Sr R&d Scientific Liaison Manager

vor 1 Woche

Lugano, Schweiz IBSA Institute Biochimique SA Vollzeit

**Open Position**
Sr R&D Scientific Liaison Manager

**Description of the position**
Ensuring, in collaboration with R&D Scientific Affairs Managers, Pharmacovigilance, Medical Affairs, Strategic Marketing and Regulatory Affairs departments, that appropriate post-marketing clinical strategies are in-place to support the needs of these departments and that post-marketing clinical activities are conducted to support products lifecycle in compliance with applicable clinical and regulatory standards and in alignment with business needs.

**Main Responsibilities and Tasks**
- Defining, under the Head of department post
- marketing clinical activities
- Supporting phase IV/post registration and Real World Evidence projects directly managing the projects or collaborating the R&D SA colleagues responsible for the projects
- Contributing to define and review SOP and guidances for the management of post-marketing clinical activities and Investigator’s Initiated (no-profit) Clinical Trials identifying, in collaboration with the clinical & DSU QA, R&D SA, Medical Affairs, Strategic Marketing and the local teams of the Affiliates and Partners, needs and gaps
- Contributing to clinical trial program ensuring that trial deliverables are met according to timelines, budget, operational procedures and quality standards. Responsibilities can include development of the protocol and related documents; development of study tools, guidelines and training material; management of clinical study material; implementations of issue resolution plan; preparation of clinical outsourcing specification
- Accountable for accuracy and timeliness of trial information in all trial database and tracking systems, including public registries
- Contributing to the on-going scientific review of the clinical data and support data trial analysis, reporting and publishing
- Selecting CROs in cooperation with QA and negotiate contracts, on behalf of and in agreement with the department head
- Ensuring compliance with SAE reporting during all sponsored clinical trials
- Overseeing study drug (IMP) supply organization and management, including relevant documents such as GMP declarations and manufacturer authorization
- Supporting Clinical & DSU QA in planning and performance of study specific audits. Ensuring follow-up of inspection and audit findings, and that corrective actions are implemented. Supporting regulatory department in response to competent authority deficiency letters
- Communicating post-marketing clinical/RWE findings and concepts to internal departments and collaborating with the Medical Affairs and Strategic Marketing in the dissemination of RWE research findings to the Affiliates and Partners and scientific community

**Your Profile**
- Academic degree in the Life Sciences (Biochemistry, Biological sciences, Chemistry, Pharmacy, Pharmacology, Medicine)
- Good knowledge of English written and spoken
- Previous work experience in the area of competence
- We are looking for an open minded analytical thinking person, which is capable to resolve complex matters, team work oriented and highly motivated
- Excellent organizational, interpersonal, and communication skills

**Work location**
IBSA Institut Biochimique SA in Collina d’Oro, Ticino, Switzerland

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