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.

Role Description The Medical Director provides physician support to Enterprise Clinical Services operations, the organization responsible for the initial clinical review of service requests for Enterprise Clinical Services. The Medical Director collaborates with Enterprise Clinical Services leadership and staff to establish, implement, support and maintain clinical and operational processes related to benefit coverage determinations, quality improvement and cost effectiveness of service for members. The Medical Director's activities primarily focus on the application of clinical knowledge in various utilization management activities with a focus on post-service benefit and coverage determination or medical necessity (according to the benefit package), and on communication regarding this process with both network and non-network physicians, as well as other Enterprise Clinical Services. The Medical Director collaborates with a multidisciplinary team and is actively involved in the management of medical benefits. The collaboration often involves the member’s primary care provider or specialist physician. It is the primary responsibility of the medical director to ensure that the appropriate and most cost effective quality medical care is provided to members. You’ll enjoy the flexibility to work remotely from anywhere within the U.S. as you take on some tough challenges. Primary Responsibilities: - Conduct coverage reviews based on individual member plan benefits and national and proprietary coverage review policies, render coverage determinations - Document clinical review findings, actions, and outcomes in accordance with policies, and regulatory and accreditation requirements - Engage with requesting providers as needed in peer-to-peer discussions - Be knowledgeable in interpreting existing benefit language and policies in the process of clinical coverage reviews - Participate in daily clinical rounds as requested - Communicate and collaborate with network and non-network providers in pursuit of accurate and timely benefit determinations for plan participants while educating providers on benefit plans and medical policy - Communicate and collaborate with other internal partners Qualifications - M.D. or D.O. - Active unrestricted medical license and ability to obtain additional state medical licenses as needed - Current board certification in Internal Medicine through ABMS or AOA - 5+ years of clinical practice experience after completing residency training - Proven sound understanding of Evidence Based Medicine (EBM) - Demonstrated PC skills, specifically using MS Word, Outlook, and Excel Requirements - Compact License - Experience in utilization review - Demonstrated data analysis and interpretation aptitude - Proven innovative problem-solving skills - Proven excellent presentation skills for both clinical and non-clinical audiences - Demonstrated excellent oral, written, and interpersonal communication skills, facilitation skills Benefits - Comprehensive benefits package - Incentive and recognition programs - Equity stock purchase - 401k contribution (all benefits are subject to eligibility requirements) Application Deadline This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.

Title: Director - Advocacy & Influencer Medical B2B (LDB) Location: New York United States Job Description: Job Title: Director - Medical Advocacy & Influence Strategy Division: L'Oreal Dermatological Beauty (LDB) Location: Hudson Yards, New York City Who We Are For more than a century, L'Oréal has devoted its energy, innovation, and scientific excellence solely to one business: Beauty. Our goal is to offer each and every person around the world the best of beauty in terms of quality, efficacy, safety, sincerity and responsibility to satisfy all beauty needs and desires in their infinite diversity. At L'Oréal, our Digital team sits at the center of L'Oréal's digital transformation. We are determined to be pioneers in the new beauty tech world - and by embedding digital into everything we do, we are redefining how beauty connects with consumers. When beauty and tech collide, the impossible can happen. Come join our dynamic team! What You Will Do This is a rare opportunity for a strategic, insight-driven leader to define and elevate LDB's medical advocacy presence across the skincare and haircare space. As Director of Medical Advocacy & Influence Strategy, you will use market data, creator intelligence, and industry trends to develop the strategies, programs, and frameworks that keep LDB at the forefront of medical influence - equipping our brands with the insights and direction they need to activate with impact. You will serve as LDB's internal authority on medical creator trends and advocacy best practices, translating what is happening in the landscape into clear, actionable strategies that drive divisional and brand growth. Market Intelligence & Creator Landscape - Analyze the medical creator landscape across platforms (TikTok, Instagram, YouTube, LinkedIn, podcasts, and emerging channels) to identify top-performing content, trending voices, and white space opportunities across relevant HCP specialties. - Synthesize creator performance data, content trends, and audience insights to surface strategic recommendations for brand teams on which voices, topics, and content formats are driving the highest share of influence in the category. - Track competitive positioning within the medical creator space, providing LDB brands with a clear view of where we lead, and where the greatest opportunity lies. - Stay continuously informed on emerging advocacy tactics, platform shifts, and HCP content trends, translating signals into proactive strategic counsel for brand and marketing teams. Strategy, Programs & Community Development - Lead the development of LDB's Medical Advocacy Strategy, grounded in market data and category insights, ensuring alignment across brands, the CDMO team, and key functions including marketing, medical relations, PR, commercial, and digital. - Design and evolve divisional advocacy programs - including tentpole campaign frameworks, product launch playbooks, seeding approaches, and creator development tracks - that brand teams can activate with consistency and scale. - Build and champion community strategies that grow LDB's presence among healthcare professionals on social media, expanding the pool of medically credible voices advocating in our categories across nano, micro, and macro tiers. - Define the Medical Spokesperson Strategy for LDB, working with the CDMO team to identify synergies across brands, topics, and activation moments, and ensuring strategic coherence at the divisional level. Insights, Reporting & Strategic Counsel - Own advocacy reporting and insights for LDB - defining the right KPIs, synthesizing performance data across campaigns and brands, and delivering regular, executive-ready updates that connect advocacy