Job Description

Job TitleRequired Skills•Domain Expertise: Deep knowledge of regulatory submission processes and health authority standards (FDA, EMA, PMDA).•Technical Acumen: Experience with RIM platforms (like Ennov).•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.Everforth Apex is a world-class IT services company that serves thousands of clients across the globe. When you join Everforth Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRateds Best of Staffing® in Talent Satisfaction in the United States and Great Place to Work® in the United Kingdom and Mexico.Everforth Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Everforth Apex team member can provide.Everforth Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Everforth Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law.If you require an accommodation under the Americans with Disabilities Act to participate in an interview with a virtual recruiter or to use our website for a search or application, please contact our Benefits Department at accommodations@apexsystems.com or 804-523-8228. Please note that this contact information is strictly to be used for medical ADA accommodations and that no other inquiries will be answered.

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