Associate Director, Disclosure Quality & Operations, Hybrid

Job Description

The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trial Operations (GCTO) creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials.

The Associate Director of Disclosure Quality and Operations overseas and leads the preparation quality control tracking and submission of clinical and regulatory documents and transparency deliverables while coordinating with stakeholders to ensure compliance accuracy and timely completion of regulated content.

Key responsibilities may include:

• Supervision of the creation review quality control (QC) and/or redaction of clinical documents across multiple therapeutic areas and development stages verifying accuracy consistency and proper formatting consistent with company and regulatory guidance and privacy/transparency regulations.
• Oversight of project timelines and tracking to drive timely completion of deliverables to ensure compliance with global requirements and voluntary policies and to maintain inspection readiness.
• Lead the collection and analysis of metrics to identify trends diagnose root causes and drive corrective actions through targeted process improvements enhanced training programs and other strategic measures to ensure sustained quality and compliance.
• Build and maintain effective cooperative relationships with internal stakeholders relevant to role policies and regulations.
• Forecast and allocate resources for deliverables using associated tracking of milestones documents and submission management systems to identify trials and submissions in scope of the transparency regulations.
• Coordinate and/or support collaborative review with authors and product development team members to confirm the information and documentation is reviewed and approved for accuracy and as applicable for confidential and privacy protection.
• Lead and provide support for clinical trial disclosures document redactions and other key departmental initiatives to maintain compliance with regulatory requirements organizational standards and public registries.
• Collaborate in the development maintenance and continuous update of Standard Operating Procedures (SOPs) job aids and guidance documents for clarity compliance and alignment with evolving regulatory and organizational requirements.
• Support regulatory audits and inspections by ensuring documentation readiness facilitating responses and coordinating with cross-functional teams to maintain compliance standards.
• Strategize design and implement innovative efficient processes technology and tools to enhance business operations document organization authoring workflows and metrics collection.
• Lead the development and execution of training programs to enhance team proficiency in processes including designing cross-training initiatives for medical writers and other cross-functional teams creating standardized learning materials and fostering a culture of continuous improvement to ensure accuracy and compliance across deliverables.
• Mentor and/or manage team members including hiring workload professional development and performance management.
• Drive administration and business objectives for their group.

Education Requirement:

Required:

• Bachelors degree or higher preferably in a health scientific or relevant discipline (e.g. life sciences pharmacy medicine public health) and at least 5 years of relevant industry experience.

Required skills & experience

• Fluent in American English.
• Proficient in Microsoft Office Suite (Word Excel PowerPoint) Adobe Acrobat SharePoint and electronic document management systems.
• Strong teamwork and leadership skills across organizational levels including conflict resolution expertise and discretion.
• Strong project management organizational and multitasking abilities
• Demonstrated ability to influence and lead in driving change in the organization.
• Excellent communication interpersonal and collaboration skills with the ability to work independently and in cross-functional teams
• Analytical mindset with problem-solving skills and ability to manage complex ambiguous situations.
• Strong commitment to quality attention to detail and ability to meet deadlines under pressure.
• Adaptability to evolving technologies and processes within CRSC and regulatory environments.
• Able to maintain confidentiality and adhere to regulatory and company standards.
• Experience writing or able to critically analyze and interpret the content of drug and/or device clinical submission documents.
• Ability to execute responsibilities with minimal oversight.
• Ability to think strategically and objectively and with creativity and innovation.

Preferred skills & experience

Clinical Transparency (CT) / Document Disclosure (DD):

• Expert-level proficiency in the US Food & Drug Administration trial disclosure or the European Medicines Agencys (EMA) and/or Health Canada publication of clinical information requirements.
• Expert knowledge of regulatory disclosure intelligence and industry trends with the ability to assess the impact on business operations and shape effective strategies for new or modified requirements
• Ability to track metrics analyze data and establish automation tools.
• Proven development testing implementation and support of tools and systems.

Quality & Process Improvement:

• Demonstrated experience identifying designing and implementing process improvements that increase efficiency reduce cycle times and strengthen operational effectiveness.
• Strong quality mindset with experience applying quality principles root cause analysis and corrective actions to support compliant inspection-ready deliverables.
• Ability to influence stakeholders across functions to align on priorities drive adoption of process improvements and support sustained quality outcomes.

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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