Senior Specialist, Business Process Excellence (RIMS)

Job Description

1886! We have more than 130 years of experience treating patients.Sandoz, a division of Novartis, is a global leader in generics and biosimilars and is committed to playing a leading role in improving access to medicines worldwide.Your Responsibilities:Your responsibilities include but not are limited to: Together with a cross-site and functional project team ensure a global harmonized and efficient process for submission documents. Make sure that documents and/or samples/standards are ordered, tracked and delivered in time and according to the requirements of the ordering function. Ensure timely communication with the ordering function and other stakeholders, as relevant. Responsible for submission resource planning, ensuring submissions are published and dispatched in a timely manner. Together with a submission resource project team ensure a global and efficient process for resource planning and establish and maintain a tool to support the process. Support the creation and maintenance of business processes in the area of Regulatory IT systems. Act as the contact person for local Regulatory functions in case of problems in the area of IT systems or process related issues. In close cooperation with IM&S ITSyS and IT ensure timely trouble shooting. In close cooperation with IM&S ITSyS support IT system projects in all phases such as configuration, migration, system validation and roll-out. Responsible for development of new/updated business processes, user requirements etc. Develop and maintain good working relationships with relevant RA, non-RA stakeholders and when relevant Health Authorities. Support creation and / or maintenance of relevant training materials, work instructions and SOPs. Make sure that documentation is archived according to given rules. Support initiatives to improve and / or increase the harmonization of business processes in the area of IM&S and ensure that updated processes are followed. Ensure a timely implementation of new or updated business processes on local and global level and coordinate trainings as appropriate.Minimum requirements What You ll bring to the role: Science degree in any field of life science or information management or a comparable degree. Fluent in English (oral and written). Good knowledge of Regulatory Affairs processes. Min 3 years of experience in one of the following areas: handling of samples and/or submission documents OR resource submission planning OR electronic document management, electronic publishing, database administration. Good expertise in organization and planning of tasks. Experience in working in international environment. Advanced computer skills, problem solution oriented, quality-conscious. Excellent communication skills.Why consider Sandoz Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.Imagine what you could do at Sandoz!Commitment to Diversity & Inclusion:Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.Join our Novartis Group 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.novartis.com/network,

Keyskills :
active directorytroubleshootingenvironmentwindowsslacomputer skillsresource planningwork instructionsuser requirementsregulatory affairsdigital conversiondocument management