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Job DescriptionEssential Duties and Responsibilities: Includes the following. Other duties may be assigned. Performs all tasks and assignments in a safe and timely manner. Strives toward continuous self-improvement in personal productivity. Develop and maintain supplier quality assurance programs aligned with FDA, ISO 22716 (GMP for cosmetics), and other applicable regulations. Conduct supplier audits, assessments, and risk evaluations to ensure compliance with quality standards. Collaborate with Supply Chain, R&D, Quality and Regulatory Affairs to qualify new suppliers and manage ongoing supplier performance. Lead investigations into supplier-related non-conformances and drive corrective and preventive actions (CAPA). Monitor and report supplier KPIs including defect rates, delivery quality, and responsiveness. Implement and manage supplier scorecards and continuous improvement initiatives. Ensure proper documentation and traceability of supplier quality records. Stay current with industry trends, regulatory changes, and emerging risks in the OTC/cosmetics supply chain. Collaborate with cross-functional teams to support continuous improvement initiatives. Develop, Review, Write, and Implement SOP's for quality functions and ensure compliance with all regulatory and GMP requirements. Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team. Reviews subordinate performance in a formal review process. Support audit preparedness and internal audit programs, as well as regulatory and customer audit inspection readiness. Preferred: ASQ Certified Quality Engineer (CQE), ASQ Certified Quality Auditor (CQA), ISO 13485 Lead Auditor Certification. Demonstrated leadership and management skills, including establishing direction and goals, and building good work ethics for the team. Willingness to travel to company and vendor facilities as needed, approximately 25%. qualifications: Minimum 5 years of relevant experience in engineering, quality assurance, or manufacturing supplier quality in regulated manufacturing environment (cosmetics or OTC drugs a plus). Bachelor’s degree in a scientific or technical field (e.g., Chemistry, Biology, Pharmaceutical Sciences). Working knowledge of Six Sigma and/or Lean Manufacturing principles. Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/ 210/ 211),including data integrity and practices. Proficiency in quality tools and methodologies, including Supplier Assessments, First Article Inspections (FAI), Failure Modes and Effects Analysis (FMEA), 8D Problem Solving, Root Cause Analysis, Corrective and Preventive Actions (CAPA), Mistake Proofing and Process Control. Exceptional problem-solving skills, attention to detail, and the ability to manage multiple priorities in a fast-paced environment. Strong attention to detail and organizational skills. Effective written and verbal communication skills. Proficiency in Microsoft Office and familiarity with electronic quality systems. Adheres to all Prime Personnel Policies as established by the company. Physical Requirements: • Ability to lift and move objects weighing up to 25 pounds regularly and occasionally heavier items with assistance., • Ability to stand, walk, bend, stoop, push, and pull for extended periods during shifts., • Good understanding of safety protocols and practices., • Willingness to work flexible hours, including shifts and weekends. At Prime, we believe that a diverse, equitable and inclusive workplace makes us a more relevant, more competitive, and more resilient company. We welcome people from all backgrounds, ethnicities, cultures, and experiences. Prime is an equal opportunity employer. Powered by JazzHR CMh0tFdSUP

Job Description For almost 30 years, SQA Services has been a premier leader in providing managed supplier quality services for audits, assessments, remote surveillance assessments, corrective actions, remediation, inspections, and engineering to manufacturers within all industries. We deliver services by deploying associates who are located throughout the United States and in 90+ countries around the world to your supplier sites. Our associates are expert quality assurance professionals with broad experience and local knowledge who can represent our clients on-demand and on-site faster than our competitors. We are seeking dedicated and detail-oriented Data Migration Specialists for a 6-month contract position supporting a project focused on ensuring the accuracy and completeness of part-specific quality data. This role involves working with proprietary systems to validate records, manage issue tickets, and support data integrity across the organization. Ideal candidates will bring a strong eye for detail, familiarity with technical documentation, and comfort navigating digital systems in a fast-paced environment. Key Responsibilities: • Review and validate part-specific quality data for completeness, accuracy, and compliance with internal standards, • Interpret technical drawings and associated notes to ensure accurate documentation, • Input and manage data within digital platforms used for record retention and issue tracking, • Submit, monitor, and follow up on issue tickets to ensure timely resolution and clear documentation, • Identify and communicate discrepancies or missing information in records, • Contribute to continuous improvement efforts by identifying opportunities to streamline data workflows Skills and Qualifications: • High school diploma or equivalent, • 1–2 years of experience in quality assurance, document control, or data management, • Strong attention to detail with the ability to identify and correct data inaccuracies, • Basic understanding of technical drawings and associated documentation, • Proficiency in Microsoft Office applications, including Excel and Word, • Strong organizational and communication skills, • Ability to adapt quickly to digital systems and collaborate with cross-functional teams, • Aerospace industry experience or warehouse experience, • Experience with warehouse management SQA is an Equal Opportunity Employer. Employment is based on merit and qualifications and is not influenced by race, color, religion, gender, national origin, veteran status, disability, age, sexual orientation, gender identity, marital status, or any other legally protected status. Must be ITAR compliant and undergo a background check. Company DescriptionSQA Services is a leading Supply Chain and Quality Assurance consulting firm specializing in the management of Supplier Audit, Quality Engineering, Inspection, and Remediation programs in the Aerospace/Defense, Semiconductor, Medical Device, Pharmaceutical, Cosmetic, and Automotive manufacturing industries. Clients leverage our network of quality professionals in more than 50 countries as an extension of their own supplier quality teams.SQA Services is a leading Supply Chain and Quality Assurance consulting firm specializing in the management of Supplier Audit, Quality Engineering, Inspection, and Remediation programs in the Aerospace/Defense, Semiconductor, Medical Device, Pharmaceutical, Cosmetic, and Automotive manufacturing industries. Clients leverage our network of quality professionals in more than 50 countries as an extension of their own supplier quality teams.

