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Job Description General Summary: Vertex is looking to hire a Senior Manager, Program Quality, to join our Pain Patient Support Team. As a subject matter expert, you will be responsible for playing a crucial role in building, monitoring and auditing compliance to the PSP policies as well as tracking corrective and preventative actions. This individual willhave anexceptionaltrack recordof driving highly cross-functional working teams,and the ability to thrive in a fast-paced,innovation-focused environment.You will report to the Head of Pain Patient Support. Key Responsibilities:
- Ensure adherence to the pain privacy standards, meet or exceed Vertex quality and compliance standards, and pull through feedback to optimize the customer experience
- Manage internal and external PSP audit programs; utilize metrics and analytics to provide insight into process adherence, assess skill gaps and ultimately inform appropriate and meaningful training programs (liaise with internal commercial training and external vendors)
- Build and conduct monthly communication monitoring (e.g. calls, texts, emails) of PSP internal and vendor engagements, develop score cards, and lead internal and external call calibrations
- Build and manage Pain Patient Support Program SOPs, manuals, and work instructions and all tactics related to document managemen
- Establish and support GXP Event Management processes including quality and compliance standards, processes and measurement systems
- Responsible for audit of external PSP vendors; lead assessment, present findings, and track outcomes & deliverables (e.g. monitor adherence of our financial support programs business rules)
- Lead for PSP on internal audits conducted directly by Vertex personnel; oversee and engage on external audits conducted by a vendor on behalf of Vertex
- Acts a liaison with Global Patient Safety and is responsible for overseeing AE/PC/other safety information reporting and monitoring compliance to these policies and training for external vendors and patient support team training
- Responsible for VCARES administration in AE / PC system platforms and oversight (admin add/remove users, ensure annual trainings occur, ensure materials are most up to date, point of escalation, engage Global Patient Safety on vendor inquiries, VCARES point of contact for releases, changes, revisions to system)
- Lead quarterly readouts to OBIE/Legal on assurance findings and trends
- Work closely with PSP stakeholders to ensure appropriate steps are taken to address audit findings/observations of nonconformance; ensures adequate and timely closure of CAPAs generated from audits
- Responsible for identifying training needs, developing corresponding materials, coordinating training of applicable team and ensuring compliance/completion deadlines are met for PSP team and all external vendors
- Act as the Privacy and Compliance champion
- Liaise with the office of Business Integrity & Ethics, Legal, Privacy Office and other field facing teams to proactively enhance how our cross-functional teams can appropriately interact together and with external stakeholders; ensure guidance is clear, up to date, and pulled through (e.g. US Guidebook)
- Identify opportunities for operational efficiencies and continuous improvement and partner with colleagues in COE (Center of Excellence) to share learnings / best practices
- Manage current and future cross-functional projects that improve processes that support the multilayered Patient Services Teams
Minimum Qualifications
- A Bachelor's degree with 5+ year's pharmaceutical/biotech industry experience
- Experience working in a Quality or Compliance role or relevant comparable background in Patient Support preferred
- Intellectually curious with a continuous improvement mindset; high customer service aptitude, seeks to understand and self-educate on current trends in patient services quality programs
- Understands how systems and databases are structured, has the ability to consolidate multiple data sources, and synthesize large datasets into key findings and recommendations.
Preferred Qualifications:
- Experience in patient focused programs within associated HIPAA regulations and other legal parameters and patient privacy policies Patient-centric and customer service minded
- Product Launch experience of drugs with complex service models
- Willingness to work in a fast pace environment, and have the ability to multi-task and self-prioritize workload
- Attention to detail, highly organized and committed follow-through in communication to internal and external partners
- Ability to work independently yet function as a team player and experience collaborating offline and managing formal reviews with legal, compliance, marketing
- Contributes to Vertex's culture of compliance by focusing on ethics and integrity in all interactions and ability to role model the expected behavior for the team
- Excellent communication skills, both written and verbal, with the ability to connect effectively with peers, as well as more diverse and large audiences
- Comfortable working in a fast-paced, results-driven, environment, with the ability to multi-task and prioritize the workload of the team
- Patient-centric and customer service minded
- Demonstrated ability to effectively collaborate across multiple teams internally & externally Ability to manage up and across an organization; can adeptly identify when/what information to share with leadership and/or cross-functional stakeholders at critical timepoints
Pay Range: $132,600 - $199,000
Disclosure Statement:
The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status: In this Hybrid-Eligible role, you can choose to be designated as: 1. Hybrid: work remotely up to two days per week; or select 2. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Hybrid Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com
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