Css Scientific Jobs in Usa

We’re Hiring: Medical Representative – Women’s Health (UTI Support Supplement) 

Location: Atlanta, GA (Home Base) 

Territory: New York + Texas + National and Regional Medical Conferences 

Travel: 60–70% 

At Pharmatoka, we are reshaping prevention-first care in women’s urinary health. With more than 20 years of scientific expertise and over 15 years in the U.S. market, our clinically supported, non-prescription supplement is trusted globally for recurrent UTI support. As we continue to expand across key U.S. regions, we are seeking a driven, science-focused Medical Representative to strengthen HCP adoption and accelerate territory growth. 

This position reports directly to the Director of E-Commerce and Marketing. 

How You’ll Make an Impact 

HCP Engagement & Reactivation 

Re-engage inactive referrers and convert cold/warm leads into consistent product recommendation. 

HCP Education & Product Adoption 

Deliver clear, evidence-based education on clinical data, and patient outcomes to drive long-term adoption. 

Territory Expansion 

Build and grow recommending accounts across three regions by nurturing strong relationships within women’s health and urology practices. 

Multi-Channel Outreach 

Connect with HCPs through in-person visits, lunch-and-learns, regional conferences, phone, email, and professional social channels to maintain engagement. 

Market & Account Insight 

Research practices, validate contacts, understand patient demographics, and identify high-potential centers of influence. 

Scientific Communication 

Confidently discuss clinical studies, outcomes, and positioning within prevention pathways in a credible, compliant manner. 

Medical Conferences 

Represent Pharmatoka at national and regional medical meetings, including booth setup, product promotion, and engagement with healthcare professionals. 

Field Reporting & Insights 

Track activities and conversions through CRM and share insights from the field to support ongoing strategy refinement. 

Qualifications 

Required 

• BA/BS degree 
• 4+ years of successful HCP-facing sales experience (healthcare, pharma, medical device, or nutraceuticals) 
• Strong understanding of sales processes, healthcare products, and industry dynamics 
• Proven ability to interpret and communicate clinical evidence clearly and confidently 
• Excellent communication, presentation, and facilitation skills 
• Strong analytical thinking, business acumen, and problem-solving capability 
• Motivational and persuasive interpersonal skills 
• Team-oriented with leadership qualities 
• Demonstrated record of sustained high sales performance 
• Exceptional planning, prioritization, and territory management 
• A proactive, accountable, “ownership” mindset 
• Proficiency in Microsoft Office Suite 

Work Conditions 

• Work performed both in the Atlanta office and in the field; regular travel required across the assigned territory and to conferences 
• Occasional lifting of up to 50 lbs (materials, booth setup, product samples, etc.) 
• Frequent standing, walking, and presenting in clinical environments 

Compensation 

• Base Salary: $95000
• Performance bonus  
• Full reimbursement of travel expenses 

Benefits 

• Medical insurance 
• Generous PTO (Vacation, Sick, and national holidays) 
• 401(k) with immediate eligibility, company match, and annual employer contribution from day one. 

This job description reflects the general nature and level of work expected. It is not an exhaustive list of all responsibilities, duties, or skills required, and additional tasks may be assigned as needed. 

All qualified applicants will receive consideration without regard to race, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. 

Quality Manager

We are seeking an experienced Quality Manager to build, implement, and lead the Quality Assurance function within our fragrance and liquid manufacturing operations. This is a hands-on, individual contributor role responsible for establishing robust quality systems, ensuring GMP compliance, leading ISO certification efforts, and driving continuous improvement across production and laboratory environments.

The ideal candidate has direct experience in fragrance, flavor, cosmetics, or other liquid consumables manufacturing and possesses strong scientific, analytical, and regulatory expertise.

Key Responsibilities

• Design, implement, and maintain the Quality Management System (QMS).
• Develop, revise, and control SOPs, work instructions, batch records, and quality documentation.
• Establish document control, change management, deviation management, and CAPA systems.
• Create scalable systems to support company growth and regulatory compliance.

• Ensure compliance with Good Manufacturing Practices (GMP) applicable to fragrance and liquid production.
• Lead ISO 9001 certification efforts and maintain audit readiness.
• Prepare for and manage internal and external audits.
• Oversee training programs to ensure adherence to quality standards.

