Senior Medical Writer

Company: Yoh, A Day & Zimmermann Company
Location: Encinitas
Posted on: May 2, 2021

Job Description:

Yoh Life Sciences is seeking a Sr. Medical Writer for one of our therapeutic clients in San Diego, CA.

Sr. Medical Writer
Full-time (ability to flex)
Compensation DOE

Flexible to hire contract or direct depending on a candidate's preference.

Full-time hours available but open to reduced scheduled for highly qualified candidate. Interested candidates should apply with their current resume.
Senior --Medical Writer needed to oversee --the production of clinical and regulatory documents including writing, reviewing and editing. -- This will --support product development and license applications. --

Responsibilities:

• 
  
• Will work with clinical and regulatory teams to author and manage document review.
  
• Will have input on timelines and deliverables.
  
• Will work with team leads to determine appropriate content.
  
• Will support writing of: --protocols and protocol amendments, clinical study reports, Investigator Brochures, annual reports and submission documents, pharmacology and PK reports, nonclinical summaries, summary documents, briefing documents, and regulatory responses
  
• Will need to perform literatures searches
  
• Should be able to follow style guides
  
  
  Requirements:
  
  
  • 
    
  • Advanced degree in life sciences or alternatively, bachelor--------s degree in life sciences field with transferable skills and pharmaceutical industry experience, ideally in safety, regulatory or clinical areas
    
  • Minimum 3-5 years of medical writing/regulatory/clinical experience in the biotech or pharmaceutical industry
    
  • The medical writer should be familiar with FDA and ICH guidelines and the current AMA Style Manual
    
  • High attention to detail, and excellent proofreading and editing skills
    
  • High-level competence in pertinent software (e.g., Word, PowerPoint, EndNote)
    
    
    --
    Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic. Keywords: Medical Writer, Location: Encinitas, CA - 92024

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