9,753 Patient Evaluation jobs in the United States
Clinical Evaluation Project Manager
Posted today
Job Viewed
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
Job Function:
R&D Operations
Job Sub Function:
Clinical/Medical Operations
Job Category:
Professional
All Job Posting Locations:
Cincinnati, Ohio, United States of America, Raritan, New Jersey, United States of America
Job Description:
Johnson & Johnson is recruiting for a Clinical Evaluation Project Manager to join our MedTech Surgery business.
This is a remote role available in multiple (states/cities). While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from various locations to apply.
About Surgery
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.
Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that's reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world's most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting!
Your unique talents will help patients on their journey to wellness. Learn more at
The Clinical Evaluation Project Manager acts as the project management process owner for the generation of Clinical Evaluation Reports (CER)/Summary of Safety Clinical Performance (SSCP) for Ethicon Endo Surgery within J&J MedTech in their scope of responsibility.
This role focuses on process optimization and the deployment and utilization of consistent project management methodologies supporting key planning and execution steps.
DUTIES & RESPONSIBILITIES
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:
- Uses project management tools, such as WRIKE, and to monitor smooth and timely execution of project milestones and tasks for the Technical Writing team.
- Ensures timelines are met and practices are being consistently deployed across the global organization.
- Maintains knowledge and access to applicable J&J MedTech Quality Systems to support the team in document retrieval and routing of documents for approval.
- Maintains and monitors metrics relevant to the assigned activities and communicates business related issues or opportunities to next management level to enable corrective and preventive action to be taken as needed.
- Sets up and leads meetings for project execution per project plan, as well as meetings in support of the overall project management process.
- Drives communication and establishes relationships with cross-functional business partners such as other Scientific Operations Team Members, Post Market Surveillance, Clinical, Medical Safety, Design Quality Engineers, R&D, and Regulatory Affairs.
- Is responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
- Performs other duties as assigned.
- Bachelors degree or equivalent experience in a technical field is required; advanced degree is preferred.
- Minimum of 2 years of related job experience is required.
- Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and state of the art and systematic literature review creation is preferred.
- Experience in resource coordination with respect to processes and outcomes.
- Experience with WRIKE or project management systems is preferred.
- Demonstrated understanding and experience in project management principles and methodologies is required.
- Strong written and oral communication skills is required.
- Strong interpersonal skills to enable ongoing communication (face to face, phone and email) with team members and coordination of data collection is required.
- Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
- Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
- This position is eligible to participate in the Company's long-term incentive program.
- Employees are eligible for the following time off benefits:
- Vacation - up to 120 hours per calendar year
- Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
- Holiday pay, including Floating Holidays - up to 13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below!
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via or contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is :
$89,000 - $43,750 (Bay Area: 103,000 - 165,600)
Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Clinical Evaluation Project Manager
Posted today
Job Viewed
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at
Job Function:
R&D Operations
Job Sub Function:
Clinical/Medical Operations
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America
Job Description:
About MedTech
Fueled by innovation at the intersection of biology and technology, were developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at
Remote work options may be considered on a case-by-case basis and if approved by the Company
An internal pre-identified candidate for consideration has been identified. However, all applications will be considered.
We are searching for the best talent for Clinical Evaluation Project Manager to be in Raritan, New Jersey .
JOB SUMMARY
The Clinical Evaluation Project Manager acts as the project management process owner for the generation of Clinical Evaluation Reports (CER)/Summary of Safety Clinical Performance (SSCP) for Ethicon Endo Surgery within J&J MedTech in their scope of responsibility.
This role focuses on process optimization and the deployment and utilization of consistent project management methodologies supporting key planning and execution steps.
DUTIES & RESPONSIBILITIES
In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson procedures and guidelines, this position:
Uses project management tools, such as WRIKE, and to monitor smooth and timely execution of project milestones and tasks for the Technical Writing team.
Ensures timelines are met and practices are being consistently deployed across the global organization.
Maintains knowledge and access to applicable J&J MedTech Quality Systems to support the team in document retrieval and routing of documents for approval.
Maintains and monitors metrics relevant to the assigned activities and communicates business related issues or opportunities to next management level to enable corrective and preventive action to be taken as needed.
Sets up and leads meetings for project execution per project plan, as well as meetings in support of the overall project management process.
Drives communication and establishes relationships with cross-functional business partners such as other Scientific Operations Team Members, Post Market Surveillance, Clinical, Medical Safety, Design Quality Engineers, R&D, and Regulatory Affairs.
Is responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
Performs other duties as assigned.
EXPERIENCE AND EDUCATION
Bachelors degree or equivalent experience in a technical field is required; advanced degree is preferred.
Minimum of 2 years of related job experience is required.
Experience within the medical device industry and knowledge of CER regulatory requirements, evidence generation, and state of the art and systematic literature review creation is preferred.
Experience in resource coordination with respect to processes and outcomes.
Experience with WRIKE or project management systems is preferred.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS
Demonstrated understanding and experience in project management principles and methodologies is required.
Strong written and oral communication skills is required.
Strong interpersonal skills to enable ongoing communication (face to face, phone and email) with team members and coordination of data collection is required.
