Training and SoP Author Lead, Regulatory - Lead Consultant - English - Remote UK

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Job Description - Training and SoP Author Lead, Regulatory - Lead Consultant - English - Remote UK (LIF022470)

Training and SoP Author Lead, Regulatory - Lead Consultant - English - Remote UK - LIF022470

Ready to shape the future of work?

At Genpact, we don't just adapt to change-we drive it. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies' most complex challenges.

If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that's shaping the future, this is your moment.

Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions - we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at and on LinkedIn, X, YouTube, and Facebook.

Inviting applications for the role of Training and SoP Author Lead, Regulatory - Lead Consultant - English - Remote UK

We are looking for a Training and SoP Author Specialist with experience in the Life Sciences pharmaceutical industry to ensure compliance with regulatory requirements, including 21 CFR Part 11, GxP , and Annex 11. The ideal candidate should have expertise in Regulatory Information Management applications, with a strong understanding of Veeva Vault RIMS being a plus.

Responsibilities

Able to understand the basics of a new system and process, the client's way of working, and the training strategy

Develop and deliver training materials per client's requirements while ensuring compliance

To be able to handle various platforms, namely Learning Management Systems (Veeva Vault Training, Cornerstone OnDemand) for training delivery, content development tools (Articulate 360, Adobe Captivate), SOP and Document Management Systems (Documentum), Assessment and Evaluation tools (Google Forms & Microsoft Forms), Virtual Training and Collaboration Tools (Microsoft Teams, Zoom, Webex Training)

To be able to collect and document the training and SOP aspects discussed in the focus topics

Assign content to the correct training module (functional vs. process, training vs. SOP)

Collaborate with different departments to identify training needs, gaps, and raise questions in case of unclarities

Update training materials as per the feedback received from SMEs

Develop, review, and update SOPs to comply with regulatory standards

Develop Work Instructions and Handouts as per industry best practices

Ensure training and SOPs are written clearly and in compliance with the language

Manage the SOP lifecycle, version control, approvals, and periodic reviews

Ensure all users are trained on the new and updated training materials & SOP in timely manner

Knowledge of GMP, GCP, GLP, and Pharmaceutical Regulation (EMA, ICH, FDA, etc.) is required

Strong experience with RIMS and DMS systems is necessary.

Understand new systems, processes, client's way of working, and training strategy.

Develop and deliver compliant training materials per client requirements.

Handle platforms for training delivery, content development, SOP and document management, assessment and evaluation, and virtual training and collaboration.

Document training and SOP aspects discussed in focus topics.

Experience

Bachelor's or Master's degree in Pharmaceutical, Computer Science, IT, Engineering, or a related field.

Relevant years of experience in Computer System Validation (CSV) in the pharmaceutical, biotech, or medical device industry.

Strong knowledge of GxP , 21 CFR Part 11, GAMP 5, Data Integrity, and Annex 11.

Experience in validating SaaS applications used in the pharmaceutical industry.

Familiarity with Veeva Vault RIMS, QualityDocs , or Submissions Archive is a plus.

Excellent documentation skills and experience with validation lifecycle documentation.

Ability to work independently and collaborate with cross-functional teams.

Atleast Bachelor's degree required in for Pharmaceutical: science, engineering, or related field (advanced degree preferred).

Veeva Vault RIM certification is a plus.

Experience working in an Agile/Scrum environment

Be a transformation leader - Work at the cutting edge of AI, automation, and digital innovation

Make an impact - Drive change for global enterprises and solve business challenges that matter

Accelerate your career - Get hands-on experience, mentorship, and continuous learning opportunities

Work with the best - Join 140,000+ bold thinkers and problem-solvers who push boundaries every day

Thrive in a values-driven culture - Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress

Come join the tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.

Let's build tomorrow together.

Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values respect and integrity, customer focus, and innovation.

Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a 'starter kit,' paying to apply, or purchasing equipment or training.