• Conduct daily floor audits of compounding, filling, labeling, and packaging operations.
• Monitor raw material inspection, in-process controls, and finished goods release.
• Oversee batch record review and approval.
• Ensure laboratory testing procedures meet established specifications and validation standards.
• Maintain calibration and preventive maintenance programs for quality-critical equipment.
  

• Establish KPIs and quality metrics for production performance and defect reduction.
• Implement statistical tools for trend analysis and process capability evaluation.
• Develop reporting dashboards and executive-level quality summaries.
• Lead root cause analysis using structured methodologies (e.g., 5 Whys, Fishbone, FMEA).
• Drive corrective and preventive actions with measurable outcomes.
  

• Investigate non-conformances, deviations, and customer complaints.
• Identify systemic risks and implement preventative controls.
• Collaborate with Production, R&D, and Supply Chain to resolve quality issues.
• Lead initiatives to reduce waste, improve batch consistency, and strengthen process control.
  

• Prepare and present regular quality performance reports to executive leadership.
• Provide clear analysis of trends, risks, and mitigation strategies.
• Serve as the subject matter expert for all quality-related matters within the organization.

Qualifications

• 5+ years of Quality Assurance experience in fragrance, flavor, cosmetics, or liquid consumables manufacturing.
• Demonstrated experience implementing and managing GMP-compliant systems.
• Direct experience with ISO 9001 certification and audit management.
• Strong understanding of chemical formulation processes, batch manufacturing, and laboratory testing.
• Proficiency in statistical analysis, data collection systems, and quality metrics tracking.
• Experience developing SOPs, quality documentation, and structured CAPA programs.
• Strong technical writing and executive reporting skills.
• Bachelor’s degree in Chemistry, Chemical Engineering, Microbiology, or related scientific discipline preferred.

Preferred Qualifications

• Experience building or restructuring a Quality department.
• Lean, Six Sigma, or other process improvement certification.
• Experience working with ERP or Quality Management Systems (QMS).
• Familiarity with IFRA guidelines and raw material compliance documentation.

Performance Expectations

• Establish a fully structured and documented Quality Management System.
• Achieve and maintain ISO certification readiness.
• Reduce deviations, defects, and customer complaints.
• Improve process consistency and batch reliability.
• Create measurable, data-driven visibility of quality performance for leadership.

Overview:

Our client is a global healthcare leader innovating the pharmaceutical industry with their cutting edge solutions. They are seeking a Strategic Account Manager to join their team. The Strategic Account Manager will play a vital role in driving sales, optimizing patient care pathways, ensuring formulary access, and cultivating strategic relationships with key stakeholders to enhance patient outcomes and achieve organizational objectives. This individual will also be responsible for delivering exceptional education and service related to disease awareness and treatment across the portfolio.

Responsibilities:

• Make informed decisions and develop plans using both business and scientific insight.
• Achieve and surpass sales goals while educating targeted healthcare providers on the full range of therapies within assigned accounts and territories.
• Develop and communicate a deep scientific understanding of disease states and therapeutic offerings.
• Increase awareness and provide early education on disease signs and symptoms.
• Educate on proper diagnostic pathways, diagnostic testing, and complimentary testing programs. Communicate the clinical benefits, efficacy, and safety profile of products.
• Provide education on product administration, treatment expectations, and the importance of adherence and compliance.
• Support referral networks by promoting referrals to appropriate specialists for optimal patient management.
• Navigate and understand key account ecosystems to build and sustain long-term business relationships with customers and key opinion leaders (KOLs).
• Clearly and effectively communicate complex clinical and reimbursement information to key stakeholders in a highly competitive market environment.

Qualifications:

• Bachelor’s degree required
• Minimum of 5 years of pharmaceutical sales experience
• Proven ability to build and strengthen networks, develop referrals, and establish infrastructure within key accounts
• Strategic sales mindset with strong analytical skills to evaluate complex market dynamics and create innovative strategies that drive sales and optimize care delivery
• Excellent communication, interpersonal, and presentation skills with strong executive presence
• Willingness to travel as necessary to engage with key stakeholders

Atlantic Health System is seeking a Full Time Respiratory Therapist for the Respiratory Therapy department at Morristown Medical Center to work 7PM - 7A, including every 3rd weekend.