Job DescriptionTTF is recruiting for DRG Auditors who have worked in Inpatient Revenue Integrity to work remotely for a company based out of the Southwest. We are seeking individuals with experience in CDI with either CCDS, CCS, or RHIT certifications. This is a full-time, direct-hire role, where you can work anywhere in the United States. The starting salary is $46-$52/hour and comes with full benefits. Qualified candidates must have: • CCDS, CCS, RHIT certifications, • Five years acute care coding experience TTF is a healthcare search and staffing company that partners with hospitals, physician groups, TPA's, medical management companies, pharmaceutical and pharmacy benefit plan organizations, surgery centers, DME/home health, consulting companies, and all other healthcare fields. The TTF Coding and HIM Division partners with healthcare organizations nationwide to match top talent in the Coding and HIM industry with organizations that want to hire the best talent. We place Remote Coders, Coding Managers, Coding Directors, and ICD10 Certified Trainers on a contract and direct-hire basis. Our goal is to offer outstanding opportunities to talented coders and coding professionals with RHIT, RHIA, CCS, CPC, and other coding certifications. #IND1

Job DescriptionSalary: $16-$23 per hour; dependent on experience Continental is looking for a Laboratory Assistant to join our team! The position requires an individual who is highly detail-oriented and can help us efficiently accession daily lab test reports, process (centrifuge, pool, aliquot, and appropriately store blood samples) for a variety of orders that may change daily. We are seeking an individual interested in taking on a variety of tasks, is highly organized, and is able to manage several tasks in a short period of time. Continental has been in business for over 55 years and is a private for-profit blood banking company. We service pharmaceutical and research companies all over the world, and our product is used for research and diagnostic testing materials. With two centers, one in Fort Lauderdale and one in Miami, we provide our blood donors with quality customer services. Your Main Responsibilities Will Include: • Effectively read order processing instructions (in English) for samples, and efficiently process according to the instructions., • Receive and account for all samples set to be drawn and processed each day., • Pack and verify accuracy and completeness for shipments of products to customers on a daily basis., • Maintain a positive and team-work work ethic, while processing a large volume of samples and orders., • Organize, process and store blood samples efficiently; be able to accurately manage hundreds of samples within the work week. Ideal Candidates Meet the Following Requirements: • Able to consistently maintain a high level of accuracy, • Willingness to assist in other areas of the blood bank, as needed, is required., • Prior laboratory experience and knowledge of Good Laboratory Practices is highly preferred., • High level proficiencyin written and spoken English is required; Spanish is a plus., • Computer literacy, including in Excel and Word, is required. What You Can Expect from Us: • Youll Be Treated Fairly-- We are a family-owned and operated company, and we consider each of our employees as part of our larger family. We operate and make our decisions based on merit, qualifications and performance., • Youll Be Challenged-- We hold very specialized and several regulatory licenses, which means our work environment is constantly evolving as agencies continue to update and improve their standards., • You'll have Phenomenal Hours-- We will not ask you to operate outside of our standard working hours, which are roughly 7:30am - 5:00pm. On Fridays, our working hours are roughly 7:30am-2:00pm. You will not be asked to work weekends, nights, or to be on call on any regular basis., • Youll Be Provided with Benefits-- After a probationary period, you have the option to partake in the health insurance plans we provide. You also will have the option to start a 401k, all expenses of setting up the account covered by us. What We Expect From You: • Communication - We feel this is the most important aspect of any job. You must be in communication with your supervisor, and make sure they are familiar and in agreement with your everyday tasks., • Timeliness - Everything we do--from shipping out specialty products to scheduling specific donors--is on a schedule. While we are very flexible in terms of time off and scheduling, we operate on the assumption that our employees will be timely, and if necessary, gives plenty of notice of their future absence., • Team Work - Our operations, testing and systems are complex and multifaceted, so we expect you to work well with our current team members--from those in the lab to those in administration--to ensure we work most cohesively., • Flexibility - We have two centers: our home office in Miami, and a second in Fort Lauderdale. We expect that if necessary, you are willing to work at either location, in the case of an emergency. Your gas and time would be compensated for a short period, if we ask that you work in a station that is not your home station. We also expect that youll be willing to jump in anywhere in the office where we might need you., • Willingness to Learn - While we expect youll come in with a variety of basic skills, we ask that you come also knowing youll learn a lot here. Salary & Benefits • Competitive salary within the field. Final determination will depend on experience level and qualifications., • Profit Sharing - Fully funded and invested., • 401k - All administrative and investment fees are paid for by Continental., • Health Insurance - A majority of the insurance fees is paid for by Continental. This includes gap, vision and dental insurance. We can talk to you about what kind of plan will work for you. About Continental Services Group Inc. We are an FDA-licensed company that has been in business for over 55 years. We provide blood components and other biological raw materials to our customers, who use the material for the further manufacturing of in-vitro diagnostic products. The vast majority of the product we sell is used for manufacturing test kits and controls, which are used in hospitals around the world. Holding some of the industry's most specialized certifications, we draw the blood and other raw material from a wide base of donors, a majority of which repeatedly and consistently visits every 56 days. This repeat-donor base allows us to provide extensively tested and unique products to the pharmaceutical industry. Continental has been an FDA licensed facility since 1971, holding multiple city, state and federal licenses. Our laboratory is CLIA certified since 1971, and ourfacilities have beenISO 9001 certified since 2003.Continental Services Group is an Equal Opportunity Employer and maintains a smoke and drug-free workplace. All offers of employment are contingent upon successful completion of drug and background checks.

