Senior Final Medical Signatory

4 weeks ago


Buckinghamshire, United Kingdom DNA Life Sciences LTD Full time

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).



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