Freyr Digital a technology-driven company building smart, AI-powered software solutions for the Life Sciences industry, including pharmaceuticals, biotech, and healthcare.

As part of Freyr Solutions, a global leader with over a decade of regulatory expertise, Freyr Digital is revolutionizing traditional processes through cutting-edge digital innovation. By leveraging AI, automation, and cloud-based platforms, we make compliance and regulatory operations faster, more intelligent, and effortlessly scalable for our 200+ global clients across multiple countries.

Website Link: https://www.freyrdigital.com/

Skills Document lifecycle, documentum, experience with document management system

Description

The DMS Functional Consultant will serve as a strategic partner to business teams, helping define, design, and optimize the organization's Document Management System. This role focuses on understanding business processes, document lifecycles, and compliance needs, and translating them into an effective DMS design. The ideal candidate brings deep experience in DMS platforms and functional expertise across regulated industries, enabling the organization to build a scalable, compliant, and user-friendly DMS.

Key Responsibilities

1. Business Analysis & Requirements Gathering

Analyse and understand existing system functionalities, process, taxonomy
Engage with global business functions (Regulatory, Quality, Clinical, R&D, Manufacturing, IT, etc.) to understand document processes and pain points.
Document business requirements, user journeys, workflows, metadata needs, and security requirements.
Conduct workshops, interviews, and process mapping sessions.

2. Solution Design & Functional Architecture

Design document types, metadata models, taxonomies, folder structures, and controlled vocabularies.
Propose DMS architecture that ensures scalability, compliance, and intuitive user experience.
Define workflows, review/approval processes, version controls, and lifecycle states.
Provide best practice recommendations based on industry standards and past implementations.
Support evaluation and selection of DMS platform
Collaborate with technical teams and vendors to ensure functional requirements are met.

4. Documentation & Governance

Prepare functional design documents (FDDs), configuration specifications, and requirement traceability matrices.
Contribute to drafting SOPs, governance models, naming conventions, and data standards.
Define content strategy and long-term information architecture.

5. Testing, Validation & Change Management

Support UAT planning, test script creation, execution, and issue resolution.
Ensure functional compliance with GxP, 21 CFR Part 11, Annex 11, and data integrity principles.
Collaborate with training and change management teams to drive user adoption.

6. Cross-Functional Collaboration

Work as a liaison between business teams and technical configuration/migration teams.
Communicate complex concepts in a clear, business-friendly manner.
Provide ongoing functional consultation during implementation and post-go-live.

Required Qualifications & Skills

Bachelor's degree in Life Sciences, Information Systems, or related field.
510 years of experience in Document Management Systems in functional/consulting roles.
Strong experience with DMS platforms (e.g., Veeva Vault, OpenText, Documentum, SharePoint).
Expertise in process mapping, requirements management, and solution design.
Deep understanding of regulated environments (GxP, 21 CFR Part 11, Annex 11).
Excellent communication, presentation, and stakeholder engagement skills.
Ability to work with global teams and manage multiple priorities.
Experience designing enterprise-wide DMS for pharmaceutical, biotech, or medical device organizations.
Strong understanding of content strategy, taxonomy governance, and metadata management.
Experience with RIM, QMS, or other regulated content systems integrations.

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