Essential Function/Responsibilities:

• The Respiratory Therapist (RRT) utilizes the application of scientific principles for the identification, prevention, remediation, research, and rehabilitation of acute or chronic cardiopulmonary dysfunction.
• The RRT will assume primary responsibility for all Respiratory Care modalities in the hospital.

Essential Function/Responsibilities:

• The Respiratory Therapist (RRT) utilizes the application of scientific principles for the identification, prevention, remediation, research, and rehabilitation of acute or chronic cardiopulmonary dysfunction.
• The RRT will assume primary responsibility for all Respiratory Care modalities in the hospital.

About Us

At Atlantic Health System, our promise to our communities is that anyone who enters anyone of our facilities, receive the highest quality care delivered at the right time, at the right place, and at the right cost. That commitment is also echoed in the respect, development and opportunities we give to our more than 18,000 team members. Headquartered in Morristown, New Jersey, we are one of the leading non-profit health care systems in the state, and committed to creating a Trusted Network of Caring®. Our facilities and sites of care include:

• Morristown Medical Center, Morristown, NJ
• Overlook Medical Center, Summit NJ
• Newton Medical Center, Newton, NJ
• Chilton Medical Center, Pompton Plains, NJ
• Hackettstown Medical Center, Hackettstown, NJ
• Goryeb Children's Hospital, Morriston NJ
• Atlantic Rehabilitation
• Atlantic Home Care and Hospice

We also have more than 900 community-based healthcare providers affiliated through Atlantic Medical Group. We are part of Atlantic Accountable Care Organization, one of the largest ACOs in the nation, and are a member of AllSpire Health Partners.

We Receiver Awards And Recognitions For What We Provide To Our Patients, Team Members And Communities. Below Are Just a Few Of Our Accolades

• 100 Best Companies to Work For ® and FORTUNE® magazine (13 years in a row)
• Best Places to Work in Healthcare - Modern Healthcare
• 150 Top Places to work in Healthcare - Becker's Healthcare
• 100 Accountable Care Organizations to Know - Becker's Hospital Review
• Best Employers for Workers over 50 - AARP
• Gold-Level "Well Workplace": Wellness Council of America (WELCOA)
• CEO Cancer Gold Standard ™
• One of the 100 Best Workplaces for Millennials" Great Place to Work® and FORTUNE® magazine
• One of the 20 Best Workplaces in Health Care: Great Place to Work® and FORTUNE® magazine
• Security 500: Security Magazine
• Official Health Care Partner of the New York Jets
• NJ Sustainable Business

Rated the number one hospital in New Jersey by U.S. News & World Report for four years in a row, Morristown Medical Center is a nationally-recognized leader in cardiology and heart surgery, orthopedics, gynecology, geriatrics, gastroenterology and GI surgery, pulmonology and lung surgery, and urology.

We are the only hospital in New Jersey named one of America's '50 Best Hopsitals' for six consecutive years by Healthgrades and one of the World's Best Hospitals (the 34th best hospital in the United States and number one in NJ) by Newsweek. We were included on Becker's Healthcare 2020 list of "100 Great Hospitals in America". In addition, Leapfrog recognized us with an "A" hospital safety grade - its highest - twelve consecutive times, and the Centers for Medicare and Medicaid Services awarded us again with its highest five-start rating in 2020.

Morristown Medical Center is a Magnet Hospital for Excellence in Nursing Service, the highest level of recognition achievable from the American Nurses Credentialing Center for facilities that provide acute care services. Our nonprofit hospital was also designated a Level I Regional Trauma Center by the American College of Surgeons and a Level II by the State of NJ.

EEO STATEMENT

Atlantic Health System, Inc. is an equal employment opportunity employer and federal contractor or subcontractor and therefore abides by applicable laws to protect applicants and employees from discrimination in hiring, promotion, discharge, pay, fringe benefits, job training, classification, referral, and other aspects of employment, on the basis of race, color, religion, sex (including pregnancy, gender identity and sexual orientation), national origin, citizenship status, disability, age, genetics, or veteran status.

