Collecting information
Organizing data
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.
This position will be a critical driver in our mission to accelerate drug development and enhance patient care by implementing innovative clinical trials and Real-World evidence-based decision-making, leveraging our expertise in advanced statistical & modeling approaches and end-to-end novel quantitative applications. These collaborations will span across therapeutic areas-translational science organization, and various R&D functions such as patient safety/pharmocovigilance, patient focused drug development, portfolio management, global regulatory and digital partners to foster innovation and ensure best practices in quantitative science are implemented across the organization. The role will establish and nurture these strategic partnerships, drive various cross functional initiatives, as well as external academic collaborations to maximize impact on drug development programs and create competitive advantages for Sanofi. Lead R&D-level initiatives and novel project deliverables requiring EGDS expertise, including innovations in pharmacovigilance, portfolio management, patient-centric early development including diversity in clinical trials, digital biomarkers, and novel clinical trial designs.. Develop and communicate a vision for the future of biostatistics and its role in drug development and evidence generation.
As a CMC Regulatory Affairs Senior Associate , you will play a critical role in shaping and executing global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies.. Develop and implement comprehensive global CMC regulatory strategies for investigational and commercial products.. Maintain up-to-date knowledge of global CMC regulatory requirements, guidelines, and industry trends.. 4+ years of experience in CMC Regulatory Affairs within the pharmaceutical or biotechnology industry.. Regulatory Expertise: Comprehensive knowledge of global CMC regulatory requirements and submission processes.
Lab Manager - Contract - Fully Remote.. Enjoy the freedom of remote work while making an impact within the pharmaceutical industry. You will act as a subject matter expert, ensuring efficient collaboration and integration across various departments to support clinical trials. Understanding of the clinical drug development process and clinical trials. Collaborate cross-departmentally with Vendor Management, Quality Assurance, Procurement, Sample Management, Data Management, and Precision Medicine.
This includes acting as a liaison between the Principal Investigator, clinical collaborators, the study sponsor, clinical trial regulatory groups (IRB, FDA. Conducts routine and advanced data analysis to identify trends, study direction and action items and for use in regulatory reporting and research publications by the principal investigator.. ·Attends the study procedure in the OR and/or cath lab/Interventional radiology.. ·Updates and obtains required approval from the MGH OR Products Committee regarding Vascular Surgery Research Devices and provides ongoing clinical trial documentation.. Serves as a liaison with various entities, including study sponsors, FDA, internal and Partners research resources and the hospital’s Institutional Review Board (IRB).
This position reports to the QA Senior Manager Site Quality Leader and is part of the Quality and Regulatory Affairs Team located in Shrewsbury, MA. and will be an on-site role.. Implement process improvement initiatives using Six Sigma, Lean Manufacturing, DBS and SPC methodologies.. Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Minitab, Visio).. Proficiency with quality management systems (QMS) and tools like Veeva, SAP, Oracle, Magic.. Certification in Six Sigma, Lean Manufacturing, or ASQ (CQE, CQA, or equivalent).
The Director CMC Regulatory Affairs is responsible for ensuring regulatory approval for new products and product amendments, as well as maintaining the currency of product licenses and permits.. Successfully communicate and negotiate with international Health Authorities, representing Takeda Global Regulatory Affairs CMC in meetings. Applies comprehensive knowledge of drug development and CMC regulatory requirements in strategic planning and execution.. 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.
Supports documents for regulatory submissions to US and global health authorities, including Investigational New Drug (IND) applications, New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), protocols, investigator brochures, clinical study reports, briefing documents, regulatory responses to health authority questions, and scheduled reports. Collaborates with cross-functional team members, eg, Clinical Pharmacology, Toxicology, Research, Clinical Development, Regulatory Affairs, Biostats, Data Management, Quality, CMC, QC, etc., to ensure accurate and timely completion and delivery of high-quality, scientifically-sound documents, slide decks, and publications.. Advanced degree, CNS, and Rare Disease experience a plus. Experience using medical writing systems and technologies including Veeva RIM. Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day.
