Project Manager

We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. •Project Delivery: Lead end-to-end implementation of RIM modules (Registrations, Submissions, Dossier Management, and IDMP).

Shift: Monday-Friday, standard working hours
Duration: 12 Months
Pay range: $135.03 - $135.03/hr.
Hybrid schedule

Job Description:

Required Skills
•Domain Expertise: Deep knowledge of regulatory submission processes and health authority standards (FDA, EMA, PMDA).
•Technical Acumen: Experience with RIM platforms (like Veeva Vault RIM, Ennov, or OpenText).
•Methodology: Certified in PMP, Agile, or Scrum frameworks.
•Change Management: Proven ability to drive user adoption across global life sciences teams.
Qualifications
•Education: Bachelor’s degree in Computer Science, Life Sciences, or a related field.
•Experience: 8+ years in IT project management with at least 5 years specifically in pharma, biotech, or medical device regulatory IT domains.

Core Responsibilities
•Project Delivery: Lead end-to-end implementation of RIM modules (Registrations, Submissions, Dossier Management, and IDMP).
•Stakeholder Management: Partner with Regulatory Operations, Quality Assurance, and R&D leaders to define business needs.
•Compliance & Validation: Oversee GxP computer system validation (CSV) and data integrity protocols.
Resource Control: Manage project scope, vendor relationships and resource allocation.
•Risk Management: Track project milestones, spot technical bottlenecks, and create risk mitigation plans.

Top 3 Skills:
•Domain Expertise: Deep knowledge of regulatory submission processes and health authority standards (FDA, EMA, PMDA).
•Technical Acumen: Experience with RIM platforms (like Ennov).
•Change Management: Proven ability to drive user adoption across global life sciences teams.

Employee Benefits:
At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance
• Voluntary Permanent Life Insurance
• Accident Insurance
• Other Employee Perks

About LanceSoft
LanceSoft is rated as one of the largest staffing firms in the US by SIA. Our mission is to establish global cross-culture human connections that further the careers of our employees and strengthen the businesses of our clients. We are driven to use the power of our global network to connect businesses with the right people, and people with the right businesses without bias. We provide Global Workforce Solutions with a human touch.