Senior Specialist, IM&S (Technical Services)

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 include but not are limited to: Ensures a controlled documentation system, record retention, and information services including electronic records retention processes in accordance with regulatory requirements. Ensures compliance to the requirements from regulatory agencies. Maintains the technical and non-technical documentation change system. Assures procedures are in place to classify and maintain records. Interprets and enforces all documentation formatting, standards, policies, and operating procedure requirements. May identify submission components, communicate documentation standards and coordinate assembly of regulatory dossiers. May analyze and evaluate data, extract pertinent information, prepare information abstracts and executive summaries of material searched. May maintain extensive knowledge of product information and continuous contacts with local, regional, and divisional customers. EEO Statement Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum requirements What You ll bring to the role: Manages multiple, large and complex global regulatory submission projects. Develop and provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products. Contribute to strategic and technical input/support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products. A seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This job is the fully qualified, career-oriented, journey-level position . -Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Networks with senior internal and external personnel in own area of expertise. Contributes to many cost center goals and objectives; may contribute to service line goals.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 directorytroubleshootingenvironmentwindowsslacareer opportunitiesdevelopment projectssummarizing informationeeoaccessrecordsstrategyanalysisretentionabstractscomplianceregulatory