Head of Companion Diagnostics & Regulatory Strategy
Precision Medicine Group
Precision Medicine Group in Frederick, MD seeks a Senior Director, Companion Diagnostics to oversee laboratory activities supporting both commercial CDx analyses and development programs. The role requires deep knowledge of FDA guidance and experience translating it into robust, pass-ready assays. You will lead design, validation, and CLSI/CLIA/CAP compliant operations, mentor staff, monitor KPIs, coordinate audits, and collaborate with QA, Regulatory and project teams to ensure timely client #J-18808-Ljbffr Precision Medicine Group
$203.2k - $304.8k
Position Summary:The Senior Director, Companion Diagnostics (sitting onsite in Frederick, MD) will be responsible for overseeing the laboratory... ...will train and mentor staff to ensure scientific rigor and regulatory compliance to GxP, CLSI, CLIA/CAP and State DOH (eg.,NY, CA...RegulatoryLocal area$17.51 - $18.36 per hour
...Frederick Health Compliance Program, including following all regulatory requirements and the Frederick Health Standards of Behavior. Essential... ...RN at beginning of Shift, or when taking over for another companion, outlining specific patient history and needs. Continuously...RegulatoryHourly payTemporary workPart timeImmediate startShift workNight shift- ...oversight for FDA-regulated clinical studies, ensuring studies are executed in accordance with approved protocols, budgets, timelines, regulatory requirements, and quality standards. Duties and Responsibilities Manage all phases of clinical trial startup, conduct,...Regulatory
- ...biosurveillance, and systems biology laboratory operations; supports next-generation sequencing and multi-omics research; maintains regulatory and biosafety compliance; trains personnel; coordinates equipment maintenance and scientific supply chains; and supports...RegulatoryContract work
- ...guide risk management, tailor insurance plans, and liaise with carriers to bind coverage while driving renewals and client satisfaction. You will analyze client needs, prepare proposals, and navigate regulatory requirements. #J-18808-Ljbffr Relation Insurance ServicesRegulatory
$58.8k - $77.44k
...protocol worksheets, adverse event reports, institutional review board documents, and annual continuing review reports. Maintains regulatory documents in accordance with USOR SOP and applicable regulations. May participate in scheduling monitoring and auditing visits,...RegulatoryFull timeWork experience placementWork at officeLocal areaMonday to Friday- ...Maryland/DC sites. You will coordinate visits, ensure protocol compliance, and train clinic staff while maintaining GCP, SOPs, and regulatory standards. This is a full-time, on-site role with a Monday-Friday schedule in a fast-paced oncology setting. The team supports...RegulatoryFull timeMonday to Friday
- ...This individual will provide strategic oversight for clinical trial execution, adverse event management, safety surveillance, and regulatory compliance while leading multidisciplinary teams. Requirements: Duties and Responsibilities Direct Phase I and Phase...Regulatory
- ...Key Responsibilities:Lead enterprise‑wide manufacturing safety strategy and executionStandardize safety onboarding, training, audits,... ...industrial environments5+ years in safety leadership rolesStrong OSHA/regulatory expertise across multi‑site operationsProven ability to...Regulatory
- We are looking for ... [Job Overview] [Job Details] Responsibilities Responsibility 1 Responsibility 2 Responsibility 3 ... Qualifications ~ BA/BS degree in ... or related field ~5+ years experience in ... ~ Experience with ... ~ ...