Job Description Location: Princeton, NJ / Miami, FL / Menlo Park, CA / Oxford, UK ONSITE About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) * HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. * HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. * HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) * HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: We are seeking an experienced clinical supplies professional to join the CMC team and support the supply chain strategy for clinical development. The Clinical Supply Manager will be responsible for planning and execution of operations for their assigned clinical supply projects and to support the ongoing development pipeline as well as optimization of Clinical Supplies department processes. The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key supply chain expert for cross functional teams. Prior experience in a small to mid-sized, fast-paced pharmaceutical environment is preferred. Summit are a global company; overseeing global activities across multiple time zones and as such may require flexibility in working hours at times. Travelling for the role (vendor facility visits, Investigator Meetings, etc) will be required at times and is estimated to be 5-10%. Role and Responsibilities: • Clinical Trial Supply Planning and Forecasting, • Develop and maintain accurate forecasts for clinical trial supplies based on protocol requirements and enrolment projections., • Collaborate with cross-functional teams to ensure alignment of clinical trial supply plans with study timelines and milestones., • Vendor Management, • Oversee relationships with external vendors, including clinical packaging and labelling partners, distribution centres, and courier services., • Monitor vendor performance, adherence to timelines, and quality standards., • Inventory Management, • Implement and maintain robust inventory management systems to track and manage clinical trial supplies throughout the supply chain., • Ensure adequate and timely supply of investigational products to clinical sites., • Oversee the planning, implementation and utilisation of effective clinical systems to support inventory management and distribution (e.g. IxRT)., • Regulatory Compliance, • Stay up to date on relevant regulatory requirements and guidelines related to clinical supply chain management., • Support regulatory strategy by overseeing provision of required documentation for submission and QP certification as required., • Ensure all activities comply with Good Manufacturing Practice (GMP) and other applicable regulations., • Risk Management, • Identify potential risks and challenges in the clinical supply chain and develop mitigation plans., • Proactively address issues that may impact the availability of clinical trial materials., • Communication and Collaboration, • Foster effective communication and collaboration with internal stakeholders, including Clinical Operations, Regulatory Affairs, Quality Assurance, and other relevant departments., • Participate in project team meetings to provide updates on clinical supply chain status and address any issues or concerns., • Contribute to monthly review cycles to ensure cross functional alignment on strategic and tactical topics., • Bachelor's degree in a relevant scientific or business discipline; advanced degree preferred., • Minimum 5 years’ experience in Supplies management at a pharma, biotech or contract development and manufacturing organization (CDMO), • Proficiency in relevant software applications (e.g., Microsoft Office, clinical trial management systems)., • Demonstrated track record of successfully managing complex international clinical studies and supply chains., • Broad understanding of regulatory and GMP requirements for IMP product packaging and supply., • Solid understanding and experience in design specifications and UAT of IXRS applications., • Project management skills, tools, principles, and applications, • Expertise in outsourcing and supplier management, • Proficiency with clinical supply planning and forecasting tools, • Successful candidate will be:, • Comfortable interacting with all levels of the organization, customers, and suppliers, • Able to work with abstract global problems, • Nimble in a highly dynamic and agile organization where changing priorities are the norm, • Intuitive with well-honed interpersonal and communication skills, • Organized and demonstrates effective team leadership, • Effective with global workgroup associates, • A promotor of inclusion and collaboration, • Able to work independently, • Able to handle multiple projects simultaneously while maintaining high-quality results, • Capable of providing and implementing innovative solutions to unique and pressing situations, • Aware and compliant with FDA, EMA, PMDA regulations and requirements for functioning under GMP, GCPs, Annex 13, and EU CT Directive/Regulation, • Able to demonstrate a fundamental knowledge of drug development process, • Technically proficient in industry standard technology and/or available software, processes, and industry trends to streamline and or improve efficiencies, • Knowledgeable of and compliant with SOPs, Change Controls, Deviations, Investigations and CAPAs The pay range for this role is $118,500-$139,000 annually. Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at to obtain prior written authorization before referring any candidates to Summit.

