Associate Director, Medical Writing

South San Francisco, CA | Direct Hire

Post Date: 06/02/2017 Job ID: 11297 Industry: Clinical & Scientific

Bayside Solutions is seeking a Associate Director, Medical Writing to be a part of our Client’ s team in South San Francisco. This is a unique opportunity to join a growing team of business professionals focused on the treatment of diseases that affect the functionality of an individual. They pride themselves on their commitment to finding cures that other biotech companies have not tackled.

A successful Associate Director, Medical Writing will have strong knowledge and experience with CMS sections of INDs and experience with Phase I – III Clinical Trials, including international regulatory requirements. The ideal candidate has a BS/MS/Ph.D with 10+ years’ of experience workings as a Medical Writer in the Biotech/Pharmaceutical industry.  

Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.

You can find additional information on our company website at www.baysidesolutions.com.

Associate Director, Medical Writing

Job Benefits:
  • Competitive compensation and assistance with  relocation to the beautiful SF Bay Area.
  • This position is eligible for medical, vision, and dental benefits, paid sick time and 401k.

Summary of Responsibilities:
  • Write, review and prepare a variety of technical documents, including: protocols, amendments, investigator brochures, consent forms, annual reports, DSURs, final study reports, and sections of INDs and NDAs.
  • Work across departments to help set priorities for document preparation and collaborate on document content.
  • Coordinate and manage consulting writers as needed.
  • Work with service providers as needed for delivery of high quality documents.
  • Write clinical abstracts, posters, and manuscripts.
  • Review and edit documents prepared by other authors.
  • Maintain document history and manage version control of documents.
  • Provide guidance for style guides for document preparation.

Requirements:
  • BS/MS/Ph.D. with 10+ years’ experience working as a Medical Writer in the biotech/pharmaceutical industry.
  • Knowledge and experience with CMC sections of INDs is required.
  • Experience with NDAs and other submissions is a strong plus.
  • Keen understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines for preparation of INDs, CTXs, NDAs and MAAs.
  • Ability to coordinate other writers in the preparation of complex submissions.
  • Experience with Phase I-III clinical trials, including international regulatory requirements.
  • Ability to work independently, manage multiple priorities, and execute on goals.
  • Must be able to work 100% onsite in South San Francisco; Monday-Friday. 

Allison Glogovac

Making a positive impact is very important to me. Which is one of the main reasons why I love what I do at Bayside Solutions. I get the chance to support companies that are making a difference in the health, treatment, and wellness of patients across the globe. I strive to be a cut above my competitors by intently listening, learning about your career goals, and identifying the types of positions that you are excited about. If you have a passion for working within clinical research and are looking to explore amazing opportunities with companies where you can make a difference, let’s link up today. I look forward to meeting you!

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