Job Description
Digital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional 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
Digital CMC will implement digital solutions to install the foundational capabilities needed to realize the 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 Associate Principal Scientist, Regulatory Authoring Business Owner, will optimize regulatory authoring processes and enhance data management by working with the business areas to define the optimal route to digitize the authoring of regulatory filing sections. The applicant will work closely with the cross-functional team to develop and implement the digital solution, prioritizing those features that provide the most value to the business area scientists across initial market applications, clinical submissions, and post approval supplements. In addition, the applicant will work with the extended team to develop data governance principles to ensure scalability and continued success of the developed solution.
The Responsibilities Of The DCMC Business Owner Include
- Roadmap Definition and Ownership: Working with Digital CMC and business stakeholders, the business owner will identify the sections, plan discovery activities with the business areas, and project deliverables into a roadmap spanning clinical, first market, and post approval submissions across the pipeline. The applicant will be responsible for maintaining this roadmap in response to shifting priorities and an evolving pipeline.
- Development and Delivery Execution: The analyst will direct the efforts of a cross-functional development and delivery team to meet the business requirements. They will maintain the project backlog and continuously populate future sprints with execution ready tasks.
- Business Adoption: The applicant will oversee user testing by business representatives and drive continuous improvement through the definition and monitoring of KPIs and performance metrics. They will identify change agents within the business and educate them in the use of the application and how to enroll additional users.
- Creation of Reusable Data: The applicant will identify key data fields for contextualization within data products in support of regulatory filings for top pipeline programs. Additional use cases will be considered and prioritized appropriately to drive the adoption of data centric processes across the CMC continuum.
- Establish Standards and Governance: The applicant will set standards for structured content, data models, and governance that support scalable and compliant authoring in a sustainable way. Recommendations for data hygiene are to be developed and incorporated into the application and digitally enabled workflows.
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 deliver results in a complex environment with shifting priorities and multiple stakeholders.
- Experience in digitization and data management initiatives in regulated environments, including creation of re-usable data products, data modeling, and data governance.
- 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 the ability to tailor messages to the audience and actively listen.
- Highly organized, able to prioritize tasks to ensure project success.
- Demonstrated project management skills, including leading cross-functional workshops, gathering and prioritizing requirements, and defining and tracking KPIs.
Preferred Experience And Skills
- Experience implementing or supporting automated regulatory authoring (structured content, template-driven generation, or document assembly) from source systems.
- Background in analytical development or commercialization, with knowledge of method development, validation, specification setting and justification.
- 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.
Education Minimum Requirement
- B.S. in chemistry, engineering, or related field with a minimum of 8 years of experience in the pharmaceutical industry
- M.S. in chemistry, engineering, or related field with a minimum of 6 years of experience in the pharmaceutical industry
- Ph.D. in chemistry, engineering, or related field with a minimum of 3 years of experience in the pharmaceutical industry
Required Skills
Accountability, Communication, Data Governance, Data Modeling, Digital Transformation, Drug Development, Key Performance Indicators (KPI), Measurement Analysis, Medicinal Chemistry, Operating Models, Operational Excellence, Portfolio, Programme, and Project Support, Program Management, Project Management, Project Planning, Regulatory Documents, Risk Management, Roadmapping, SAP Master Data Governance (MDG), Stakeholder Relationship Management, Team Leadership, Technical Management, Technical Projects, Technology Transfer, Waterfall Model
Preferred Skills
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Current Contingent Workers apply HERE
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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.
Requirements
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:
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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
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
$139,600.00 - $219,700.00
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
10%
Flexible Work Arrangements
Remote
Shift
Not Indicated
Valid Driving License
No
Hazardous Material(s)
n/a
Job Posting End Date
12/10/2025
- 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:R375187