Job DescriptionDescription: Job purpose The Process Engineer I is responsible for evaluating and improving manufacturing processes to reduce cost, improve yields, and reduce variation. This position performs new process design and implementation, process validations and process qualifications. Process Engineers also participate in technology transfer to ensure the processes necessary for new products are effectively translated to manufacturing from R&D. Process Engineer I makes use of statistical analysis methods, critical thinking, process development, and scaling principles to achieve the objectives mentioned above. Duties and responsibilities • Plan and execute process optimization, equipment qualification, and process validation or process qualification projects., • Use LEAN Manufacturing principles to analyze processes and make recommendations for improvements., • Lead and perform equipment qualifications, process validations or process qualifications, including writing of protocols and reports., • Lead efforts to solve problems using formal problem resolution techniques and root cause analysis., • Create, communicate, and follow project plans with detailed tasks and timelines necessary for project completion. Communicate to management of performance against plan., • Identify and resolve insufficiencies in routine manufacturing and provide constant support to manufacturing team., • Develop standard operating procedures (SOPs) for newly designed or optimized processes, while ensuring compliance with safety and quality standards., • Assess processes, take measurements, and interpret data., • Develop and monitor process and equipment metrics to use for optimization analysis., • Comply with FDA and AATB tissue banking standards., • Other duties as assigned. Requirements: Qualifications Qualifications include: • BS in Biomedical, Mechanical or Industrial Engineering or other applicable engineering discipline. Advanced degree (Master’s) a plus., • 1-3 years of experience in Tissue Banking, Device, Biologics, or Pharmaceutical industry in a relevant engineering role preferred., • Strong analytical, planning, project management, critical thinking, troubleshooting, clear communication, and problem-solving skills., • Ability to effectively communicate with multidisciplinary teams., • Excellent technical skills and writing., • Strong knowledge of LEAN manufacturing principles preferred., • Working knowledge of 21 CFR 1271 regulations and AATB guidelines preferred., • Proficient in project planning software. Microsoft Project preferred., • CTBS certified (or certified within two years of employment)., • Strong work ethics. Working conditions Job requires working in office. Must be willing to work weekends and evening hours as necessary. Must be willing to accommodate travel if necessary. The job may require work to be performed inside the controlled clean room processing area where the engineer would be exposed to tissue processing. Physical requirements The job may entail the occasional requirement to stand for extended periods of time and lifting heavy objects of up to 30 lbs. and do repetitive tasks with few breaks while executing engineering plans. Direct reports No direct reports

Job DescriptionAbout MMS MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit or follow MMS on LinkedIn. Responsibilities • Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias, • Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals, • Complete writing assignments in a timely manner, • Maintain timelines and workflow of writing assignments, • Practice good internal and external customer service, • Highly proficient with styles of writing for various regulatory documents, • Expert proficiency with client templates & style guides, • Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects, • Contribute substantially to, or manages, production of interpretive guides, • Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary, • Mentor medical writers and other members of the project team who are involved in the writing processRequirements, • At least 3 years of previous experience in the pharmaceutical industry, • Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience, • The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline, • Substantial clinical study protocol experience, as lead author, required, • Experience leading and managing teams while authoring regulatory documents with aggressive timelines, • Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus, • Understanding of clinical data, • Exceptional writing skills are a must, • Excellent organizational skills and the ability to multi-task are essential prerequisites, • Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools, • Experience being a project lead, or managing a project team, • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus DLSVS3wQqb

