Sr. Spclst , Digital CMC Regulatory Authoring Data Analyst
Sr. Spclst , Digital CMC Regulatory Authoring Data Analyst
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$ 114700 - 180500
1 Vacancy
Job Description
Job Description
Digital Chemistry Manufacturing and Controls (dCMC) is a cross-divisional digital transformation initiative that will enable the pipeline by establishing a digital continuum of data from development through manufacturing for our products and processes. dCMC intends to deliver:
Increased productivity and speed to clinic/market
Accelerated timelines for site filing and launch readiness
Improved access to product and process data
Streamlined transfer of process and product knowledge with reduced error rates
A key enabler of these outcomes is implementation of digital solutions that will install the foundational capabilities needed to realize dCMCs vision of frictionless flow of data from development to commercialization and supply.
A key workstream within this initiative is the auto-generation of regulatory filing sections enabled by a dedicated application designed to create a frictionless flow of data from source systems to regulatory documentation.
Under the guidance of dCMC Regulatory Authoring Leadership the Senior Specialist Regulatory Authoring Data Analyst will optimize regulatory authoring processes and enhance data management by mapping workflows prioritizing source documents for digitization and collaborating with cross-functional teams to implement digital solutions. The applicant will help define and implement the approach of structured content management. They will also support project management activities to ensure efficient execution and compliance within CMC operations.
The responsibilities of the dCMC Data Analyst include:
Business Process Mapping and Optimization: Working with Digital CMC and associated business stakeholders the analyst will map end-to-end processes that produce regulatory authoring data convert complex tasks into clear workflows identify gaps and prioritize solutions to improve efficiency and compliance.
Source Document Identification and Prioritization: The analyst will identify true source documents for past regulatory filings to prioritize digitization and integration. They will drive decisions in collaboration with the data strategy team on areas of priority and opportunities for further investment.
Stakeholder Management & Communication: The analyst will organize and lead information gathering sessions with the internal CMC community collaborate with cross-functional teams to gather business requirements and coordinate with IT Research and Manufacturing to capture feedback on developed capabilities to ensure effective digital solution integration and adoption.
Documentation and Project Management Support: The analyst will create detailed process documentation including workflows and data models. They will support project management by tracking tasks reporting status coordinating meetings managing timelines and risks and monitoring KPIs to measure digitization success.
Application SME and Data Steward: The analyst will support application deployment and use with responsibilities ranging from data template creation and maintenance onboarding data stewards from the business authoring SOPs for new application releases and troubleshooting use and data management.
Required Skills and Experience:
Knowledge of manufacturing testing quality and supply chain processes from late clinical development through commercialization with practical insight into how these operations generate CMC regulatory content
Understanding of CMC operations technology transfer control strategy development and regulatory authoring requirements that inform automated filing generation
Hands-on experience in regulatory authoring and submission documentation including preparing reviewing or supporting filing ready content and structured filing outputs.
Proven ability to map business processes perform gap analyses and redesign workflows to improve efficiency reduce errors and enable digitization.
Experience in digitization and data management initiatives in regulated environments including source-document identification/prioritization metadata design and content/ data modeling.
Working knowledge of key enterprise systems (LIMS MES SAP) and practical experience coordinating their integration into data pipelines APIs or ETL processes for downstream authoring use
Skilled in creating and managing detailed cross-functional project plans and driving execution with accountability.
Strong team contributor promoting an inclusive and collaborative environment
Effective problem-solving conflict resolution and ownership-driving skills.
Excellent verbal and written communication with ability to tailor messages and actively listen.
Highly organized able to prioritize tasks to ensure project success.
Preferred Experience and Skills
Experience implementing or supporting automated regulatory authoring (structured content template-driven generation or document assembly) from source systems.
Strong background in business process mapping gap analysis and workflow optimization for CMC/regulatory authoring.
Familiarity with CMC operations and technology transfer from late clinical development to commercialization (manufacturing testing quality supply).
Practical knowledge of content models/structured content metadata and data template design to enable automated authoring.
Experience with data integration patterns and tools (APIs data pipelines) and relevant systems (LIMS MES SAP).
Experience in data governance data stewardship and data quality management in regulated environments.
Strong stakeholder facilitation and project management skills (cross-functional workshops requirements synthesis KPI tracking SOPs and training).
Education Minimum Requirement:
Bachelors of Science in a related discipline (e.g. Chemistry Pharmaceutical Sciences Data Analytics Information Systems) with a minimum 4 years of experience
Masters degree in a related discipline (e.g. Chemistry Pharmaceutical Sciences Data Analytics Information Systems) with a minimum of 3 years of experience
Ph.D in a related discipline (e.g. Chemistry Pharmaceutical Sciences Data Analytics Information Systems) with relevant academic Experience
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 office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining 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 salary range for this role is
$114700.00 - $180500.00This 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.
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 pre-existing 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:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
n/aRequired Skills:
Business Management Process Social CollaborationPreferred Skills:
Job Posting End Date:
09/18/2025*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:
Senior IC
Employment Type
Full-Time
