Senior Regulatory Medical Writer

March 7

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Clinigen

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Clinigen is a specialized pharmaceutical company focused on providing access to medicines for patients worldwide. With a mission to accelerate the journey through clinical development, Clinigen supports pharmaceutical and biotech companies, healthcare professionals, and patient groups by offering services in clinical trial supplies, packaging, labeling, and supply chain management. The company's global reach allows it to facilitate market access and managed access programs, ensuring patients receive innovative medicines regardless of geography. Clinigen also provides regulatory affairs and pharmacovigilance services to enhance patient safety and compliance. Dedicated to sustainability and addressing rare diseases, Clinigen partners with organizations to meet unmet medical needs, while their expertise in licensed and unlicensed distribution furthers their impact across 130+ countries. Their comprehensive services make them a vital player in the healthcare industry, committed to improving patient outcomes globally.

Clinical trial services • Specialty pharmaceuticals • Unlicensed medicines • Managed access • Comparator drugs

1001 - 5000 employees

Founded 2010

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🧬 Biotechnology

📋 Description

• Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. • Currently seeking a detailed orientated and collaborative Senior Regulatory & Scientific Writer to join our expanding team. • You will be responsible for producing high-quality scientific and regulatory documents that support the development and commercialisation of pharmaceutical and biotechnology products across a variety of therapeutic areas. • Your valuable work will contribute to the success of regulatory submissions to EU, US, UK and other global Health Authorities, and various medical communications, ensuring that all documents meet the highest standards of accuracy, clarity, and compliance. • This is a 12-month maternity cover fixed-term contract, with possibility of becoming a permanent position as we continue to grow and expand our team. • For the right candidate, there could be excellent opportunities to build a long-term career with us. • Key Responsibilities include Regulatory & Scientific Writing, Collaboration & Coordination, Editing & Quality Control, Medical Literature & Research, Regulatory Compliance & Documentation Standards.

🎯 Requirements

• A degree in life sciences (e.g., Biology, Pharmacology, Medicine, or related fields) is required; advanced degree (e.g., MSc, PhD, MD) preferred. • Minimum 3 years’ experience as a medical writer within a pharmaceutical, biotech, or CRO environment, with experience in authoring clinical and/or regulatory documentation. • Familiarity with drug development processes, regulatory submission requirements, and guidelines. • Experience with clinical trial documentation and regulatory submissions. • Previous experience in writing for specific therapeutic areas (e.g., oncology, neurology) is a plus • Excellent written and verbal communication skills, with a strong attention to detail and commitment to accuracy and quality. • Ability to interpret complex scientific data and present it in a clear and concise manner. • Knowledge of clinical research terminology, medical literature, and regulatory guidelines. • Understanding of biostatistics principles. • Strong organisational and project management skills with the ability to manage multiple deadlines. • Collaborative mindset and ability to work effectively in a team environment. • Critical thinking and problem-solving skills to address challenges and improve document processes. • Excellent presentation skills. • Fluent English (oral and written).