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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 Executive Director will build the clinical pharmacology function to enable the design and efficient execution of all Phase 1 programs across multiple therapeutic areas including epilepsy, psychiatry, and pain.. In addition, the role will require the development of strong working relationships within Clinical Development Department and with other key functions including, for example, Pharmacovigilance and Drug Safety, Regulatory, Discovery, CMC, Translational, Trial Operations, Biostatistics and Program Management.. Provide strategic and clinical pharmacology leadership to all development programs across epilepsy, psychiatry, and pain programs. Xenon highly values employee development and has an expanding Training, Learning & Development program, including a Tuition Assistance program for advanced degrees.
Development, implementation, maintenance and overall success of the companys regulatory affairs and quality assurance strategy & programs; including establishing quality standards/metrics/objectives, developing methods to embed quality into the product development and manufacturing process, establishing supplier relationships and quality standards and developing and implementing innovative programs to focus employees on improving product quality.. Serve as the company representative for the FDA and other relevant external stakeholders, including Twist Biopharmaceutical partnerships.. Advanced Degree in Law, Health Policy, Regulatory Affairs or Science. Experience with in vitro diagnostics, laboratory-developed tests, diagnostics medical device products, and/or therapeutics development including hands-on experience in developing and implementing policies and procedures for Regulatory Affairs and Quality. Excellent working knowledge of the US and global regulatory framework and their relevant governing authorities with direct experience handling submissions (e.g., PMA, 510(k), CE Marking).
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique CELL+GENE platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.. Experience and knowledge of global regulations for the development of cell therapy products is required, and any experience in the neurology and/or ophthalmology therapeutic areas is desired.. Represent Regulatory CMC on and/or lead matrix teams for cell therapy pipeline products.. The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.. At least 12-15 years in Regulatory Affairs, CMC, and relevant years in a global pharmaceutical and/or biotechnology company with expertise in biologicals and/or cell and gene therapy products (preferred).
BlueRock Therapeutics, a wholly-owned and independently operated subsidiary of Bayer AG, is a leading engineered cell therapy company using its unique CELL+GENE platform to direct cellular differentiation and genetically engineer cells to create a new generation of cellular medicines that address large patient populations suffering from neurological, cardiovascular, and immunology diseases.. Experience and knowledge of global regulations for the development of cell therapy products is required, and any experience in the neurology and/or ophthalmology therapeutic areas is desired.. Represent Regulatory CMC on and/or lead matrix teamsfor cell therapy pipeline products.. The ideal candidate should have a strong background in Regulatory Affairs CMC in a global pharmaceutical and/or biotechnology company with expertise in biologics, deep experience in product development and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development.. At least 12-15 years in Regulatory Affairs, CMC, and relevant years in a global pharmaceutical and/or biotechnology company with expertise in biologicals and/or cell and gene therapy products (preferred).
We are seeking an experienced Medical Director to provide clinical leadership for cardiovascular drug development programs spanning early- to late-phase trials.. Collaborate with cross-functional teams including Clinical Operations, Regulatory Affairs, Biostatistics, Drug Safety, Translational Medicine, and Commercial.. Provide medical monitoring oversight to ensure patient safety, data integrity, and regulatory compliance.. Proven track record in cardiovascular clinical research, including late-phase trial experience.. Prior experience with global regulatory submissions (NDA/BLA/MAA) preferred.
Responsible for increasing membership through direct sales and marketing of Molina Medicare products to dual eligible, Medicare-Medicaid recipients within approved market areas to achieve stated revenue, profitability, and retention goals, while following ethical sales practices and adhering to established policies and procedures.. Develop sales strategies to procure sufficient number of referrals and other self-generated leads to meet sales targets through active participation in community events and targeted community outreach to group associations, community centers, senior centers, senior residences and other potential marketing sites.. Ensure Medicare beneficiaries accurately understand the product choices available to them, the enrollment process (eligibility requirements, Medicare review/approval of their enrollment application, timing of ID card receipt, etc.). 2+ years Medicare, Medicaid, managed care or other health/insurance related sales experience. To all current Molina employees: If you are interested in applying for this position, please apply through the intranet job listing.
