Manager Clinical Due Dilligence (d/f/m) limited in part-time
Sandoz is a global leader in generic pharmaceuticals and biosimilars and a division of the Novartis Group. Our purpose is to reimagine medicine to improve and extend people’s lives through the use of innovative science and technology.
Limited contract (18 months) in part- time (70%)
Your responsibilities :
• Evaluate the appropriateness of clinical documents, clinical development plans or dossiers together with other functions (i.e. regulatory, medical) to verify compliance with internal quality standards, GxP and regulatory requirements for global submissions • Review the clinical documents in detail and prepare review summaries • Discuss a suitable clinical development plan with the partner where applicable • Assess potential risks for approval and prepare risk minimization strategies if feasible. Provide inputs to costs for additional clinical investigations and studies needed • Collaborate with and contribute the clinical expertise to a cross-functional team, manage exchange of information • Provide inputs to contract negotiations and budget planning where applicable • Collaborate and contribute to responding to deficiency letters as needed
What you bring to the role:
• Graduate in natural sciences (Pharmacy, Chemistry, Biology, or equivalent) • Minimum 3 years' experience in clinical development or associated fields • In-depth pharmaceutical knowledge, in particular in pharmacokinetics, pharmacology, pharmacotherapy, pharmaceutical legislation, solid knowledge of GCP and of clinical trial design (especially bioequivalence studies) including basic statistics. • Knowledge of worldwide regulatory requirements regarding development of medicinal products and bioequivalence studies • Ability to analyze, discuss, interpret and present pharmacokinetic, efficacy and safety data • Solid medical/scientific writing skills • Strong capabilities in communication and organization of complex projects • Computer literacy • Fluent in English with excellent communication skills in spoken/written word
Why consider Sandoz?
Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?
The answers come when curious, courageous and collaborative people are empowered to ask new questions, make ambitious decisions and take smart risks.
Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.
Join us, and help reimagine access to medicine.
Sandoz stands up for equal opportunities and for the integration of persons with disabilities. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.