Reporting to the Head of Biometrics in the Development Organization, this role will work closely with internal team members and vendors to ensure that assigned clinical trials are conducted in a timely fashion and a manner compliant with SOPs, ICH/GCP/regulatory guidelines, company goals and expectations, and budget.. Collaborate with Biostatistics, Statistical Programming, and Clinical Operations to ensure timely delivery of datasets with clearly defined quality requirements supporting data readouts for company business activities, including internal decision-making, interim analysis, publications, conference presentations, interactions with health authorities, and regulatory submissions.. Lead the data monitoring process in partnership with internal and external stakeholders, including Clinical Operations, Clinical and Translational Sciences, Clinical Pharmacology, and Biostatistics, to proactively identify data quality issues and ensure timely data entry, query resolution, and completeness.. Collaborate with Clinical Operations and Quality Assurance to ensure data integrity, traceability, and compliance with CDISC (CDASH, SDTM) standards and 21 CFR Part 11 standards.. Experience with Medidata Rave is preferred.
As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care.. The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Data Specialist (CRDS).. The CRDS works independently under minimal supervision to extract clinical data and research data from electronic medical records and other sources and enter into electronic data capture system utilized for the clinical research protocol.. This position is fully remote.. No experience needed for a CRDS I. 1-2 years of previous data entry experience as a clinical research coordinator, clinical research assistant or data entry specialist for therapeutic clinical trials to be considered for a CRDS II.
D. graduates in various areas of industry pharmacy including regulatory affairs, medical information/affairs, patient safety, outcomes research, and many other areas.. In partnership with Northeastern University, Blueprint Medicines is offering a two-year Clinical Scientist PharmD fellowship based in Cambridge, MA. In your second year, you will have the opportunity to rotate based on your preferences, through different departments in Clinical Development (examples include Clinical Operations, Clinical Pharmacology, Pharmacovigilance and/or Translational Research) as well as in other areas of expertise outside clinical development according to your interests.. LOR writers should include the candidate's name and fellowship program(s) in the subject line (e.g. Smith, John - Alnylam, GSK).. J. Andrew Orr-Skirvin, PharmD, BCOP
PathAI is seeking a Senior Clinical Scientist to play a key role in driving our in vitro diagnostic (IVD) device projects, strategy and roadmaps.. Study Design & Documentation Develop and author clinical protocols, study reports, and regulatory submission documents in compliance with Good Clinical Practice (GCP) and Good Clinical Laboratory Practice (GCLP) guidelines.. Support data review and interpretation to ensure clinical relevance and regulatory compliance.. Advanced degree (PhD, MD, PharmD, or equivalent) in a relevant scientific discipline such as biomedical sciences, pathology, or clinical research.. 3+ years of experience in clinical development, clinical trials, or regulatory affairs within diagnostics, medical devices, or biotech/pharmaceutical industries.
Drawing on a broad understanding of Home Hospital practices and policies and displaying a high degree of initiative and independent judgment, the Rehab at Home MA will help to care for patients by assisting clinicians with daily clinical tasks such as providing patient education, responding to patient requests, taking vital signs, assisting with physical therapy exercises, and facilitating communications between patients, family caregivers, providers, and outside agencies.. The incumbent will work in tandem with a team of geriatricians, nurses, and physical therapists, and receive general direction from the Principal Investigator and Project Manager.. The MA will support patient care in the Rehab at Home randomized control trial, in which patients receive Skilled Nursing Facility level care in their own homes.. Makes recommendations to supervisors, administrator and/or clinician director for improvements.. Comprehensive knowledge of medical terminology, procedures, and protocols -Proficiency in electronic health record (EHR) systems and medical office software.
The Medical Director will be responsible for clinical research activities pertaining to advancing the development of GSK’s clinical portfolio and will also have responsibility for engaging in medical dialogues with relevant scientific and medical leaders in order to lead clinical data generation activities.. Participate in the authoring of clinical study reports and regulatory documents and collaborate with colleagues in Regulatory Affairs, CMC, Toxicology, Research, Pharmacology to respond to health authority and ethics committee queries.. Network extensively to develop long-term strategic partnerships with thought leaders both internally and externally, in support of GSK’s vision.. 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.
