Senior Clinical Affairs Manager

hace 1 día

Bogotá, Bogotá D.E., Colombia Ingepsy A tiempo completo
Job Description

Ingepsy is a leading medical technology company, dedicated to enhancing patients' mobility and quality of life. As a Clinical Strategy Lead, you will be responsible for driving clinical research outcomes and developing strategic plans to meet business needs.

Job Summary:

We are seeking an experienced Clinical Strategy Lead to join our team. The successful candidate will have a strong background in clinical research, regulatory affairs, or medical writing, with experience in orthopedic medical device marketing and regulations preferred.

Responsibilities:

  • Evaluate clinical evidence requirements on specific products/brands and gather required clinical data in a cost-effective, timely, and efficient fashion.
  • Work closely with Clinical Strategy to ensure projects are aligned with business needs.
  • Critically review and analyze pertinent internal and external scientific content, including documents and reports that provide scientific or economic rationale for the use of marketed Ingepsy products.
  • Participate in Post-Market Surveillance (PMS) process as the clinical representative.
  • May provide literature searches, registry data, or study results for annual reports, notified bodies, or other internal and external needs.
  • Oversight of PMS commitments and aligning study outputs to PMS reviews.
  • Strategically partner with Clinical Affairs & Brand Marketing teams to collaborate, understand, and proactively review marketing deliverables as well as scientific publications and presentations.
  • Support development of clinical data summary by Clinical Evidence to meet tender/reimbursement requirements.
  • Proactively drive clinical research outcomes by developing publication strategies and plans.
  • Collate available clinical evidence for key products and assist in delivering effective presentations on Ingepsy products for multiple audiences.
  • Create and maintain a database of published literature with summaries of key findings for assigned product lines.
  • Grows and maintains collaborative working relationships with internal partners to provide scientific and marketing content development support.
  • Reviews and updates scientific communication dashboards as requested.
  • Supports the development of regulatory documents or reviews based on company needs including regulatory inquiries.
  • Represents Scientific Communications within Clinical Marketing and other cross-functional teams as needed.
  • Creation and maintenance of a claims matrix.

Requirements:

  • Bachelor's Degree required; concentration in Health, Life Sciences, or Engineering preferred.
  • Post-graduate degree preferred.
  • Minimum of three (3) years of experience in clinical research, regulatory, or medical writing environments for medical devices, or an equivalent combination of additional education and experience.
  • Experience in orthopedic medical device marketing and regulations preferred.
  • Strong knowledge of applicable regulations governing clinical studies.
  • Proficient in Microsoft Office Suite.
  • Good Clinical Practice guidelines.

Salary: $120,000 - $150,000 per year

Benefits: Competitive total rewards package, flexible working environment, location-specific benefits, wellness incentives, and a culture of recognition and performance awards.

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