Merck & Co, Inc

Associate Director, Disclosure Quality & Operations, Hybrid

Merck & Co, Inc • $142K — $224K *
Rahway, NJ 07065Hybrid
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in a health or scientific discipline; advanced degree preferred.
  • 5+ years of relevant industry experience in clinical or regulatory environments.
  • Fluent in American English with strong communication skills.
  • Proficient in Microsoft Office Suite, Adobe Acrobat, SharePoint, and document management systems.
  • Strong project management and organizational skills with multitasking ability.
  • Proven ability to influence change and lead cross-functional teams.

Responsibilities

  • Supervise and ensure quality and compliance of clinical document creation across various therapeutic areas.
  • Oversee project timelines to ensure timely completion of regulatory deliverables and maintain inspection readiness.
  • Collect and analyze metrics to drive process improvements and enhance training programs.
  • Build effective relationships with internal stakeholders regarding compliance and regulations.
  • Forecast resources for deliverables and manage tracking systems for submissions.
  • Coordinate collaborative reviews with product development teams for document accuracy and confidentiality.
  • Lead efforts in clinical trial disclosures and compliance initiatives.

Benefits

  • Flexible work arrangements with a hybrid model.
  • Strong emphasis on continuous professional development and training.
  • Collaborative and inclusive workplace culture promoting teamwork and innovation.
  • Opportunities for mentorship and guidance in team management.
  • Direct involvement in strategic initiatives shaping the future of clinical transparency practices.
Full Job Description
Job Description

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:
  • Bachelor's 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 Agency's (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.


clinicaltrialjobs

Required Skills:
Critical Thinking, Cross-Cultural Awareness, Good Clinical Practice (GCP), Independent Thinking, Medical Writing, New Technology Integration, People Leadership, Process Improvements, Regulatory Compliance, Stakeholder Management

Preferred Skills:
Continuous Improvement, Standard Operating Procedure (SOP)

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.

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 pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
08/24/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

Merck & Co, Inc Careers

Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

Work You’ll Do

At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

Explore Career Paths

Whether you're seeking an internship, a graduate opportunity, or a professional position, Merck & Co, Inc offers a range of career paths in environments that promote rapid professional growth and development. Explore job opportunities in research, digital transformation, manufacturing, and more, all while benefiting from a culture that supports diversity and inclusion.

Innovate and Lead

Merck & Co, Inc is an ideal environment for those who lead with curiosity and the drive to innovate. Our leadership is committed to fostering a culture where inventive thinking and collaboration are encouraged, making it a perfect place for professionals who seek to make an impact through their work.

Develop Your Skills

With Merck & Co, Inc, you are not just getting a job; you're gaining access to unparalleled career development opportunities. Enhance your skills through diverse training programs, workshops, and continuous learning courses designed to help you grow at every stage of your career.

Benefits and Culture

We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

Join Our Team

Ready to advance your career at Merck & Co, Inc? Search open positions that match your skills and interests. We are continuously hiring and looking for passionate, creative, and solution-driven team players. Prepare your resume, sharpen your interview skills, and become part of a company that's dedicated to making a difference.

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Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Engage with us through our careers blog and by participating in networking events and employment fairs. Subscribe to receive personalized job alerts and the latest news tailored to your preferences. Discover the exciting and rewarding opportunities that await at Merck & Co, Inc. Join us in our mission to improve health and wellness around the world.
Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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