Associate Director/Director, Medical & Regulatory Writing - Remote
Bring your Passion to RPI!
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 an Associate Director, Medical and Regulatory Writing to join our growing team at RPI!
The Associate Director -Medical and Regulatory Writing is responsible for managing other internal or external (contract) medical/regulatory writers, assigning projects to direct reports, and assuring the quality of a direct report’s work. In addition, this individual also fulfills the role of a senior level medical/ regulatory writer: authoring, managing and providing critical oversight of clinical and regulatory documents including but not limited to clinical study reports, protocols, Investigator Brochures, non-clinical and clinical eCTD summaries and overviews, integrated summaries, meeting packages and other clinical or regulatory documents. This individual should also be a technically skilled and strategic regulatory writer with deep experience with and understanding of document development, ICH guidelines and Good Clinical Practice, a well-honed ability to convert scientific data into clear, well-structured, scientifically sound, clinical and regulatory documents intended for global health authorities and stakeholders.
What you'll be doing:
- Work with the Head of Medical and Regulatory Writing to resource writers across the larger portfolio of work
- Manage personnel and workload to ensure timely deliverables; evaluate performance and provide feedback accordingly
- Ensure timeline adherence of reports and self, provide project status updates on a regular basis to stakeholders, RPI leads and Head of Medical and Regulatory Writing (or another manager)
- Manage contractual obligations for each assigned project, and assure reports meet obligations
- Manage the mentoring and training of writing team members
- Contribute to the development and maintenance of the Medical and Regulatory Writing working practices and procedures, as well as lead efforts to maintain and update templates, style guides, SOPs, etc
- Coordinate with other internal Regulatory Affairs and Regulatory Operations leads to organize efforts to efficiently and seamlessly develop submission deliverables for clients
- Able to utilize reports to assist in the preparation of multiple-document projects
- Create strategies and timelines for the creation of regulatory submissions (e.g. meeting packages, Investigational New Drug [INDs] applications, and sections of marketing applications [NDA/BLA/MAA])
- Advise clients on appropriate document preparation and the basic regulatory requirements of various types of documents. Aid in development of submission messaging, assist with study design, advise to achieve effective health authority interactions, and assure ICH and GCP-compliance
- Lead multiple projects and/or project teams at one time (dependent on complexity and time commitment for each project) in collaboration with other writers, RPI leads and stakeholders
- Act as a senior level medical/regulatory writer; contribute to clinical and regulatory document creation, review the work of reports
- Interpret clinical and non-clinical data as needed to prepare documents
- Create or critically review ancillary documents required for submissions or interactions
- Assist in the editing and QC of documents for other company medical/regulatory writers and for the Regulatory Affairs team
- Write Integrated Summaries of Safety and Efficacy (ISS and ISE), and be able to utilize reports to assist in their preparation
- Work independently with minimal supervision
- Bachelor’s degree or equivalent from an accredited institution in a scientific discipline, journalism, or other major that requires excellent writing skills and extensive documentation experience in the pharmaceutical or related industry; MS, PharmD or PhD in a scientific discipline preferred
- 10 or more years of experience in CRO/ Pharmaceutical/ Biotechnology or Medical Device industries and 7 or more of progressive medical/technical writing experience, or 5 or more years if MS, PharmD, PhD or equivalent
- Five or more years of people management experience
- Ability to learn fast, devise a strategy or develop messaging quickly to convert relevant scientific data/information into high-quality summaries and reports, and a depth of knowledge and industry experience in drug development
- Excellent organizational, writing, communication and project management skills and ability to apply these to manage multiple reports or projects simultaneously
- International regulatory experience (EMA, TGA, PMDA) preferred
- Extensive experience with Common Technical Document content
- Superior working knowledge of software programs in Windows environment with excellent proficiency in word processing, flow diagrams, and spreadsheets