Careers


Position:  Director of Patient Services

Date:  July 31, 2018

Job Summary:  

Longeveron LLC is an emerging cellular therapy company whose mission is to advance the field of regenerative medicine through the conduct of clinical trials of our novel stem cell products.  We are seeking a dynamic and experienced professional to grow with our team as the Director of Patient Services.  This position is on-site at Longeveron’s headquarters in Miami, Florida and reports to the International Executive Director.

Responsibilities:

This position involves implementation and management of the Company’s international clinical programs under the guidance of the Company’s senior leadership.

Specific responsibilities include:

  • Identify and work with partner physicians and patients.
  • Collect and review patients medical and other materials.
  • Coordinate and oversee patients’ experience and follow-ups.
  • Assure an excellent customer service experience patients.
  • Assist with regulatory compliance with all aspects of the Longeveron programs.
  • Prepare scientific/medical/regulatory documents, protocols, SOPs, and miscellaneous documents on behalf of Longeveron for submission to international regulatory agencies and the Food and Drug Administration (FDA) (e.g., Investigational New Drug applications, annual reports, preclinical and clinical study reports, safety reports, and Investigator Brochures).
  • Assist with oversight of Longeveron programs.
  • Assist with medical writing as needed, including informed consent forms, patient communications and various regulatory materials.
  • Adhere strictly to stipulated timelines.
  • Adhere to work hours as needed to complete required tasks (may be required to work after hours and/or weekends as needed as part of stipulated salary);
  • Travel to conferences and other designated venues as required.
  • Perform other related duties as assigned or requested.

Minimum Education & Experience:

  • Registered Nurse with current U.S. licensure (required).
  • Familiarity with Infusions, and/or Geriatrics, cardiovascular, immunology a plus.
  • Minimum of 5 years of experience in nursing in a pharmaceutical/biotech industry, concierge medicine or academic research, with demonstrated results (strongly desired).
  • Superior computer skills and general computer literacy.
  • Excellent communication skills (English language; written and verbal)
  • Proficiency in Microsoft Office (particularly Word, Excel and PowerPoint)
  • Excellent interpersonal/human relations skills; ability to work collaboratively in a fast-paced team environment.
  • Outstanding customer service skills.
  • Logical thinking, attention to detail.

For further detail please contact:

info@longeveron.com


Position:  Medical Writer

Date:  June 15, 2018

Job Summary:  Longeveron LLC is an emerging cellular therapy whose mission is to advance the field of regenerative medicine through the conduct of clinical trials of our novel stem cell products.  We are seeking a dynamic and experienced professional to grow with our team as a Medical Writer.  This position is on-site at Longeveron’s headquarters in Miami, Florida.

Responsibilities: 

This position involves preparing scientific and regulatory documents on behalf of Longeveron for submission to the Food and Drug Administration (FDA) (Investigational New Drug applications, annual reports, preclinical and clinical study reports, safety reports, and Investigator’s Brochures); performing literature searches; preparing and editing manuscripts, meeting reports and proceedings, and safety documents; and data analysis.  This position also requires experience in writing grants proposals.  Additional responsibilities include:

  • Develop necessary regulatory expertise, and propose regulatory strategies, meetings and response to FDA comments.
  • Prepare medical/scientific/regulatory documents, SOPs, and miscellaneous documents.
  • Maintain databases.
  • Contribute to design of databases of scientific and drug development information.
  • Prepare grant applications to federal and state agencies, foundations, etc.
  • Adhere strictly to stipulated timelines.
  • Adhere to work hours as needed to complete required tasks (may be required to work after hours and/or weekends as needed as part of stipulated salary);
  • Perform other related duties as assigned or requested.

Minimum Education & Experience:

  • D. in pharmacology, biochemistry, molecular biology, immunology, or a related field; or PharmD (required).
  • Familiarity with Geriatrics, cardiovascular, immunology a plus.
  • Industry experience (preferred).
  • Minimum of 5 years of experience in medical writing in a CRO or pharmaceutical/biotech industry (strongly desired).
  • Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines.
  • Experience in managing and directing medical writing projects.
  • Strong familiarity with Regulatory Agency guidelines, including Good Clinical Practice.
  • Advanced knowledge of scientific methodology in the design, conduct and description of clinical research.
  • Expertise in analyzing and describing research results.
  • Familiarity with statistical principles/concepts used in clinical research.
  • Superior computer skills and general computer literacy.
  • Excellent communication skills (English language; written and verbal)
  • Proficiency in Microsoft Office (particularly Word, Excel and PowerPoint)
  • Excellent interpersonal/human relations skills; ability to work collaboratively in a fast-paced team environment.
  • Logical thinking, attention to detail.

Submission of published writing samples will be requested during the interview process. A writing test may also be required.

For further detail please contact:

info@longeveron.com