But in this world of digital and technological transformation, we must also continue to evolve our approaches to clinical document management and unleash the power of information from this expanding universe of data.
Major responsibilities:
Your responsibilities include, but are not limited to:
• Lead a global clinical records archives team, ensuring delivery of a fit for purpose archiving service for electronic and paper clinical records.
• Identifies, plans and drives implementation of CDGM initiatives, projects and process improvement activities to enhance clinical document management systems, processes and standards at Novartis.
• Act as CDGM contact for key stakeholders, collaborating with them to improve clinical documentation process, systems and capabilities across the organisation.
• Delivers excellence in service delivery, including optimisation and simplification in compliance with Novartis policies & regulatory requirements, responding in an agile way to new or evolving business priorities.
• Provide robust oversight of 3rd party vendor activities including monitoring sustainable performance against SLAs.
• Embeds a risk-based mindset across the team and in service delivery, ensuring identification, evaluation and management of risks, including mitigation activities.
• Support CDGM and business teams in preparation for and during audits, inspections and migration activities. Own CAPAs arising from inspections/audits ensuring they are closed out on time.
• Leads team, recruits, retains, manages and develops associates through coaching and feedback, talent reviews and other available Novartis resources and tools, and fosters a safe environment for team dialogue and growth. Set priorities, manage schedules and develop robust resourcing model to support timely delivery of TMF services.
The pay range for this position at commencement of employment is expected to be between $130,400 and $195,600/year; however, while salary ranges are effective from 1/1/23 through 12/31/23, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
The role can be based in either Ireland, UK or East Hanover, NJ USA. Should you be interested in a non-US listed location, please refer to requisition #363997BR to apply. Please note relocation will not be provided.. Our selection process will prioritize associates whose roles may be changing or may be impacted.Minimum requirements:
What you’ll bring to the role:
• Advanced degree or combination of Bachelor’s degree in life-sciences/healthcare/pharmacy and relevant industry experience
• Minimum of 8 years of working in clinical research and development in the pharmaceutical industry (and/or Contract Research Organization) with specific experience in clinical documentation and/or records & information management.
• Minimum of 3 years’ experience in direct people management or matrix management of project/clinical teams.
• Deep understanding of drug development process, international drug approval procedures and standards (e.g., ICH-E3, ICH-E6, eCTD) and industry-wide standards in clinical document management (e.g., DIA TMF reference model).
• Demonstrated success in planning and executing cross functional projects.
• Strong influencing and presentation skills. Ability to communicate effectively at all levels.
• Good organizational awareness, including experience working in multi-disciplinary teams, across cultures and geographies.
• Good negotiation, problem solving and conflict resolution skills; experience establishing trusted relationships with internal and external stakeholders.
#GCO
#CDGM
Why Novartis?
736 million. That’s how many lives our products touched in 2022. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis. Network here: https://talentnetwork.network.
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