Healthcare & Pharma Careers

Through questioning the status quo and collaborating cross-functionally, the Senior Quality Assurance Auditor is responsible for leading, planning, scheduling, performing, and reporting a range of GxP audits across all phases of Clinical Research.. Title: Senior Quality Assurance Auditor (GCP Auditor)Who we’re looking for: Minimum of 2 years’ experience in quality assurance, auditing, including sound experience of applicable GxP auditing.. At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science such as technology, third party supplier management.. Excellent knowledge, understanding and experience of Good Practices (GxPs) and international, national, and local regulations and laws related to clinical trials and other clinical research.. Act as QA Lead on audits program(s).

CCS serves hospitals, biotech and pharmaceutical clients with cell sourcing, apheresis, medical programs, product and assay development, clinical trials, and contract manufacturing of traditional and advanced cellular therapies.. Reporting to the SVP of Quality and Regulatory Affairs, the VP provides focused oversight of quality systems within CCS to ensure compliance with regulatory and corporate requirements.. Manage the preparation of formal meeting packets and cell therapy regulatory submissions to the FDA. Prepare and submit regulatory registrations, applications, and amendments to support operations as assigned.. Minimum fifteen years of combined experience in quality management and regulatory affairs related to cGMP manufacturing, clinical trials, and cellular therapies.. Knowledge of FDA regulatory submissions preparation and processes.

MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), amyotrophic lateral sclerosis (ALS), and is currently developing medicines in Neurology in Parkinson’s (PD), Spinal Cord Injury (SCI), and in high unmet areas in Immunology and Oncology.. In the United States, MTPA launched rare disease treatments including RADICAVA® (edaravone) injectables in 2017 and RADICAVA® (edaravone) oral suspension in 2022.. MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness.. Strongly preferred: PhD or PharmD or equivalent experience; Regulatory Affairs Certification.. Proven track record designing and executing creative development strategies and programs for drugs, biologics/vaccines and in the rare disease space.

The increasing global regulatory requirements—especially in the U.S. (510(k) submissions), Canada, and Europe (MDR)—demand agility and expertise to ensure compliance across our expanding product portfolio.. The Regulatory Affairs Specialist plays a central role in navigating complex regulatory landscapes, driving product approvals, and ensuring compliance with evolving industry standards.. To strengthen our regulatory expertise and support our growing global operations, we are looking for a Regulatory Affairs Specialist M/F.. Contribute to post-market surveillance efforts, ensuring compliance with clinical evaluation and safety requirements.. Technical Writing & Documentation: Strong skills in writing, editing, and structuring regulatory documents, including 510(k) submissions, validation protocols, and risk assessments.

A Clinical Research Coordinator II position is currently available within the Medicine Clinical Trials Office.. Report adverse advents and serious adverse events in accordance with the Institutional Review Board (IRB) Standard Operating Procedures, sponsor guidelines, and federal regulations. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients’ medical and emotional needs at the center of all treatment.. We are consistently ranked by U.S. News & World Report's Best Hospitals, receiving high "Honor Roll" status, and are highly ranked: No. 1 in Geriatrics and top 20 in Cardiology/Heart Surgery, Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology.. Newsweek’s “The World’s Best Smart Hospitals” ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.

Job Advertisement: Regulatory Affairs Manager. Company: Confidential (Stealth-mode startup environment). Position Overview: We are seeking a hands-on Regulatory Affairs Manager with a strong background in medical devices, particularly SaMD (Software as a Medical Device).. Prepare and update documentation for EU MDR conformity.. Experience with FDA submissions and writing MDR-compliant CERs and PMCFs∯*∯

Position SummaryThe Senior Director/Director of Clinical Quality Assurance (CQA) is responsible for overseeing and conducting audits for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP), and ensuring compliance with all applicable regulations and guidelines (FDA, EMA, ICH, etc. Oversee the management and maintenance of the company's clinical trial master files (TMF) and audit reporting through the Quality Management System (QMS).. A minimum of 5 years of experience in a leadership role, managing a QA team and conducting clinical audits, with a focus on GLP, GCP, and/or Pharmacovigilance (PV).. Knowledge and SkillsExperience with the development and commercialization of products, ideally with expertise in Pharmacovigilance and clinical vendor management.. Deep knowledge of GLP, GCP, GVP, FDA, EMA, ICH regulations, and international standards for clinical research and pharmacovigilance.

