6 months ago
As an Associate Director of Regulatory Writing , you will prepare clinical documentation to support global regulatory submissions. You will have the opportunity to develop expertise in the preparation of a wide range of documents, particularly for protocol development. You will work collaboratively within cross-functional teams (eg, Regulatory Affairs, Clinical Research, Clinical Operations, Clinical Pharmacology, Global Patient Safety, and Clinical Data Science) to lead protocol development for large clinical programs and drive document strategy for Medical Writing. Direct experience in protocol authoring or management is highly preferred.
Key responsibilities include:
- Past experience working on Oncology/Virology Regulatory documents
- Lead the development of protocols and amendments for Medical Writing in the Oncology, Virology, or Inflammation therapeutic areas, including development and management of timelines and resource planning, supporting large clinical programs.
- Independently author clinical/regulatory documents such as protocols and amendments, CSRs (all phases), and IBs according to regulatory requirements and internal document standards.
- Author high complexity documents such as integrated CTD summaries/overviews, PIPs/PIP modifications, or regulatory responses with some input from a more senior writer.
- Oversee contract medical writers on protocols and amendments to ensure the highest quality of medical writing and adherence to internal document standards.
- Collaborate with other lead writers to support a development program from first study through regulatory submissions.
- May coach, train, and provide guidance to less experienced writers.
- Participates in development/improvement of document standards, templates, and processes and other non-medical writing activities.
You Will Need:
- The ability to understand the needs of a team and manage their expectations and to use various communication styles to work effectively with teams
- The ability to balance integrity and efficiency when managing attention to detail
- In-depth knowledge of industry regulations, regulatory documentation requirements, and medical writing processes and standards
- Investigator's Brochure preparation experience
- Proficient in the use of Microsoft Office and document management system
- Bachelor’s degree, or local equivalent, or equivalent experience qualification
- Relevant experience includes clinical R&D, regulatory affairs, or related industry/academic experience, with direct experience preparing clinical/regulatory documents in a medical writing/clinical submissions environment.