Saxon Global
5 to 7 Year(s)
The Regulatory Content Source Management Analyst will be part of the Regulatory Content & Information Management (RCIM) function within Merck's Global Regulatory Affairs and Clinical Safety organization. The Analyst will work under the direction of the Regulatory Content Source Management Lead to provide support for the business end users. This includes basic training and troubleshooting, escalation and tracking of priority tickets with the IT help desk, and providing system support for non-users. The Regulatory Content Source Management Analyst will also provide support in the implementation of new business processes, system upgrades, and assist with developing associated process documentation, job aids and frequently asked questions.Role and Responsibilities:Support the Regulatory Content Source Management Lead with day-to-day operational activities:Basic troubleshooting and process questions relating to RCAMTicket escalation for high priority requestsBusiness continuity and disaster recoveryChange controlInspections/auditsParticipate on projects and business process teams where content source management expertise is requiredAssist with system upgrades and associated project work, including the current implementation of the new global solution (i.e., supporting transition, roll-out and adoption)Educational Qualification:Bachelors in Life ScienceExperience Required:5+ years of industry experience, preferably in a regulatory/compliance industry utilizing content management systemsWorking knowledge of enterprise content management using industry-leading technologies, preferably Documentum (FirstDoc, OpenText Life Sciences R&D) and SharePointExposure to regulatory affairs and/or pharmacovigilance, either through direct experience, or via a role in R&D or manufacturingKnowledge and capabilities applying technology within a regulatory/compliance business environmentExperience working closely with IT organizations in the design, development, and implementation technical solutions; general knowledge of system development lifecycle (SDLC)Demonstrated collaborative skills and ability to work on cross-functional teams in customer (client) facing rolesStrong communication skills (written and verbal), organizational skills and attention to detailExperience with developing business processes and training documentationSkills required:Experience with developing business processes and training documentationKnowledge of end-to-end submission document lifecycle through publishingKnowledge of structured content management and non-submission content managementKnowledge of data and content integration, lifecycle, and administration conceptsProgram/Project management skills and methodologiesChange management knowledge (communications, training, stakeholder management)Role Location:US Onsite and East coast time zone preferred (100% remote work is OK)Benefits:Medical Plans.Dental Plans.Vision Plans.Flexible Spending Plans.Short Term Disability.Long Term Disability.Basic Life Insurance and Accidental Death & Dismemberment Insurance.Supplemental Life and Accidental Death & Dismemberment Insurance.Identity Theft Protection.Pet Insurance.Commuter Benefits.Certification or Training Reimbursement.401(k).Vacation:Ten days of vacation per year for the first five years of service.Vacation increases to 15 days per year after five years of service.Sick Days:Associates are eligible for 5 sick days per year unless provided otherwise by local municipal / city / state regulations.The year is based on fiscal year (April 1st of each year).Accrual of sick days begins upon the first day of employment with Company, accumulating at the rate of 1 day per month up to a maximum of 5 per year.Holidays:Ten paid holidays each year.