Regulatory information management (RIM) - Sr. Manager
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Role: Sr. Manager - Regulatory Information Management (RIM)
Location: Remote
Experience: 10+ Years
Key Skill: RIM Suite
Experience: 10+ Years
Key Skill: RIM Suite
What You'll Do
Lead software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs
Lead the solution design for implementation and use of the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing)
Lead configuration requirements workshops, design, prototype, configure and document content solutions
Program and project management including resource planning, leading, and motivating a cross-functional team
Primary customer liaison managing communication between the project team, customer, and internal stakeholders
Mentor project team and consultants, helping others improve their consulting skills
Requirements
8+ years experience working with life sciences or healthcare companies performing system implementation experience either as a consultant, business, or IT representative
In-depth knowledge of drug development processes and regulatory submissions; including, Labeling, Submission Publishing and/or Viewing systems
Proven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction
Influential; experience leading teams through hard decisions and negotiating compromises
Technical abilities and willingness to "roll up your sleeves" to design and implement a RIM solution
Expert on life sciences compliance and computer systems validation requirements
Ability to work independently in a dynamic environment
Typical travel is 25% but may be up to 50% based on customer requirements
Nice to Have
Direct experience with systems such as Veeva Vault, PAREXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems, etc.
Consulting experience, working with a major system integrator or software vendor
Regulatory Affairs, Regulatory Operations, or Pharmacovigilance background
Knowledge of Pharmaceutical, Biotechnology, and/or Medical Device and Diagnostics regulatory processes, data and content
PMP certification
Execution experience with Agile methodology and/or ACP Certification
Life Science, computer science or related degree
SaaS/Cloud experience
Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL)
Please share updated resume to:
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job Role: Sr. Manager - Regulatory Information Management (RIM)
Location: Remote
Experience: 10+ Years
Key Skill: RIM Suite
Experience: 10+ Years
Key Skill: RIM Suite
What You'll Do
Lead software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs
Lead the solution design for implementation and use of the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing)
Lead configuration requirements workshops, design, prototype, configure and document content solutions
Program and project management including resource planning, leading, and motivating a cross-functional team
Primary customer liaison managing communication between the project team, customer, and internal stakeholders
Mentor project team and consultants, helping others improve their consulting skills
Requirements
8+ years experience working with life sciences or healthcare companies performing system implementation experience either as a consultant, business, or IT representative
In-depth knowledge of drug development processes and regulatory submissions; including, Labeling, Submission Publishing and/or Viewing systems
Proven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction
Influential; experience leading teams through hard decisions and negotiating compromises
Technical abilities and willingness to "roll up your sleeves" to design and implement a RIM solution
Expert on life sciences compliance and computer systems validation requirements
Ability to work independently in a dynamic environment
Typical travel is 25% but may be up to 50% based on customer requirements
Nice to Have
Direct experience with systems such as Veeva Vault, PAREXEL/LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems, etc.
Consulting experience, working with a major system integrator or software vendor
Regulatory Affairs, Regulatory Operations, or Pharmacovigilance background
Knowledge of Pharmaceutical, Biotechnology, and/or Medical Device and Diagnostics regulatory processes, data and content
PMP certification
Execution experience with Agile methodology and/or ACP Certification
Life Science, computer science or related degree
SaaS/Cloud experience
Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL)
Please share updated resume to:
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
Report this job