Job DescriptionDescription: The Quality Control Microbiologist II is responsible for performing microbiological testing and managing results of incoming raw materials, in-process samples, and final product samples. Review and analyze testing data to ensure internal specifications are in accordance with standard operating procedures requirements. Ensure testing results are accurate, and results are available in a timely manner. Must write and review procedures, reports, and investigations. Performs all functions in accordance with standard operating procedures, all applicable federal and state regulatory and accrediting standards requirements. Requirements: • Perform microbiology testing including, but not limited to reading of cultures, gram staining, microbial limit test, cell count and cell viability testing, growth promotion testing, and biochemical testing., • Support the environmental monitoring program (EM), Stability Program, and the Dose Audit Program., • Perform microbial characterization including subcultures of samples, gram stain, biochemical testing, and final identification using VITEK 2., • Conduct testing of clean utilities of the facility, including but not limited to performing TOC, pH, and conductivity testing., • Review and analyze test results according to internal standard procedures to ensure proper management, tracking, and disposition of materials and products., • Performs reviews and approval of routine testing documents., • Responsible for reporting and analyzing all variances, errors, and deviations to Quality Management., • Maintain proper documentation and trend analysis of QC test results., • Perform laboratory cleaning and maintenance of equipment., • Maintains the laboratory stock of media, reagents and laboratory supplies., • Lead QC validations and supports interdepartmental validations and qualifications that require microbiological testing., • Support Write investigations, deviations, and change controls. Manages the implementation of controlled changes and corrective actions., • Participate in the on-call weekend schedule., • Perform other duties as assigned by QC Management Qualifications Education/Experience: Bachelor’s degree in science with at least 3-4 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). Associate’s degree in science with at least 4 years of experience in a regulated environment (e.g., Biologics, Medical Device, Pharmaceutical, etc.). Skills: Excellent interpersonal, verbal, and written communication skills required. Must demonstrate excellent organizational and record-keeping skills. Must be detail oriented with the ability to multi-task in a high-pressure environment. Proficient in Microsoft Office. Working conditions Fast paced, lab-oriented work environment. Evening and weekend work may be required. Physical requirements While performing the duties of this job, the employee is regularly required to sit or stand for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds. Direct Reports No direct reports. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job any time. VIVEX Biologics is an equal opportunity employer (EEO) and expressly prohibits any form of workplace discrimination and/or harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

Job Description Work 100% remotely, set your own schedule, and earn additional income while making a real difference in men's health and lives. Hone is one of the fastest-growing health companies in the United States, and we are looking for physicians who have deep knowledge and experience in prescribing for men with hypogonadism. If you are a physician with a strong background in treating hypogonadism and experience prescribing testosterone and other hormone-optimizing pharmaceuticals, this is an opportunity to join a mission-driven team that is reshaping access to care. We treat patients with a combination of pharmaceutical products in accordance with AUA-defined protocols, supplements, and lifestyle changes. We are committed to making care more convenient and affordable for patients. Experience with weight-loss and thyroid medications is a plus, as we have expanded beyond men's hormones into these treatment areas. We have also launched services for women. Experience with women's hormone therapy allows you to see our female patients as well, but is certainly not required. We are looking nationwide and value physicians licensed in multiple states. Who We Are We're a modern health company with a simple mission: help our patients take control of their health and age with confidence. Our platform removes barriers to care through education, technology, and convenience. Our primary focus is hormone optimization for men. We are looking to add to our growing team of 150+ physicians who specialize in treating hormones and are passionate about improving patient outcomes through telemedicine. You'll join a supportive, innovative environment where you'll receive full training on our proprietary telemedicine platform, HIPAA-compliant technology, and technical support. What You'll Do • Conduct video-based consultations from anywhere with an internet connection, • Review labs and create personalized treatment plans, • Prescribe and titrate medications based on clinical findings, • Educate patients on safe and effective hormone optimization, • Provide feedback to help us continuously enhance the patient experienceWhat We're Looking For, • MD or DO with an active license (multi-state licenses preferred), • Minimum 2 years of experience in Endocrinology, Urology, Family Medicine, or Hormone Therapy, • DEA license with authority to prescribe Schedule III medications, • Strong communication skills and a passion for patient-centered care, • Comfort with technology and willingness to learn telemedicine workflows, • Availability for at least 8 hours per week, • A prescribing philosophy that values holistic care and hormone optimization, not just prescribing testosterone to everyone Help men regain their health and confidence - from anywhere. If you are passionate about hormone health, thrive in innovative environments, and want to help men live their best lives, we would love to hear from you.

