Clinical Development Lead

Contract: Initial 12 Months (Outside IR35)

Location: Burgess Hill (Hybrid Working, up to 3 days per week on site)

Rate: £49.73 - £86.09 per hour (Outside IR35)

We are seeking an experienced Clinical Development Lead (Scientific & Medical Writing) to support the delivery of clinical evidence programmes within a global diagnostics environment. This role will play a key part in the development of clinical and performance evaluation documentation required to support regulatory submissions and product development activities. Working across Clinical Development, Regulatory Affairs, Quality, R&D, and Medical Affairs teams, you will lead the creation of high-quality scientific and regulatory documentation that supports innovative diagnostic solutions and advances patient care.

Key Responsibilities:

As a Senior Document Controller, you will:

Lead the development, authoring, review, and lifecycle management of clinical and performance evaluation documentation.

Collaborate with Clinical Development, Clinical Operations, Regulatory Affairs, Quality, Labelling, and R&D teams to ensure alignment of clinical evidence strategies.

Author and review critical regulatory documents including:

Performance Evaluation Plans and Reports

Clinical Study Protocols

Clinical Study Reports

Investigator Brochures

Regulatory submission documentation

Conduct scientific literature reviews and evaluate published clinical evidence.

Synthesise complex clinical, laboratory, and scientific data into clear, concise, and regulatory-ready reports.

Support clinical evidence generation activities in accordance with applicable regulatory requirements, including IVDR.

Provide scientific expertise and guidance to cross-functional project teams.

Drive documentation quality, consistency, and compliance throughout the product development lifecycle.

What Our Client Is Looking For:

Required Experience and Skills:

Advanced degree (PhD, PharmD, MSc, MD, or equivalent) in Life Sciences, Pharmacology, Biomedical Engineering, Biostatistics, Epidemiology, Clinical Research, or a related scientific discipline.

Significant experience in scientific, medical, or clinical writing within the pharmaceutical, biotechnology, medical device, or diagnostics industry.

Demonstrable experience authoring clinical and regulatory documentation for global regulatory submissions.

Strong understanding of clinical research methodologies and evidence generation processes.

Experience interpreting and communicating complex scientific and clinical data to a range of stakeholders.

Excellent written communication and document management skills.

Strong project management and organisational capabilities, with the ability to manage multiple projects simultaneously.

Proven ability to work effectively within multidisciplinary and cross-functional teams.

Familiarity with regulatory environments including IVDR, GCP, and applicable clinical research regulations.

Desirable Qualifications/Experience:

While not mandatory, the following qualifications and experiences will be advantageous:

Experience working within in-vitro diagnostics (IVD) or medical devices.

Publication history within peer-reviewed scientific journals.

Experience supporting global regulatory submissions.

Knowledge of Performance Evaluation documentation under IVDR.

Experience using AI-enabled tools and technologies to support literature reviews, scientific analysis, and document preparation while maintaining scientific accuracy and regulatory compliance.

If you're ready to take on this exciting challenge and drive customer insights forward, we'd love to hear from you! Apply today to join a forward-thinking organisation that values innovation and excellence.

Apply now!

Please be advised: if you haven't heard from us within 48 hours, then unfortunately your application has not been successful on this occasion. We may, however, keep your details on file for any suitable future vacancies and contact you accordingly.

We use generative AI tools to support our candidate screening process. This helps us ensure a fair, consistent, and efficient experience for all applicants. Rest assured, all final decisions are made by our hiring team, and your application will be reviewed with care and attention