Voit hakea tätä työpaikkaa osoitteesta http://rekry.oikotie.fi/recruitment/application/k/54596/locale/en_US
- Ilmoituksen julkaisupäivä 29.6.2021
- Työsuhde Vakituinen
- Työn tyyppi Kokopäiväinen
- Työtehtävän taso Asiantuntija
We are now looking for an experienced professional with excellent interpersonal and collaborative skills to work in an inspiring global role based in Finland in Espoo as
MEDICAL CONTENT & ONTOLOGY GOVERNANCE EXPERT
YOUR TASKS AND RESPONSIBILITIES
• Closely collaborates with the Medical Standards Manager and the members of the Medical Standards Evaluation Team when new project or study specific demands are identified that require additions and /or modifications of Medical Standard Objects. In this regard the Medical Content & Ontology Governance Expert takes care about the evaluation, categorization, and specification of new medical needs. If deemed necessary, the Medical Content & Ontology Governance Expert involves Medical Experts from other R&D functions into the evaluation, to facilitate the preparation of medically well-grounded user requirements.
• Closely collaborates with the members of the Medical Standards Alignment and Approval Team with respect to the development and approval of new Medical Standard Objects (e.g. CRF pages, data transformations, and table definitions). Ensures by the provision of medical expertise and guidance that new standard solutions are from the medical perspective consistent and meaningful and serve as a proper basis for data retrieval and analysis activities. In addition, considers medical needs beyond single studies and projects to foster the maintenance of a flexible, reusable, and extensible Medical Standard.
• Contributes to the development and maintenance of Standardized Terminologies and Code Lists, including the Standardized Laboratory Analyte Table, from the Medical Content perspective. Supports code list consistency and alignment with international standards (e.g. CDISC). Ensures together with the responsible Medical Standards Manger that code list requests are address in a timely manner.
• Closely collaborates with the members of the Medical Coding Content Teams. Supports in this context the review of pre-specified CRF terms that are subject to Medical Coding, as well as the review of Medical Code Lists that contain terms that need to be aligned with Medical Coding Dictionaries (e.g. MedDRA, WHODrug Global).
WHO YOU ARE
• Graduate in Medicine with at least 6 years of experience in different areas of the drug development process, including Clinical Development
• Profound medical knowledge and expertise across different therapeutic areas including knowledge on laboratory test and other types of medical investigations
• Practical experiences in study protocol preparation, CRF review, medical data cleaning and consistency checks
• Basic understanding of CDISC concepts
• Basic knowledge of Medical Coding concepts and coding dictionaries (MedDRA, WHODrug Global)
• Sound understanding of cross-functional requirements within an R&D department
• Good knowledge of global regulatory requirements, rules, guidance and industry standards
• Demonstration of leadership and strong communication skills in global, cross-functional teams; providing clear vision and direction to achieve high quality deliverables in the expected time frame
• Proven ability to execute responsibilities with knowledge, accuracy, persistence and creativity, working both independently and collaboratively
• Expertise in usage of IT tools and systems
• Effective written and verbal communication skills in English
We offer a competitive compensation, independent and challenging role in an international environment with a chance to develop your skills and experience further.
If you feel this unique role is just what you are looking for, we are keen to hear from you! For further information, please contact Luiz Giorgiani, Head of Clinical Data Management RED II, Data Sciences & Analytics, phone +358 400 807 868.
Please send your application by August 10, 2021 at the latest. Candidates will be reviewed on a continuous basis.
Functional area: Clinical Development & Operations
Seniority level: Professional
Ilmianna kiinnostuksesi tai vinkkaa kaverille 10.8.2021 mennessä! Hakemuksen voit täyttää "Tutustu työpaikkaan" -linkin kautta.