Title: Regulatory Affairs Associate. Reporting to: Regulatory Affairs Manager. We are seeking a highly motivated and results-driven Regulatory Affairs Associate to join our dynamic sales team at Venus AI. You are responsible for supporting global registrations and ensuring that medical devices produced by Venus Concept meet all regulatory requirements for countries where the devices are marketed.. Venus Concept is an innovative global medical aesthetic technology leader with a broad product portfolio of minimally invasive and non-invasive medical aesthetic and hair restoration technologies and reach in over 60 countries and 10 direct markets.. Venus Concept's product portfolio consists of aesthetic device platforms, including Venus Versa, Venus Versa Pro, Venus Legacy, Venus Velocity, Venus Viva, Venus Glow, Venus Bliss, Venus Bliss MAX, Venus Epileve, Venus Viva MD and AI.ME. Venus Concept's hair restoration systems include NeoGraft® and the ARTAS iX® Robotic Hair Restoration system.

Summary: LHH Recruitment Solutions has partnered with a client in downtown Chicago seeking a dedicated and detail-oriented Medical Biller to join their team!. The ideal candidate will have a strong background in reimbursement processes, and appeals/denials management, with experience handling both Medicare and commercial insurance claims.. Qualifications: Education: High school diploma or equivalent Experience: Minimum of 1 year of experience in medical billing, with specific experience in handling Medicare and commercial insurance claims.. Skills: Proficiency in medical billing software and electronic health records (EHR) systems.. Strong understanding of medical terminology, ICD-10, CPT, and HCPCS coding.

Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans.. Provide CMC regulatory guidance and support to internal teams including manufacturing/MSAT, Quality Assurance, and R&D.. Review and approve CMC regulatory documentation, ensuring compliance with regulatory requirements.. Provide CMC regulatory support for post-approval CMC-associated commitments as well as post-marketing CMC activities.. Knowledge and experience with authoring and preparation of global regulatory submissions (IND, CTA, BLA, MAA), post-approval and post-marketing regulatory CMC activities.

Join Takeda as an Associate Director, Quantitative Clinical Pharmacology Lead in Cambridge, MA, where you will lead strategic, scientific, and operational aspects of multiple drug development projects with a high level of technical and strategic independence from first in human dosing through life cycle management.. These scientists (from quantitative clinical pharmacology, statistics, programming, outcomes research and epidemiology, patient safety & pharmacovigilance, digital strategy, library sciences and data architecture/governance) bring their expertise to our global program teams and reimagine our disciplines.. Be responsible for drafting and executing clinical pharmacology plans, including integration of M&S, in close collaboration with key partner functions (e.g., pharmacometrics, statistics, and DMPK).. Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.. Advanced knowledge of pharmaceutical industry, overall drug development process with expertise in the cross-functional interfaces with key partners such as Pharmacometrics, Statistics, Drug Safety, Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs.

This role will work with the company’s legal resources to ensure all sales activities comply with regulatory requirements, which include guidelines set by the Centers for Medicare and Medicaid Services (CMS) as well as carrier partners.. Responsibilities include but are not limited to developing, monitoring, and enforcing compliance policies and procedures related to Medicare Advantage and Prescription Drug Plans (PDP) sales.. Prepares reports and presentations required by senior leadership regarding Medicare compliance activities and sales floor activity.. Minimum of 3-5 years of experience in healthcare compliance, particularly in Medicare sales compliance.. Strong knowledge of Medicare Advantage, Medicare Supplement, and PDP regulations

Xenon Pharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric disorders.. In addition, we are proud of the leading-edge science coming out of our discovery labs, including early-stage research programs that leverage our extensive ion channel expertise and drug discovery capabilities to identify validated drug targets and develop new product candidates.. A Bachelor's, or Master's, PharmD or PhD in a scientific, medical or regulatory discipline with a minimum of 6 years Regulatory Affairs management experience in a pharmaceutical, biotechnology, contract research organization (CRO) or related environment required.. Our Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.

