Description

You will lead software implementation projects for life sciences companies, from large pharmaceutical organizations to emerging biotech firms.

Responsibilities

• Lead solution design for the implementation and use of the Vault Regulatory suite, including Registrations, Submissions, Submissions Archive, and Publishing.
• Conduct configuration requirements workshops, prototype, configure, and document content solutions.
• Manage programs and projects, including resource planning and leading cross-functional teams.
• Act as the primary customer liaison between project teams, customers, and internal stakeholders.
• Mentor project team members and consultants to improve technical and consulting skills.

Required Skills

• 8+ years of experience in system implementation within life sciences or healthcare companies.
• In-depth knowledge of drug development processes and regulatory submissions, including Labeling, Submission Publishing, and/or Viewing systems.
• Expertise in life sciences compliance and computer systems validation requirements.
• Ability to design and implement RIM solutions.
• Experience leading teams through complex decisions and negotiating compromises.
• Ability to work independently in a dynamic environment.
• Willingness to travel up to 50% based on customer requirements.

Preferred Skills

• Experience with SaaS/Cloud environments and Agile methodology.
• Direct experience with Nextdocs, Cara, Salesforce, Workday, Oracle, SAP, Lorenz Docubridge, or Extedo eCTD Manager.
• Background in Regulatory Affairs, Regulatory Operations, or Pharmacovigilance.

Key Skills

Education

Any Graduate