Job Description
Job Purpose:
To lead and engage, coordinate and influence the external advocacy either for regulatory environment and industrial associations across the portfolio and across the Global CPOs and GLF’s.
Works with the department to help pro-actively shape future Global QA regulatory policies and on our liaison and advocacy activities. Supports Head Quality Systems & Standards Management to establish and develop strong relationships with key decision makers of the Global QA environment
Organizes and coordinates Global QA Liaison and Policy activities.
Accountabilities:
• Partner with Head Quality Systems & Standards Management to provide technical guidance and support their establishment and development of strong relationships with key decision makers of the Global QA environment, e.g. through creation, maintenance and execution of a key account management plan for all key global advocacy groups.
• Guide development and support of contacts with industry associations to ensure No-vartis priorities and policies are supported
• Lead key groups ( eg ICN, EFPIA, MQO, ISPE ILF.) in representing the company and industry
• Identify company experts and manage their topic specific contributions to the de-partment in addition to managing routes of advocacy and present company advocacy postions to industry and regulators
• Manage appropriate Novartis QA participation at external meetings, where decision makers and influencers are present and manage harmonisation of expert opinions and functions within the Company
• Define the strategy and roadmap for External relationship to leverage Novartis visibility in Regulatory Authorities and Industrial Associations and assure strategic advice and guidance to QA and other GLFs on Global Procedures and on any obligations of new or emerging QA legislation. Provide implementation guidance as needed.
• Assure strong regulatory / industrial intelligence for QA, anticipate and identify any forthcoming regulatory GMP/GDP TOPICS and update management accordingly
• Manage and host QA global / regional meetings
• Assure appropriate information flow to and from CPOs and GLF’sand facilitate alignment on key issues across these groups – primarily responsible for overall policy alignment / coordination, communication and implementation, as well as non project specific related information flow
• Lead / coordinate QA project advocacy across CPOs & GLF’s for key projects in regulatory procedures and participate in associations and workshops representing Novartis in a proper manner from technical point of view
• Advise and coach cross-functional project teams during the phases of key QA authority interactions and negotiations, preparations for key hearings / opinions.
• As member of QA work with Head Quality Systems & Standards Management to assure design of optimal regulatory strategies globally
• Amplify leadership communications of management team through all channels and research, write and edit communications texts so that messages are clear and aligned. Prepare text for multiple traditional, online and social channels
• Supports GQO in shaping and delivering clear and consistent messages on GxP matters.
• Establishes and maintains a virtual, cross-divisional network of GxP external relations across the company
• Ensures regular updates and communication of feedback from the different associations and meetings where Novarits is present that is of use / interest to management.
Desired Skills & Experience
Education:
Degree level in Science. Ph.D. in science, Pharm. D. or equivalent higher degree an advantage
Languages:
Fluent spoken and written English; additional languages an advantage
Experience/Professional requirement:
• At least 10-15 years experience in a pharmaceutical QA business (or any of its support industries) is required
• Communication skills with a multicultural and international focus. Ability to extract key messages from documents and processes and to create professional articles or presentations. Experience on managing and presenting at lectures is required
• Ability to implement advocacy routes to positioned Novartis in external environment.
• Ability to persuade regulators in a smooth way
• Utilization of technical and science background to positioned Novartis in external events.
• Project- and event management skills, creative and systematic work approach, excellent time- and customer management.
• Ability to consolidate & analyze input from expert groups.
• Understanding for objectives and strategy of GQO. General understanding of business processes.
Apply Now - Resume or CV with Job Post Title
Email: jobs@aarenconsultants.in
