Life Science Consultant: Document Quality Specialist

Job content

We are looking for enthusiastsKVALITO Consulting Group is a strategic partner and global Life Science network for regulated industries with a focus on quality. Headquartered in Basel, Switzerland, we have subsidiaries in Germany, Czech Republic, Ireland and Malaysia. With our enthusiasm for progressive technologies and our in-depth knowledge of industry best practices and regulations, we drive effective and efficient project delivery to keep our industry-leading clients ahead of the competition. Our leadership and consultants combine decades of experience in enterprise environments. To cover all essential technical areas in the field of digital and mobile, KVALITO works with reliable Technology Partners worldwide. For more information, please visit us at www.KVALITO.ch.Life Science Consultant: Document Quality SpecialistLocation: Basel The purpose of the role is to work with our clients to understand their needs, offer advice, solve problems, manage change, and improve efficiency.Responsibilities

• Perform assessment, quality control and publishing of scientific documents to ensure consistency with source data and to achieve technical quality to comply with internal and external guidelines and requirements.
• Collaborate with external service providers as related to areas of responsibility.
• Collaborate to support timely compilation of high-quality submissions for Global Health Authorities.
• Perform source data verification (SDV) and technical quality control (QC) of submission documents (simple to medium complexity) to ensure both content and format fulfil requirements.
• Collaborate with globally located scientific personnel to ensure finalization of the documents, according to timelines and quality requirements.
• Compile, integrate and publish applicable documents with state-of-the-art word processing, electronic publishing and document management systems in collaboration with the responsible author(s).
• Work with external consultants (vendors) to coordinate outsourced QC activities related to the processed tasks. Responsible for verifying and consolidating the QC recommendations from the external consultants and partner with the respective document author(s) to reconcile findings and finalize the submission document(s).
• Resolve technical document or workflow issues as applicable on the documents being processed.
• Advise authors, newcomers and vendors on SDV requirements, technical formatting processes and the use of Novartis’ document management systems.
• Remain abreast of current processes, regulatory guidelines and legal requirements, as relevant.
• Collaborate with Submissions Management team on specialized projects, to support key submission deliverables.
• Collaborate to provide metrics, KQIs, and KPIs
• Completion of an adequate number of regulatory documents (taking into account complexity and size)
• Timeliness of deliverables, such that both individual document review KPIs are satisfied, and overall project timelines are adhered to.
• Proactive and collaborative communication with key stakeholders based on feedback from internal colleagues and customers.
• Adherence to clients Values and Behaviors and code of conduct.

Minimum Qualification And ExperienceEducationBachelor or Master degree in Life Sciences, Chemistry, Computer Science, Engineering or similar.Language

• Fluent in English (oral and written)
• German is nice to have

Work Experience

• Relevant work experience with electronic document management systems and document review

Hard Skills

• Basic understanding of clinical and nonclinical information contained in a submission dossier.
• Demonstrated ability to work successfully within a matrix environment and influence cross-functional teams.
• Flexible and detail-oriented approach to documentation management, as appropriate.
• Experience with and ability to understand compliance practices, which include GxPs and Standard Operating Procedures.
• Proficiency in MS Office programs ( MS word) and Adobe Acrobat Reader

Soft Skills

• Excellent people management, leadership, and decision-making skills.
• Ability to facilitate a holistic perspective and understand business needs.
• Motivated to continuously expand her/his knowledge of the life science industry.
• Strong communication and problem-solving skills.
• Ability to work globally to coordinate the work of associates at all levels.
• Considerable organization awareness (e.g., the interrelationship of departments, business priorities) including experience in working cross-functionally and in global teams across cultures.

We Offer Great Benefits

• Flat hierarchies and responsibility from the beginning
• People-oriented culture
• Diversity and inclusion-focused environment
• Global client projects in a multinational environment
• Flexible working hours and home office
• Involvement in global conferences
• Individual professional development, training, and coaching
• Unlimited full employment contract
• Excellent remuneration package consisting of a competitive salary plus a substantial bonus

ContactIf you have the necessary background and experience and would like to join a small team responsible for a truly global operation, then please send your application to recruiting(at)kvalito.ch including your:

• CV, cover letter, and supporting documents (i.e., diplomas, certificates, references)
• Availability - earliest start date
• Salary expectations
• Location preference

We are looking forward to your application.Your KVALITO Team.