Csr manager Jobs in Oftersheim

The job that makes possibilities real in patients lives. And yours.

The job that helps you get ahead in life. Moving mountains together.

Welcome to AbbVie! As part of an international company with 48000 employees worldwide and around 3000 employees in Germany you will have the opportunity of addressing some of tomorrows unmet medical needs in close collaboration with your colleagues. Are you passionate about improving global health care Do you want to contribute to improving patients quality of life through your expertise In a challenging work environment that offers opportunities of developing and increasing your own skills Youve come to the right place!

Moving mountains together as Senior Manager CMC Dossier Strategy & Leadership (all genders) (permanent / fulltime)

This position ensures that global regulatory dossiers are aligned with current AbbVies CMC best practices.  The role works with CMC teams during the development of cuttingedge control strategies and influences in generating data packages that support the CMC control strategy.  The role authors narrative sections of CTDs to communicate a single integrated strategy to health authorities contributes to the preparation of regulatory query responses and briefing books and serves as a subject matter expert (SME) for technical topics related to dossier content.

Responsibilities

• Embedded in the CMC team throughout development to collaborate on control strategy development and the planning of the data packages that will support the strategies.
• Provides realtime input on source document preparation to ensure a submissionready data set is generated.
• Actively contributes and / or leads team discussion on control strategy topics actively participates in control strategy reviews (CSR) and regulatory strategy (storyboarding) as part of the CMC team.
• Primary author of narrativerich sections of INDs and MAAs to ensure a single consistent story is communicated to health authorities.
• Reviews datarich sections of INDs and MAAs to ensure content alignment across the submission.
• Ensures timely delivery of dossiers to meet regulatory submission timelines
• Authors regulatory query responses and contributes to briefing books.
• Attend meetings of interactions with agencies on CMC topics
• Serves as an internal SME for technical topics across the portfolio (for example mutagenic impurities gross content control etc).
• Independently identifies opportunities for improvement of departmental work processes and contributes to crossfunctional process improvement processes.
• Establish and maintain strong network within department and external stakeholders. Utilize established organizational network to identify opportunities gaps and synergies consistent with project strategy. Actively mediates internal team disputes and facilitates establishment of high performing teams.

Qualifications :

Heres how we can move mountains together

Multiple times we have been globally recognized as a Great Place to Work and we are proud to provide our employees with the flexibility to maintain a healthy worklife balance. We take our impact on the environment and our communities seriously and therefore focus on giving something back on a regular basis. We are committed to equality equity diversity and inclusion (EED&I) a commitment that is fundamental to us. This includes appreciating different perspectives creating an inclusive culture and treating all employees with dignity and respect.

At AbbVie your individual contributions count help us move mountains together. Be a part of our success grow with us and accomplish more than you could have imagined. Sounds like the perfect career opportunity for you We look forward to receiving your application! All you need is a complete CV we will discuss everything else with you in person.

Have questions Email  we look forward to hearing from you!

Zustzliche Informationen :

Nur gemeinsam knnen wir das Beste fr Patienten erreichen. Daher setzen wir bei AbbVie auf Chancengleichheit Vielfalt & Inklusion. Wir gestalten ein Arbeitsumfeld in dem alle Mitarbeiter ihr Potenzial entfalten knnen unabhngig von Geschlecht Herkunft Religion sexueller Orientierung oder anderen Vielfaltsdimensionen. Doch fr uns bedeutet Vielfalt mehr als nur offensichtliche Unterschiede zu bercksichtigen : Sie bezieht sich auch auf unterschiedliche Ausbildungshintergrnde Fachkenntnisse Persnlichkeitstypen Denkweisen und Lebenserfahrungen.

Remote Work : Employment Type :

Fulltime

Key Skills

Abinitio,Administration And Accounting,Android,Bid Management,Inventory Management,Embedded C

Experience : years

Vacancy : 1