Description

Lead complex software implementation projects for life sciences companies, driving solution design and project delivery for Vault Regulatory suites.

Responsibilities

• Lead solution design for Vault Regulatory suites, including Registrations, Submissions, Archive, and Publishing.
• Drive configuration requirements workshops, prototyping, and documentation of 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 teams and consultants to improve overall consulting delivery.

Required Skills

• 8+ years of experience performing system implementations for life sciences or healthcare companies.
• In-depth knowledge of drug development processes and regulatory submissions, including labeling and submission publishing.
• Expertise in life sciences compliance and computer systems validation requirements.
• Proven ability to design and implement RIM solutions.
• Experience with Veeva Vault, OpenText, SharePoint, Documentum, Salesforce, Workday, Oracle, or SAP.
• Proven ability to lead teams through complex decision-making and negotiations.
• Ability to work independently and manage travel requirements of up to 50%.

Preferred Skills

• Background in Regulatory Affairs, Regulatory Operations, or Pharmacovigilance.
• Experience with SaaS/Cloud environments.

Key Skills

Education

Any Graduate