• Serve as the subject matter expert for our products and related data within a Therapeutic Area • Interface with key stakeholders across CMR, Marketing, and the Global organization to drive scientific exchange and communication • Assist the Sr. Medical Director in the development and execution of strategic priorities within a therapeutic area • Lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings for a Therapeutic Area • Assist with the development of strategies to appropriately position the Brand as part of the Novo Nordisk portfolio

Role Description Responsible for reviewing the overall quality and completeness of clinical documentation. Inpatient CDI focuses on the concurrent review of patient records with an emphasis on improving documentation while the patient is still in-house while outpatient CDI focuses on improving clinical staff documentation of outpatient encounters. - Facilitating improved overall quality, education, and completeness and accuracy of medical record documentation. - Promoting appropriate clinical documentation through extensive interaction with physicians, other patient caregivers, HIM coding staff, and other associated staff. - Developing and/or updating medical center policy memoranda pertaining to documentation improvement. - Serving as a technical expert in health record content and documentation requirements. - Performing reviews of health record documentation; developing criteria, collecting data, graphing and analyzing results, creating reports, and communicating with appropriate leadership and groups. - Obtaining appropriate corrective action plans from responsible clinical services directors when necessary. - Recommending improvements or changes in documentation as deemed necessary. - Adhering to established documentation requirements as outlined by accrediting agencies guidelines, regulations, policy, and medical-legal requirements. - Developing and implementing active training/education programs for all providers to ensure the CDIS program objectives are met. - Applying comprehensive knowledge of medical terminology, anatomy & physiology, disease processes, treatment modalities, diagnostic tests, medications, procedures, and the principles and practices of health services. - Selecting and assigning codes from the current version of several coding systems including ICD, CPT, and HCPCS. - Adhering to accepted coding practices, guidelines, and conventions. - Monitoring ever-changing regulatory and policy requirements affecting coded information. - Assisting facility staff with documentation requirements to accurately reflect patient care provided. - Providing technical support in areas such as regulations and policy, coding requirements, resident supervision, and reimbursement. - Ensuring provider documentation is complete and supports the diagnoses and procedures coded. - Directly consulting with professional staff for clarification of conflicting or ambiguous clinical data. - Reporting incorrect documentation or codes in the electronic patient health record. - Using a variety of window-based applications in day-to-day activities, such as Outlook, Excel, Word, and Access. - Ensuring current versions of all software applications are loaded and functional after updates or changes. Requirements - Work Schedule: Monday-Friday 8:00am - 4:30pm - Paid Time Off: 37-50 days of annual paid time off per year (13-26 days of annual leave, 13 days of sick leave, 11 paid Federal holidays per year). - Selected applicants may qualify for credit toward annual leave accrual based on prior work experience or military service experience. - Parental Leave: After 12 months of employment, up to 12 weeks of paid parental leave in connection with the birth, adoption, or foster care placement of a child. - Child Care Subsidy: After 60 days of employment, full-time employees with a total family income below $144,000 may be eligible for a childcare subsidy up to 25% of total eligible childcare costs for eligible children up to the monthly maximum of $416.66. - Retirement: Traditional federal pension (5 years vesting) and federal 401K with up to 5% in contributions by VA. - Insurance: Federal health/vision/dental/term life/long-term care (many federal insurance programs can be carried into retirement). - Remote: Yes - This position is designated as remote. The option for remote work will be assessed continuously, and the selected individual may need to return to a VA office if required. The selectees must live within 50 miles of a VA Medical Center. Qualifications - United States Citizenship: Non-citizens may only be appointed when it is not possible to recruit qualified citizens in accordance with VA Policy. - Experience: One year of creditable experience that indicates knowledge of medical terminology, anatomy, physiology, pathophysiology, medical coding, and the structure and format of health records. - Education: An associate's degree from an accredited college or university recognized by the U.S. Department of Education with a major field of study in health information technology/health information management, or a related degree with a minimum of 12 semester hours in health information technology/health information management. - Completion of an AHIMA approved coding program, or other intense coding training program of approximately one year or more that included courses in anatomy and physiology, medical terminology, basic ICD diagnostic/procedural, and basic CPT coding. - Equivalent combinations of creditable experience and education are qualifying for meeting the basic requirements. - Certification: Persons hired or reassigned to MRT (Coder) positions in the GS-0675 series in VHA must have either Apprentice/Associate Level Certification through AHIMA or AAPC, Mastery Level Certification through AHIMA or AAPC, or Clinical Documentation Improvement Certification through AHIMA or ACDIS. Grade Determinations - MRT (CDIS - Inpatient/Outpatient), GS-9: One year of creditable experience equivalent to the GS-8 of a MRT (Coder-inpatient/outpatient). - An associate's degree or higher, and three years of experience in clinical documentation improvement. - Mastery level certification through AHIMA or AAPC, and two years of experience in clinical documentation improvement. - Clinical experience such as RN, M.D., or DO, and one year of experience in clinical documentation improvement. Demonstrated KSAs - Knowledge of coding and documentation concepts, guidelines, and clinical terminology. - Knowledge of anatomy and physiology, pathophysiology, and pharmacology to interpret and analyze all information in a patient's health record. - Ability to collect and analyze data and present results in various formats. - Ability to establish and maintain strong verbal and written communication with providers. - Knowledge of regulations that define healthcare documentation requirements. - Extensive knowledge of coding rules and regulations, including current clinical classification systems. - Knowledge of severity of illness, risk of mortality, complexity of care for inpatients, and CPT Evaluation and Management (E/M) criteria. - Knowledge of training methods and teaching skills sufficient to conduct continuing education for staff development. Physical Requirements See VA Directive and Handbook 5019, Employee Occupational Health Service.

