Specialist, Document Systems

Job description

Job Description Position Description Within the dynamic environment of Nonclinical Drug Safety (NDS), a Specialist in Information Management works with internal scientific staff and across our Research & Development Division to coordinate, assemble, and manage regulatory documents for internal studies and those acquired from external efforts. Using technical skills in document management, publishing, and other tools, the Specialist will support Preclinical Development (PCD) end user operations in Veeva and development of internal processes and tools to optimize document functions. The successful candidate with collaborate closely with NDS data scientists to establish a new, validatable pipeline to leverage generative AI in authoring and reviewing draft reports across the NDS portfolio. Responsibilities: -Actively contribute to report automation efforts by using advanced document management systems skills (e.g. APIs, data structures, and document / content knowledge). Bring strong process and systems thinking to bear to drive business integration and enable scalable solutions that facilitate the effective and compliant use of generative AI in document generation in PCD. -Collaborate with appropriate specialists to build, implement, and train users on related processes and tools for cross-functional participation. Utilize advanced document management skills (e.g. Veeva super user or equivalent skills) to troubleshoot and resolve issues and recommend process and functionality improvements. Contribute to the training and skills development of end-users. -Using document management, publishing, and project planning tools, manage the generation of nonclinical study and supporting documents from creation through to finalization through careful oversight of required processes, content development & review, and document integration. -Facilitate quality review to ensure that documents are appropriate, complete, and consistent with regulatory and company expectations. -Careful collaboration with internal and external stakeholders throughout the document development and related processes. -Participate in the development and implementation of tools and metrics to understand and improve processes and productivity. Science qualifications required: -BS/BA degree including degrees in biological, chemical, computer science, and/or medical science disciplines - A minimum 3 years direct and relevant experience (OR) -MS/MA, including degrees in biological, chemical, computer science, and/or medical science disciplines - A minimum 2 years direct and relevant experience. Required experience and skills: -Experience supporting nonclinical drug development programs within the pharmaceutical, biotechnology, or related industry -Direct, advanced experience with Veeva Vault operations and functions (e.g. super / advanced user, system owner, or equivalent); experience including process design / development, generation of procedural controls, and/or end-user support -Strong understanding of document lifecycle management, metadata, workflows, version control, and records management principles -Some experience with report automation functions and technology (e.g. API calls, data, prompt engineering, strong LLM usage, systems thinking, technical design, development, operation, implementation, business integration, etc.) -Experience with standard document publishing tools -Proven ability to review, revise, and prepare high-quality documents with accuracy and consistency -Excellent leadership skills, written and verbal communication skills (including a strong command of English grammar, editing, and proofreading) -Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and other business-related computer systems and software applications -Demonstrated exceptional attention to detail with a strong commitment to accuracy, quality, and compliance Preferred experience & education: -2+ years of experience supporting document management systems, scientific platforms, enterprise content management, or regulated business applications -Experience with Python, prompt engineering, strong LLM usage a plus -Experience gathering business requirements and translating them into technology solutions -Solid understanding of applicable GxP regulations highly preferred Required Skills: API Calls, API Calls, Automation Tools, Content Editing, Content Management, Detail-Oriented, Document Lifecycle Management, Document Management, Document Management Tools, Drug Development, GxP Regulations, Information Management, LLM Evaluation, Metadata, Microsoft Office, Professional Proofreading, Project Document Management, Project Management Planning, Project Planning, Proofreading, Python (Programming Language), Regulatory Affairs Management, Regulatory Compliance, Regulatory Reporting, Regulatory Submissions {+ 6 more} 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 $96,200.00 - $151,400.00 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 Representati