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Clinical & medical project manager

Swiss Biotech Association
Mendrisio, TI

Jetzt bewerben

Details zur Stelle

Festanstellung | 100%

Qualifikationen

Englisch
Klinische Erfahrung
Master
Organisationstalent
Kommunikationsfähigkeit

Vollständige Stellenbeschreibung

Founded in 1921 and headquartered in Mendrisio (Switzerland), Sintetica's mission is to continuously strive to improve therapies by enhancing its products' formulations and usability for the benefit of clinicians and patients.

We do so in close cooperation with clinical experts, who shape our understanding of their unmet needs and drive our efforts to address them. With this trust and insight, we push the limits of science and technology to make therapies safer for patients and easier to perform. Every year we reliably supply millions of doses of our products across a range of therapeutic classes, including anaesthesia and analgesia, while expanding to address further healthcare needs.

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

Position summary

The Clinical & Medical Project Manager, together with the other members from the Nonclinical and Clinical department and in collaboration with the pharmaceutical development and regulatory teams, plays a crucial role in ensuring the successful registration of new products and the effective maintenance of legacy products.
The role demands a deep, up-to-date understanding of the clinical and medical features of the Sintetica pipeline and portfolio products, and the ability to prepare a variety of technical documents for regulatory or scientific dissemination purposes, meeting project requirements and timelines. Very strong technical writing skills to ensure effectiveness and clarity are essential.

Key responsibilities

Offer medical expertise and clinical interpretation of data for regulatory and scientific dissemination purposes.
Contribute to regulatory strategies assessment 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 IRs and DLs, PIPs, PSPs, etc.
Evaluate scientific literature, clinical trial data and other relevant information to assess the safety, efficacy of drugs of interest.
Contribute to the design of clinical studies to ensure that they are scientifically sound and aligned with the objectives of the research, compile information on the investigational product to inform clinical investigators of the drug’s properties, clinical data and safety profile.
Revise Clinical Study Reports of completed clinical trials.
Keep updated on the evolving global regulatory environment (FDA, EMA, ICH, etc.) in the clinical area of expertise and ensure that documents and submissions adhere to those 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 insights needed for regulatory documents.

Qualifications and skills

Master’s Degree in a health sciences discipline (e.g., Medicine, Pharmacy, Biotechnology, Biology or a related field), Master’s Degree 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 constitute a plus.
Proven experience in drafting and revising clinical sections of regulatory documents, clinical trials protocols and reports.
Expertise in literature searches and ability to select and synthetize the most pertaining information for the purpose.
Understanding of the regulatory guidelines relevant for the role.
Excellent communication skills with a proactive approach and the ability to work autonomously.
Strong attention to detail and accuracy.
Ability to take ownership of assignments, proactively consulting with project team representatives as needed.
Strong organizational skills, including planning, prioritization and flexibility.
Strategic thinking capabilities.
Proficiency in written and spoken English, other languages constitute a plus.

Preference will be given to candidates based in Switzerland.

We offer

Fulltime permanent employment in a young working environment and positive culture.
Sintetica promotes diversity and gender equality.

Company

Sintetica SA

Location

Mendrisio, Switzerland

Type of job

Clinical Development

Contact information

Camilla Ferrari

[email protected]

0916404250

Jetzt bewerben

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