Organization

Breathing is one of the most essential functions of life, so any disease that diminishes the effectiveness of the lungs should be taken seriously. At the Atlantic Respiratory Institute, we offer state-of-the-art diagnostics and treatments for a variety of respiratory conditions. Because so much of the human body relies on oxygen, a multidisciplinary approach is essential to treating respiratory conditions. Our center of excellence’s pulmonary specialists, thoracic surgeons and critical care specialists regularly collaborate with experts in allergens, cardiology, otolaryngology, endocrinology, neurology, oncology, radiology, and pediatrics. Additional support is provided by a team of care managers, clinical nurse specialists, clinical social workers, nurse practitioners, nutritionists, physical therapists, respiratory care practitioners, registered nurses, registered pulmonary function technologists and registered sleep technologists. A nurse navigator offers individualized attention and support and coordinates the transition of pulmonary care from the hospital to an outpatient setting.

Part Time Registered Dietitian - Hybrid (remote charting)

(3 days/week: Monday, Thursday, Friday)

Position Purpose

Registered Dietitian - health professionals who are experts in nutrition and the human diet. Dietitians blend scientific research, nutrition, behavioral science, and social science topromote health, prevent disease, and shape the dietary choices of healthy and sick people.

What you will do:

• Develops, implements and documents plan of care based on assessments of nutritional needs in correlation with other health care plans.
• Provides individualized diet counseling for patient/family as needed. Complies/develops appropriate educational materials. Translates scientific research into meaningful instruction for clients.
• Evaluates and documents the effectiveness of nutritional intervention and provides follow up for continuity of care. Provides effective hand-off communication between team members.
• Maintains accurate department records and documentation in a timely and understandable manner.
• Attends discharge-planning conferences when offered.
• Practices within the Academy of Nutrition and Dietetics (AND) Scope of Practice, AND Standards of Practice in Nutrition Care, AND Standards of Professional Performance, Florida Department of Health licensure laws, Florida Department of Health rules and guidelines, and Holy Cross and Department of Food and Nutrition Services policies and procedures.
• Complies with regulatory standards and is knowledgeable of the standards, quality management efforts, and performance improvement projects.
• Provides meaningful direction to the diet office staff. Reviews menus as needed to assure compliance with established criteria and standards.
• Maintains flexibility in schedule according to patient and department staffing needs.
• Provides in-services and nutrition education for the healthcare team members. Serves as a liaison between the Food and Nutrition Services Department and individual patient care units.

Minimum Qualifications:

• Education: Bachelor's degree (B. S.) from four-year college or university.
• Licensure / Certification: Requires current Commission on Dietetic Registration (CDR) credential as a Registered Dietitian, or registry eligible and must achieve Registered Dietitian credential within six (6) months of date of hire. Requires current dietetic licensure in the state of Florida. Completes continuing professional educational requirements to maintain credentials. Active status as Registered Dietitian (RD), Registered Dietitian Nutrition (RDN), or Registered Dietitian Eligible (RDE) with the Commission on Dietetic Registration (CDR) is required.
• Experience: Minimum 1 year of experience in an acute care setting preferred.

About ZRT Laboratory

ZRT Laboratory is an internationally recognized leader in hormone and wellness testing. For over 24 years, healthcare providers and academic research teams worldwide have trusted our expertise in accurately measuring hormones, Neurotransmitters, and elements in saliva, finger-stick dried blood, and dried urine and serum. With results from over 10 million tests, ZRT offers a commitment to the best science and the best people, delivering premier personalized home-collection testing solutions.

The incumbent will lead all LC-MS method development, troubleshooting, and technical oversight while supporting laboratory operations and management. Will serve as technical expert for LC-MS testing operations, research projects, and commercial development initiatives, and collaborate with Laboratory and Mass Spectrometry Managers to provide technical leadership.

Responsibilities:

Technical Leadership & Method Development:

• Lead all LC-MS method development, improvement, and validation initiatives
• Conduct advanced troubleshooting for LC-MS instrumentation and experimental protocols
• Oversee development, management and validation of new analyte tests
• Ensure non-commercial testing projects remain on schedule and meet objectives
• Perform and record quality control procedures for applicable equipment and protocols

Data Management & Analysis:

• Lead presentation and handling of complex analytical data
• Communicate anomalous LC-MS test results to clinical consulting team
• Write clinical monographs explaining clinical relevance of LC-MS testing
• Review quarterly quality assurance reports for LC-MS data

Collaboration & Support:

