Sr. Manager of Research Regulatory Affairs

We need to output HTML fragment with sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections that have real specific content. Must not repeat job title. Must not include Job ID etc. Must remove boilerplate, navigation, legal, EEO, scam warning, duplicated lines, application instructions. Must preserve all substantive info. We need to parse the posting. Let's extract sections: - Intro: "It’s More Than a Career, It’s a Mission..." etc. That's about the role? Could be "About the role". We'll put that in

About the role

with

content. - Skills: The posting has a "Skills" heading then a long paragraph describing responsibilities. Actually after "Skills" heading, there is a block describing responsibilities. So we need to separate responsibilities and skills. The text after "Skills" heading: "The Senior Manager for Research Regulatory Affairs is responsible for the overall operations of, which include but is not limited to Regulatory Affairs Specialist, Conflict of Interest, Safety, Process Specialist. This individual will also work very closely with study activation site research teams, protocol research operations, budget, and contract department, and finance to continue evaluating our regulatory processes and metrics to ensure regulatory is working as efficiently as possible to meet or exceed our goals. In this role, the individual must have managerial and leadership skills as well great customer service skills to comfortably interact and communicate with internal teams, pharma/CRO teams, IRBs, site research teams and our physicians." Then a list of duties: "The Senior Manager: Oversees the regulatory start-up and maintenance of trials; including safety and conflict of interest Works closely with our research sites, study activation, research protocol operations, budget, and contracts team Develops and implements regulatory policies and procedures for the sites and the site Clinical Operations team; including managing and planning regulatory affairs compliance for industry sponsors and/or sites Manages the regulatory affairs between the organization for multiple clinical trials according to FDA and GCP guidelines; for individual sites, studies, sponsors and/or other networks Manages the relationships between industry partners and the FDA regarding regulatory compliance for the organization and managing regulatory audits of studies by sponsor/industry and governmental auditors Problem solves with the department managers and other site leadership as they arise Assists in developing and executing the Sarah Cannon internal and external strategies Provides oversight, leadership, and direction in the regulatory study startup of trials and in maintenance areas where support is provided Assesses organizational processes associated with regulatory startup and support to identify ways to improve and streamline processes Meets with site leadership as needed to ensure contracted services are being provided by the teams Accountable for leading people, setting direction, and deploying resources; responsible for attracting and selecting talent; support onboarding new employees to decrease time to productivity; driving performance through their team members by setting direction, providing feedback, and creating a trust-based, inclusive work environment; developing employees through coaching and feedback; rewarding and recognizing employees via ongoing recognition and core pay-for-performance practices are primarily achieved through the work of others and typically depend on the manager's ability to influence and negotiate with parts of the organization where formal authority is not held. Develops metrics and reports KPI on weekly and monthly basis to department managers to ensure targets initiatives are being met. Investigates complex and unusual customer requests and complaints, develops remediation plan and leads implementation. Provides leadership and direction to employees either through other managers or directly to employees. Develops, adapts, and executes functional or departmental strategy to achieve key business objectives in area of responsibility. Keeps executive and management team abreast of issues, progress, and risks related to regulatory affairs Develops, implements, and evaluates programs to promote recruitment, retention, and continuing education of the team Attends and participates in all required meetings including weekly operational review and Director’s meeting Assists in development and tracking of department goals and metrics Works closely with monitors, sponsors/CROs, sites, and team to ensure quality and timely work being delivered Support and collaborate with IRB counterparts to ensure quality relationships Represents company vision to colleagues and external customers Tracks and communicates to team and sites performance expectations and status Works with other members in Research Operations to ensure communication and responsibility are effective and appropriate Adhere to professional standards and SOPs established for clinical research and develop newSOPs and or Working Practice Guidelines as appropriate. Monitor adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required. Participate in educational activities and programs Maintain strictest confidentiality Provide proactive and creative recommendations on how to meet corporate and role-specific goals and handle identified deviations Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management Provide high level customer service, support and problem resolution to ensure the delivery of organizational goals" Then "You Should Have For This Position A Bachelor’s Degree preferably a Master’s Degree At least three years of Research experience either on the site side or within industry At least three years of Management with direct reports Research certification (ACRP or CCRP) is preferred" Then "About Sarah Cannon Research Institute ..." describing organization. Then benefits: "We care about the well-being of the patients and communities we serve, and that starts with caring for our people. That’s why we have a Total Rewards package that includes comprehensive benefits to support physical, mental, and financial well-being. Our Total Rewards offerings serve the different needs of our diverse colleague population and ensure they are the healthiest versions of themselves. For more information regarding benefits through our parent company, McKesson, please click here." Then compensation: "As part of Total Rewards, we are proud to offer a competitive compensation package. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered." Then scam warning and EEO etc which we must remove. Thus we have sections: - About the role: intro paragraph(s) about mission, etc. - Responsibilities: list of duties (the long list after "The Senior Manager:"). - Requirements: maybe the "You Should Have For This Position" bullet points (education, experience, certification). Could be considered Requirements. - Qualifications: maybe overlapping with Requirements? The instruction says use headings for Requirements, Qualifications, Skills, Benefits, Pay, Schedule. We need to decide what goes where. The posting has a "Skills" heading earlier but that seems to be more about responsibilities. We could treat that as Skills section? But the "Skills" heading in the posting is followed by responsibilities description. However we need to follow instruction: Use

