FAQs
What is the primary role of the Medical Writing Manager?
The primary role of the Medical Writing Manager is to prepare clinical documentation for global regulatory submissions, ensuring compliance with regulatory requirements and internal document standards while collaborating with cross-functional teams.
What types of documents will I be responsible for authoring?
You will be responsible for authoring clinical/regulatory documents such as clinical study reports, protocols and amendments, investigator brochures, as well as potentially integrated clinical summaries, pediatric investigation plans, and regulatory responses.
Will I work independently or as part of a team?
You will work as part of a team, collaborating closely with other medical writers and cross-functional teams, providing guidance and support on document strategy and presentation of data.
What qualifications are needed for this position?
A Bachelor’s degree (or local equivalent) or relevant experience in clinical research and development, regulatory affairs, or a related field is required, along with direct experience preparing clinical/regulatory documents in a medical writing or clinical submissions environment.
Are there specific knowledge areas that are important for this job?
Yes, important knowledge areas include regulatory document requirements and guidelines, as well as an understanding of pediatric plans such as PIPs, PSPs, and PPSRs.
What skills are necessary to succeed in this role?
Key skills include the ability to manage team expectations, adaptability in communication styles, attention to detail, and proficiency in Microsoft Office and document management systems.
Will I have the opportunity to participate in the development of document standards?
Yes, you will participate in the development and improvement of document standards, templates, processes, and may engage in other non-medical writing activities.
What kind of experience is considered relevant for this position?
Relevant experience includes a background in clinical research and development, regulatory affairs, or related industry/academic experience, particularly within a medical writing or clinical submissions environment.