activity to business outcomes. - Translate performance data into strategic recommendations, identifying what is working, what needs to shift, and where LDB should invest next to grow its medical share of influence. - Identify cross-brand opportunities using data - surfacing moments, creators, or content territories where a coordinated divisional approach can amplify impact beyond what individual brands can achieve alone. - Provide strategic counsel to brand teams on campaign planning, creator selection, and content strategy - ensuring every advocacy activation is grounded in data and aligned to divisional priorities. - Support forecast accuracy for medical advocacy budgets, partnering with brand and finance teams to connect investment decisions to performance insights and strategic priorities. - Serve as LDB's medical advocacy center of excellence - the go-to expert for marketing, medical, PR, commercial, and digital teams seeking strategic guidance, industry intelligence, and best practice frameworks. Brand Enablement & Cross-Functional Alignment - Equip brand teams to activate HCP creator partnerships with confidence, providing strategic briefs, insight-led recommendations, compliance guardrails, and clear performance benchmarks that enable brands to lead their own creator engagements effectively. - Guarantee message coherence across all touchpoints - B2B, B2C, and B2B2C - by working closely with medical relations, marketing, medical detailing, PR, commercial, and digital teams to ensure the right message reaches the right audience through the right channel. - Partner with Corporate Affairs & Engagement and the Divisional Head of Communications on relevant industry body engagement, ensuring advocacy programs align with L'Oréal's broader reputation standards. - Act as the integrity anchor for medical advocacy at LDB - ensuring all programs, strategies, and brand activations adhere to L'Oréal's standards for working with healthcare professionals. What We Are Looking For Required Qualifications - Bachelor's degree (BA/BS); 8-10 years of professional experience spanning digital marketing, advocacy, data-driven strategy, and/or the medical or pharmaceutical industry. - Strong analytical skills - able to interpret creator performance data, campaign insights, and market trends to develop clear, strategic recommendations. - Demonstrated experience designing and scaling advocacy strategies and programs across a matrixed organization - a strategic leader who builds frameworks others can execute against. - Experience working in or with the medical, pharmaceutical, or health & wellness creator ecosystem, with a strong understanding of HCP compliance requirements and content dynamics. - Proven ability to synthesize complex data and market intelligence into actionable strategies that drive brand and divisional decisions. - Experience managing vendors, agencies, and advocacy platforms, including budget ownership and performance accountability. - Strong cross-functional leadership skills - able to align marketing, medical, digital, commercial, and communications teams around a shared strategic direction. - Proficiency in social listening and creator analytics tools (e.g., Sprinklr, Traackr, CreatorIQ, Brandwatch, Tubular, or equivalent platforms). - Excellent reporting and communication skills - able to present complex insights clearly and compellingly to brand teams and senior leadership alike. - Strong project and program management skills - able to manage multiple workstreams and drive execution across a complex, matrixed organization. - Proven change agent with a track record of introducing new strategic frameworks or ways of working that improved organizational performance. - Self-motivated, results-oriented strategic thinker who thrives in ambiguity and brings clarity and direction to evolving spaces. Preferred Qualifications - Master's degree in Marketing, Communications, Business, or a related field. - Experience with creator economy platforms or social intelligence tools at an enterprise level. - Background in community strategy or advocacy program development within healthcare, beauty, or wellness. - Relevant Industry Certifications in digital marketing, healthcare communications, or advocacy. As an integral part of our culture at L'Oréal, wellness is at our core. We not only offer a generous Benefits Package (Medical, Dental, Vision, 401K), we also offer flexible time off, work from home days, and a pension plan! Additionally, you will have access to company perks such as Makeup, Skincare, and Fragrance! Employees receive a stipend for L'Oréal products as well as VIP Access to L'Oréal's Internal Shop for Discounted Products, and other perks such as Monthly Mobile Allowance, discounted gym memberships, and ERGs. Additional Benefits Information As Follows: Salary Range: $138,500 - $200,800 (The actual compensation will depend on a variety of job-related factors which may include geographic location, work experience, education, and skill level) - Competitive Benefit Package (Medical, Dental, Vision, 401K, Pension Plan) - Hybrid Work Policy (3 Days in Office, 2 Days Work from Home) - Flexible Time Off (Paid Company Holidays, Paid Vacation, Vacation Buy Program, Volunteer Time, Summer Fridays & More!) - Access to Company Perks (VIP Access to L'Oréal's Internal Shop for Discounted Products, Monthly Mobile Allowance) - Learning & Development Opportunities (Unlimited Access to E-learnings, Lunch & Learn Sessions, Mentorship Programs, & More!) - Employee Resource Groups (Think Tanks and Innovation Squads) - Access to Mental Health & Wellness Programs Don't meet every single requirement? At L'Oréal, we are dedicated to building a diverse, inclusive, and innovative workplace. If you're excited about this role but your past experience doesn't align perfectly with the qualifications listed in the job description, we encourage you to apply anyways! You may just be the right candidate for this or other roles! We are an Equal Opportunity Employer and take pride in a diverse environment. We would love to find out more about you as a candidate and do not discriminate in recruitment, hiring, training, promotion, or other employment practices for reasons of race, color, religion, gender, sexual orientation, national origin, age, marital or veteran status, medical condition or disability, or any other legally protected status. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to access job openings or apply for a job on this site as a result of your disability. You can request reasonable accommodations by contacting [email protected]. If you need assistance to accommodate a disability, you may request an accommodation at any time. Our Safe Together Plan: Your safety is our highest priority. We will proceed with caution and adhere to enhanced protection standards to ensure our sites are safe for all employees. We must all operate with the shared responsibility for each other's health & safety in mind.