Portfolio Documentation Lead

Jobinhalt

Make your mark for patientsTo strengthen our Pharma Science team,we are looking for a high caliber, self-motivated, PS Portfolio Documentation Lead based in Braine l’Alleud, BelgiumAt UCB everything we do starts with a simple question: “How will this make a difference to the lives of people living with severe diseases?” We do that by connecting our ground-breaking science with patients and their families around the world living with the physical and social burdens of autoimmune and neurological disorders. Those connections offer new perspectives, drive innovation, and offer the hope of a new generation of therapies that will help improve lives on a global scale.You like to work in an environmentwhere you will:

• Coordinate activities related to the preparation of supportive documentation of regulatory dossiers for clinical studies and for the registration of UCB drug candidates (focusing on New Chemical Entities).
• Ensure integrity of information/data transposed from technical documentation into regulatory submission documents in relation with the preparation of dossiers (Data integrity check).
• Ensure alignment of content and details across technical documents from different sources (eg. DS, DP, Devices) to support regulatory submission
• Support and promote knowledge management in connection with the needs of Pharma Sciences departments.
• Be the central entry point for Pharma Sciences for consultation/implementation of any new or changing pharma regulation that may impact Pharma Sciences activities.

REGULATORY

• Coordinate and be responsible for all aspects of the preparation of technical dossiers emanating from Pharma Sciences for eventual submission to regulatory authorities. Liaison with appropriate departments and organisation of meetings (kick-off and follow-up meetings) as required in order to progress the completion of work in a coherent and timely manner.
• Ensure close and effective liaison with key regulatory CMC representatives in order to allow coordination of dossier-related activities.
• Be in charge of the forward planning and management of the activities required for the preparation of technical dossiers in discussion and agreement with the appropriate project leaders.
• Be in charge of the management and analysis of scientific and technical information issuing from the Pharma Sciences departments, liaising closely with R&D and Production departments as appropriate.
• Be the catalysis of further development activity within teams to ensure balanced and comprehensive process development effort from both a technical and regulatory perspective.
• Be responsible for regular update & review of long-term project planning related to specific CMC Sections and technical documentation, in order to assist in effectively assigning resources, using appropriate project management tools and in discussion and agreement with the appropriate project leaders.
• Participate in, and give active contribution to, project meetings and to project management activities, in connection with the preparation of dossiers in progress.
• Give active provision of guidance for the preparation of high-quality documentation relating to development projects in response to drug registration and all Regulatory Affairs requirements.
• Give active provision of guidance for the technical activities within Pharma Sciences departments as a function of the evolution of the technical dossier.
• Be in charge of the establishment and maintenance of contacts with outside organisations (e.g. consultants, sub-contractors) as required following discussion with the appropriate project leaders.
• Be the liaison with technical translators and translating agencies as required.

COMPLIANCE

• Be responsible for ensuring integrity of information/data transposed from technical documentation into regulatory submission documents in relation with the preparation of dossiers in progress.
• Be in charge of the preparation of written procedures and instructions covering activities within the department, in order to meet QA, GMP or other requirements.

KNOWLEDGE MANAGEMENT

• Be in charge of the development and maintenance of organisational systems and methodologies for the management and communication of knowledge management at departmental level.
• Participate in, and give active contribution to, knowledge management project meetings and to knowledge management activities, in connection with Pharma Sciences’ needs.
• Give an active provision of guidance for the knowledge management activities within Pharma Sciences departments.

Regulatory Intelligence Network (RIN)

• Be the central entry point for Pharma Sciences for consultation/implementation of any new or changing pharma regulation in relation with chemical/pharmaceutical/analytical development.
• Liaise with the appropriate experts, coordinate, collect and consolidate experts’ comments in order to provide a unified Pharma Sciences position to the appropriate RIN leader.
• Inform about the potential risks associated with the implementation of any new regulation.
• Ensure knowledge management associated to any consultation or implementation of new regulation.

Interested? For this position you’ll need the following education, experience andskills:

• A Master’s Degree in scientific area
• Strong experience in knowledge management
• Expertise in project management with cross-functional team
• General understanding of all chemical, pharmaceutical, technical and analytical aspects of the projects, and specifically those related to drug candidates (focusing on New Chemical Entities) intended for short-medium term regulatory submission for which dossiers are currently in preparation
• High level of awareness of regulatory requirements linked to the preparation of technical dossiers (specifically CMC Section) for submission to regulatory authorities in Europe, US, China and eventually Japan
• Good understanding of all quality aspects related to projects under development (GxP rules …)

Why you should applyWe can offer you an informal and open working environment that does not lock scientists into structure and hierarchy. Freedom to take space to pursue your own ideas and make a difference. Opportunity to gain internal and external visibility through interactions with other UCB teams and with world-renown academic investigators. Opportunity to grow both as a drug hunter and leader through participation in project teams and our career/personal development programs.At UCB, we strive to attract passionate and outstanding talents who thrive on change and are ready to bring real value to patients. Working for us you’ll discover a place where you can grow and express your full potential. We place an emphasis on innovation, collaboration and impact. Through meaningful recognition and a motivating work atmosphere, we aim to provide an optimal experience by caring about and valuing our employees – just as we do for the patients we serve.If you believe you are the perfect match to join us on our pioneering adventure, then we invite you to apply and tell us more about your profile and motivation.Are you ready to ‘go beyond’ to create value and make your mark for patients? If this sounds like you, then we would love to hear from you!About UsUCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.Why work for us?At UCB, we don’t just complete tasks, we create value. We aren’t afraid to push forward, collaborate, and innovate to make our mark for patients. We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work. We ‘go beyond’ to create value for our patients, and always with a human focus, whether that’s on our patients, our employees or our planet. Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.Learn more about sustainability at UCB and how it is integrated into our business approach.UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.