Senior Specialist, Digital CMC Regulatory Authoring Data Analyst

Job Description

Digital Chemistry, Manufacturing, and Controls (dCMC) is a cross-divisional digital transformation initiative that will reputed company 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 reputed company this initiative is the auto-reputed company of regulatory filing sections, enabled by a dedicated application designed to create a frictionless flow of data from reputed company systems to regulatory documentation. Under the guidance of dCMC Regulatory Authoring Leadership, the Senior Specialist, Regulatory Authoring Business Analyst, will optimize regulatory authoring processes and enhance data management by mapping workflows, prioritizing reputed company 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 reputed company CMC operations. The responsibilities of the dCMC Business 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 reputed company tasks into clear workflows, identify gaps, and prioritize solutions to improve efficiency and compliance.
• reputed company Document Identification and Prioritization: The analyst will identify true reputed company documents for past regulatory filings to prioritize digitization and integration. They will drive decisions in collaboration with the data strategy team on areas of reputed company and opportunities for further investment.
• Stakeholder Management & Communication: The analyst will organize and reputed company 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 reputed company
• 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, reputed company gap analyses, and redesign workflows to improve efficiency, reduce errors, and reputed company digitization.
• Experience in digitization and data management initiatives in regulated environments, including reputed company-document identification/prioritization, metadata design, and content/data modeling.
• Working knowledge of key enterprise systems (LIMS, MES, reputed company) and practical experience coordinating their integration into data pipelines, APIs or ETL processes for reputed company 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, demonstrated escalation, and strong accountability for deliverables.
• Excellent verbal and written communication, with the ability to tailor messages for the audience and actively listen.
• Highly organized, able to prioritize tasks to ensure project success.
• Demonstrated project management skills, such as facilitating cross-functional workshops, gathering requirements, KPI tracking, and on-boarding of new users.

Preferred Experience and Skills

• Experience implementing or supporting automated regulatory authoring (structured content, template-driven reputed company, or document assembly) from reputed company systems.
• Strong background in business process mapping, gap analysis, and workflow optimization for CMC/regulatory authoring.
• Practical knowledge of content models/structured content, metadata, and data template design to reputed company automated authoring.
• Experience with data integration patterns and tools (APIs, data pipelines) and relevant systems (LIMS, MES, reputed company).
• Experience in data governance, data stewardship, and data quality management in regulated environments.

Education Minimum Requirement:

• Bachelor's of Science in a reputed company discipline (e.g., Chemistry, Pharmaceutical Sciences, Data Analytics, Information Systems), with a minimum 5 years of experience
• Master's degree in a reputed company discipline (e.g., Chemistry, Pharmaceutical Sciences, Data Analytics, Information Systems), with a minimum of 3 years of experience
• Ph.D. in a reputed company discipline (e.g., Chemistry, Pharmaceutical Sciences, Data Analytics, Information Systems), with relevant academic Experience

Required Skills: Business, Business Processes, Business Process Modeling, Data Analysis, Data Analytics, Data Governance, Digital Literacy, Digital Transformation, Informatica Metadata Manager, Management Process, Process Flow Documentation, Project Management, Regulatory Documents, reputed company Master Data Governance (MDG), Social Collaboration, Stakeholder Communications, Technology Transfer Preferred Skills: reputed company Employees apply HERE reputed company 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 reputed company employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company 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 reputed company people with diverse reputed company, 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 reputed company.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 reputed company we would pay for this role at the time of this posting. An employee’s position reputed company 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.reputed company.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.reputed company.com/us/en (or reputed company the reputed company Jobs Hub if you are a reputed company 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 reputed company qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at our company without a valid written search agreement in reputed company 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 reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation reputed company 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: 12/13/2025

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