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Job Description

The Clinical Trial Data Transparency (CTDT) Associate Director is responsible for executing Vertex’s clinical trial data transparency and disclosure activities as directed, according to all applicable laws, regulations, and policies. The CTDT Associate Director collaborates across functions and local affiliates to effectively communicate deliverables, processes and timelines to accomplish projects and ensure adherence to Vertex’s processes/strategies and compliance with regulatory requirements. The role will also contribute to and/or lead the development and maintenance of processes, standards and training to support timely completion and delivery of high-quality submission documents to meet current and future
global clinical trial data transparency and disclosure requirements.

Key Responsibilities:

• Consults and works with cross-functional teams and other internal stakeholders to ensure delivery of high-quality outputs in a timely and compliant manner

• Contributes to and/or leads standardization of internal best practices, including the development and review of relevant policies, SOPs, guidance documents and training resources

• Manages and coordinates the preparation and review/approval of redacted and anonymized regulatory documents for compliance with Health Authority transparency submissions, clinical trial results postings and other applicable laws, regulations and policies

• Assists in raising and maintaining awareness across the organization of changes in the transparency and disclosure landscape, including regulatory requirements and industry trends

• Ensures consistency of publicly disclosed information across countries/jurisdictions and channels

• Develops and maintains effective working relationships with global functional leadership and other internal stakeholders

• Maintains knowledge of global policies and regulations as they apply to data sharing, data disclosures and transparency

• May serve as a member of Working Groups related to transparency and disclosure activities

Knowledge and Skills:

• Excellent knowledge of clinical trial data transparency and disclosure laws/policies, such as FDAAA801, EudraCT, and PhRMA/EFPIA principles for responsible data sharing

• Demonstrated record of driving and successfully completing time-sensitive projects, with conflicting priorities, across functions and countries

• Demonstrated experience with Health Authority transparency submissions and/or clinical trial data disclosures, processes and systems

• Must demonstrate excellent interpersonal, communication, and organizational skills to communicate difficult concepts and persuade others

• Strong attention to detail and outstanding quality, consistency, and accuracy in deliverables

• Ability to work in a team environment and across all levels of the organization

• Competent in Microsoft Office (Word, Excel, PowerPoint) and Outlook; experience with Adobe Acrobat

• Experience working in a clinical trial transparency / disclosure, clinical trial operations, medical writing, or regulatory affairs related environment

Requirements:

• Bachelor's degree in a scientific discipline or other relevant discipline

• Typically requires 8 years of experience in the pharmaceutical industry and/or clinical research experience, or the equivalent combination of education and experience

Pay Range $156,880– $235,320 USD annually

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.

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