The opportunity
As a Manager in Global Regulatory Medical Writing, you will write and edit high-quality clinical regulatory documents, including submission summaries and other complex materials critical for drug development and product registrations. You will also provide guidance, basic oversight, and resource management to ensure the seamless production of clinical research documentation that supports our mission to deliver innovative healthcare solutions.
How you’ll spend your day
Write and edit clinical regulatory documents, including submission summaries and other complex documents
Types of documents: lead author for clinical regulatory documents, including but not limited to
Protocols
clinical study reports
CTD Clinical Overview M2.5 and Clinical Summaries M2.7.1, M2.7.2, M2.7.3 and M2.7.4
ISS/ISE
investigator brochures
briefing documents
responses to regulatory authority questions
Other daily duties:
Individual contributor who works independently with minimal supervision
Proficiency in applying statistical and regulatory concepts when writing clinical regulatory documents
Ability to efficiently work on multiple documents simultaneously as the lead writer
Offer leadership and basic accountability, provide strategic assistance, and planning support for clinical regulatory documents.
Collaborate with cross-functional teams to ensure high-quality documents are produced within the given timeframe.
Lead comment resolution meetings to resolve issues pertaining to documents and guide the team to successful resolution.
Contribute to the preparation and revision of document templates to enhance process efficiency and quality.
Ensure that documents include the proper content and context with clear, accurate, and consistent medical/scientific messaging.
Ensure documents adhere to applicable regulatory guidelines and departmental and editorial standards – just rephrased this sentence for better clarity.
May manage contingent workers and/or vendors, offering training and resource management support.
