Director, Disclosure Quality & Compliance
Director, Disclosure Quality & Compliance
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$ 169700 - 267200
1 Vacancy
Job Description
Job Description
Brief Description of Position
The Medical Writing & Disclosure (MW&D) department of the GCTO organization prepares a variety of regulated documentation in support of the clinical development portfolio and compliance in public disclosure of clinical trials and their results document disclosure and data sharing with external researchers.
The Director Disclosure Quality & Compliance is responsible for independently leading/executing projects that contribute to successfully achieving disclosure quality goals while ensuring compliance with US and global laws regulations and policy leading teams through changing processes and negotiating with stakeholders across the organization.
The responsibilities of the Director Disclosure Quality & Compliance are to:
Apply advanced competencies knowledge of applicable regulations and critical thinking in support of disclosure operational activities; proactively identify/resolve complex issues with input from the disclosure leadership team. Role requires effective collaboration strong leadership and proactive partnering with crossfunctional stakeholders.
Contribute to the development of the disclosure group and the departments objectives through strategic input continual process improvement innovation stakeholder engagement and leadership for disclosure processes standards and initiatives.
Serve as a subject matter expert for functional group processes systems and regulations driving disclosure quality assurance and compliance. Actively monitor evolving standards within the dynamic transparency landscape and apply evidencebased approaches in transforming quality management across the disclosure framework. Assess insights into disclosure regulatory intelligence and industry trends to strategize business activities impacted by new or modified requirements. May assist with the preparation or review of relevant Standard Operating Procedures policies or guidance relevant to disclosure.
Provide strategic direction for optimized project management across disclosure functional groups. Implement modernization strategies and streamlined workflows to enhance efficiency of disclosure functions while ensuring compliance with federal and global transparency requirements in an inspectionready environment.
Build capabilities competencies and process understanding of staff and stakeholders through development/delivery of educational materials to MW&D and across the organization. May lead coach develop or manage staff.
Required Education Experience and Skills:
Bachelors degree in healthrelated life science or analyticalrelated field advanced degree preferred.
10 years pharmaceutical and/or clinical drug development experience.
Organization leadership (e.g. program management) with indepth experience managing and driving complex projects and collaborating with crossfunctional stakeholders.
Advanced knowledge and understanding of global and local transparency regulations endtoend drug development and clinical research processes.
Strong decisionmaking and analytical skills. Ability to influence and drive a broader view of issues to maximize benefit and/or impact across the organization.
Demonstrated leadership & project management skills in overseeing people managing programs and processes facilitating meetings and influencing matrix environments.
Advanced problem solving conflict resolution and critical thinking skills with an ability to innovate and drive change.
Excellent communication and presentation skills.
Technical expertise in typical office applications (e.g. Microsoft Office Suite) and shared document systems (e.g. SharePoint); experience with Clinical Trial Management systems (e.g. Veeva) AI tools and project management software preferred.
Expert knowledge of GCP and ICH regulations and corporate policies.
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:
We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors which may include but not be limited to the primary work location and the chosen candidates relevant skills experience and education.
Expected US salary range:
$169700.00 $267200.00Available benefits include bonus eligibility long term incentive if applicable health care and other insurance benefits (for employee and family) retirement benefits paid holidays vacation and sick days. A summary of benefits is listed here.
San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway NJ USA does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/14/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
