Senior Final Medical Signatory - Buckinghamshire, United Kingdom - DNA Life Sciences LTD

Description

Responsibilities:

• Review and approve promotional materials, including advertising, marketing collateral, and educational resources, to ensure compliance with regulatory requirements and company policies.
• Serve as the final point of approval for medical communications, such as medical information documents, scientific publications, and medical education materials.
• Provide expert medical guidance and support to internal teams, including marketing, sales, and medical affairs, to ensure accurate and compliant communication of product information.
• Collaborate with cross-functional teams to develop and execute medical strategies aligned with business objectives and regulatory expectations.
• Stay abreast of relevant regulations, guidelines, and industry best practices to inform decision-making and ensure compliance with evolving standards.
• Act as a liaison between the company and regulatory authorities, addressing inquiries and submissions related to medical review and compliance.
• Mentor and train junior staff members on medical review processes, regulatory requirements, and best practices for promotional materials.

Qualifications:

• Medical degree (MD, MBBS, or equivalent) or advanced degree (e.g., PhD, PharmD) required.
• Minimum 2 years of experience in medical affairs, medical communications, or a related field within the pharmaceutical industry.
• Prior experience as a Medical Signatory or similar role, with a proven track record of reviewing and approving promotional materials in accordance with regulatory requirements.
• Deep understanding of pharmaceutical regulations, including but not limited to FDA, EMA, and PMDA guidelines, as well as industry codes of practice (e.g., ABPI, EFPIA).