- Żwirki i Wigury 16, 02-143 Warszawa, PolskaWarszawa, mazowieckie
- Ogłoszenie wygasło 18 dni temu
- Umowa o pracę
Manager - Clinical Trial ApplicationsNumer ref.: 107845
- Drives global submission management activities for their assigned assets. Partners with product teams and/or third-party partners, with responsibility for representation and management of required regulatory activities, standards and deliverables associated with CTA submission development and execution for designated assets and/or geographies.
- Key participant and member of development teams and relevant meetings to advocate realistic deliverable timelines.
- Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
- Liaises with Study Management, regarding essential core documents that cross HA and EC submission process.
- Prepare, review and submit submissions to HA/Regional CTA Hub.
- Responsible for the co-ordination of translations for core documents required for submission.
- Manages the compilation for core package build, contributing to CTA and authoring documentation as required.
- Acts as Subject Matter Expert for Regulatory Ops and provides country-level intelligence on clinical trial regulatory(CTR).
- Escalates and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
- Serves as a major source of innovative ideas seeking and developing efficiencies and effectiveness within the Submissions process by collaboration with key customer and supplier groups and business partners.
- Promotes the use of Document Management and Archival systems and standard document authoring.
- Functions as a change agent that can exhibit regulatory knowledge and awareness, technical competence, sound judgment and a professional demeanor.
- Operates as single BU Liaison point of contact for Regional Regulatory Leads and designated CTAs.
- Manages own time to meet objectives; forecasts and plans resource requirements (people, financial and technology) for projects across Dept.
- Provides guidance to and leads CTA submissions and process improvement projects, making decisions independently.
Technical Skill Requirements
- Proven aptitude in leadership, problem solving and logistics.
- Ability to work on multiple highly complex projects simultaneously.
- Demonstrated attention to detail.
- Strong knowledge of the drug development process, regulatory affairs, Clinical Trial Applications and submissions management.
- In-depth understanding of systems and electronic technologies used to support submission and planning activities, as well as demonstrated experiences in process development and new technology implementation.
- Ability to operate seamlessly and influence direct and indirect reports, as well as across organizations.
Qualifications (preferred education, experience, attributes)
- B.S./B.Sc is in Pharmacy, Life Sciences, Business or Information Technology (desirable); equivalent relevant professional experience will be considered.
- In-depth understanding and proven execution of CTA processes globally.
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards.
- Comprehensive understanding of ICH/GCP & EU Clinical Trial Directive.
- Understanding of EU Clinical Trial Regulation Desirable.
- Familiarity with pharmaceutical organizational structures, systems, and culture is preferre.