500 million+, this is the number of patients treated with a Sandoz medicine globally. A division of Novartis, Sandoz is a global leader in generic and biosimilar medicines is looking for a Medical Project Manager.
The role of the Medical Project Manager is overseeing a wide set of essential Medical Affairs activities. You will be responsible for owning and maintaining key Medical Affairs processes, forms and tools and to drive continuous improvement through collaboration and alignment with relevant cross-functional stakeholders on local and selectively regional or global level. This also includes supporting key medical affairs team activities, driving medical excellence and maximising efficiencies for fundamental operations such as medical governance and compliance.
The position holder supports the set-up and management of key operational activities and processes related to local phase IV and/or Non-interventional studies and conducted under the responsibility of the Sandoz Country Organisation, oversight of Investigator Initiated Trials, Grants and Sponsorships supported by the Sandoz Country Organisation.
Medical Project Manager is responsible for ensuring compliance with Sandoz processes, Industry Guidelines and regulatory requirements for promotional and non-promotional activities, Investigator Initiated Trials (IITs), Research Collaborations (RCs), Non-Clinical Investigator Initiated Research (Non-Clinical IIRs), locally sponsored Real-World Evidence (RWE) and Non-Interventional Studies (NIS).
Is also responsible for timely and compliant qualification of External Service Providers (Vendors) for vendor services.
Your responsibilities include, but are not limited to:
• Project management
o Manage medical affairs initiatives (e.g. key system upgrades, process enhancements, database development, knowledge sharing, training initiatives, metrics collation, reporting)
o Represent Medical Affairs interests in cross-divisional initiatives, particularly regarding process or system introduction proposals at a local affiliate level.
o Responsible for review and approval process of activities within the P3 framework across company portfolio, reviewing against compliance with applicable guidelines and regulations.
• Training and Collaboration
o Works with Medical Director/Medical Managers and other relevant groups to identify local Medical Affairs gaps/areas of improvement, and to mitigate risks, and identify and lead continuous improvement.
o Coordinate internal stakeholder training, support and best practice sharing to a limited extent as fundamentally required; represent Medical Affairs interests in cross divisional database initiatives.
o Coordination and preparation of key internal Medical Affairs meetings.
o Serve as a key point of contact/super user for company systems and processes within the medical team. Provide training on systems for newly joined colleagues, support onboarding and off boarding of medical associates.
• Processes and Regulations
o Ensures robust processes are in place to facilitate proper oversight and management of Medical Affairs activities.
o Support the implementation of Standard Operating Procedures as required.
o Ensure compliance with corporate policies and procedures, as well as applicable healthcare laws and regulations.
o Maintain local operational governance by ensuring and actively championing end to end oversight and continuous process improvement.
o Communicate to the NIS/IIT activity owners regarding requirements to implement or update SOPs and systems and provide governance or training support, as needed, to the respective activity owners.
o Oversee the implementation of the relevant end-to-end systems by the activity owners, according to project type and related training locally.
o Subject matter expert on the related NIS/IIT/Grant/Sponsorship requirements and ensures proper classification of activities.
• Vendor Qualification Governance Lead
o Proactively seek relevant expertise to qualify and engage services.
o Oversee the vendor engagement, and internal use.
o Liaising with Quality Assurance, due diligence teams, procurement, and external vendors for vendor services.
o Conduct vendor due diligence activities with vendor Due Diligence Team.
o Provide vendor champion support for audits and inspections.
• Copy approval / Professional Policy and Practice (P3) and Ethical Compliance
o Operates with integrity and proactively serves as am ambassador internally and for Sandoz UK externally.
o Provide ethical leadership to ensure ABPI Code of Practice and P3 requirements are fully met and adhered to.