**Job Description** **Position 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 dCMC’s 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 Leadership, the Senior Specialist, Digital CMC Data Analyst, will support development and implementation of the regulatory authoring application by identifying, implementing and enforcing data standards from key source systems; contributing to data model development; and assisting in evolving data products for automated filing content. The Sr. Specialist will work closely with cross-functional teams to ensure integration of the data into regulatory documentation, supporting consistent data standards and the growth or our regulatory data ecosystem. **The responsibilities of the dCMC Data Analyst include:** + **Data Standardization and Source Integration:** Define and implement data standardization rules and practices across multiple source systems . Support the extraction, transformation, and validation of process and analytical data to ensure consistency and quality before auto generation into regulatory documentation. Collaborate with source system SME’s and data stewards to understand data nuances and improve data quality at the source. + **Data Model Development and Maintenance:** Contribute to the creation and refinement of the data models that represent regulatory filing sections and their underlying data relationships. Assist in documenting data models, metadata, and data lineage to support transparency and traceability. Support iterative updates to data models as new sources are connected or regulatory requirements evolve. + **Data Product Support and Evolution:** Develop and maintain data products that enable auto-generation of regulatory filing content. Collaborate with product owners and technical teams to gather requirements, test new features, and trouble shoot data related issues. Support user onboarding and training related to data standards and product usage, including defining data governance requirements and expectations. + **Cross-Functional Collaboration and Communication** Work closely with regulatory authoring, IT, data strategy, and source system teams to align on data requirements and understanding integration priorities. Participate in meetings to gather feedback, report progress, and escalate issues as needed. Assist in preparing documentation, reports, and presentations related to data standardization and product status. **Required** **Skills and Experience** + Understanding of data within the CMC (Chemistry, Manufacturing, and Controls) domain, including experience in analytical testing, manufacturing processes, and laboratory development. + Basic understanding of regulatory authoring processes and the role of data in regulatory filings, including how data supports submissions and the importance of accuracy and traceability. + Familiarity with source systems such as LIMS, Veeva, and document formats like PDF, enabling effective data extraction, validation, and integration. + Experience in data standardization, modeling, and semantic ontologies to define standards, maintain data models, and enhance data interoperability. + Strong analytical skills with attention to detail and accuracy in data handling. + Understanding of master data management and manufacturing ontologies to support consistent data definitions, relationships, and governance. + Proven success collaborating within cross-functional teams and communicating effectively with technical and business stakeholders to align on data requirements and project goals. **Preferred Experience and Skills** + Preferred direct experience in the development and commercialization of processes and analytical methods. + Data engineering and experience with extract, transform, load tools and scripting techniques. + Advanced knowledge of regulatory frameworks and insight to electronic submission standards (eCTD etc) + Experience with data governance frameworks and data quality management tools. + Familiarity with Agile methodologies and software development lifecycle to collaborate with IT teams. + Exposure to PKM (Process Knowledge Management) and Signals is an advantage and knowledge in automation technologies. **Education Minimum Requirement:** + Bachelor's of Science in a related discipline (e.g., Chemistry, Chemical Engineering, Pharmaceutical Sciences, Data Analytics, Information Systems), with a minimum 4 years of experience + Master's degree in a related discipline (e.g., Chemistry, Chemical Engineering, Pharmaceutical Sciences, Data Analytics, Information Systems), with a minimum of 3 years of experience + Ph.D in a related discipline (e.g., Chemistry, Chemical Engineering, Pharmaceutical Sciences, Data Analytics, Information Systems), with relevant academic Experience Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld) **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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088\_EEOC\_KnowYourRights\_10\_20.pdf) 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 (https://www.msdprivacy.com/us/en/CCPA-notice/) **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 presence.This 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 $114,700.00 - $180,500.00 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** 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:** No Travel Required **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** n/a **Required Skills:** Agile Application Development, Agile Application Development, Agile Methodology, Business, Business Intelligence (BI), Chemical Biology, Chemical Engineering, Database Administration, Data Engineering, Data Governance, Data Lineage, Data Management, Data Modeling, Data Quality Control, Data Visualization, Data Warehouse Development, Design Applications, Digital Transformation, ICT Strategy, Information Management, IT Coordination, Regulatory Documents, Regulatory Frameworks, Social Collaboration, Software Development {+ 1 more} **Preferred Skills:** **Job Posting End Date:** 09/24/2025 ***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.** **Requisition ID:** R363816