Beschreibung
Senior Global Labeling Expert (m/w/d)
Referenz: -de
Beginn: asap
Dauer: 9 MM+
Meine Aufgaben:
- Maintaining and generating the following: development Company Core Data Sheet (dCCDS), Company Core Data Sheet (CCDS), United States Prescribing Information (USPI), EU Summary of Product Characteristics (EU SmPC)
- Delivering labeling strategy to early development activities and aligning it with the overall strategy of product regulatory, registration and development
- Contributing to Clinical Study designs, Protocols, Investigator Brochures and Briefing Books from the labeling / labeling environment point of view
- Leading interactions with relevant Subject Matter Experts (SMEs) and stakeholders for dCCDS and CCDS
- Collaborating with the Regional Regulatory Therapeutic Area to lead the review of the labels and interaction with relevant SMEs for USPI and EU SmPC
- Ensuring steady communication to the Global Labeling Associates (GLAs), regions and countries regarding new and updated CCDSs for Therapuetic Area
- Leading the assessment and the review through the Global Labeling Committee (GLC) of proposed exceptions between the CCDS and the USPI and SmPC making use of the established departmental processes whilst retaining compliance
- Representing Global Labeling (internal and external) and ensuring an effective communication between this team and the teams of Global Regulatory Affairs Strategy Teams (GRASTs) and GRA Therapeutic Area (TA)
- Remaining up to date with the global labeling requirements and expectations
Meine Qualifikation
- Must have a minimum of 10 years of experience in the biotech / pharmaceutical industry, including 6 years of labeling / regulatory experience, also in the global field
- Strong scientific background: University Degree in Life Science or another related Pharmaceutical field; advanced degree like MSc, PhD or Pharm D is preferred
- Proficient knowledge of regulatory and drug development (pre- to post-clinical) including knowledge of broad scientific concepts within labeling and their global and organizational impact
- Strong ability of understanding and interpretating scientific documents and concepts to translate them into labeling content
- Good understanding and knowledge of the regulatory principles that are relevant to drug development, global labeling and post-marketing requirements
- Team-Leading experience in a matrix organization is also mandatory
- Profound team-player abilities to be able to work within global and cross-cultural teams
- Excellent problem-solving ability: Analyzing risks and making according recommendations and decisions
- Extensive communication skills: Being able to explain concepts, options and impacts to a variety of audiences
- Good organizational skills by interacting (internally and externally) on strategic and scientific matters
- Fluent in English (written and spoken)
Über uns:
Mit über 15 Jahren Erfahrung in der klassischen Pharmaindustrie, Biotechnologie, Chemie und Medizintechnik kennen wir die entscheidenden Kontaktpersonen, die anspruchsvolle Aufgaben mit Potenzial ausschreiben. Die hohe Personalnachfrage eröffnet spannende Möglichkeiten für engagierte Fach- und Führungskräfte, um sich beruflich zu entwickeln und an der eigenen Karriere zu arbeiten. Als spezialisierte Personalberatung mit einem internationalen Netzwerk bieten wir Ihnen entscheidende Vorteile – und das völlig kostenfrei für Sie. Registrieren Sie sich und profitieren Sie von interessanten und passenden Positionen und Projekten.
Mein Kontakt bei Hays:
Mein Ansprechpartner:
Josephin Rosa Christmann
Referenznummer:
Kontakt aufnehmen:
Email: