Medical Writer – Clinical Regulatory Documentation

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Logo of Perspective Therapeutics

Perspective Therapeutics

51 - 200 employees

Founded 2023

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 $400k Grant on 2024-02

Biotechnology • Healthcare Insurance • Pharmaceuticals

Perspective Therapeutics is a biotechnology company focused on developing innovative cancer treatments through a unique class of theranostics. Their proprietary technologies enable the targeting of specific tumors for treatment while minimizing toxicity to healthy tissues. By utilizing radiation, radiopharmaceuticals, and advanced imaging technologies, they aim to improve treatment efficacy and provide better outcomes for cancer patients.

📋 Description

• Prepare and deliver high-quality, scientifically accurate, and regulatory-compliant clinical/medical documentation • Collaborate with cross-functional teams • Author clinical/regulatory documents, including protocols, CSRs, IBs, and clinical modules for INDs/CTAs, NDAs/MAAs • Participate in document reviews and revisions • Manage document preparation within established timelines

🎯 Requirements

• 5-8 years in medical writing within the pharmaceutical, biotechnology, or clinical research industry • Experience in oncology therapeutic area is highly preferred • Familiarity with global regulatory requirements for clinical documentation (e.g., FDA, EMA, ICH) • Strong understanding of clinical trial processes and regulatory submissions • A minimum of a Bachelor’s degree in a life sciences discipline

🏖️ Benefits

• Medical Writing • Cross-Functional Collaboration • Regulatory Compliance • Document Review and Revision • Quality Assurance • Project Support • Knowledge Management

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