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Fusion Pharmaceuticals, a member of the AstraZeneca Group, is a clinical-stage oncology company focused on developing next-generation radioconjugates (RCs) as precision medicines.. In addition, Fusion is pursuing combination programs between RCs and DNA Damage Response Inhibitors (DDRis) and immune-oncology agents.. Fusion has a fully operational Good Manufacturing Practice (GMP) compliant state-of-the-art radiopharmaceutical manufacturing facility to meet supply demand for Fusion's growing pipeline of RCs.. This position will focus on GxP compliance within Fusion Pharmaceuticals internal systems, sponsored clinical trials, manufacturing, and the R & D organization and provide quality systems oversight in preparation for commercialization.. Knowledge of GxP quality systems, quality assurance, quality control, and GMP/GCP/GLP/PV audits.
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.. The Vice President, Regulatory Affairs (Clinical) will establish and manage global regulatory strategy and operations for the Company's product pipeline from early and late-stage development through registration and post-approval activities.. Develop, propose and implement global regulatory strategies for development of the Company's portfolio of products and product candidates from discovery through development and commercialization in alignment with corporate strategy.. Minimum of 15 years of Regulatory leadership roles of increasing responsibility with small and large multi-national biopharma companies; neurology experience, specifically epilepsy, highly desirable. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
Milliken & Company is a global manufacturing leaderwhose focus on materials science delivers tomorrow's breakthroughs today.. Drawing on thousands of patents and a portfolio with applications across the textile, flooring, chemical and healthcare businesses, the company harnesses a shared sense of integrity and excellence to positively impact the world for generations.. POSITION TITLE / LOCATION: Quality Assurance Manager, Salisbury, MA. Manage and maintain the quality inspection and product release programs for a) incoming raw materials, b) in-process materials, c) components and d) finished goods. Support an effective supplier quality assurance system while ensuring supplier corrective actions are timely and effective
KalVista seeks a dynamic and experienced Vice President, Regulatory Affairs to expand, enhance and manage all aspects of our global Regulatory Affairs function.. Reporting to the Sr. VP, Regulatory Affairs & Quality Assurance, you will be an integral member of the Senior Leadership Team accountable for providing leadership and expert regulatory input to the strategic direction and long-term success of KalVista.. Provide input/expert review of regulatory submissions as required (e.g. CTA/IND, Orphan Drug Designations/Fast Track/Breakthrough Designations NDA/MAAs). Review and approve regulatory SOPs as needed and ensure regulatory affairs function is compliant with all aspects of the QMS. 20+ years experience in global regulatory affairs, including hands on preparing/writing/submitting of at least one NDA or MAA and management of post-approval regulatory activities
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients around the world. The Executive Director, Regulatory Affairs will be responsible for providing strategic leadership and direction for all clinical, development, and operational regulatory activities within Zenas Biopharma. This position reports to the SVP, Global Regulatory Affairs and Medical Writing. Collaborate with cross-functional teams, including clinical development, quality assurance, pharmacovigilance, and legal, to ensure alignment of regulatory strategies, activities and compliance. Our base salary is just one component of Zenas’ competitive total rewards strategy that also includes annual performance bonus, equity, full range of benefits and other incentive compensation plans.
Medical Billing & Coding•Understand and document workflows related to medical billing and coding processes.. Ensure compliance with industry standards such as ICD-10, CPT, HCPCS, HIPAA, andMedicare/Medicaid guidelines.. Assist in optimizing revenue cycle management (RCM) through effective processdocumentation.. Strong knowledge of medical billing & coding (ICD-10, CPT, HCPCS, RCM, HIPAA).. Certified Professional Coder (CPC), Certified Professional Biller (CPB), or similarcertification is a plus.
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.. As part of DSI, the Quantitative Clinical Pharmacology (QCP) Team at Takeda consists of therapeutically aligned teams who drive the clinical pharmacology strategy from pre-FIH through life-cycle management within the global project team.. 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.