Role Description The mission of the FDA Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. Tunnell Government Services, Inc. is providing professional and scientific services to the CDRH with expert consultants with scientific expertise in the regulation and approval of medical devices. - Provide consultation related to supporting medical device reviews (EUA, 510(k), PME and De Novo marketing applications, Pre-submissions). - Participate in meetings and teleconferences. - Coordinate meetings with internal and external stakeholders. - Develop written reviews and correspondence. - Perform research and conduct data analysis. - Write detailed documents and reports. - Execute other administrative office tasks related to CDRH’s projects. Tunnell is seeking a candidate to provide expert consulting services to assist the CDRH with their regulatory responsibilities. This candidate should possess specific expertise and training in surgical oncology, as relevant to medical devices. Qualifications - Doctor of Medicine (M.D. or equivalent) from an accredited medical school in the United States. - Current, active, full, and unrestricted medical license or registration as a Physician to practice medicine in a State, District of Columbia, the Commonwealth of Puerto Rico, or a territory of the United States. - At least ten (10) years of relevant clinical experience. - Certification from a U.S. relevant specialty board organization (e.g., the American Board of Surgery (ABS), Society of Surgical Oncology (SSO), etc.). - Thorough understanding of current clinical practices in surgical oncology, including diagnosis and treatment, and current/emerging trends in practice. - Expert in function and utilization of medical devices commonly used as part of surgical oncology. - Familiarity with relevant FDA medical device regulatory processes, regulations (e.g., 21 CFR Part 878 – General and Plastic Surgery Devices), and guidances is preferred. - Ability to communicate well with others using excellent written and verbal communication skills. - Excellent interpersonal skills, with the ability to effectively work both independently and within a team of technical personnel. - Must be a US Citizen or a Full Green Card holder. Requirements - This position is 100% telework. Benefits - Tunnell strives to hire and retain the most qualified talent. - All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

• Lead medical design and oversight for major projects; review and approve protocols, IB, ICF, SAP and key medical documents; provide medical input on feasibility, risk mitigation and endpoint selection. • Oversee drug safety and AE/SAE management; review medical adjudication and causality assessments; collaborate with PV teams and external experts. • Provide medical guidance to project teams, biostatistics and data management; participate in key milestones (per request or specific plan). • Support regulatory interactions and ethics committees; draft/review medical position papers, CSRs and regulatory responses. • Lead and mentor Medical Monitors/Managers; develop capability plans and participate in performance and resource decisions. • Establish/improve medical governance, QA processes and SOPs to ensure high-quality clinical and medical deliverables. • Serve as company medical representative in client meetings, support RFPs (bidding) and engage in medical communications with IRBs/ethics committees and regulators. • In some case role of Safety Physician may be taken.