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Associate Director, Medical Writing
Associate Director, Medical WritingCompass Consulting • San Francisco, CA, US
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Associate Director, Medical Writing

Associate Director, Medical Writing

Compass Consulting • San Francisco, CA, US
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Our client is a clinical-stage biopharma company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients.


Summary:
  • This position will report to the Medical Writing Department Head and will lead scientific, medical and regulatory writing activities for development projects, ensuring full life-cycle support from clinical study protocols through regulatory submission and post-approval activities, and that documents are written in compliance with all regulations (ICH, GLPs, and GCPs).
  • The professional will also perform the medical writing, QC reviews, and editing of the documents and will be responsible for the management, planning and direction of a team of medical writers.
  • The professional will ensure the timely presentation/dissemination of clinical data from investigational pipeline products according to budget, timelines, strategic publication plans, and tactical approaches; and ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications (manuscripts, abstracts, posters, oral presentations, etc.) are accurate and supported by appropriate data.
  • This job contributes to and supports the company’s research and development efforts to create high value therapeutics to address medical needs.

Duties and Responsibilites:
  • Manages all clinical writing activities outlined in the Project Clinical Development Plans.
  • Reviews documents, offers guidance, and takes lead in creating and managing the document timelines in the preparation of regulatory and publication documents.
  • Organizes, conducts, and leads document production meetings and other meetings as necessary. Creates the agendas and minutes to document meetings according to SOPs.
  • Manages the oversight of CT.gov updates and when required enters CT.gov updates directly into the system including data entry when necessary.
  • Projects Medical Writing assignments, resource allocation, and timeline requirements for CDP.
  • Responsible for implementing the departmental guidelines, writing style guide and departmental templates such as, protocols, investigator's brochures, final clinical study reports, and IND sections.
  • Remote work, must be available PST time zone but offsite location is flexible.

Qualification Requirements:
  • A minimum of 10 years in a pharmaceutical, biotech, or CRO medical writing position is required. A minimum of 8 years writing management experience is also required. A minimum of 10 years previous supervisory experience is required.
  • Demonstrated experience as a primary author writing protocols, IBs, CSRs, IND/NDA sections and other regulated documents. Knowledge of regulatory functions, FDA and ICH guidelines for various scientific documents. Knowledge of CTD format.
  • Strong analytical and strategic thinking skills with the ability to implement.
  • An ability to create effective presentations from raw data is essential.
  • An ability to interpret statistical and clinical data is essential.
  • Must have an ability to work well with others in high-pressure situations.
  • Must have demonstrated problem solving abilities.
  • Strong organizational skills are required.
  • Experience managing CT.gov and other registries for clinical trials
  • Strong written and verbal communication skills are required. An understanding of clinical research, biostatistics, and regulatory affairs is required.
  • Excellent computer skills are required. Working knowledge of MS word, Excel, Power point is required. Omnicia template and PleaseReview experience preferred.

Education:
  • A Bachelors/Masters degree in a scientific discipline with a strong medical writing background is required. PhD. in a scientific or life sciences discipline preferred.
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Associate Director, Medical Writing • San Francisco, CA, US

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