The Clinical Research Nurse II (CRN II) will report directly to the Medical Director (MD) of the Cancer Clinical Trials Program and the Administrative Director in Hematology and Medical Oncology.. Will see patients during required study visits and, partnering with the clinical research coordinator, ensure compliance with study requirements.. The Clinical Research Nurse will also provide clinical perspective and information to regulatory coordinators as needed to facilitate trial activation.. Licensed to practice professional nursing as a registered nurse (RN) in the Commonwealth of Massachusetts. Pioneering Research: Engage in groundbreaking research projects that are driving the forefront of biomedical science.
Our employees are our greatest asset as we work to achieve our bold ambitions, and were looking for the next wave of passionate and ambitious people ready to make a direct impact. PharmD/PhD with 2+ years relevant experience. Significant regulatory, quality, compliance or related experience in the biopharma industry. Significant experience participating in cross-functional projects and teams with responsibilities related to clinical trials or other drug development activities. In-depth knowledge of current global and regional trends in biopharmaceutical regulatory affairs.
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.
The VP, Head of Clinical Pharmacology & Pharmacometrics Systems & Tools will lead efforts to establish standardized, reproducible, and quality-assured practices across R&D. You will ensure the development and maintenance of an optimal and adaptable framework for supporting drug development by applying systems engineering principles to pharmacokinetic (PK) systems, and pharmacodynamic (PD) modeling and simulation.. Influence the delivery and alignment of clinical pharmacology function with peer groups across the TA CPMS groups leading the relationship with Regulatory (internal), Biostatistics, DMPK, Clinical, Imaging, Clinical Biomarker, and Research Units.. PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacodynamics, Pharmacy, Pharmacology, Mathematics, Statistics, Engineering, or Bioinformatics.. 15+ years' experience in clinical pharmacology, pharmacometrics/modeling and simulation in the global pharmaceutical industry, with a focus on clinical drug development and regulatory submissions.. 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.
Collaborate with Drug Metabolism and Pharmacokinetics (DMPK) teams to prepare and submit New Drug Applications (NDAs), focusing on precision in drug labeling.. Develop clinical pharmacology strategies for Phase 3 clinical trials, ensuring alignment with regulatory standards and expectations.. Provide expert clinical pharmacology insights to cross-functional teams, ensuring compliance in trial documentation and strategic regulatory interactions.. PhD, MD, or PharmD with 8-10 years of experience in clinical pharmacology and oncology drug development.. Expert in IND to NDA drug development phases, with skills in clinical trial design, execution, and analysis.
Servier in the U.S. is a Boston-based, commercial-stage biopharmaceutical company launched by Servier Group in 2018.. Responsibilities include serving as lead author of regulatory and scientific documents, managing the collection of content from cross-functional teams ensuring compliance with internal and external standards, mentoring junior writers, overseeing vendor activities, and acting as the Medical Writing point of contact for an assigned drug development franchise.. Experience with authoring/management of clinical and non-clinical documents for drug development. Servier is committed to modeling diversity, equity, and inclusion within the industry.. Servier also offers a competitive and comprehensive benefits package that includes benefits such as medical, dental, vision, flexible time off (Servier provides unlimited sick time and flex time, and does not accrue time off), 401(k), life and disability insurance, recognition programs among other great benefits (all benefits are subject to eligibility requirements).
The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio.. Lead regulatory reviewer in due diligence for licensing opportunities.. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.. Demonstrates acceptable skills with increasing independence in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies.. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy.
