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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. Build effective partnerships with cross-functional teams (e.g., regulatory affairs, clinical development, biometrics). Extensive experience writing regulatory submission documents across all phases of drug development (e.g., clinical protocols, Investigator’s Brochures, clinical study reports, briefing books, INDs/CTAs, NDAs/MAAs). Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
Collaborate globally and cross-functionally (e.g., Clinical Affairs, Business Development, Regulatory Affairs, Research and Development, Product and Program Management) to achieve project goals and meet timelines.. Define regulatory strategy and plans for clearance / approval of Leica Biosystems technologies intended for cancer diagnostics in the anatomic pathology, IVD, and Companion Diagnostics markets, including providing input into 510(k), PMA and companion diagnostic submissions and acting on regulatory intelligence changes to ensure minimal impact to current and future portfolio.. Proven experience supporting submissions for high-complexity diagnostic products in a global market, specifically 510(k) and PMA submissions in the USA.. Substantial experience in commercial product development including transfer of complex feasibility projects into product commercialization.. At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.
Position Purpose: The Senior Director, Healthcare Analytics leads analytic service delivery by aligning strategic objectives with the development of tools and capabilities and appropriate deployment of supporting analytic teams. Education/Experience: Bachelor's degree in business, economics, statistics, mathematics, actuarial science, public health, health informatics, healthcare administration, finance or related field. Preferred knowledge of programmatic coding languages such as Python and R. Knowledge of basic statistical, analytical, or data mining techniques including basic data modeling, trend analysis, and root-cause analysis preferred. Centene offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules. Qualified applicants with arrest or conviction records will be considered in accordance with the LA County Ordinance and the California Fair Chance Act
Performs inpatient and outpatient billing for professional services. Completes or initiates original billing for one or more pay classes including follow up on bills with insurance companies. Utilizes resources available including websites to ensure full compliance of federal Medicare and Medicaid law and regulation provision and in keeping with the health center mission. Two years clerical/bookkeeping experience.. Medical billing for physician services preferred
The Regulatory and Clinical Specialist will support the clinical evaluation activities, review promotional materials and support regulatory submissions for the active implantable medical devices for the Neuromodulation Business Unit. The Regulatory and Clinical Specialist is a liaison with the organization working with various groups to effectively communicate and collaborate on the deliverables and meet the project deadlines in line with the regulatory requirements.. Prepare regulatory submissions assigned (510(k); IDE & IDE Supplements; PMA Supplements, notification of change, etc.). Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature. experience in the development, writing and editing of regulatory/ clinical submissions (e.g. FDA PMA applications, IDE Progress Reports, technical files).. EducationMinimum of a master's degree in biomedical engineering, science or equivalent technical discipline and at least 5 years of previous related experience in medical writing and medical device regulatory affairs or a Ph. D. with at least 3 years of experienceTravel RequirementsOccasional travel may be required ~10Pay TransparencyA reasonable estimate of the annual base salary for this position is $70,000 - $95,000 plus discretionary annual bonus.
Whether you're a clinical research associate (CRA), clinical trial coordinator, or involved in regulatory affairs, attending these conferences can significantly enhance your knowledge and skills.. Why Attend : Gain insights into the global regulatory landscape, including updates on the European Union’s Clinical Trials Regulation (CTR).. Key Focus : The summit will focus on clinical trial innovation, precision medicine, and adaptive trial designs.. Clinical Research Coordinator Certification. Clinical Research Associate (CRA) Certification
The Clinical Research Program Manager will provide compliance and quality assurance reviews for the Montefiore Einstein Cancer Clinical Trials Office under the supervision of the Director of Quality Assurance.. The Clinical Research Program Manager will be responsible for all ongoing monitoring activities including patient case reviews, pharmacy reviews, and regulatory reviews for Montefiore Einstein Cancer Center Investigator Initiated Trials.. The duties of this position must be executed in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), the Montefiore Einstein Cancer Center Data and Safety Monitoring Plan (DSMP), and any other applicable regulatory requirements.. The Clinical Research Program Manager will work under the direction of the Director, Quality Assurance, providing constant feedback on findings and evaluation of instituted Corrective and Preventative Action Plans (CAPA).. The Clinical Research Program Manager will serve as the Administrator for the MECC Data and Safety Monitoring Committee and will work with the Director, Quality Assurance to develop and support an eligibility review process for all patients enrolled on cancer clinical studies.
