Position Overview

Provides medical expertise for developing clinical evaluations, risk management, and /or clinical studies. Conducts literature analyses and critical review and appraisal of medical literature for clinical evaluation reports or clinical trial protocols and scientific publications. This position will support medical monitoring and external physician committee activities. Job duties might include:
  • Provide medical support to justify trial design and ongoing scientific analysis during protocol development, including generation of pre-protocol documentation of scientific information.
  • Synthesize literature and competitive information across multiple products and/or therapies within the assigned therapeutic area.
  • Responsible for updating medical affairs procedural documents and submitting change requests when needed.
  • Generate documents to support regulatory submissions and/or respond to questions from regulatory authorities about existing submissions.
  • Review and critically analyze clinical data and statistical analysis plans.
  • Support the generation of white and position papers by evaluating scientific literature, analyzing medical data and staying abreast of current medical practice.
  • Assist the medical director with direct customer interactions as needed.
    1. Minimum qualification for this position is PhD degree in a relevant science.
    2. A minimum of three (3) years of relevant experience.
    3. An M.D. degree with clinical academic or industry experience in relevant field is highly preferred.
    4. Ability to function successfully in a highly matrixed and geographically diverse business environment.
    5. Strong leadership skills since position requires significant interaction with executive leadership, physicians and regulatory authorities.
    6. Willing to travel up to 30%.
    7. Experience as author or contributor or peer-reviewed manuscripts is strongly desired.
    Desired Qualification
    1. Excellent writing and editing skills, and a keen attention to detail.
    2. Strong verbal, written, and interpersonal communication skills.
    3. Clinical protocol development experience.
    4. Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases.
    5. Proven analytical skills working with clinical or research data.
    6. Strong leadership skills and ability to work collaboratively within a diverse, global, matrixed organization.