth knowledge of Roche and regulatory guidelines, policies, procedures and best practices Maintain current awareness of evolving FDA opinions; including advisory letters, enforcement letters and policy issues. Communicate significant changes or other relevant matters to internal partners and stakeholders Collaborate with commercial leadership to influence marketing strategies, implementation and promotion objectives Facilitate the timely development and approval of disease state and promotional materials by interpreting and applying regulations and guidelines from the FDA and Roche policies Provide regulatory input on commercial concepts and draft materials Develop and implement effective strategies for FDA marketing, advertising and communications submissions Develop and deliver initial correspondence with the FDA and manage interpretation of FDA comments. Oversee and guide follow-on correspondence, such as resubmissions Actively represent commercial regulatory for Core Data Sheet (CDS) and U.S. product label development Support development of the cross-functional regulatory strategy for each product or portfolio assignment by providing commercial regulatory affairs expertise, insights, perspective and recommendations Provide oversight and decision-making leadership to junior CORA staff as well as day-to- day guidance to other CORA team members supporting the same PRCs or other assignments Keep internal partners and stakeholders abreast on primary PRC/CORA activities and status Consult direct manager on all matters related to FDA communications, audits, POC presentations and compliance violations Other:
As appropriate, participate as an ad hoc member in the Regulatory Affairs Functional Team (RAFT) for relevant products As assigned, lead or otherwise participate in special projects and act as a standing or ad hoc member of other teams Competencies successful candidates will demonstrate the following competencies critical to this position:
Strategic Agility - Articulates wise, long-term objectives and strategies. Links his/her responsibilities with the mission of the whole organization. Regularly updates plans to reflect changing circumstances. Focuses on activities that provide the most value. Decision Making - Understands the broad context for decisions and reflects that context in how decisions are made. Makes good decisions even in the face of ambiguous circumstances or contradictory requirements. Able to manage divergent perspectives and to deliver difficult or unwelcome information in a constructive and productive manner. Gathers information necessary to make decisions. Thinks through problems clearly and logically. Is decisive; doesn't procrastinate on decisions. Expresses regulatory position and rationale clearly and fluently. Encourages direct and open discussions about important issues - eliminating churn and driving towards clarity. Inspiring and Influencing - Fosters an exchange of ideas and support amongst colleagues. Is good at promoting an idea or vision:
persuading. Works effectively with other people over whom he or she has no direct authority. Understands what motivates other people to perform at their best Technical and Business Expertise - Has a firm grasp of internal and external conditions affecting the organization. Applies emerging knowledge and trends in one's area of expertise to improve results. Builds strong relationships with key customers. Contributes expertise to help colleagues within and beyond his or her area.
Qualifications:
Bachelors 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) Experience 7 or more years' work experience in regulatory, legal, compliance, policy, auditing, training, communications or related disciplines in the bio/pharma industry Regulatory advertising and promotion experience strongly preferred Must demonstrate in-depth knowledge of the bio/pharma industry (compliance, legal, clinical affairs, regulatory and product marketing) as well as in-depth 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.) Additional Skills
Salary Range:
$150K -- $200K
Minimum Qualification
Life SciencesEstimated Salary: $20 to $28 per hour based on qualifications.
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