Director of Medical Writing

Menlo Park, CA 94025

Posted: 07/19/2018 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 13527

Our client in Menlo Park is looking to have a Director of Medical Writing join their growing team!

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.

 

Director of Medical Writing

Job Benefits:
  • An opportunity to significantly impart the future of the company’ s operations
  • A competitive base salary
  • On the job training, both in person/online

Summary of Responsibilities:
  • Lead document review and comment resolution meetings with cross-functional teams according to the timeline
  • Prepare scientific literature searches, scientific abstracts, posters, manuscripts, Advisory Committee presentations, exhibits, etc. as needed
  • Build and maintain knowledge base in both Medical Writing expertise and therapeutic area understanding to ensure the overall document quality
  • Oversee document preparation activities and timeline development
  • Use scientific expertise to write, review, and edit science-based reports such as clinical protocols, Investigator’ s Brochures, clinical study reports, risk/benefit analysis and integrated summaries, IND sections, Briefing Documents, annual reports
  • Meet ICH, GLPs, and GCPs guidelines, develop a writing style guide and template, as needed
  • Direct, train, and assist other medical writers in the writing and editing and technical aspects of clinical and regulatory document development
  • Work with key company stakeholders to help integrate nonclinical and clinical trial data into concise and compelling reports
  • Work with cross-functional teams to be sure that all deliverables are in accordance with regulations, standards, guidelines and timelines

Required Qualifications:
  • BS, MS, RN, PharmD or doctorate in a scientific or medical field (an equivalent combination of education and experience may be considered)
  • A minimum of 10 years’ experience as a Medical Writer in the pharmaceutical, biotech industry or clinical research organization
  • Previous management experience in the medical writing function
  • Demonstrated leadership capability and strong writing skills
  • Demonstrates strong organizational skills and ability to work collaboratively in a cross-functional team environment
  • Experience working on INDs, BLAs, and other regulatory submission activities
  • Exceptional oral and written communication skills
  • Strong understanding of drug development, clinical study design, regulations (FDA and EU), ICH and other guidances, and scientific principles
  • Ability to effectively work in a multi-disciplinary team, build and maintain effective partnerships
  • Able to manage timelines for document development, review and completion according to expectations
  • Detail oriented and dedicated to producing high-quality documents
  • Strong communication, negotiation and interpersonal skills
  • Experience mentoring/training other writers
  • Proficient in Word, Excel, PowerPoint, the use of templates, email, and internet

Felicia Id-Deen

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