• Work with Laboratory Manager and Mass Spectrometry Managers to guide operational and technical decisions
• Facilitate communication between laboratory staff and upper management
• Work with IT, marketing, and sales teams to prepare tests for commercialization
• Collaborate with other laboratory leadership on daily LC-MS operations
• Support maintenance of electronic files for CLIA-regulated research and development

Research & Development:

• Conduct LC-MS product development focusing on nutritional and herbal supplements
• Lead research projects with academic and commercial partners
• Direct technical aspects of LC-MS assays for IRB-approved scientific studies

Professional Development & Communication:

• Conduct presentations, webinars, and lectures on LC-MS research and testing
• Present at scientific conferences and professionais meetings
• Attend conferences to maintain current knowledge of LC-MS/GC-MS innovation
• Provide technical presentations to internal staff and external audiences

Education and Experience:

• Doctorate in biochemistry, analytical chemistry, or other life science
• Minimum 5 years of relevant LC-MS experience in clinical or research laboratory setting
• Management experience strongly preferred
• Demonstrated presentation and communication experience preferred

Competencies:

• Expert-level knowledge in LC-MS maintenance, troubleshooting, and method development
• Proficient in sample extraction and processing techniques for LC-MS applications
• Advanced experience with quantitative data analysis approaches
• Strong ability to interpret analytical data in biological contexts
• Excellent written and oral communication skills with presentation experience
• Proven ability to manage multiple complex research projects simultaneously
• Strong organizational and analytical skills with attention to detail
• Ability to work independently while supporting team objectives

We offer a competitive salary, exceptional benefits, many great perks, and promote a healthy and diverse work environment. If this sounds like the right fit, please apply today!

ZRT Laboratory is an Equal Opportunity Employer committed to creating an inclusive environment for all employees.

Lighthouse Lab Services is working new state-of-the-art reference laboratory in Austin, TX that is focused on delivering high-quality clinical testing services through advanced chemistry, hematology, immunology, and serology testing. This lab is backed by a collaborative culture that values quality, compliance, and continuous improvement. You’ll work with industry-leading instruments from Horiba and Thermo Fisher Scientific, operating in a fast-paced, regulated environment.

WHAT YOU’LL DO:

As the Laboratory Supervisor, you’ll oversee daily operations of the reference laboratory. Key responsibilities include:

• Supervising and mentoring laboratory personnel to ensure high performance and quality outcomes.

• Coordinating workflow across chemistry, hematology, immunology, and serology departments.

• Managing testing schedules, troubleshooting technical issues, and ensuring reliable instrument performance (Horiba, Thermo Fisher).

• Overseeing quality control (QC) processes, competency assessments, and documentation in compliance with CLIA/CAP standards.

• Partnering with leadership to drive process improvements, instrument validation, and training initiatives.

• Supporting regulatory inspections, audits, and accreditation readiness.

QUALIFICATIONS:

• Bachelor’s degree in Medical Laboratory Science, Chemistry, Biology, or related scientific discipline required.

• Minimum 4 years of relevant clinical laboratory experience, including hands-on work in chemistry, hematology, immunology, and serology.

• Prior supervisory or lead experience preferred.

• Demonstrated knowledge of laboratory workflows, quality systems, and regulatory requirements.

• Experience with Horiba and Thermo Fisher instrumentation is a plus.

• Strong communication, leadership, and problem-solving skills.

Salary and Benefits:

• $85-100k

• Health insurance, PTO and Holidays

About Us:

At Lighthouse Lab Services, we offer solutions to help start, grow, and run clinical laboratories. Our recruiting team has more than 18 years of proven success placing job seekers in positions ranging from entry-level Medical Technologists to seasoned Laboratory Directors. We recruit nationwide, for permanent and travel positions with clients ranging from small hospitals to large reference laboratories.

It is the policy of Lighthouse Lab Services to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Lighthouse Lab Services will provide reasonable accommodations for qualified individuals with disabilities.

Lighthouse Lab Services |?844-914-0785?|?

#LLS2

Immediate need for a talented Laboratory Technician II .This is a 12+ Months contract opportunity with long-term potential and is located in Swiftwater, PA USA(Onsite). Please review the job description below and contact me ASAP if you are interested.

