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Sr. Manager Regulatory Operations – Veeva Vault RIM

Vertex Pharmaceuticals

This is a Full-time position in Boston, MA posted April 6, 2021.

Job DescriptionThe Sr.

Manager will be hands-on in regulatory and/or cross-functional project initiatives, and process development that expands Vault RIM feature usage.

A key responsibility will be to assist with design and establish collateral that can be used in operations to monitor end-user effectiveness and compliance control of the process to satisfy standard operating procedures and work instructions.

This role will also be responsible for developing the instructional program to provide best-in class tools for end-users to ensure that all quality standards are achieved and maintained.This role will participate in and continue to drive regulatory operations transformation that increases adoption and supports an engaged end-user experience, high business value effectiveness and acceptance of change to a digitally oriented environment.The role requires a solid range of skills – be an agent of change, project manager, have and expand regulatory expertise, passion for RIM processes supported by Veeva Vault, ability to challenge the status quo to benefit colleagues and the long-term health of the global regulatory operations functions.

This role is a business SME role, not an IT/application configuration role.Key responsibilities:Learn the Vertex Vault data model, document structure and object and record flow to understand how it relates to regulatory and associated processes (e.g., Vault Quality change control SPARK integration, Vault Clinical eTMF connection)Work with regulatory and cross-functional subject matter experts to analyze, propose, develop, and implement Regulatory processes that answer business difficulties and support regulatory business needs using Vault RIM features and functionsAnalyze and document current state business processes, identifying pain points and gaps in process or system functionality as areas to increase end-user effectiveness and compliance with regulation requirementsArticulate via business case structure of why, what, how and who recommendations for improvement in business process, working closely with configuration colleagues to understand system potential within the proposal to eliminate redundant and non-value add operationsLead workshops for analysis, building alignment with end-user groups, and work in cooperation with Global Information Systems (GIS), RIM Team and other Regulatory Operations function throughout a projectCoordinate as needed with Veeva Managed Services and Customer Success Manager to ensure Vault RIM use as designed and to support the deliverables for the Veeva release cycle scheduleCreate end-user Work Instruction policies and deliver supporting materials to support system enhancements, releases and major function implementations.Create and maintain Standard Operating Procedures to ensure clarity of standards for process and digital assetsCreate instructional collateral, including Quick Reference Cards, process flows, Job-Aids and other forms of feature, function or process specific supportParticipate in change management scoping, planning and execution related to releases and implementation of new featuresServe as a back-up for routine compliance quality control work that maintains the integrity of documents and data within Vault RIMCommunicate status on a regular basis to direct management and regulatory leadership as requestedCompetencies and SkillsEnergetic self-starter, able to work independently in a fast-paced environmentAppetite for learning and expanding regulatory knowledge of regulations that can be translated into digital processesProject management experience, PMP certification is desirableUnderstanding of digital standards, capabilities, and effective use to meet business goalsAdvanced and contemporary knowledge and experience in interpretation of regulations, guidelines, and precedents related to global regulatory and development activities (e.g., US, CA, EU and LATAM)Demonstrable knowledge of regulatory submission process from document authoring through archiveExcellent communication skills; written, verbal and presentationSkills in problem resolution, negotiation, dealing with ambiguity, establishment of effective processes, influencing without authorityExperience leading disparate groups through difficult process flow, hard decisions and negotiation for compromisesAbility to create and maintain collateral that is appealing and has clarity of process deliveryQualificationsM.S.

in a scientific or allied health field or MBA and 7+ years of relevant regulatory affairs/operations or compliance work experience or B.S.

in a scientific or allied health field or B.A, in business or information services and 10+ years of relevant regulatory operations or compliance work experience5+ years cross-functional experience in Clinical Operations, Medical Writing, Regulatory Affairs and/or Quality Assurance at a pharmaceutical, biotechnology or medical device companyDemonstrable knowledge of document management structure and principals, eCTD and Non-eCTD, MS Project, and content analytics2 years working with Veeva Vault RIM either Submissions, Registrations or Submissions ArchiveHighest integrity committed to ethics and scientific standards#LI-LM1Company InformationVertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law.

Vertex is an E-Verify Employer in the United States.

Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at time