Senior Regulatory & Medical Writer - (12 Month FTC)

Clinigen; United Kingdom; On-site; GBP 40,000 - 70,000; Full time

Job description

Clinigen is a rapidly growing global specialty pharmaceutical services business with a unique combination of services across the pharmaceutical lifecycle. We currently have over 1,000 employees headquartered in the UK with global offices in the US, EU (Belgium, Germany, France), Asia Pacific and South Africa. Clinigen is growing rapidly and is positioned well for an exciting future of continued expansion.

To support our growth, we are 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.

Please note this is a 12-month maternity cover fixed-term contract, with the 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:

Regulatory & Scientific Writing:

1. In relation to the development and regulation of novel medicines, develop, write, and edit various scientific and regulatory documents, including clinical study reports, investigator brochures, CTD modules, briefing documents, and manuscripts for publication.
2. Ensure all documents comply with regulatory requirements, industry guidelines and internal company standards.
3. Participate in interpreting and planning of data presentation to be used in individual study reports and summary documents for nonclinical and clinical programmes.
4. Contribute to the development of templates, style guides, and writing best practices.
5. Assist in responding to Regulatory Agency queries and document revisions as required.

Collaboration & Coordination:

1. Collaborate with cross-functional teams, including nonclinical and clinical team members, regulatory affairs staff, biostatisticians, and medical affairs, to gather information and ensure the accuracy of scientific data.
2. Review and incorporate feedback from team members and stakeholders, in line with project plan and timelines.
3. Together with senior regulatory affairs colleagues, ensure alignment of work with client objectives and relevant regulatory requirements.
4. Ensure adequate medical writing resources are available for assigned project and consistency between documents.
5. Attend and contribute in client meetings, lead comment resolution/roundtable meetings.

Editing & Quality Control:

1. Perform quality control reviews of documents to ensure consistency, grammar, and adherence to templates.
2. Ensure that all content meets the highest standards of clarity, accuracy, and scientific integrity.

Medical Literature & Research:

1. Conduct literature reviews and stay up-to-date with relevant medical and pharmaceutical guidelines.
2. Provide scientific expertise in interpreting data and transforming it into clear documents/summaries.

Regulatory Compliance & Documentation Standards:

1. Together with senior regulatory affairs colleagues, ensure that all documents comply with applicable regulatory requirements, industry guidelines, and company standards.
2. Maintain up-to-date knowledge of regulatory writing trends and pharmaceutical industry standards.

Requirements:

1. A degree in life sciences (e.g., Biology, Pharmacology, Medicine, or related fields) is required; advanced degree (e.g., MSc, PhD, MD) preferred.
2. Minimum 3 years' experience as a medical writer within a pharmaceutical, biotech, or CRO environment, with experience in authoring clinical and/or regulatory documentation.
3. Familiarity with drug development processes, regulatory submission requirements, and guidelines.
4. Experience with clinical trial documentation and regulatory submissions.
5. Previous experience in writing for specific therapeutic areas (e.g., oncology, neurology) is a plus.

Additional Skills:

1. Excellent written and verbal communication skills, with a strong attention to detail and commitment to accuracy and quality.
2. Ability to interpret complex scientific data and present it in a clear and concise manner.
3. Knowledge of clinical research terminology, medical literature, and regulatory guidelines.
4. Understanding of biostatistics principles.
5. Strong organisational and project management skills with the ability to manage multiple deadlines.
6. Collaborative mindset and ability to work effectively in a team environment.
7. Critical thinking and problem-solving skills to address challenges and improve document processes.
8. Excellent presentation skills.
9. Fluent English (oral and written).

Software Proficiency:

1. Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
2. Proficient with reference management tools (e.g., EndNote, Reference Manager, Zotero).
3. Familiarity with medical publishing standards and platforms.

Interested? We would love to hear from you, please apply today for consideration.