Molecular Consultants

Clinical Molecular Consultant

Field Management · San Antonio, Texas
 
Description of Account Manager Duties & Responsibilities
Account Manager of Product Stewardship and Support of Clinical Services
 
The Account Manager of Product Stewardship and other clinical services provides expert guidance and leadership to the Product Stewardship and other clinical services function. This position reports to the President of the company and is a remote/self-managed role. This role is a key leader who provides strategic and technical guidance in client experience and offers executive technology support regarding product risk assessment and regulatory requirements impacting products in the Laboratory portfolio. Must have a demonstrated knowledge of regulations for HIPPA, HI-TECH, Federal healthcare regulations as it applies to Anti-Kickback, Sunshine Act, Stark Laws, food drug and device regulations, and the management systems needed to ensure compliance.
 
Position Responsibilities:
  • Ability to assess and manage complex product stewardship and other clinical services programs including, new product/service introduction, licensing, registration, and compliance with applicable regulatory requirements;
  • Ability to work with cross-functional teams to manage and facilitate regulatory compliance within large growth projects;
  • Ability to advocate for and achieve the right level of balance between technology and business to drive the right decisions and visibility for risk management;
  • Ability to create a clear and compelling business case for change (e.g. compliance, business development, process improvement);
  • Strong organizational and management skills to direct the Product Stewardship and other clinical services function; enabling it to effectively partner with business and technology to deliver sustainable products/services that can be used, and disposed of safely;
  • Support other clinical services in their work to determine other clinical services testing needs for product offerings based on business objectives, clinical needs, intended use, and current or proposed global regulatory requirements;
  • Interact with Regulatory Agencies to address technical questions related to product stewardship, safety, and compliance. And provide meaningful input to these organizations to responsibly advocate for product solutions in current markets;
  • Anticipate, assess, and communicate emerging regulations that may impact existing
            product/service lines or benefit new product/service introduction;
  • Participate as a key partner with business leaders in the development of strategic business plans and associated budgets;
  • Manage work and consultant spend on product stewardship and other clinical services;
  • Communicate highly technical and regulatory matters to non-experts;
  • Possess excellent executive communication skills with the courage to take bold action when necessary.
You Must Have:
  • Demonstrated business acumen and the ability to be self-managed / work independently;
  • Outstanding verbal, written, and presentation clarity;
  • Excellent leadership, project management, and team-building skills; with a proven track record of achieving extraordinary results;
  • Demonstrated knowledge of industry standards;
  • Demonstrated capability to work within regulatory areas and emerging regulation conditions.
We Value:
  • Background in a laboratory, law, health science, or related technical discipline;
  • Experience in New Product/Service Introduction;
  • Ability to address/influence a wide range of cultures, disciplines, and levels within the organization;
  • Willingness and ability to work effectively in a self-managed or independent environment;
  • Work to the highest levels of integrity.