Manager, Information & Compliance Management
817 million. That’s how many lives our products touched in 2018. 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?
To manage Information & Compliance Management activities at GNF and NITD. This position will align globally with ICM to implement and oversee the management of controlled substances, domestic and international shipping, biosample compliance and records management activities in compliance with internal policies, guidelines, applicable local and national laws and regulations.
• Manage the Research Use of Controlled Substances Program
o Actively manage the site DEA controlled substance registration and program
o Oversee the compliance aspects of the process
o Review new substances and existing substances (lists and database outputs) to determine applicability to current program and DEA requirements
o Represent the site and interface with other NIBR sites on networking calls
o Requirement - This will require a good working knowledge of chemical structures and organic chemistry.
• Manage the Research Use of Pre-curser Compliance Program
o Actively manage the site Pre-cursor chemical program per California DOJ requirements
o Ensure that site based procedures and processes are compliant with applicable regulations
• Oversee Research Material Shipping Compliance
o Interact with the site transportation safety associate to ensure that both Novartis and regulatory compliance standards are met
o Assist the shipping and receiving department in the review and processing of permits such as USDA, CDC, Fish & Wildlife and transfer permits
o Assist with the implementation of a new site shipment management database and system
o Participate in network based calls with other sites
o Ensure that the site DOT security plan is in place
o Training Requirement – IATA and DOT hazardous material shipping certification and training desired
• Manage the Free Alcohol Program
o Manage the site tax free alcohol program per company and regulatory requirements
o Oversee the compliance aspects of the process which includes stocking, inventory and permitting and permit renewal
• Manage the Biosample Compliance process
o Point of contact for researchers and stakeholders and SME on matters involving Human Tissue Registration; supporting West Coast time zone
o Perform Compliance checks on specimens; label, document, and redact information per SOPs as required by regulations and Novartis policies
o Receive and release specimens (physical and electronic), enter compliance data into a computer system
o Appropriately prepare specimens for routing and transfer to departments and researchers, if needed
• Manage the Archives & Records Management
o May include storage, retrieval, and scanning of data, coordinating offsite storage, maintain database of archived material
o May include contract management regarding filing, properties, and archiving.
o Participation in local and global teams, deliver valuable input and act as group representative for ARM team needs.
o Support actively the NIBRIS groups to fulfill all authority need to pass all internal and external inspections regarding records management successfully.
o Work with the records managers globally to maintain all digital raw data regarding archiving and retention. Deputize the US archivist during absences.
• Develop and maintain KPIs and metrics, record keeping, and internal auditing
• Work closely with NIBR Legal, Compliance, Quality to ensure compliance with all business, legal and regulatory requirements
What you'll bring to the role:
• Previous experience in a management operational role, working successfully within a scientific / pharmaceutical matrix, multidisciplinary organization across countries and cultures as well as experience in the supervision and training of operational staff.
• Degree in chemistry or biology with 2-5 years of experience in the pharmaceutical industry or regulated agency coupled with significant compliance experience, in local regulations preferably regarding controlled substances or biosample compliance.
• Experience in research material management including importation / exportation and trade compliance is an advantage
• Strong strategic vision and problem solving skills including excellent communication (written and spoken), collaboration / consensus building, influencing and negotiation skills. Demonstrated ability to successfully work globally and effectuate change within a high-performing organization
• A strong project / program manager with a courageous, innovative and pragmatic approach, used to developing and leading complex change programs that deliver successful high-quality outcomes for Novartis
• Proven experience conducting investigations and internal audits in a regulated or distribution environment.
• Advanced degree in chemistry or related field preferred
• Languages: English (written and spoken), other languages such as German and French would be advantageous
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.
We are Novartis. Join us and help us reimagine medicine.