Quality & Operations Specialist

Job description

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 Quality & Operations Specialist manages 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: Coordinate the review, quality control, and/or redaction of clinical documents across multiple therapeutic areas and development stages, verifying accuracy, consistency, and proper formatting consistent with ICH, regulatory guidance, and privacy/transparency regulations. Manage deliverables timelines to keep a record of process activities and participate in submission planning meetings as needed to ensure timely completion of submission deliverables. Reference and track trial and submission information (e.g., clinical trial applications, new drug applications) via associated milestones, documents, and submission management systems to identify trials and submissions in scope of the transparency regulations. Facilitate collaborative review with authors and product development team members to ensure the information and documentation is reviewed and approved for accuracy, and, as applicable, for confidential and privacy protection. Manage the submission of transparency deliverables to public registries and health authorities within compliance timelines. Coordinate clinical deliverables related to global regulatory submissions, including initiation, review, and finalization of Electronic Common Technical Document (eCTD) modules. Provide input and feedback to the standard operating procedures and work instructions with a mindset of process improvement and efficiency. Design and implement innovative, efficient processes and tools to enhance business operations, document organization, authoring workflows, and metrics collection. Coordinate the collection, reconciliation, analysis, and reporting of operational metrics to support decision-making and continuous improvement activities. Qualifications Required: Associate degree preferably in health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and/or at least 10 years of relevant experience for this role. Preferred: Bachelor’s degree preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 2 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 project management, organizational, and multitasking abilities. 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. 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 general understanding of the content of drug and/or device clinical submission documents. Business Operations: Supports technology-enabled business operations by applying digital tools, automation, analytics, and cross-functional collaboration to improve Clinical and Regulatory Strategic Communications (CRSC) processes and outcomes. Experience with technology-enabled business operations, including SDLC, requirements, testing, implementation, and system support. Proficiency with Microsoft 365 tools, including SharePoint, Excel, Word, and Power Platform; understanding of AI and automation use cases. Analytical mindset with strong critical thinking, problem-solving, project management, and proactive execution skills; able to manage complex, ambiguous situations. Excellent communicator and collaborator; able to work independently, partner across cross-functional teams, and support change adoption. clinicaltrialjobs Required Skills: Accountability, Adaptability, Business Operations, Good Clinical Practice (GCP), New Technology Integration, Power Platform, Project Management, Standard Operating Procedure (SOP), Technology Adaptation, Working Independently Preferred Skills: 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 characteristics. As 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: EEOC Know Your Rights EEOC GINA Supplement​ 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 another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $87,300.00 - $137,400.00 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 employee’s 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 https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. 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 M