Freelance Clinical Expert (EU-Based) - Signatory for Clinical Reports & Summaries

We are looking for an experienced freelance Clinical Expert to act as a regulatory signatory for clinical overviews in the EU/UK. The successful candidate will be capable of reviewing and signing clinical reports and clinical summaries, ensuring compliance with EMA and ICH guidelines.

Key Responsibilities:

Review and sign clinical reports and clinical summaries for regulatory submissions.

Ensure compliance with EU regulatory requirements, including EMA, ICH E3, and GCP principles.

Provide expert assessments on clinical data, safety, and efficacy to support product approval.

Collaborate with regulatory teams to ensure high-quality documentation for submission.

Offer strategic advice on clinical aspects of product development and regulatory strategies.

Requirements:

Medical degree (MD) or advanced degree in Clinical Pharmacology, Medicine, or a related field.

Extensive experience in clinical research, clinical development, and regulatory submissions.

In-depth knowledge of EMA and ICH guidelines, including GCP (Good Clinical Practice).

Ability to provide legally recognized expert signatory services for clinical documents.

Strong analytical, communication, and decision-making skills.

Preferred Qualifications:

Board-certified physician or equivalent accreditation in a relevant clinical specialty.

Prior experience in pharmaceutical, biotech clinical works

Previous experience in a freelance or consultancy role for clinical document review.

Job Type:

Freelance/Contract-Based

Remote work with flexibility

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