for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we must create those headings if content exists. We need to map content: - About the role: introductory mission statement. - Responsibilities: the bullet list of duties (the long list after "The Senior Manager:"). - Requirements: education and experience requirements (Bachelor's preferably Master's, 3 years research, 3 years management, certification preferred). Could also include "Research certification (ACRP or CCRP) is preferred". - Qualifications: maybe we could include managerial and leadership skills, customer service skills, etc. But those are more like skills. The posting mentions "must have managerial and leadership skills as well great customer service skills". That could go under Skills. - Skills: maybe we list specific skills: managerial, leadership, customer service, ability to interact with internal teams, pharma/CRO, IRBs, site research teams, physicians, etc. Also maybe "developing metrics and reports KPI", "investigates complex requests", etc. But many of those are responsibilities. However we need to avoid duplication. The instruction says preserve ALL substantive information; do not invent or summarize away detail. So we need to keep all info, but we can categorize. We could put the long list of duties under Responsibilities. Then under Skills we could put the managerial/leadership/customer service skills and ability to interact with various stakeholders. Under Requirements we put education/experience/certification. Under Qualifications we could put maybe "Ability to develop and implement regulatory policies and procedures", "Knowledge of FDA and GCP guidelines", etc. But those are also responsibilities. We need to decide a sensible split that preserves all info without duplication. Perhaps we can treat the "Skills" heading in the posting as the Skills section, and the long list after "The Senior Manager:" as Responsibilities. Then Requirements as education/experience/certification. Qualifications maybe we can leave empty? But we must not create a heading with filler. So if we don't have specific content for Qualifications, we should omit it. Similarly for Benefits, Pay, Schedule: we have benefits description, compensation description (pay), but no schedule info. So we include Benefits and Pay sections, but not Schedule. Thus sections: - About the role - Responsibilities - Requirements - Skills - Benefits - Pay We must not include Qualifications or Schedule. Now we need to extract precise content for each. About the role: The first paragraph(s) up to "Skills". Let's capture: "It’s More Than a Career, It’s a Mission. Our people are the foundation of our success. By joining our growing team at Sarah Cannon Research Institute (SCRI), a subsidiary of McKesson, you will have the opportunity to become part of one of the largest community-based cancer programs to advance oncology treatments and improve outcomes for cancer patients across the globe. We look for mission-driven candidates who have a desire to advance the fight against cancer and make a difference in the lives of patients diagnosed with cancer every day. Our Mission People who live with cancer – those who work to prevent it, fight it, and survive it – are at the heart of every decision we make. Bringing the most innovative medical minds together with the most passionate caregivers in their communities, we are transforming care and personalizing treatment. Through clinical excellence and cutting-edge research, SCRI is redefining cancer care around the world." We need to ensure we keep all substantive info. There's a weird "Our Mission People" missing punctuation but we keep as is. Now Responsibilities: The list after "The Senior Manager:" (including the preceding sentence about overseeing regulatory start-up etc). Actually the sentence "The Senior Manager for Research Regulatory Affairs is responsible for the overall operations of, which include but is not limited to Regulatory Affairs Specialist, Conflict of Interest, Safety, Process Specialist. This individual will also work very closely with study activation site research teams, protocol research operations, budget, and contract department, and finance to continue evaluating our regulatory processes and metrics to ensure regulatory is working as efficiently as possible to meet or exceed our goals. In this role, the individual must have managerial and leadership skills as well great customer service skills to comfortably interact and communicate with internal teams, pharma/CRO teams, IRBs, site research teams and our physicians." This seems more like skills/requirements. But we already have Skills section for managerial/leadership/customer service. However the instruction says we must preserve all info; we can allocate that sentence to Skills (since it mentions skills). The list after "The Senior Manager:" is clearly responsibilities. Thus Responsibilities: the bullet list starting with "Oversees the regulatory start-up and maintenance of trials; including safety and conflict of interest" and continuing through all the semicolon-separated items until the end before "You Should Have For This Position". Let's capture that entire block. We need to format as

• for each item. The block is a series of statements separated by semicolons and line breaks. We'll split each statement into a list item. Let's extract each distinct responsibility: 1. Oversees the regulatory start-up and maintenance of trials; including safety and conflict of interest 2. Works closely with our research sites, study activation, research protocol operations, budget, and contracts team 3. Develops and implements regulatory policies and procedures for the sites and the site Clinical Operations team; including managing and planning regulatory affairs compliance for industry sponsors and/or sites 4. Manages the regulatory affairs between the organization for multiple clinical trials according to FDA and GCP guidelines; for individual sites, studies, sponsors and/or other networks 5. Manages the relationships between industry partners and the FDA regarding regulatory compliance for the organization and managing regulatory audits of studies by sponsor/industry and governmental aud