They have asked us to assist them in their search for a Vice President, Clinical Pharmacology Major tasks and responsibilities include: Oversees the design and implementation of clinical pharmacology plans using traditional and model informed drug development approaches.. Ensures timely and accurate communication of study results and interpretation to appropriate internal drug development teams.. Maintains a current understanding of PK and PD literature and methodology, as well as the scientific literature related to the specific drug discovery projects.. We seek candidates with the following qualifications: A PhD, MD, or PharmD with relevant expertise in pharmacokinetics, pharmacology or pharmaceutical science is required.. Must hold knowledge and experience in the application of current practices in the areas of clinical pharmacology, pharmacokinetics, oncology, drug metabolism, bioanalysis, biopharmaceutics, regulatory affairs, and toxicology.
Job DescriptionJob DescriptionCompany OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of people living with rare neuroendocrine diseases.. Their courage inspires us to challenge convention, ask bold questions and seek answers for them.. Opportunity OverviewRhythm seeks an experienced and highly motivated Associate Director of Medical Writing (MW) who can independently develop as well as oversee the development and advancement of clinical, regulatory, medical and safety documents spanning across the development lifecycle.. This role reports to the Head of Medical Writing yet works autonomously to lead work with cross-functional stakeholders to advance Rhythm’s goal of delivering precision medicines to patients living with rare, neuroendocrine diseases.. At Rhythm we are dedicated to transforming the lives of patients living with rare neuroendocrine diseases by rapidly advancing care and precision medicines that address the root cause.
This role is ideal for candidates interested in clinical research, healthcare analytics, or medical data management.. The Clinical Data Specialist will serve a key role in supporting the collection, organization, and reporting of data related to post-market medical device research studies and clinical outcomes.. The role will include completing data quality assurance and compliance reviews, as well as coordinating with the Data Analytics and Clinical Research teams to ensure timely and accurate data reporting.. Bachelor's degree in a relevant field (e.g., public health, health sciences, biology, healthcare administration, or related) or equivalent work experience.. Exposure to data visualization or statistical tools (e.g., Tableau, R, Python) is advantageous but not required.
GSK is seeking a dynamic and experienced Executive Medical Director, Clinical Research for Hepatology Clinical Trials to lead our clinical development programs within the hepatology therapeutic area.. This career opportunity requires an on-site office presence (minimum of two days a week) in one of GSK’s UK (London - New Oxford Street or Stevenage) or US(PA or MA) sites.. Oversee the development and implementation of clinical trial protocols, ensuring alignment with regulatory requirements and GSK’s scientific standards.. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.. GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
This role ensures compliance with SOPs, regulatory requirements, and ICH/GCP guidelines, aligning with company strategies.. Key Responsibilities Plan and Conduct Clinical Trials: Lead cross-functional teams to meet trial deliverables; collaborate on trial design; establish project milestones, budgets, and timelines; manage trial progress; identify risks and develop mitigation plans; contribute to regulatory documentation; oversee Clinical Research Associates and Trial Administrators as needed.. Key Qualifications Degree in Life Sciences (biology, pharmacology, nursing, health sciences).. ≥15 years in clinical research/operations, including 5 years managerial experience, preferably in Pharma/Biotech or CRO.. Deep understanding of drug development, ICH/GCP, GMP/GDP, and local regulations.
Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare — people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds – to apply.. The Regulatory Affairs Coordinator (RAC) will work with investigators, study staff, Institutional Review Boards (IRB), clinical trial sponsors and federal regulatory agencies to ensure that regulatory requirements are met for clinical trials.. This role reports to the Regulatory Affairs Research Manager and works closely with research teams across the Cancer Center to ensure regulatory compliance for multiple cancer trials.. Preparation and submission of clinical trials to the IRB. Completion and submission of clinical trials amendments to the IRB. This includes large amendments to the Protocol and other study documents received from industry sponsors throughout the course of the study, as well as smaller amendments to keep documents and processes up-to-date
To achieve its mission of improving people’s quality of life by acting responsibly towards society and the environment, the Group research, develops and markets innovative drugs in its three therapeutic areas: AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-rare diseases) and CAR E (products and services that support special care and consumer-facing self-care).. We are proud to be the largest global pharmaceutical group to be awarded B Corp Certification , a recognition of high social and environmental standards.. Chiesi USA is a specialty pharmaceutical company focused on developing and promoting products for the hospital, adjacent specialty and rare disease markets.. Purpose Currently seeking for a Regulatory Affairs Specialist to support preparation of CMC related submissions and assessment of quality change controls for Chiesi’s Global Rare Diseases (GRD) global portfolio of commercial products.. Execute preparation of timely responses to CMC regulatory questions in coordination with Subject Matter Experts (SME) as needed.
