Senior Regulatory Writing
Role and Responsibilities:
Your roles & responsibilities include, but are not limited to:
Drafting/Reviewing/Editing
- Scientific documents like manuscripts, abstracts, posters, slide decks, training content, white papers, internal and external reports
- Regulatory documents like dossiers for product approval: CER, 510 (k) filing, IVD submissions, responding to regulatory queries
- Medico-marketing documents like newsletters, product monographs, brochures, leave behind leaflets, patient education
- Development of technical SOP’s and technical processes to ensure quality of documents and deliverables
Training & Development
- Prepare training plan for internal and external trainings
- Development of content for internal and external workshops and client projects.
- Take trainings sessions, review the assignments and give feedback to the students
- Subject matter expert for medical device and IVD training content
Project and Client Management
- Track the progress of projects and individual document assigned to the team. Estimate effort hours and track work in progress.
- Supporting BD with their queries for prospective projects.
- Manage client communication for all the assigned projects.
- Prompt response to client emails and resolving client queries/concerns
- Resource allocation and team alignment