Tanner and Associates is recruiting several Medical Directors of Oncology Clinical Research for major biotech companies located in San Francisco, Los Angeles, Salt Lake, and New Jersey.. Major biotech companies are seeking Medical Directors/Clinical Scientists with drug development experience to join their Oncology programs.. Candidates should have an M.D. with board certification or eligibility in hematology/oncology, or a PhD, PharmD with at least 5 years of drug development experience.. Develop initial clinical designs for future trials, collaborating with research, translational oncology, biostatistics, clinical operations, regulatory, and pharmacology teams, and presenting at Therapeutic Development Team meetings.. As Medical Monitor, oversee all aspects of key clinical trials in accordance with ICH/GCP guidelines.
Become a part of our caring community and help us put health first. The Clinical Pharmacist Lead monitors drug development pipeline, and medical literature, while providing clinical support for internal stakeholders.. The Pharmacy Director, internally known as a Clinical Pharmacy Lead, plans, directs, and monitors all financial, operational, professional, and clinical activities for the purposes of pharmacy program development for our Fully Integrated Dual Eligible Special Needs Plan (FIDE-SNP) Michigan Medicare - Medicaid health plan.. Manages the Humana Michigan FIDE-SNP health plan relationship with our internal PBM, Humana Pharmacy Solutions ensuring compliance with programmatic requirements, such as claims processing, prior authorization, formulary management and clinical programming. Board Certified Specialty Pharmacist
Provide expertise on translational patient safety based on biomarkers, precision medicine, and real-world data and contribute to the advancing of pipeline programs.. Provide mentorship and expertise to educate and develop scientific capabilities of Global Safety Officers and contribute to Benefit-Risk assessment. A proven and successful track record with at least 5-10+ years of experience in biopharmaceutical clinical development in at least one of the following areas: early development, safety, risk management, pharmacoepidemiology or pharmacovigilance.. Experience working in basic science or clinical development, in one or more of the following domains: gene therapy, cell therapy, biologics, small molecules and medical devices.. Knowledgeable of relevant concepts in healthcare, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance, drug development and statistics
Provide expertise on translational patient safety based on biomarkers, precision medicine, and real-world data and contribute to the advancing of pipeline programs. Provide mentorship and expertise to educate and develop scientific capabilities of Global Safety Officers and contribute to Benefit-Risk assessment.. A proven and successful track record with at least 5-10+ years of experience in biopharmaceutical clinical development in at least one of the following areas: early development, safety, risk management, pharmacoepidemiology or pharmacovigilance. Experience working in basic science or clinical development, in one or more of the following domains: gene therapy, cell therapy, biologics, small molecules and medical devices. Knowledgeable of relevant concepts in healthcare, human biology, data management and systems, epidemiology, pharmacology, pharmacovigilance, drug development and statistics
Carbon Health is looking for a physician with clinical research experience as a Principal Investigator to join a growing community of healthcare providers to deliver compassionate, evidence-based urgent care and conduct clinical trials in infectious disease and indications related to general medicine, including vaccine research and cardiometabolic health. Serve as a Principal Investigator for multiple clinical trials, Phases I to IV, where you will be responsible for the clinical research conduct and quality assurance, as well as supervising sub-investigators in their clinical trial work. Review and provide guidance on labs, diagnostic reports, diary reports, safety reports, and AEs/SAEs within a trial. Experience serving as a Principal Investigator on at least 3 prior randomized double-blinded therapeutic clinical trials. Hippo Education subscription, internal education resources and clinical rounds to support continuing medical education requirements.