Job Diva ID: 26-06522

Pay Range: $ 26-$36 /hour. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• The candidate will be a member of the Viral Technology Flu support lab team and will be responsible for assisting with the execution of experiments within the process development laboratory.
• The candidate for this position will need to become trained on applicable production operations on the unit operations in the lab as well as general laboratory procedures.
• Following training, the candidate will be expected to independently execute assigned experiments with minimal direction from laboratory supervision.
• Perform technical process operations for developmental lots.
• Execute process unit operations including: tangential flow filtration, centrifugation (continuous and batch), virus inoculation and propagation, and sterile filtration.
• In order to support process development operations, candidate will also be required to support various lab functions such as: Solution and buffer preparation.
• Equipment cleaning, assembly, and sterilization.
• Sampling, sample login, transfer, and logging of results.
• General lab duties such as general housekeeping and cleaning and inventory management.
• Identify production issues and relays them to the laboratory management.
• Ensure all required paperwork is complete, accurate and done in a timely manner to ensure a quality product.
• Participation in cross-functional teams, where necessary, to assure correct performance of process operations and working with management to resolve process operations issues.
• Follow all procedures put into effect to ensure your safety as well as the safety of others.
• Participate in safety meetings, report all safety issues, concerns, incidents and near misses to the team leadership.
• Follow good documentation practices to record all activities performed and data generated in production of developmental experiments.
• The primary shift will be standard business hours, however, experiment schedule will also require overtime and off shift work.

Key Requirements and Technology Experience:

• Key skills: - Hands-on experience with tangential flow filtration, batch/continuous centrifugation, virus inoculation and propagation, and sterile filtration.
• Skilled in solution and buffer preparation, equipment cleaning/sterilization, sample handling, and general lab maintenance
• Experience with assay testing Flexibility and ability to take initiative.
• Demonstrated interpersonal skill, including flexibility and ability to work in a team environment.
• Experience with biopharmaceuticals, vaccines process development, or laboratory scale execution of tangential flow filtration, centrifugation (batch and continuous), cell culture.
• Demonstrated written and verbal communication skills.
• Demonstrated organization skills, ability to multitask, and work in a dynamic environment.
• MS Office 2010 or higher.
• Education: Two years of university in a scientific discipline plus experience in Vaccine, Biologic, or Pharmaceutical manufacturing or development or Bachelor?s Degree/Undergraduate Degree in scientific discipline plus experience in Vaccine, Biologic, or Pharmaceutical manufacturing or development.
• Preferred BS/BA Chemistry or Life Science..
• Hours 7am-3:30pm Open candidates who are willing to relocate at own expense Requirement to have the most recent influenza vaccination.
• Free Parking Possibility of 1 year extension, depending on performance NIOSH/ CSSE (Safety) respirators are required to be worn within the lab Lung function test will be required Role will entail 80% lab work, documentation
• PhD candidates would be considered overqualified
• MS Office Suite 1-3 year of experience relevant experience
• Hands-on experience with tangential flow filtration, batch/continuous centrifugation, virus inoculation and propagation, and sterile filtration.
• Skilled in solution and buffer preparation, equipment cleaning/sterilization, sample handling, and general lab maintenance.
• Experience with assay testing Flexibility and ability to take initiative Nive to have skills: HPLC - High Performance Liquid Chromatography

Our client is a leading Pharmaceuticals industry , and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.

Sr Specialist, Clinical Development

Duration - 8 Months

Location - Irvine, CA

Pay Rate:- $55.00-$66.92/hour, depending on experience

Ensures product development includes all necessary clinical input and aspects for the best interest of patients and utility for treating physicians.

Key Responsibilities:

*Ensure successful product lifecycle management, from early human use through commercial submission

*Develop and implement pre-clinical test strategy and provide guidance to team members on execution strategy

*Provide scientific rationale for product attributes and pre-clinical test results

*Provide product and procedural expertise for new product development as well as introduction training for clinical and site personnel

* Develop, review, and update clinical design control documents including providing advice and guidance to product development team on development of technical summaries, clinical risk assessments, product training, instructions for use, design of validation protocols and reports, usability protocols and reports, design and application of FMEAs (Failure Modes and Effects Analysis), for technical and clinical documentation in product development.

* Ensure procedural, medical and scientific factors are considered during cross-functional product development project team meetings.

