Sanaria Inc., an award-winning biotechnology company based in Rockville, Maryland, USA, offers a unique and challenging opportunity to join a world-class team developing and commercializing a live sporozoite-based malaria vaccine for use in international travelers and in residents of malaria-endemic countries, where malaria causes half a million deaths each year, mostly in children. Sanaria is conducting clinical trials at multiple sites in Africa, Europe, and the United States aiming for licensure in the next few years. Sanaria is seeking a Medical/Science Writer experienced with scientific manuscripts, clinical research protocols, clinical safety reports and regulatory submissions, ideally with background in vaccine or drug development.
Development, writing, editing, and finalization of clinical documentation required for:
the initiation and conduct of a clinical study, including clinical study protocols, informed consent documents, and other relevant documentation given to volunteers.
submission to regulatory health authorities and ethical review committees, during the course of a clinical study, including interim safety reports, abstracts for scientific presentation, and integrated summaries of efficacy and safety.
study close-out, including clinical study reports, safety reports, and scientific manuscripts for publication.
Analysis of clinical data, compilation of clinical data tables, and integration of clinical data summaries into above mentioned clinical study reports and manuscripts.
Coordination of teams generating these documents, which may include the Deputy and Chief Medical Officers, the Chief Executive Officer, Principal Investigators, and operational staff.
Support and coordination of grant applications, including development and writing support and meeting of submission deadlines.
Development of processes, templates and libraries to serve as a manual of procedures for creation of study protocols, study reports and other clinical documentation.
Qualified Candidates will have a bachelor’s, master’s or doctoral degree, 3 to 5 years of prior experience in writing and developing clinical documents such as clinical study reports, safety reports, clinical protocols, informed consent forms and grant applications; demonstrated knowledge of protocol structure, clinical data analysis and presentation; demonstrated knowledge of GCPs. The successful candidate will be mission-driven, exhibit high professional standards, and communicate effectively as a member of a collaborative team.
We offer a competitive salary and benefits package. Please send cover letter, resumé and salary history to: firstname.lastname@example.org, subject line Medical/Science Writer. For more information, please visit www.sanaria.com. Sanaria Inc. is an equal opportunity employer.