Regulatory Affairs Manager M/F. We are committed to ensuring the highest possible level of care and well-being for farm animals (poultry, pigs, ruminants), companion animals (dogs and cats), and wildlife.. As part of our “Diversity, Equity and Inclusion” policy, Ceva Animal Health is committed to the employment of people with disabilities and will make reasonable accommodations throughout the interview process to ensure an inclusive and accessible experience for all applicants.. The RAM's primary task is to manage the Regulatory Affairs (RA) activities of Ceva’s veterinary medicinal products, maintain product and manufacturing site authorizations, ensure business continuity, and monitor RA compliance against internal and external regulations and requirements.. You have a degree in veterinary medicine or pharmacology or a master's degree in biology with additional training in regulatory affairs.
The Director of Clinical Pharmacology will lead the design, execution, and analysis of clinical pharmacology studies to support drug development programs.. This role requires deep expertise in pharmacokinetics (PK), pharmacodynamics (PD), and regulatory strategy to optimize study design, data interpretation, and regulatory submissions.. The successful candidate will be expected to both conduct hands-on PK/PD modeling and simulation and provide strategic leadership across programs.. Conduct hands-on PK/PD modeling and simulation (e.g., Phoenix WinNonlin, NONMEM, R) to guide study design, dosing strategies, and data analysis.. Work closely with preclinical, clinical, regulatory, biostatistics, and medical affairs teams to drive drug development programs.
San Diego Blood Bank’s Cord Blood Banking Program provides lifesaving stem cell transplants to patients worldwide.. Under the direction of the Manager, Quality & Regulatory Affairs, the Quality Assurance and Compliance Specialist II participates in maintaining a Quality Management System that supports the manufacture of FDregulated biologic blood, cell and tissue products and other related regulatory activities.. ASQ, CPHQ, Health Care Compliance Certification Board (CHC, CHRC), or similar certification required or must be obtained within two (2) years of hire.. Must have good knowledge of standards and regulations that apply to blood banking, umbilical cord banking, cellular therapy services, clinical laboratory, and clinical research.. Additional Experience in cellular therapy services, umbilical cord banking, molecular testing and/or clinical research preferred.
With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services.. Our Project Delivery colleagues within our PPD clinical research services direct, coordinate and manage the technical and operational aspects of projects, securing the successful completion of clinical trials.. Therapeutic scopes include: infectious and respiratory diseases, oncology/hematology, neurosciences, cardiovascular and metabolic, general medicine and vaccines.. Advanced, broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas, such as preclinical, clinical, CMC, publishing, etc.. Expert financial acumen with an in-depth of knowledge and practical application of budgeting, forecasting and resource management
The Senior Director, Healthcare Analytics leads analytic service delivery by aligning strategic objectives with the development of tools and capabilities and appropriate deployment of supporting analytic teams.. Bachelor’s degree in business, economics, statistics, mathematics, actuarial science, public health, health informatics, healthcare administration, finance or related field.. Preferred knowledge of programmatic coding languages such as Python and R. Knowledge of basic statistical, analytical, or data mining techniques including basic data modeling, trend analysis, and root-cause analysis preferred.. Pay Range: $145,100.00 - $268,800.00 per year Centene offers a comprehensive benefits package including: competitive pay, health insurance, 401K and stock purchase plans, tuition reimbursement, paid time off plus holidays, and a flexible approach to work with remote, hybrid, field or office work schedules.. Qualified applicants with arrest or conviction records will be considered in accordance with the LA County Ordinance and the California Fair Chance Act
As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers.. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.. The Director, Clinical Pharmacology Lead (D-CPhL) is a senior level Clinical Pharmacologist at Boehringer Ingelheim Pharmaceuticals Incorporated.. The D-CPhL supports the clinical drug research and development process by strategic planning of Clinical Pharmacology data generation and by developing and implementing Clinical Pharmacology strategies (e.g., assessment of pharmacokinetic/pharmacodynamic (PK/PD), drug interaction, formulation development, dose selection decision, impact of renal/hepatic impairment, food effect on PK, QT prolongation and pediatric drug development).. Expert knowledge in CP, BioPharma, clinical drug development and relevant regulatory guidelines.
Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology.. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. Vertex is a global biotechnology company that invests in scientific innovation.
Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients.. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office.. Broad understanding of drug development, clinical research, study designs, biostatistics, pharmacology, regulatory requirements, and medical terminology. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.. On-Site : work five days per week on-site with ad hoc flexibility.