Job Description

. 3-5 years submission publishing experience in Pharma or related industry. . Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria. . Effective interpersonal skills, strong written and oral communication and presentation skills. Project management and time management skills to manage multiple ongoing projects simultaneously. . Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives. . Working knowledge of regulatory affairs. Works independently and with minimal supervision. . Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly. . Analytical skills and problem solving skills. Ability to coordinate and work effectively with cross-functional teams. WHY NOVARTIS 769 million lives were touched by Novartis medicines in 2020, and while we\'re proud of this, we know there is so much more we could do to help improve and extend people\'s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team\'s representative of the patients and communities we serve. Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: Diversity & Inclusion / EEO Minimum Requirements . 3-5 years submission publishing experience in Pharma or related industry. . Experience with regulatory submission format, including familiarity with submission publishing activities and CTD format criteria. . Effective interpersonal skills, strong written and oral communication and presentation skills. Project management and time management skills to manage multiple ongoing projects simultaneously. . Familiar with regulatory requirements and HA guidances, including FDA regulations, ICH and EMA guidelines/directives. . Working knowledge of regulatory affairs. Works independently and with minimal supervision. . Proficiency with computer programs/systems (MS office, etc.) with demonstrated ability to learn new systems quickly. . Analytical skills and problem solving skills. Ability to coordinate and work effectively with cross-functional teams. WHY NOVARTIS 769 million lives were touched by Novartis medicines in 2020, and while we\'re proud of this, we know there is so much more we could do to help improve and extend people\'s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what\'s possible, when we collaborate with courage to aggressively and ambitiously tackle the world\'s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team\'s representative of the patients and communities we serve. Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:

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