Senior Principal Scientist, Precision Medicine, Immunology. Precision Medicine is an integral part of our Immunology Therapeutic Area. To support our growing Immunology pipeline across Gastroenterology, Rheumatology and Dermatology we are seeking an experienced experimental medicine leader in our newly created Precision Medicine and Diagnostics function.. Work closely with a cross-functional group of experts, including clinical directors, clinical trial operations, and biomarker operations teams as they key liaison to enable implementation of precision medicine strategy in clinical trials. Collaborate with discovery colleagues for programs in early stage to influence biomarker assessments and readouts to drive forward and reverse translation tied to Precision Medicine goals. Bioinformatics, Bioinformatics, Biomarker Research, Clinical Development, Clinical Immunology, Clinical Medicine, Clinical Research, Clinical Testing, Clinical Trial Management, Cross-Cultural Awareness, Cross-Functional Teamwork, Dermatology, Drug Development, Ethical Compliance, Ethical Standards, Immunoassays, Immunotherapy, Management Process, Medical Research, Mentorship, Parasitology, Patient Care, Professional Networking, Protocol Development, Regulatory Compliance {+ 4 more}
The company is also recruiting for talented scientists who have deep knowledge in immunology, translational science, bioinformatics and biologics platforms to develop novel drugs leveraging disease-driving biology, novel technology in protein engineering, antibody discovery and new modalities.. Data Analysis and Interpretation Oversee the analysis, interpretation, and reporting of in vitro and in vivo pharmacology/translational biomarker data, including pharmacokinetic and pharmacodynamic parameters, exposure-response relationships, and safety/tolerability profiles.. Cross-Functional Collaboration Collaborate closely with colleagues in data sciences, biologics, immunology/pharmacology, clinical development, clinical operations and regulatory affairs to integrate translational biomarker and mechanism of action insights into overall drug development strategies.. M.D or Ph. D. in oncology, immunology, immuno-oncology, pharmacology, pharmaceutical sciences, or a related discipline.. Experience with immuno-oncology and autoimmune disease/chronic inflammation targets and associated in vitro and in vivo models.
Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients worldwide.. 7+ years of medical writing experience in pharma, biopharma, or CRO.. Track record of contributing to successful regulatory filings (IND/CTAs, NDA/BLA/MAA).. Knowledge of biologics, clinical research, study design, biostatistics, and medical terminology.. Proficiency in Microsoft Office, with experience in Veeva Vault and AI writing tools a plus.
The Regulatory Affairs Program Manager will play a critical role within Philips Patient Safety & Quality Organization, responsible for enhancing tracking and controlling systems to optimize regulatory compliance monitoring and reporting efficiency, implementing robust systems and processes to ensure accurate and timely compliance of global Unique Device Identification (UDI) requirements.. Leads programs/projects focused on regulatory compliance with UDI requirements, Computer System Validation (CSV) and process improvement by applying/utilizing lean tools- 6S, Kaizen, and continuous improvement methodologies to enhance performance, address regulatory challenges, problem solving techniques, management practices and drive organizational change.. Enhances tracking and control systems to optimize regulatory compliance monitoring and reporting efficiency, implementing robust systems and processes to ensure accurate and timely tracking of regulatory activities and ensures validation of regulatory affairs software tools.. You have demonstrated Regulatory Domain knowledge/expertise in Unique Device Identification (UDI), ensuring traceability and facilitating better management throughout the product lifecycle, as well as desired experience in Computer System Validation (CSV) and knowledge in 510K, PMA, Technical Files/Design Dossiers, etc.. Desired certifications-RAPS-RAC, PMP/CAPM, Six Sigma Certified Change Management Professional (CCMP)
Through artificial intelligence technologies, collaboration with healthcare professionals, and patient advocacy, Every Cure is dedicated to unlocking the full potential of existing medicines to treat every disease and every patient we possibly can.. This position plays a critical role in translating early-stage discoveries into real-world treatments by overseeing a diverse portfolio of studies, including natural history research, real-world evidence generation, and interventional clinical trials.. Program Oversight & Clinical ExecutionLead the design and implementation of clinical research studies, including real-world evidence studies, natural history registries, and clinical trials.. Expertise in clinical trial design, protocol development, drug development, and decision-making.. SkillsDeep knowledge of clinical research methods, real-world evidence generation, and regulatory requirements.
As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care.. The Cancer Center Protocol Office is seeking motivated, detail-oriented individuals to join our team as a Clinical Research Data Specialist (CRDS).. This position is fully remote.. No experience needed for a CRDS I. 1-2 years of previous data entry experience as a clinical research coordinator, clinical research assistant or data entry specialist for therapeutic clinical trials to be considered for a CRDS II.. Mass General Brigham is a passionate, welcoming community where minds meet caring hearts.