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Apex Life Sciences

Medical Writer, Translational Development - CA

Post Date:Dec 27, 2017Type:Contractor
Start Date:12/27/2017Salary:
Location:US-CA-San Francisco Job Reference:803071
Skills:
 

Job Description:

Summary/Scope: 

  • We are looking to add a Medical Writer to our Translational Development team based in San Francisco, CA.
  • Our team is 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. 

Skills/Knowledge Required: 

  • 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)




Contact Information
Apex Life Sciences



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