Job DescriptionSalary: Competitive in Field; Experience Based Location: Miami, FL (with occasional travel to Fort Lauderdale) Company: Continental Services Group (CSG) About Us Continental Services Group (CSG) is a private, FDA-registered commercial blood bank that has been serving pharmaceutical, diagnostic development and research companies worldwide for over 50 years. We specialize in providing high-quality blood components and biological materials that support the development of diagnostic products used in hospitals and medical facilities worldwide. With FDA, CLIA/COLA, and ISO 9001 certifications, we take pride in our long-standing commitment to quality and regulatory excellence. The Opportunity We are seeking an experienced Quality Assurance Manager to join our team and strengthen our Quality Systems. This is a hands-on role that will partner closely with staff across all departments to ensure compliance, drive continuous improvement, and prepare the organization for regulatory and customer audits. If youre passionate about CAPA management, SOP development, and ensuring compliance in an FDA-regulated environment, this role offers the chance to make a direct impact. What Youll Do • Lead CAPA & Risk Management: Drive corrective and preventive action (CAPA) investigations, assess risk, and ensure effective closure and follow-up., • Own SOPs & Document Control: Revise, maintain, and oversee controlled documents; collaborate with staff to ensure accuracy and compliance., • Conduct Internal Audits: Plan and execute audits to FDA, CLIA, ISO 9001, and customer requirements; present findings and corrective actions to leadership., • Support Regulatory Readiness: Host and support external audits from FDA, ISO, and customers., • Train & Educate Staff: Deliver training on SOPs, QMS principles, and quality culture expectations., • Provide Data & Insights: Analyze QMS data, calibration records, and KPIs to identify trends and provide clear reports to management. What Were Looking For • Experience: 3+ years in Quality Assurance within an FDA-regulated industry (biologicals experience strongly preferred)., • Technical Skills: Hands-on CAPA management, SOP writing/revisions, internal auditing, and quality planning experience., • Regulatory Knowledge: Familiarity with FDA CFRs, ISO 9001, and CLIA; experience hosting or supporting regulatory inspections., • Education: Bachelors degree in a science-related field., • Other Skills: Strong technical writing, root cause analysis, and communication skills; ability to work independently and collaboratively., • Bonus: Spanish fluency. What We Offer • Competitive Pay: Based on experience and qualifications., • Work-Life Balance: Standard weekday hours (MonThu 8am5pm, Fri 8am2pm). No nights, weekends, or on-call., • Comprehensive Benefits: Health, vision, dental, and gap insurance (majority employer-paid)., • Retirement & Profit Sharing: 401(k) with profit-sharing opportunities., • Supportive Culture: Family-owned company with a collaborative, respectful, and merit-based environment. Why Join Us At CSG, youll join a team where Quality isnt just a department its our reputation. Youll be empowered to help reshape and continue quality processes, contribute to international healthcare impact, and grow within a stable and respected organization thats been thriving for more than five decades.

In addition, the Compliance Officer will lead the Quality Control Department, supervising a. We are seeking a Compliance & Quality Control Officer with strong experience in the pharmaceutical industry to. Lead and manage the Quality Control Department, supervising a team of at least four.

Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital and veteran status, and any other status or classification prote

Job DescriptionLitigation Attorney – Product Liability (Associate or Of Counsel) Direct Counsel is seeking a litigation attorney to join a leading national firm with openings at both the mid-level associate and of counsel levels. Locations: Atlanta, Austin, Baltimore, Boston, Chicago, Dallas, Houston, Los Angeles, Miami, Minneapolis, New York, Northfield, Palo Alto, Philadelphia, Phoenix, Raleigh, Reston, San Diego, San Francisco, Seattle, Short Hills, Washington, Wilmington About the Role The firm is looking for attorneys with strong legal writing skills and substantial experience in pharmaceutical and medical device product liability matters, particularly involving Daubert and Rule 702 motions practice. Candidates should have a background in complex litigation and be comfortable handling a range of responsibilities, including: * Drafting and reviewing motions, briefs, memoranda, and discovery responses * Developing case strategy and working with experts * Assisting with fact development and depositions * Communicating with clients and supervising junior attorneys Experience Levels Mid-Level Associate * 3–5+ years of litigation experience, ideally from an Am Law 100 firm * Demonstrated experience with Rule 702 and Daubert issues * Product liability and pharmaceutical/medical device experience preferred Of Counsel * 8+ years of litigation experience, preferably in an Am Law 100 environment * Extensive brief writing experience on Daubert and Rule 702 motions * Background in products liability litigation required; pharma/medical device is a plus Qualifications * JD from a nationally recognized law school * Admission to practice in the jurisdiction of the office location * Strong analytical, writing, and organizational skills * Ability to manage multiple priorities and work collaboratively or independently Compensation * Associate range: $250,000–$370,000, depending on location and experience * Of Counsel range: $400,000–$500,000, depending on location and experience * Comprehensive benefits package, including medical/dental/vision and 401(k) Work Environment Hybrid schedule with regular in-office presence and flexibility for remote work.

