Clinical & Medical Project Manager

About Sintetica

Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to continuously strive to improve therapies by enhancing the usability and formulation of its products for the benefit of physicians and patients. We do this in close collaboration with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and understanding, we push the boundaries of science and technology to make therapies safer for patients and easier to perform. Each year, we reliably deliver millions of doses of our products across a range of therapeutic classes, including anesthesia and analgesia, while expanding to address further healthcare needs.

To strengthen our Scientific Department team at our headquarters in Mendrisio (Switzerland), we are currently looking for a Clinical & Medical Project Manager.

Role

The Clinical & Medical Project Manager, together with the other members of the Nonclinical and Clinical Department and in collaboration with the Pharmaceutical Development and Regulatory teams, plays a crucial role in ensuring the registration of new products and the effective maintenance of legacy products. The role requires a deep and up-to-date understanding of the clinical and medical characteristics of Sintetica's pipeline and portfolio products, and the ability to prepare a variety of technical documents for regulatory or scientific purposes, meeting project requirements and timelines. Very strong technical skills to ensure effectiveness and clarity are essential.

Key Responsibilities

• Offer medical expertise and clinical interpretation of data for regulatory and scientific disclosure purposes.
• Contribute to the evaluation of regulatory strategies for the clinical aspects of each project.
• Draft clinical documents for regulatory filings such as Scientific Advice and Pre-IND Meetings, NDA, ANDA and MAA, responses to IR and DL, PIP, PSP, etc.
• Evaluate scientific literature, clinical trial data, and other pertinent information to assess the safety, efficacy of drugs of interest.
• Contribute to the design of clinical studies to ensure they are scientifically sound and aligned with research objectives, compile information on the investigational product to inform clinical investigators of the drug’s properties, clinical data, and safety profile.
• Review reports of completed clinical studies.
• Stay updated on the evolution of the global regulatory environment (FDA, EMA, ICH, etc.) in the clinical area of expertise and ensure documents and submissions adhere to such standards; contribute to regulatory strategies accordingly.
• Collaborate with Cross-Functional teams: work closely with non-clinical and clinical operations, regulatory affairs, and other departments to gather data and information necessary for regulatory documents.

Requirements

• Master's degree in a health science discipline (e.g., Medicine, Pharmacy, Biotechnology, Biology or a related field), Master in Medicine constitutes a plus.
• Minimum of 10 years of experience in a similar role in the pharmaceutical industry.
• Experience in small molecules and small peptides constitutes a plus.
• Proven experience in drafting and reviewing clinical sections of regulatory documents, study protocols, and clinical study reports.
• Proficiency in literature searches and ability to select and synthesize the most relevant information for the purpose.
• Understanding of regulatory guidelines relevant to the role.
• Excellent communication skills with a proactive approach and the ability to work independently.
• Strong attention to detail and accuracy.
• Ability to take ownership of assignments, proactive consulting with project team representatives as needed.
• Strong organizational skills, including planning, prioritizing, and flexibility.
• Strategic thinking capabilities.
• Proficiency in written and spoken English, other languages constitute a plus.

Preferences will be given to candidates based in Switzerland.

What?

• Permanent full-time employment in a young work environment and positive culture.
• Sintetica promotes diversity and gender equality.