At OPIS, we are always looking for qualified candidates to join our team. With offices throughout the EU,
we offer a wide range of exciting career opportunities in a variety of regions. We further the professional development of all our employees through continuous qualification and training programmes that encourage personal
and professional fulfillment. Begin your journey with OPIS today by browsing through our latest job opportunities or follow us on LinkedIn. If you are interested in joining OPIS, please send your CV to jobs@opis.it.

FEATURED JOB OPPORTUNITIES
At OPIS, you will find open positions in various areas:

Senior Clinical Research Associate


Location
Desio (MB), Italy
Job Description

We are looking for an experienced CRA with expertise in performing on-site pre-study, initiation, monitoring and close-out visits according to ICH/GCP, regulatory and protocol specific requirements.

Qualifications

  • Masters Degree in scientific/healthcare related subject
  • At least 2 years monitoring experience of clinical studies Phase I – IV/observational studies
  • ICH/GCP knowledge, basic understanding of regulatory affairs
  • Full understanding of Serious Adverse Event (SAE) reporting and follow-up of SAEs
  • Good planning, organization and problem solving abilities
  • Good communicative and interpersonal skills
  • Willingness for travel (up to 50%) including overnight stays where necessary
  • Good knowledge of English
  • Valid drivers license
Apply

Clinical Research Associate


Location
Desio (MB), Italy
Job Description

We offer the opportunity to start a career in the clinical research of drugs and medical devices. An entry level positions as Clinical Research Associate/Clinical Monitor for those with a scientific background, willing to travel in Italy, interested in the research field.

We will consider profile with at least one of the following experiences:

  • Postgraduate Masters Degree in Clinical Research related topic
  • At least 4 months of professional experience in the field of Clinical Research (Pharmacovigilance, Submission, Study Coordinator, Data Management)

 

Qualifications

  • Masters Degree in scientific/healthcare related subject
  • ICH/GCP knowledge, basic understanding of regulatory affairs
  • Good planning, organization and problem-solving abilities
  • Good communication and interpersonal skills
  • Willingness to travel including overnight stays where necessary
  • Good knowledge of English
Apply

Legal Affairs Specialist


Location
Desio MB
Job Description

Department: Legal

 

Job Type: Permanent, Full-time

 

We are looking for a Legal Affairs Specialist who takes care and provides consultancy about all the activities related to contracts, legal issues connected with clinical trials, trademark legal protection and corporate secretary.

Reporting to the Head of Legal & Compliance, she/he will take care of the managing of relevant corporate and legal secretary matters and for ensuring that the Organization’s activities are carried out in accordance with internal governing documents and relevant laws, rules, policies and ethical standards.

 

Main tasks:

She/he will

  • Ensure the negotiation, coordination, reviewing of all kind of agreements (including contracts with third parties) cooperating with the involved Business Units.
  • Provide in-house clients with legal opinions, strategic or interpretative advices, offering solutions to problems in order to mitigate the risks concerning the functions, structure, and activities of the Organization;
  • Involving effectively internal departments (General Affairs, Business Development, Finance, Medical Department etc.) to provide the required support in order to successfully manage major and critical legal issues.
  • Draft, review, negotiate, interpret agreements and other legal documents, in cooperation with in-house clients;
  • Oversee the work of external lawyers by providing clear direction, guidance and support;
  • Ensure the legal evaluation and legal consultancy about subsidiaries issues;
  • Ensure the proper conduction of all the activities related to the management of corporate governance and corporate secretary, such as the preparation of all the documentation necessary for the Board of Directors meeting;
  • Manage the follow-up and update of corporate regulation applicable to the Groups entities and support its implementation, promptly updating the Top Management;
  • Guarantee trademark legal protection and legal advice on intellectual property

 

Qualifications:

  • Master’s Degree in Law
  • 2/3 years of professional experience in Contract law, civil law in international Law Firms
  • Experience Corporate Governance
  • Fluent in English is essential (oral, written, legal, commercial)
  • Good Interpersonal skills and ability to work in team;
  • Proven capacity to negotiate and resolve delicate issues in a diplomatic and balanced way.
Apply

Junior Medical Writer


Location
Desio, Italy
Job Description

Department: Medical Affairs

 

Job Type: Full-time, internship or fixed-term contract

 

The Junior Medical Writer, working closely with a senior colleague and under the supervision of the Head of Medical Affairs Unit, will be in charge of the following activities:

 

  • Draw up, edit and review clinical documents such as clinical study reports, statistical analysis plans, study protocols, patient information and informed consent forms and other medical and regulatory documents;
  • Develop scientific manuscripts and abstracts reporting clinical study results, as well as slide and poster presentations;
  • Prepare regulatory and clinical documents for drug development and registration activities;
  • Liaise with Biometrics staff, Pharmacovigilance and Clinical Operations Units for information or guidance, as necessary;
  • Coordinate and manage documents to produce submission-ready content for customers;
  • Perform literature searches and reviews as necessary to obtain background information for the development of documents;
  • Work in accordance with Regulations, Good Clinical Practices and ICH guidelines and Company Standard Operating Procedures;
  • Create and maintain audit trails of all document changes
  • Review the quality and accuracy of documents in English

 

Profile:

  • Master’s degree in Biotechnology, Biology, Pharmacy, Pharmaceutical Chemistry and Technology (CTF) or equivalent
  • Fluent in English, specific knowledge of biomedical English is required
  • Good Interpersonal skills and ability to work in team
Apply

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