The Senior Director/Director of Clinical Quality Assurance (CQA) is responsible for overseeing and conducting audits for Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Pharmacovigilance Practice (GVP), ensuring compliance with all applicable regulations and guidelines (FDA, EMA, ICH, etc. Oversee the management and maintenance of the company’s clinical trial master files (TMF) and audit reporting through the Quality Management System (QMS).. A minimum of 5 years of experience in a leadership role, managing a QA team and conducting clinical audits, with a focus on GLP, GCP, and/or Pharmacovigilance (PV).. Experience with the development and commercialization of products, ideally with expertise in Pharmacovigilance and clinical vendor management.. Deep knowledge of GLP, GCP, GVP, FDA, EMA, ICH regulations, and international standards for clinical research and pharmacovigilance.

The Research Nurse in collaboration with the physician, is responsible for the implementation and evaluation of clinical research in the Center for Cancer Therapeutic Innovation (CCTI).. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care.. Collaborates with the Dana-Farber Harvard Cancer Center DFHCC quality assurance of clinical trials office in developing protocol specific materials.. At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong.. Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other characteristics protected by law.

The Regulatory Affairs and Quality Assurance Associate shall also conduct reviews of all and all future target markets to ensure knowledge and fulfillment of establishment registration, device licensing, surveillance, adverse event and corrective action reporting, translation, product standards, and all other requirements necessary to support import, sales, distribution, and support in all chosen distribution markets.. Support preparing IDE, 510(k), PMA, CE Mark, and other related regulatory filings.. Establish and implement necessary policies, procedures, templates related to Regulatory Affairs and Quality Assurance. Excellent public speaking, professional writing, typing, and general office application skills are essential for substantial cross-organizational interaction and facilitation, as well as process and record generation.. Experience with Post-Market Surveillance and Clinical Evaluation preferred.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need.. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.. Developing and communicating CMC regulatory strategies for combination products/medical devices that are in alignment with project goals and timelines.. Ensure submissions and responses to regulatory questions are of high quality and right first time; that content and format of regulatory submissions comply with applicable regulations and guidance governing the development, licensure and marketing of drugs, biologics and /or gene therapy medicinal products.. Minimum requirement is for a bachelor's degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need.. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.. RESPONSIBILITIES As an Associate Director in Regulatory Affairs, CMC, focusing on Combination Products and Medical Devices, you will be responsible for: Developing and communicating CMC regulatory strategies for combination products/medical devices that are in alignment with project goals and timelines.. Ensure submissions and responses to regulatory questions are of high quality and right first time; that content and format of regulatory submissions comply with applicable regulations and guidance governing the development, licensure and marketing of drugs, biologics and/or gene therapy medicinal products.. EDUCATION AND EXPERIENCE Minimum requirement is for a bachelor’s degree in a pharmacy, biological discipline, chemistry, or molecular biology or other science.

Senior Manager, Medical WritingWho we are: is a biopharmaceutical company that is fueled by connections.. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.. The impact you will make:Agios Pharmaceuticals is searching for a dynamic Senior Manager, Medical Writing to join our growing Regulatory Affairs & Medical Writing team.. What you bring: 5+ years as a medical or scientific writer, or equivalent professional or educational experience (eg, graduate degree in life sciences).. Working knowledge of drug development, clinical research, study design, biostatistics, pharmacokinetics, the regulatory environment, and medical terminology.

Several major Biotech companies are seeking Medical Directors/Clinical Scientists with drug development experience to join the Oncology program.. Candidates should have an M.D. with board certification/eligibility in hematology/oncology, or a PhD, PharmD with at least 5 years of drug development experience.. Provide initial clinical designs for future trials, partnering with research, translational oncology, biostatistics, clinical operations, regulatory, and pharmacology for input/alignment and presentation at the Therapeutic Development Team meetings.. As Medical Monitor, be responsible for all aspects of certain key clinical trials as per ICH/GCP guidelines.. Perform regular clinical reviews of listings and partner with clinical operations/drug safety to develop a safety monitoring plan.