We are looking for an experienced MEDICAL WRITER for the Clinical Development department. Depending on the Head of the Medical Writing area, their main role will be the writing of documents to be used in regulatory purposes or with a scientific communication aim.
The position is based in any of the two offices in Spain: MADRID or BARCELONA.
- 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).