* Design, review and/or conduct literature searches and complete literature reviews for design concept, product development, protocol preparation, clinical risk assessments and/or clinical evaluation reports

* Consult with field personnel to gather field device performance feedback, as well as to ensure national and country clinical/regulatory requirements compliance.

* Evaluate collected data documentation and imaging media, draw findings, make recommendations, and provide advice and guidance to complete product evaluations, product complaint review and other required interim or final reports.

*Analyze data to support clinical trial safety investigations and new product development

*Other duties as assigned by leadership

Education and Experience:

Bachelor's Degree in biology or lifesciences field, 5 Years years experience Class II and III medical device technologies and/or clinical studies background Required

Bachelor's Degree in engineering Preferred

Additional Skills:

* Proven expertise with computer skills - Microsoft Office (Word, Excel, Project, PowerPoint), Outlook, Internet

* Proven expertise in MS Office Suite, Adobe, and ability to operate general office machinery

* Experience with pre-clinical testing protocols, hospital environments and sterile techniques

* Data analysis skills, with understanding of statistical analysis techniques

* Good communication and organizational skills

* Excellent written and verbal communication skills and interpersonal relationship skills including consultative and relationship management skills

* Full knowledge of US and international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP)

* Demonstrated problem-solving and critical thinking skills

* Thorough, conscientious and results oriented working style

* Team oriented

* Ability to work in a dynamic work environment

* Knowledge of US/international medical device regulations, of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP).

* Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control

* Experience in TMVR and/or fluroscopic and echocardiographic imaging preferred

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.

• Schedule: Weekend Day Shifts
• Department: Cardiac II
• Location: New Hanover Regional Medical Center

Remarkable Care. Remarkable Careers.

The Registered Nurse serves as a leader of the healthcare team at Novant Health by establishing an authentic personalized relationship with the patient and their chosen support system, collaborating with physicians and other team members to assess, plan, implement, and evaluate an individualized plan of care that promotes optimal health or supports a peaceful death. The Registered Nurse utilizes best scientific evidence and compassion to assist the patient in navigating their health journey. The Registered Nurse accepts responsibility, authority, and accountability for management and provision of care in accordance with the current policies and procedures.

 At Novant Health, one of our core values is diversity and inclusion. By engaging the strengths and talents of each team member, we ensure a strong organization capable of providing remarkable healthcare to our patients, families and communities. Therefore, we invite applicants from all group dynamics to apply to our exciting career opportunities.

Remarkable Care. Remarkable Careers.

Why become a Registered Nurse at Novant Health?

• Clinical Ladder Program to help you advance your nursing career.
• Recognized by Forbes as one of America’s Best Employers By State for 2022
• One of the nation’s 150 Best Places to Work in Healthcare by Becker’s Hospital Review
• Recognized asLeaders in LGBTQ+ Healthcare Equalityby the Human Rights Campaign
• One of theBest Places to Work for Disability InclusionbyDisability:IN and the American Association of People with Disabilities
• One of the Best Places for Diverse & Women Managers to Work by Diversity MBA Magazine
• Top ratings in patient safety from The Leapfrog Group
• Quality and safety recognition from CMS

Novant Health is committed to improving the health of its communities, one person at a time. We have a strong focus on innovation and research offering best-in-class technology and clinical care. We are committed to providing high-quality, affordable healthcare to all our patients as well as equipping our workforce with the tools and support needed.

Come join a remarkable team where quality care meets quality service, in every dimension, every time.

1. Graduate of an accredited school of nursing required.
2. Associate's or Bachelor's degree in nursing.
3. Current valid North Carolina nursing license required.
4. One-year relevant experience, preferred.

If your RN nursing license has been inactive, retired or lapsed for five years or more and you have not been licensed in another state during the last five years, successful completion of a Board approved refresher course is required prior to reactivating or reinstating your license. In order to be considered for current licensure status, you must apply for reinstatement within one year of completing the refresher course.

It is the responsibility of every Novant Health team member to deliver the most remarkable patient experience in every dimension, every time.

• Our team members are part of an environment that fosters teamwork, team member engagement and community involvement.
• The successful team member has a commitment to leveraging diversity and inclusion in support of quality care.
• All Novant Health team members are responsible for fostering a safe patient environment driven by the principles of "First Do No Harm".