Director of Medical Writing

Regulatory Professionals is a consultancy firm specializing in drug, biologics and device regulatory affairs. Our purpose as a company is to support our clients by furthering the development of human therapeutics that will benefit the health and well-being of patients around the world. With a presence in the US, EU, Canada and Japan we are growing and looking for talented people to grow our business, advance the goals of our clients and contribute to our unique culture.

The Director of Medical Writing is responsible for building a team of professionals and mentoring, managing, and authoring the review and approval of clinical and regulatory documents for clinical research including but not limited to clinical study reports, protocols, investigator’s brochures, clinical sections of the common technical document, and other clinical documents. Ensures conversion of scientific data into a clear, scientifically sound, well-structured scientific, clinical and regulatory submission documents to global health authorities which follow relevant styles and references in support of the company’s product development plans and objectives.

Responsibilities

  • Manage, mentor, recruit and build out the medical writing practice at Regulatory Professionals.
  • Independently or with minimal supervision writes, manages, reviews, formats and obtains approval of clinical documents including, clinical study reports, plan outlines, protocols, documents for regulatory submissions (e.g. meeting packages, investigational new drug (INDs) applications, and sections of marketing applications (NDA/BLA/MAA/CTD)), investigator brochures, or other clinical and regulatory documents
  • Interprets clinical and non-clinical data in the preparation of various documents
  • Coordinates with other internal regulatory affairs and regulatory operations team members to develop deliverables for clients
  • Reviews all relevant documents and interacts with internal regulatory team members and external clients to develop a thorough understanding of project timelines

Qualifications - Skills/Knowledge Required:

  • Previous experience and desire to mentor, recruit, and build out a medical writing team
  • Degree in scientific discipline required; advanced scientific degree (PhD) preferred
  • Has at least 4-6 years of experience as a medical writer. International experience desirable
  • Knowledge and experience with Common Technical Document content templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
  • Excellent working knowledge of software programs in Windows environment with high proficiency in word processing, flow diagrams, and spreadsheets
  • Ability to learn fast, grasp the ‘essence’ of a strategy or a story quickly to convert relevant scientific data/information into high quality summaries and reports
  • Excellent organizational, writing, communication and time management skills needed to manage multiple ongoing projects simultaneously and meet timelines
  • Exceptionally keen skills for attention to detail

RPI is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status.

RPI complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for RPI in the U.S.

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