Medical Writer, Translational Development
San Francisco Metro Area, CA
Responsible for the development and execution of translational strategies to support the development of therapies in myeloid diseases post-clinical proof-of-concept, including clinical registration and life-cycle studies, as well as supportive non-clinical studies.
Responsibilities will include, but are not limited to, the following:
With guidance and in collaboration with other scientists (translational, clinical, discovery, DMPK), prepare non-clinical and translational clinical study reports, abstracts, manuscripts and regulatory documents.
Prepare regulatory documents, including pharmacology and biomarker sections of Investigator's Brochures, Clinical Study Reports, and NDA/MAA modules 2.4 (Non-clinical overview), 2.6 (Non-clinical written and tabulated summaries), 2.7 (Clinical summary), 4.2 Non-clinical study reports, 5 (Clinical study reports).
Participate in study and clinical team meetings and assist the teams in managing timelines for written deliverables and resolving issues related to document preparation.
Review data to determine the appropriate tabular and textual formats, and the clarity, logic, and order of presentation.
Facilitate document review meetings and discussions.
Review work of other writers for accuracy, quality, focus and adherence to format and stylistic requirements, in order to ensure high quality documents.
PREREQUISITES: Advanced degree in biological or related sciences (MS or PhD), with
approximately 3-5 years of experience writing non-clinical and/or clinical biomarker documents
Advanced degree in biological or related sciences (MS or PhD), with approximately 3-5 years of experience writing non-clinical and/or clinical biomarker documents
Excellent grammar and communication skills, both written and oral
Scientific accuracy and attention to details
Ability to concisely summarize complex scientific non-clinical and clinical translational data.
Skill with logical organization of concepts, and ability to map details to big-picture messages
Understanding of drug development processes, including translational/biomarker studies
Knowledge of EMA, FDA and ICH document guidelines preferred, such as experience with Investigational New Drug Application, New Drug Application, and/or Common Technical Documents and electronic document submissions (eCTD)
Ability to work across cross-functional teams
Excellent time management
Expertise in MS WORD, Excel, and graphics software (e.g. Prism, Spotfire)