- ...requires expertise in leading product technical operations, managing regulatory compliance, and providing support for investigational products... ...requirements. Responsibilities include overseeing product strategies and collaboration with cross-functional teams to enhance...RegulatoryFull time
- ...caregivers on home safety, energy conservation, joint protection, and strategies to support successful discharge and community reintegration.... ...within the electronic medical record, in accordance with regulatory and professional standards. You will contribute to...Regulatory
- Pace Analytical Services, LLC is seeking a senior CMC/regulatory affairs professional to lead and execute global regulatory strategies for INDs, IMPDs, CTAs, and filings. The role emphasizes high-quality submissions, documentation, and effective communication with FDA,...Regulatory
- ...expertise in the areas of medical devices, diagnostics, drugs and biologics, and/or other... ...aid in the development of the research strategy for clinical trials. Provide subject... ...meetings. Orchestrate the requisite regulatory strategy as well as organization and compliance...RegulatoryContract workLocal areaWork visa
- Bering-Alaka`ina Holdings, LLC is seeking a Regulatory Affairs Support Specialist to support our government customer at Fort Detrick, MD. The role focuses on regulatory strategies, submissions planning, and ensuring compliance across medical devices, drugs, and biologics...Regulatory
$80k - $120k
...Responsibilities Provide expertise on continuous process improvement strategies, organizational redesign, change management projects, and... ...Provide expertise and guidance in interpreting policies, regulatory, and/or governmental regulations, and agency guidelines to ensure...RegulatoryFull timeRemote workFlexible hours$96k - $110k
...Help identify systemic issues within the unit and help develop strategies to address them to accomplish the work of the unit. Provide... ...reporting and writing, and ensuring that administrative and regulatory requirements are met. Fill in for the chief and assume their...RegulatoryFull timeWork at officeLocal areaImmediate start- ...service delivery by supervising residential staff, maintaining regulatory and agency compliance, coordinating schedules, monitoring... .... Must complete, pass, and maintain Behavioral Principles and Strategies (BPS) training, if applicable. Must complete, pass, and maintain...RegulatoryWork at officeImmediate startMonday to FridayNight shiftDay shift
- Petco Animal Supplies, Inc. in Frederick, MD is seeking a Companion Animal Specialist to care for companion animals and aquatic life, support customers, and help maintain clean habitats. You will work on the sales floor, participate in inventory management, and collaborate...
- .... This role requires a strong leader who can navigate complex regulatory environments, manage cross-functional teams, and foster relationships... ...solutions and cloud-based platforms. Adapt business strategies to align with evolving market demands and technological advancements...RegulatoryFull timeContract workWork at officeLocal area
- ...Frederick, Maryland. This role leads validation and assurance strategies for computerized systems in a regulated pharmaceutical environment... ...strategies aligned with GxP impact, system complexity, and regulatory requirements Lead or approve validation deliverables...Regulatory
- ...Job Description Job Description Description: Senior Regulatory Affairs Scientist Venesco LLC is seeking a Senior Regulatory... ...subject matter expert responsible for developing regulatory strategies, leading FDA interactions, managing submissions, and ensuring...Regulatory
$65k - $110k
Position Summary Odyssey is looking for a Regulatory Affairs Support (Warfighter Expeditionary Medicine and Treatment) to support the... ...-relevant medical solutions. Develop and review regulatory strategies, submission planning, dossier preparation, and communication with...RegulatoryFull timeContract workTemporary workWork experience placementLive outRemote workFlexible hours- ...Registers, Microsoft Office ABOUT THE PROGRAM The Office of Regulatory Activities (ORA) provides regulatory and clinical support... ...activities and issues. Contribute to written regulatory strategies describing the pathway to approval, licensure, or clearance....RegulatoryInterim roleWork at office
$126k - $150k
...exterior. You will oversee maintenance programs, vendor management, and risk mitigation strategies, ensuring the infrastructure remains operationally sound, compliant with regulatory standards, and aligned with tenant needs. Travel: Ability to travel up to (20%) for...RegulatoryContract workFor contractorsWork at officeLocal area$1,772 - $2,135 per week
...home exercise programs, proper body mechanics, injury prevention strategies, and self-management techniques to promote long-term... ...adhering to infection control protocols, safety guidelines, and regulatory standards while addressing patients’ comfort needs during therapy...RegulatoryFull timeContract workTemporary workImmediate startWork from homeShift work$82k - $102k
...solutions. Evaluate project risks and implement mitigation strategies to maintain progress and achieve established objectives.... ...operational changes comply with applicable policies, procedures, and regulatory requirements. Support internal and external audits,...RegulatoryFull timeTemporary workImmediate start$46.92k
Description: Located in Hershey, PA, Milton Hershey School (MHS) is a top-notch home and school where over 2,200 pre-K through 12th grade students from disadvantaged backgrounds are provided an extraordinary, cost-free, career-focused education. This is made possible ...Full timeRelocationRelocation packageFlexible hoursWeekday work- ...emphasizes timely scheduling, vacancy management, and coordination with payroll for accurate hours and time off approvals. Strong regulatory knowledge is essential. Candidates should have at least one year of relevant experience, excellent communication skills, and the...RegulatoryShift work
- ...duties that support quality patient outcomes. The role emphasizes adherence to FH Compliance Program and Standards of Behavior within regulatory guidelines. Responsibilities include comprehensive assessments, care planning, documentation, and collaboration across...Regulatory
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