
Regulatory Content Specialist
2 days ago
ProPharma is a leading Research Consulting Organization that has been improving the health and wellness of patients for 20 years. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate clients' most high-profile drug and device programs.
Job Description
The successful candidate will be responsible for authoring high-quality regulatory writing deliverables, including clinical, safety, regulatory, device, diagnostics, or disclosures documents. This may involve participating in the authoring of more complex documents under the supervision of senior personnel. The ideal candidate will have excellent communication skills, attention to detail, and the ability to work independently in a fast-paced environment.
Key Responsibilities
- Author high-quality regulatory writing deliverables on time and within budget.
- Interact and communicate directly with clients, lead team meetings, and manage deliverable timelines.
- Collaborate with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed.
- Maintain familiarity with current industry practices, regulatory requirements, and guidelines related to regulatory writing.
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