1 week ago

Director, Medical Writing and Publications, Global Medical Affairs

Boston 0 - 0 Permanent

Job Reference: BBBH44209_1626166084


Description:

The Director, Medical Writing and Publications is responsible for strategic publication planning for the companies pipeline programs including those in Research, as well as the preparation of high-quality, strategically aligned medical writing deliverables. This position oversees internal and external resources focused on the development and management of publications, ensuring compliance with the publications planning and approval process.

Main Tasks and Responsibilities:

  • Drive cross-functional, global strategic publication efforts to ensure prioritized submission and publication of data to address unmet educational needs across stakeholder audiences
  • Lead strategic publication planning teams
  • Work with internal and external authors in actively facilitating the development of abstracts, posters, presentations, original manuscripts, and review papers to ensure timely delivery and submission
  • Ensure that medical writing deliverables reflect pillars of the scientific platform and that communication points are consistent across the program
  • Manage and track progress toward goals outlined in strategic publications plans
  • Maintain archives of approved materials, documentation of author participation, and other critical records
  • Review publications for medical and scientific content accuracy in partnership with content owners including Biostatistics
  • Manage assigned publications spend to ensure accurate accounting and reconciliation to available budget
  • Manage all financial and contractual aspects of assigned projects, including vendor relationships
  • Drive the development, implementation and communication of best practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high-quality medical writing deliverables
  • Develop and manage publications budget
  • Ensure consistent adherence to established publication process in accordance with good publication practices; ensure compliance with company policies and procedures



Functional Roles:

N/A

Impact/Influences:

  • Highly cross-functional role requiring strong partnerships with authors and colleagues across KalVista's data-generating functions to support global strategic publication efforts



Skills, Knowledge & Experience:

  • Advanced degree in scientific field required (e.g., PhD, PharmD)
  • Minimum of 5 years of writing and/or publications experience in the pharmaceutical or affiliated industries (e.g., publications agency)
  • History of effective journal selection, optimizing for first-time acceptance, navigating journal submission
  • Knowledge of pharmaceutical industry regulations, guidelines, standards and practices including best practices governing reporting of biomedical research (GPP3, ICMJE, CONSORT, etc.)
  • Ability to work in a deadline-driven, fast-paced environment with competing priorities
  • Ability to interpret and synthesize complex clinical/scientific findings, statistical reports, translate findings and adapt messages for diverse audiences
  • Takes initiative and works independently and collaboratively with minimal supervision
  • Experience leading cross-functional initiatives and/or teams
  • Excellent project management and interpersonal skills
  • Based in Cambridge, MA
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