Director - Regulatory Data Management

5 maanden geleden

Waalwijk, Nederland Celegence Voltijd

**About Celegence**

Our company is a rapidly growing innovator in the healthcare sector, committed to transforming the healthcare landscape through cutting-edge solutions. Celegence Provides Services and Solutions to Support the Life Sciences Industry with Regulatory Affairs Operations and Strategy. We are dedicated to improving patient outcomes through intelligent regulatory compliance. We support companies in ensuring their regulatory compliance across the globe by providing trained resources, knowledge, and technology to assist our clients in their day-to-day operations.

**Role Description**
- The Director Regulatory Data Management is responsible for delivering high quality services and projects to Celegence customers for data management.
- The position leads a team specialized in the submission and reporting of data (primarily) describing Medicinal
- and pharmaceutical products, Organizations and Substances.
- Focus is on ensuring the highest possible data quality and compliance with existing guidance, regulations, and data standards.
- The position closely cooperates with the Regulatory Affairs (RA) department of Celegence customers and contributes to the correct use and implementation of data to support their business processes.
- Typical activities include providing consultancy and other support related to process development, data cleansing and remediation activities, vendor selection and system implementation.
- The position coordinates daily operations, project and resource planning for the Data Management group and establishes and maintains an excellent working relationship with Celegence customers.
- The position can also be involved in the development of the in-house developed and maintained solutions (such as Dossplorer, Dosscriberand Hosted platform). This position on a need basis function as a Subject Matter Expert, where the responsibilities are ensuring translating business needs to functional requirements and supporting Software Development activities.
- This position will support pre-sales and marketing initiatives related to regulatory data management function.
- The position will act as line manager for individual team members and acts as a coach on achieving goals and developing necessary skills of all team members within the department.

**Key Responsibilities & Tasks**

**Details**
- Organization of team roles and responsibilities
- Volunteers to assist team with overflow duties

**Project and services delivery**
- Ensure high quality projects and services are delivered to Data Management customers.
- Consults with team members to ensure targets and deliverables are met.
- Provides consultancy on data management related aspects in business process development and implementation

**Vendor selection and system implementation**
- Evaluate and validate software supporting regulatory information management.
- Leading role in implementing regulatory information management solutions and vendor selection.
- Leading/ supporting data migration and remediation tasks

**Quality Management System**
- Responsible for the Data Management related processes and procedural documents
- Participates in the development, maintenance and

improvement of procedural documents and templates to support the activities mentioned above

**Track regulatory documents, publications, and other related materials**
- Proactively consulting and checking information sources for

new, changed, and updated materials. For example: new regulatory guidance or data standards

**Data management**
- Monitor data quality and initiate mitigating and corrective activities to improve data quality.
- Ensure compliance with guidelines and regulations.
- Ensure and promote correct use of data.
- Ensure timely and valid submission of electronic data submissions

**Solution Development Support**
- Support technical solutions for regulatory data management as SME.
- Implement tech enabled services by adopting technology solutions to increase efficiency, quality and consistency.

**Qualifications**

**General soft skills**:

- Affinity with Information Technology and automation
- Strong Leadership abilities
- Good organizational skills, including efficiency and collaboration in a team environment.
- Proficiency with computer skills, including MS Office and Adobe Acrobat
- Ability to manage and deliver through others in a matrix environment.
- Ability to work within a demanding environment with a strong focus on quality and timelines.
- A passion for data quality and a commitment to continuous improvement
- Eager to learn an array of technical tools.
- High analytical skills
- Flexible, able to adapt to emerging situations.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good knowledge of English (spoken and written)
- Quality focused by transparent systematic and consistent approach
- Ability to work concurrently on multiple projects, each with specific features that may differ from proj

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