| || The Global Business Development Manager Due Diligence is responsible to ensure successful product launches by assessing the development/dossier offered for purchase regarding pharmaceutical, biopharmaceutical, biowaiver, pharmacokinetic, toxicological and clinical aspects, considering pharmaceutical law, to ensure realization of project targets, supporting the BD manager with contractual terms and support, with technical expertise, the RCC, the Global BD Managers Submissions & Projects and the external partner after contract signature until launch of the respective product. In detail you:
• Ensure only high standardized quality developments, dossiers and registrations with qualified clinical studies are purchased, which are suitable for the purpose of applying for registrations in the countries of interest and allowing a timely global marketing
• Evaluate the appropriateness of developments or dossiers (biowaiver, clinical summary, the pharmacological-toxicological and the clinical documentation) of external partners to verify compliance with internal quality standards, GxP and regulatory requirements for global submissions
• Support the Manager Submissions & Projects to follow up recommendations to correct deficiencies, with regard to biopharmaceutical and clinical development data and costs for additional investigations and studies to comply with local requirements outside EU, identified with external partners.
• Prepare dossier review summaries for BD and Global Quality Assurance
• Assess project related risk, implement solution strategies and manage the exchange of information with Global BD Managers Submissions & Projects on product related challenges
• Advise BD managers, Global BD Managers Submissions & Projects and other departments (e.g., launch management, patents, legal, QA) regarding development, clinical topics and control as applicable to assigned products as well as pharmaceutical law (to be taken into consideration in the contract) in order to market the products
• Support the Global BD Managers with contract negotiations and budget planning where applicable
• Advise Global BD Managers, Managers Submissions & Projects, licensors and SDC experts to ensure that the development team will provide appropriate development plans as well as biowaiver or clinical data presentable in registration files according to current international (pharmaceutical, clinical and legislation aspects) requirements (ICH + regional)
| || • Graduate in natural sciences (Pharmacy, Chemistry, Biology, or equivalent)
• Fluent in English with excellent communication skills in spoken/written word
• Some years` experience in clinical development or associated fields with in-depth pharmaceutical knowledge, in particular in pharmacokinetics, biopharmaceutical, pharmaceutical technology, pharmacology/toxicology, pharmacotherapy and pharmaceutical legislation, solid knowledge of GCP and of clinical trial design as well as basic statistics.
• Knowledge of worldwide regulatory requirements regarding development of medicinal products and bioequivalence studies.
• Solid medical/scientific writing skills Computer literacy and the ability to analyze, discuss, interpret and present pharmacokinetic, efficacy and safety data
• Strong capabilities in communication and organization of complex projects.