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. We also have leading-edge science from our discovery labs, leveraging ion channel expertise and drug discovery capabilities to identify targets and develop new candidates. Build effective partnerships with cross-functional teams (regulatory affairs, clinical development, biometrics). Author or oversee creation of clinical and regulatory documents such as protocols, study reports, briefing books, INDs/CTAs, NDAs, and Investigator Brochures. Represent medical writing in cross-functional meetings to ensure timely document delivery.
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.. Explores and excels in synergistic relationships with experts in digital health, global outcomes/epidemiology, biostatistics, and other key data science disciplines.. Serves as an ambassador of Quantitative Clinical Pharmacology (QCP) and Data Sciences Institute (DSI) to the R&D organization and the external scientific community through high-value participation at scientific meetings and impactful publications.. 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).. 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.
Company OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of people living with rare neuroendocrine diseases.. Responsibilities and DutiesAuthor and serve as lead writer for complex clinical and regulatory documents (e.g., protocols and amendments, clinical study reports, Investigator’s Brochures, regulatory submissions and responses to health authority inquiries) and contribute to the clinical study design and regulatory/clinical strategies.. Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents (e.g., Regulatory submissions, Annual Reports and updates, DSURs, PBRERs, Posters and Manuscripts).. Delegate, oversee, as needed act as lead Medical Writer, and serve as key communicator and liaison between any vendors or service providers and cross functional internal teams, including clinical, medical, pharmacovigilance and regulatory.. Direct experience in the pharmaceutical/biotech industry with an advanced understanding of requirements for clinical trials and drug development, regulatory submissions, pharmacovigilance reporting and medical communications.
The position provides Quality Assurance support for the Translational Medicine, Clinical Development, and Clinical Operations functions, including the areas of clinical pharmacology, toxicology, pharmacovigilance, clinical trial conduct, and clinical data management.. The Director, Clinical Quality Assurance works directly with the Cardurion Quality Team, Translational Medicine, Cardurion K.K., Clinical Development, Clinical Operations, Regulatory Affairs, and the corresponding quality assurance staff members from the various CROs, clinical study sites, and clinical service providers to ensure effective execution of the Cardurion Quality System requirements and compliance with the applicable GLP, GCP, and GPvP guidelines, regulations, and industry standards.. Provides Quality Assurance input/guidance on the handling of GLP and GCP non-compliance events to ensure these events are appropriately reported, investigated, and documented and that appropriate CAPA are identified and implemented.. Remains current in the US and international regulatory and industry requirements and inspectional trends for GLP, GCP, GPvP, and pharmaceutical quality systems.. Highly competitive benefits package including: Blue Cross Blue Shield PPO, Delta Dental, and VSP vision
Senior Principal Scientist Translational Medicine, Immunology. The preferred candidate will have at least 5-year experience in the pharmaceutical industry and Immunology R&D and clinical and academic expertise in Immunology-related areas such as Dermatology, Rheumatology, or Gastroenterology.. Development and execution of early clinical strategy for novel Immunology assets and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, Phase 1a/b trials and clinical pharmacology studies for programs in Phases I through IV of development.. Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations). Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout sites in the USA, UK and Belgium.
Senior Principal Scientist Translational Medicine, Immunology. The preferred candidate will have at least 5-year experience in the pharmaceutical industry and Immunology R&D and clinical and academic expertise in Immunology-related areas such as Dermatology, Rheumatology, or Gastroenterology.. Development and execution of early clinical strategy for novel Immunology assets and therapeutics including authoring initial clinical and biomarker plans for Lead Optimization programs, early clinical development plans for Preclinical Candidate molecules, Phase 1a/b trials and clinical pharmacology studies for programs in Phases I through IV of development.. Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations).. Interface broadly with key functions including Discovery Sciences, Preclinical Pharmacology, Pharmaceutical Sciences, Toxicology, Translational Biomarkers, Translational Medicine Operations, Translational Medicine-EU, Drug Metabolism/Modeling & Simulation, Regulatory Affairs, and late-stage Clinical Research throughout sites in the USA, UK and Belgium.