Doctoral degree in life/health sciences is preferred (PharmD, MD, PhD, or equivalent), master’s degree in health sciences (MSN, NP or PA) is the minimum requirement. A minimum of 3 years of experience post-doctorate as a field-based medical science liaison (MSL) in the pharmaceutical industry is r

Must have a minimum of 5 years of experience within the pharmaceutical industry overseeing a Medical Science Liaison team or related function. The annual base salary range for the Associate Director/Director, Medical Science Liaison - Oncology, Central Region (Field-based) is from :$198,900-$261,000

A minimum of 3 years of experience post-doctorate as a field-based medical science liaison (MSL) in the pharmaceutical industry is required. Join Takeda as a Senior Medical Science Liaison, Solid Tumor covering the Florida and Puerto Rico territory. Participate in executing medical strategy at medic

Job Description Pharmaceutical Sales Representative – Specialty & Entry Level We are a diverse and fast growing Biopharmaceutical company that is committed to focusing on patient health while delivering consistently high performance. Our Pharmaceutical Sales Rep team provides the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit. These values help our Pharmaceutical Sales Representatives set goals based on our organization’s potential and what we hope it will become. We are looking for a consistent and driven high performance with proven selling skills to join its innovative and skilled Pharmaceutical Sales Rep organization. Each Pharmaceutical Sales Rep will be responsible for establishing, promoting and maintaining a high level of sales. Our Pharmaceutical Sales Representative responsibilities: • Promote and sell products to current and potential customers within a defined geography., • Develop, analyze, prioritize and execute in order to execute territory plans to achieve business results through compliant means., • Uses functional and technical knowledge of pharmacology products, healthcare, pharmaceutical market places, managed care, and customer markets to meet or exceed customer needs. Understand and execute sales territory management and customer development., • Establish and maintain excellent communications and sound working relationships with physicians and healthcare providers., • Actively participate in scheduled Company sales meetings, district and regional conference calls and other business meetings., • Demonstrate honesty and integrity while modeling behaviors consistent with company standards and policies for business and compliance related matters., • Other related duties as required. Requirements The Pharmaceutical Sales Rep opening qualifications: • Have some sales abilities or sales experience in quota driven role, • Some education and/or knowledge of pharmaceutical and healthcare products, • Demonstration of sustained, high performance in current position or a strong aptitude for learning, • High sense of urgency in particular with regards to customer service orientation, • Strong business acumen and ability to understand market opportunities, • Strong knowledge of the business and market in the assigned territory is preferred, • Ability to thrive in a highly driven culture that is performance based, fast paced, and results oriented, • Private Health Insurance, • Paid Time Off, • Training & Development, • Performance Bonus Please apply today for this opportunity. We are committed to leveraging the talent of a diverse workforce to create great opportunities for our business and our people. EOE/AA. Minority/Female/Sexual Orientation/Gender Identity/Disability/Vet

Job DescriptionSalary: 16$ - 18$ About Us: Continental Services Group, Inc. is a trusted leader in the blood and biologicals industry with over 50 years of manufacturing and quality assurance experience. Our work supports the creation of life-saving in-vitro diagnostic products used in laboratories and healthcare facilities globally. As an ISO 9001 certified and FDA-licensed facility, we pride ourselves on delivering high-quality, ethically sourced products to the pharmaceutical, diagnostic and research industries. Position Overview: We are seeking a dedicated Warehouse & Maintenance Associate to support the daily operations of our blood bank. This role involves assisting with warehouse organization, inventory management, facility upkeep, and delivery services across Miami and Fort Lauderdale. If you are hands-on, detail-oriented, and ready to contribute to a critical industry, we encourage you to apply. Key Responsibilities: • Organize and prepare a high volume of outgoing shipments daily., • Maintain accurate inventory control and documentation., • Perform lifting and moving of 50+ lb. boxes regularly., • Ensure facility cleanliness and upkeep across our Miami and Fort Lauderdale locations., • Deliver products and materials to clients and partners in the Miami and Fort Lauderdale areas., • Complete deliveries to the post office, bank, and other customers as required., • Assist in the upkeep and maintenance of warehouse tools and systems., • Support basic facility maintenance functions as requested by management. Qualifications: • Basic handy-work and mechanical skills., • Proficient computer skills, especially for inventory tracking and documentation., • Valid, clean drivers license with ability to make deliveries., • Physically able to lift and move 50+ lbs consistently., • Ability to work well under the guidance of a warehouse supervisor / manager and adapt to various tasks., • Strong attention to detail and good reading comprehension skills. What We Offer: • Competitive salary aligned with industry standards., • 401(k):We cover all administrative and investment fees, with the option for you to open an account., • Health Insurance:Comprehensive plans with partial employer contribution, based on your selection. Why Join Us? Continental Services Group, Inc. is more than just a workplace we are a community driven by purpose. Join our mission to make a global impact in the medical field, contributing to the development of essential diagnostic products.