The VP, Head of Clinical Pharmacology & Pharmacometrics Systems & Tools will lead efforts to establish standardized, reproducible, and quality-assured practices across R&D. You will ensure the development and maintenance of an optimal and adaptable framework for supporting drug development by applying systems engineering principles to pharmacokinetic (PK) systems, and pharmacodynamic (PD) modeling and simulation.. Influence the delivery and alignment of clinical pharmacology function with peer groups across the TA CPMS groups - leading the relationship with Regulatory (internal), Biostatistics, DMPK, Clinical, Imaging, Clinical Biomarker, and Research Units.. PhD in Clinical Pharmacology, Pharmacokinetics, Pharmacodynamics, Pharmacy, Pharmacology, Mathematics, Statistics, Engineering, or Bioinformatics.. 15+ years' experience in clinical pharmacology, pharmacometrics/modeling and simulation in the global pharmaceutical industry, with a focus on clinical drug development and regulatory submissions.. 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.
The Director Global Regulatory Affairs, Neuroscience is responsible for developing innovative global regulatory strategies and providing strategic regulatory guidance for the global development of various products within the Neuroscience Therapeutic Area Unit (TAU) portfolio.. Lead regulatory reviewer in due diligence for licensing opportunities.. Partner with global market access colleagues to Lead interactions with joint regulatory/health agency/HTA bodies on product specific value evidence topics, as applicable.. This position is currently classified as hybrid following Takeda's Hybrid and Remote Work policy.. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
CRO Regulatory Specialist Job Description. The Regulatory Specialist ensures clinical trials operate within a compliant framework while supporting sponsors and sites in meeting FDA, ICH, and GCP requirements.. Experience: Minimum 5 years in clinical research with 3+ years in regulatory affairs at a CRO or sponsor.. Regulatory Knowledge: Deep understanding of FDA regulations (21 CFR Parts 11, 50, 54, 56, 312/812), ICH GCP guidelines (E6(R3. Problem Solving Risk Management Quality Management Systems Professional Attributes Critical Thinking Attention to Detail Cross-functional Collaboration Written/Verbal Communication Time Management A key role ensuring regulatory compliance throughout the clinical trial lifecycle, maintaining GCP standards, and supporting inspection readiness.
Since its inception over a decade ago,CRISPR Therapeuticshas transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. To accelerate and expand its efforts,CRISPR Therapeuticshas established strategic partnerships with leading companies including Vertex Pharmaceuticals. Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, regulatory affairs and program management) to ensure translation of the clinical protocol into operational deliverables.. PhD, RN, or NP with significant experience as a Clinical Scientist in a biopharmaceutical organizationAssociate Director: 6+ years of experienceDirector: 10+ years of experience.. Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators
Our award-winning products are sold in thousands of retail and eCommerce stores nationwide, including Walmart, Amazon, Walgreens, Target, CVS, The Vitamin Shoppe, Sam’s Club and iHerb. Force Factor is based in Boston’s innovative Seaport District. Force Factor is seeking a sharp, detail-driven Quality & Regulatory Compliance Manager to lead and oversee all regulatory and quality assurance efforts for our growing portfolio of dietary supplements and vitamins. 5+ years of experience in regulatory affairs or quality assurance within dietary supplements, CPG, or pharmaceuticals.. Strong knowledge of U.S. regulations governing dietary supplements (FDA, DSHEA, cGMPs, etc.)
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. Collaborate with internal stakeholders (clinical operations, data management, statistics, safety, regulatory affairs and program management) to ensure translation of the clinical protocol into operational deliverables.. PhD, RN, or NP with significant experience as a Clinical Scientist in a biopharmaceutical organization Associate Director: 6+ years of experience.. Familiarity with ICH, GCP, and relevant regulatory requirements, and strong analytical and strategic thinking skills, experience with interacting with medical monitors, development operations (preclinical, clinical operations, regulatory affairs, Quality Assurance) and clinical investigators
This leadership role is responsible for the strategic planning, preparation, and delivery of high-quality clinical and regulatory documents in support of global drug development programs.. Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and other departments to gather necessary information and align timelines.. Assist in vendor selection and management for outsourced writing projects, ensuring quality and on-time delivery.. Advanced degree in life sciences (PhD, PharmD, or MS preferred).. Experience with global regulatory submissions (e.g., IND, CTA, NDA, MAA).