Medical Writer - Spain
Want to know company name or location? Company managed [?]
- Write and edit documents related to clinical development activities (protocols, amendments to protocols, clinical study reports, investigator brochures, DSURs, etc.).
- Support global submissions to Regulatory Authorities including writing of CTD Module 2 clinical summaries and overviews.
- Coordinate and manage the review and approval process of documents, including comment reconciliation and timely completion.
- Support the clinical team in publishing study results in peer-reviewed journals and through poster and slide presentations at international medical congresses
- Support in other specific functions of the area: translations (usually Spanish-English), standard operating procedures, etc.
- B.Sc/ M.Sc in a scientific discipline (life science background); PhD is desired.
- Minimum experience of one year as a medical writer.
- Expert knowledge of international regulations, requirements and guidelines associated with clinical document preparation and submission. Understanding of EMA and FDA associated regulatory guidelines.
- Proficiency in MS Office and bibliographic data software (Endnote/Reference Manager). Expert command of Microsoft Word is a must; experience in the use of a document management system (Please Review, DocCompliance) is an advantage.
- Expertise in the analytical evaluation of clinical data.
- Close attention to detail; excellent communication skills.
- Ability to work independently within an interdisciplinary team. Project management skills are welcome. Ability to self-organize, coordinate and prioritize activities across several parallel projects.
- Experience in Oncology and International experience will be highly valued.
- Excellent English, both written and spoken.
- Ability to write, speak and understand Spanish would be a clear advantage.
- Currently living in, or willing to relocate to Spain (Madrid or Barcelona).