Overview

The Associate Director, Medical Writing will be responsible for writing and coordinating the writing of peer-reviewed scientific publications, and other clinical and regulatory documents, including distribution of work to contract medical writers or agencies as needed.

This is an individual contributor position with team leadership responsibilities. The Associate Director, Medical Writing will work closely with cross-functional teams to ensure the documents are high quality and completed in a timely fashion compliant with SOPs, Good Publication Practice, ICH/GCP/regulatory guidelines, and company goals.

The core duties of the Associate Director, Medical Writing are delineated below.

Work Model:
Flex can complete work from home during the pandemic; once return to the office 2-3 days in office to be expected and established with manager,

Remote, officially documented as working full time from home, with travel to the company’s offices or other location on occasion as needed.

Responsibilities:

  • Work with external authors and essential team members to develop high-quality publications (manuscripts, abstracts, posters, and slide presentations) for peer-reviewed journals and scientific congresses, and to provide publication support and ensure compliant development of company-sponsored publications
  • Work with the Publication Planner to ensure agreement on timelines and data communication plans
  • May lead the development of publication plans for some assigned products/programs and manage the publication plans
  • Ensure smooth document management from start to finish (i.e., generation of a blank document to a final approved version), which may include: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing multiple processes (e.g., reviews, QC, QA, formatting, publishing, document archiving, journal and congress submissions)
  • Oversee quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives and ensure standards are being followed
  • Distill large amounts of clinical and scientific data into essential elements for graphical display
  • Partner with the lead author to oversee document review and comment resolution meetings with teams and authoring teams
  • Form essential messages from clinical study data
  • Work with relevant corporate functions and partner(s), as applicable, to ensure communication of publications-related activities including manuscripts and congress abstracts/posters/presentations
  • Perform literature-based research to support writing activities
  • Develop best practices for authoring and reviewing
  • Develop templates and outlines for important documents
  • Mentor junior medical writers

Requirements:

  • BS, or doctorate in a scientific or medical field
  • 8+ years publications medical writing experience in the biotechnology/pharmaceutical industry
  • In-house experience
  • Experience analyzing and communicating scientific data in peer-reviewed scientific publications; knowledge of applicable publications-related guidelines (i.e., ICMJE, GPP) and best practices, and legal, regulatory, compliance, and clinical/medical affairs
  • experience in medical writing, editing, and clinical development; previous work on protocols, IBs, CSRs
  • Planning, and project management skills, along with initiative and ability to be productive with minimal administrative support
  • with multiple high priority projects
  • Experience developing medical writing processes and standards
  • Understand and respond to multicultural communication styles and business practices with alliance partners and internal colleagues
  • Flexible; adapt work style to meet organization needs
  • Organizational abilities and experience in a multitasking environment; project management experience
  • Motivated, self-directed, and able to work autonomously and in team settings to meet organizational goals
  • (Microsoft Office Suite, PowerPoint, Adobe Illustrator, figures and graphic design; Project and Visio)
  • Develop partnerships
  • Hold self and others accountable for adherence to high ethical standards; adopt and maintain the utmost integrity and respect for colleagues at all levels
  • Rare disease experience and a strong understanding of bone disease or metabolic genetics

The following are some highlighted benefits, but not limited to:

  • Summer and Winter shutdown in addition to generous vacation benefit and many observed company holidays
  • Long-term Incentive and Employee Stock Purchase Plans
  • Paid parental, adoption, and caregiver leave
  • Wellness Offering
  • Deferred compensation for specific roles
  • Fitness reimbursement
  • Tuition Reimbursement
  • Professional development programs