• Serving as medical point person on assigned accounts • Developing, writing and translating complex scientific data to a broad audience across multiple and wide-ranging therapeutic areas • Ensuring project quality and outcomes by demonstrating in depth technical expertise of assigned therapeutic category and/or managed care areas • Developing strategic content for full range of medical content (slide presentations, advisory boards, strategy guides, monographs, discussion guides, training resources, etc.) • Working closely with account teams to refine content in keeping with strategic imperatives • Communicating medical content with internal team and pharmaceutical clients, as necessary • Attending medical, legal, regulatory review meetings • Participating in internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings • Chipping in ideas for new business proposals and tactical planning within assigned accounts • Mentoring junior level writers

• Lead the preparation, update, and quality control of Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) • Design and document systematic literature searches, appraise clinical evidence, and produce evidence synthesis • Support PMCF planning and reporting, and where applicable, the SSCP • Translate clinical and technical data into scientific manuscripts, research summaries, and white papers • Act as the link between clinical, R&D, and regulatory teams, ensuring clinical evidence is reflected in documentation • Establish project-specific style guidelines and maintain high quality standards

Role Description Our mission is to prevent vision loss and ultimately blindness by developing AI software that assists eye doctors in therapy planning for their patients. We use computer vision deep learning models (AI) trained on thousands of cases and millions of images to predict disease progression, individualize therapy and improve outcomes. The decision support algorithm targets widespread eye diseases like Age-related Macular Degeneration (AMD, 7.5mio affected in Germany alone). What you'll do - Clinical Evaluation (core assignment): Lead the preparation, update, and quality control of the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER) in accordance with Regulation (EU) 2017/745 (EU MDR), Article 61 and Annex XIV, Part A, following the methodological principles of MEDDEV 2.7/1 rev. 4. - Literature search & appraisal: Design and document systematic literature searches, appraise clinical evidence, and produce a traceable, audit-ready evidence synthesis suitable for review by our Notified Body. - Post-market clinical follow-up: Support PMCF planning and reporting (Annex XIV, Part B) and, where applicable, the SSCP. - Scientific publications (secondary): Translate clinical and technical data into scientific manuscripts, research summaries, and white papers for peer-reviewed journals and other channels. - Cross-functional collaboration: Act as the link between our clinical, R&D, and regulatory teams, ensuring clinical evidence is accurately reflected in the technical documentation. - Documentation standards: Establish project-specific style guidelines and maintain high quality standards, ensuring compliance with relevant regulatory requirements. Qualifications - Suitably qualified evaluator: Meet the competency expectations for clinical evaluators, including expertise in the diagnosis and management of the target indication, and qualifications are documentable (e.g., CV) for Notified Body review in line with EU MDR Annex XIV and MEDDEV 2.7/1 rev. 4. - Working style: Reliable freelancer mindset with strong project management, ability to work with cross-functional stakeholders (Clinical, RA/QA, R&D) and meet timelines. - Publication support: Demonstrated experience drafting and editing scientific manuscripts/abstracts/posters and other clinical/scientific communications in English. - Medical device experience (SaMD/digital health preferred): Proven track record (5+ years) in medical writing for medical devices (ideally SaMD/AI) with strong understanding of intended purpose/claims and how they map to clinical evidence. - Clinical evidence synthesis: Ability to plan and execute (or manage) systematic literature searches, critically appraise clinical data, and synthesize evidence for safety, performance, and clinical benefit; traceable, audit-ready documentation and referencing. - EU MDR clinical evaluation expertise: Hands-on experience authoring and/or updating Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance with Regulation (EU) 2017/745 (EU MDR), incl. MEDDEV 2.7/1 rev. 4 principles, and strong familiarity with MDR requirements for clinical evaluation and clinical evidence (e.g., Annex XIV Part A and Part B; relevant links to Annex II/III where applicable). Requirements - Your nice-to-haves: - Advanced degree (Master/PhD) in a scientific or health-related field. - Experience in ophthalmology, medical AI, or digital health. - Proficiency in German (C1). Benefits - Project-based collaboration - Flexible, fully remote setup - Potential for long-term partnership on upcoming clinical and regulatory projects - Startup culture & a great, international team - High personal responsibility for your project & fast personal growth - Direct impact on improving quality of life for our end users (patients) Company Description deepeye is a fast-growing medical device software startup based in Munich, with an international rockstar team spread mostly across Germany.

Role Description Under the direction of The Administrator, Coding & Clinical Documentation Improvement and Patient Access, the Manager of Clinical Documentation Integrity (CDI) and DRG Denials is responsible for the day-to-day operation of the CDI department and DRG Denials appeals process. The Manager will: - Develop, implement, and evaluate processes, policies, and procedures related to clinical documentation improvement for all Garnet Health hospitals. - Lead CDI functions and oversee the day-to-day work in the department. - Ensure that reviews of the patient’s medical data are conducted to assess appropriateness and medical necessity for admission and continued stay. - Facilitate improvement in the overall quality, completeness, and accuracy of medical record documentation. - Evaluate denials and work closely with the outcomes manager and coding denial coordinator to oversee and write compelling, factual arguments when warranted to the third parties denying claims. Join the Garnet Health team and let your excellence shine. Compensation for the role is $80,106-$100,133 USD per year. Fully remote from the following states: Pennsylvania; Florida; South Carolina; North Carolina; Texas. Garnet Health System provides a compensation range to comply with the New York State law on Salary Transparency in Job Advertisements. The range or contractual rate listed does not include bonuses/incentives, differential pay, or other forms of compensation or benefits. When determining a team member’s compensation and/or rate, several factors may be considered as applicable (e.g., location, specialty, service line, years of relevant experience, education, credentials, negotiated contracts, budget, and internal equity). Qualifications - Bachelor's Degree in Nursing - Minimum of 3-5 years of progressive experience in an acute care hospital (larger than 100 beds) - Minimum of five years of experience in the CDI industry - Strong knowledge of ICD 10 diagnosis coding, CPT Coding guidelines, and DRG-based reimbursement knowledge - Exceptional ability to communicate effectively with physicians and other clinical professional staff - Knowledge of DRG and Coding appeal process Requirements - Certified Clinical Documentation Specialist (CCDS) credentialed within 6 months - Current license to practice as a Registered Professional Nurse in New York State required - Travel to multiple facilities is required Working Conditions - Environmental Demands and Exposure to Hazards: Works in a clean, well-lighted, heated, or ventilated facility. No routine exposure to hazards. - Physical Demands: Demonstrates physical and functional ability to perform full anatomical range of motion to accomplish tasks. Evidence of visual and aural acuity and finger and hand dexterity to operate computer and office equipment. Can withstand long periods of sitting, standing, and/or constant walking. Ability to lift 10 lbs. - Mental Demands: Ability to foster collaborative relationships, work well under pressure, organize and synthesize new information, and prioritize tasks. Possesses critical thinking, analytical skills, and flexibility. Ability to multi-task. Required detailed attention to work in an environment where interruptions cannot be controlled. Demonstrates sensitivity to customer needs and expectations. May be subject to irregular hours including evenings or potentially weekends to participate in operational and community events as necessary. Workplace Type Hybrid