Description

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

Responsibilities

• Lead solution design for the implementation and use of the Vault Regulatory suite, including Registrations, Submissions, Archive, and Publishing.
• Direct 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 functional consulting skills.

Required Skills

• 8+ years of experience in life sciences or healthcare performing system implementations 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.
• Expertise in life sciences compliance and computer systems validation requirements.
• Technical ability to design and implement RIM solutions.
• Proven experience leading teams through complex decisions and negotiating compromises.
• Ability to work independently and manage travel requirements of 25% to 50%.
• Strong communication skills for collaborating with diverse stakeholders.

Preferred Skills

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

Key Skills

Education

Any Graduate