Job DescriptionSalary: $15-17 per hour WE WILL TRAIN YOU IN ALL ASPECTS OF THE JOB Interested in joining the Medical Field and making a difference for the medical community? We could be a match! Continental is looking for a Product Processor & Packer in our Miami location. You'll be responsible for processing blood units drawn and preparing blood components for shipment on a daily basis. This position is within our manufacturing area; this means the staff is expected to work consistently and quickly, following the same process each time a task is performed. We are looking for someone who works well with our small fast-paced team, has an eye for detail when reading and writing, and is seeking a full-time position. This is a position requires standing and moving for extended periods of time. Continental has been in business for over 53 years and is a private for-profit blood banking company. We service pharmaceutical and research companies all over the world, and our product is used for research and diagnostic testing materials. With two centers, one in Fort Lauderdale and one in Miami, we provide our blood donors with quality customer services. Your Responsibilities Will Include: • Handling the blood units that come from the donor room after donation., • Properly reading, labeling and assigning units and samples in a timely, efficient manner., • Labeling and processing of bags being prepped for phlebotomy., • Processing and packing blood components, and preparing for shipment to customers., • Checking prepared shipments to be fully accurate to customer specifications., • Other duties, as assigned. Expect to sit for long periods of time, stand for long periods of time and change positions frequently. Ideal Candidates Meet the Following Requirements: • Has worked in a manufacturing and/or laboratory accessioning facility before, • Has prior experience in the medical field, • Must have highly proficient reading and writing skills, • Bilingual in Spanish and English is a plus What You Can Expect from Us: • Youll Be Treated Fairly-- We are a family-owned company, and we consider each of our employees as part of our larger family. We operate and make our decisions based on merit, qualifications and performance., • Youll Be Challenged-- We hold very specialized and several regulatory licenses, which means our work environment is constantly evolving as agencies continue to update and improve their standards., • You'll have phenomenal hours-- We will not ask you to operate outside of our standard working hours, which are roughly 8:00am - 5:00pm. On Fridays, our working hours are roughly 8:00am-2:30pm. You will not be asked to work weekends, nights, or to be on call., • Youll Be Provided with Benefits-- After a probationary period, you have the option to part take in the health, dental, and vision insurance we provide. After a year with us, you also will have the option to start a 401k, all expenses of setting up the account covered by us. Youll also have access to profit sharing. What We Expect From You: • Communication- We feel this is the most important aspect of any job. You must be in communication with your supervisor, and make sure they are familiar and in agreement with your everyday tasks., • Timeliness- Everything we do--from shipping out specialty products to scheduling specific donors--is on a schedule. While we are very flexible in terms of time off and scheduling, we operate on the assumption that our employees will be timely, and if necessary, gives plenty of notice of their future absence., • Team Work- Our operations, testing and systems are complex and multifaceted, so we expect you to work well with our current team members--from those in the lab to those in administration--to ensure we work most cohesively., • Flexibility- We have two centers: our home office in Miami, and a second in Fort Lauderdale. We expect that if necessary, you are willing to work at either location, in the case of an emergency. Your gas and time would be compensated for a short period, if we ask that you work in a station that is not your home station. We also expect that youll be willing to jump in anywhere in the office where we might need you., • Willingness to Learn- While we expect youll come in with a variety of basic skills, we ask that you come also knowing youll learn a lot here. Salary & Benefits • Competitive salarywithin the field. Final determination will depend on experience level and qualifications., • 401k- All administrative and investment fees are paid for by Continental., • Health Insurance- A majority of the insurance fees is paid for by Continental. We can talk to you about what kind of plan will work for you and your family. About Continental Services Group Inc. We are an FDA-licensed company that has been in business for over 53 years. We provide blood components and other biological raw materials to our customers, who use the material for the further manufacturing of in-vitro diagnostic products. The vast majority of the product we sell is used for manufacturing test kits and controls, which are used in hospitals around the world. Holding some of the industry's most specialized certifications, we draw the blood and other raw material from a wide base of donors, a majority of which repeatedly and consistently visits every 56 days. This repeat-donor base allows us to provide extensively tested and unique products to the pharmaceutical industry. Continental has been an FDA licensed facility since 1971, holding multiple city, state and federal licenses, and has been ISO certified since 2003.Continental Services Group is an Equal Opportunity Employer and maintains a smoke and drug-free workplace. All offers of employment are contingent upon successful completion of drug andbackgroundchecks.