Head of RA BI&A
Your tasks and responsibilities
Lead and direct the Business Intelligence and Automation team to:
1. further develop, establish and maintain an integrated tracking data base system within an integrated system landscape containing key data on regulatoryevents and the documentation submitted in each country,
2. operate - based on development and product strategy - a global tracking system and provide the related reporting and business intelligence capabilities, provide RA data to effectively run the RA business and keep RA business compliant with requirements of Health Authorities; ensure compliance reports for the submission of safety related documents to Health Authorities and necessary follow-up activities,
3. provide the RA contribution for Product Quality Reports to Product Supply; support global change management activities within RA;
4. ensure close cooperation with other ISY teams in the data-systems-process matrix structure,
5. ensure global communication (across functions and locations) for tracking regulatory processes and issues; develop a support network and provides training for users of the tracking system,
6. focus on opportunities for automation of existing systems and processes to increase efficiency.
Requires Ph.D., Pharm D, or equivalent scientific degree with 8 years pharmaceutical industry experience (preferably within development functions) including 5 years of relevant experience in RA or related function. Or MS degree in life sciences with 10 years pharmaceutical industry experience (preferably within development functions), which includes 7 years of relevant RA experience.
• Fluent in English and in another language.
• Excellent oral and written communication skills.
• Well developed management and leadership skills, as incumbent has to Iead multidisciplinary teams.
Demonstrated cross-functional communication, interpersonal, influence, and negotiation skills.
• Ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment often under time pressure lncumbent must be able to work focused and target oriented in a complex scientific I technical environment. Ability to harmonize and reconcile competing objectives to achieve the overall objectives.
• Thorough knowledge of company policies and procedures in drug development and maintenance.
• Ability to work within a global team framework and a multi-cultural environment.
• The job holder must be able to absorb large amounts of information efficiently.
• The position requires scientific and technical expertise and good understanding of IT aspects, including the ability to develop robust communication and optimization strategies, timelines and action plans.