Senior/Principal Medical Writer - Remote

Regulatory Affairs United States


Description

Position at Regulatory Professionals

Bring your Passion!

Regulatory Professionals, a division of Premier Research, 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. Our focus is to provide strategic and tactical support in all aspects of regulatory affairs, including preclinical, CMC and clinical development for drugs, biologics, devices, and combination products.

We are seeking a talented Senior or Principal Medical Writer to join our growing team at RPI! This position is available as a fully remote role.

RPI is an experienced team of regulatory professionals dedicated to helping our clients advance the development and registration of their products with worldwide health authorities. Our focus is to provide strategic and tactical support in all aspects of regulatory affairs, including preclinical, CMC and clinical development for drugs, biologics, devices, and combination products.

The Senior or Principal Medical Writer works on problems of diverse scope and is responsible for authoring and managing the review and approval of moderate and complex clinical and regulatory documents including but not limited to clinical study reports, protocols, Investigator's Brochures, non-clinical and clinical sections of the Common Technical Document, and other regulatory documents. Converts scientific data into clear, scientifically sound, well-structured scientific, clinical, and regulatory documents intended for global health authorities and stakeholders, which follow relevant styles and provide references in support of a client’s product development plans and objectives, as well as those of RPI. Understands study design and has an excellent working knowledge of Good Clinical Practices. This role manages the efforts of and provides guidance and mentoring to the Medical Writer I/II/III positions.

You will be accountable to:

  • Independently write and format clinical and regulatory documents
  • Project manage assignments
  • Review and approve clinical and regulatory documents including: clinical study reports, in text tables, appendices, addendums, study plan outlines, synopses and protocols, and documents for regulatory submissions (e.g. meeting packages, Investigational New Drug (INDs) applications, and sections of marketing applications (NDA/BLA/MAA), Investigator Brochures, or other clinical and regulatory documents)
  • Ensure timeline adherence for each assigned project, provide project status updates on a regular basis and carry out contractual obligations for each assigned project
  • Work on multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with project managers and clients
  • Interpret clinical and non-clinical data as needed to prepare documents
  • Review all source documents, perform literature searches, and interact with internal regulatory team members and external clients to develop a thorough understanding of project background, timelines, and goals
  • Advise clients on appropriate document preparation and the basic regulatory requirements of various types of documents
  • Aid in study design, GCP-compliance, and effective responses to health authorities
  • Write Integrated Summaries of Safety and Efficacy (ISS and ISE), and guide more junior writers to assist in their preparation
  • Edit and QC documents for other company medical writers and for Regulatory Affairs team members
  • Identify and solve problems relating to medical/regulatory writing issues
  • Coordinate with other internal Regulatory Affairs and Regulatory Operations team members to develop deliverables for clients
  • Contribute to the development and maintenance of the Regulatory Affairs working practices and procedures, as well as help update and maintain templates
  • Assist in the review of statistical analysis plans (SAPs) prior to database lock and provide feedback to the team when appropriate
  • Manage the efforts of other writers and mentor more junior writers

You will need this background to be considered:

  • Bachelor’s degree, or international equivalent from an accredited institution in a scientific discipline, journalism, or English; MS or PhD/PharmD in a scientific or medical discipline preferred
  • BA/BS and 5-10 years of experience in medical/technical writing; or MS and 4 years of experience in medical/regulatory writing; or PhD/PharmD and 2+ years of experience in medical/regulatory writing
  • International experience desirable (EMA, TGA, PMDA)
  • Depth of industry and drug development knowledge
  • Expert in literature search techniques
  • Strong knowledge and experience with Common Technical Document templates as well as content expectations for IND/NDA/BLA/MAA and other regulatory documentation
  • Superior working knowledge of software programs in Windows environment with excellent 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 and/or other writers simultaneously
  • Well-developed analytical skills and strong knowledge of medical terminology
  • Cross therapeutic experience across therapeutic areas and phases
#LI-AB1