Additional Information:
The expected base pay range for this position is $89,00 to $143,000 / annually.
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporations performance over a calendar/performance year. Bonuses are awarded at the Companys discretion on an individual basis.
Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
Employees may be eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Companys long-term incentive program.
Employees are eligible for the following time off benefits:
o Vacation 120 hours per calendar year
o Sick time - 40 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year
o Holiday pay, including Floating Holidays 13 days per calendar year
o Work, Personal and Family Time - up to 40 hours per calendar year
o Parental Leave 480 hours within one year of the birth/adoption/foster care of a child
o Condolence Leave 30 days for an immediate family member: 5 days for an extended family member
o Caregiver Leave 10 days
o Volunteer Leave 4 days
o Military Spouse Time-Off 80 hours
Additional information can be found through the link below.
This job posting is anticipated to close on July 19, 2025. The Company may however extend this time-period, in which case the posting will remain available on to accept additional applications
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ) or contact AskGS to be directed to your accommodation resource
The anticipated base pay range for this position is :
89,000 - 143,000
Additional Description for Pay Transparency:
Remote: Yes
#J-18808-LjbffrStaff Clinical Evaluation Specialist (Remote)
Posted today
Job Viewed
Job Description
In your role as a Staff Clinical Evaluation Specialist on the Clinical Affairs team, you will lead the process of planning, writing, and updating Clinical Evaluation documentation (e.g., CERs, CEPs, SSCPs, PMCFPs, PMCFRs) to bring State of the Art medical devices to market. You will act as the subject matter expert that drives Clinical Evidence generation. You will conduct thorough research on the subject device, perform systematic reviews of published literature, extract data, interpret trends, and communicate scientific findings to support regulatory body submissions for diverse geographies. You will apply your project management skills to compile the body of Clinical Evidence on which you, in collaboration with other stakeholders, will reach a scientific conclusion on the safety and performance of our products throughout its entire lifecycle. **Your valuable work will help deliver industry-leading Joint Replacement products to the customer and rebuild lives of patients across the globe.**
**What you will do**
+ Prepares clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g., CERs, CEPs, PMCFRs, PMCFPs, SSCPs).
+ Supports the needs of other business units (e.g., R&D, Marketing, Clinical Research) regarding communication of clinical data in the form of peer-reviewed publications, white papers, 1-pagers, clinical summaries, posters, and slide decks/presentations.
+ Designs compliant and sustainable literature search strategies, performs systematic reviews to capture and summarize published clinical data, and analyzes current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques.
+ Acts as the dedicated Clinical Evaluation Project Manager, driving the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle, and fosters alignment with adjacent processes (marketing strategy and claims, regulatory strategy, clinical research strategy, preclinical testing strategy).
+ Identifies, appraises, and analyzes relevant clinical, post-market surveillance, marketing, and preclinical testing data to create comprehensive scientific reviews, which may include in-depth quantitative analyses, qualitative analyses, and risk management cross-checks.
+ Forms a conclusion on the overall benefit-risk profile of the subject device, in collaboration with a Medical Expert and other stakeholders, based on up-to-date US, European, and Australian regulatory requirements.
+ Identifies unanswered questions and residual risks in the Clinical Evidence and designs Post Market Clinical Follow Up activities in collaboration with Clinical Research to address these questions.
**What you need**
+ A minimum of a Bachelor's Degree (B.S. or B.A.) in Life Sciences, Engineering, or similar concentration required.
+ A minimum of 4 years of experience in an FDA or highly regulated industry required; preferably with medical devices.
+ A minimum of 2 years in a Regulatory Affairs role required.
+ Experience in scientific writing, performing systematic reviews, analyzing published literature, and statistical methods (may be in the form of peer-reviewed publications).
**Preferred**
+ Strong interest in medical science, clinical research, and scientific communication.
+ Demonstrated project management and organizational skills.
+ Knowledge of FDA / MDR regulations for medical devices.
+ Independent problem solver and ability to apply creative solutions
$105,100.00 - $172,300.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Medical Writer/ Clinical Evaluation Reporting
Posted today
Job Viewed
Job Description
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
+ An excellent retirement savings plan with high employer contribution
+ Tuition reimbursement, the Freedom 2 Save ( student debt program and FreeU ( education benefit - an affordable and convenient path to getting a bachelor's degree.
+ A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?nger sticks.
**The Opportunity**
Our location in Maple Grove MN, or St. Paul, MN, or Santa Clara, CA currently has an on-site opportunity for a Medical Writer / Clinical Evaluation Reporting (CER). The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are related to authoring Clinical Evaluation Reporting documents for the Neuromodulation, Structural Heart and Electrophysiology products. Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management and strong written and verbal communication skills are needed.
**What You'll Work On**
+ Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses and other related documentation.
+ Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for product applications and submissions.
+ Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes.
+ Supports additional clinical, regulatory, quality and engineering related deliverable as assigned.
+ Effectively communicates and collaborates with Regulatory Affairs, Marketing Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Risk Management and Medical Affairs in completing clinical evaluation project related deliverables.
+ Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
+ Reviews IFUs, Patient Guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), physician training materials, to ensure alignment of risk information.
+ Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
+ Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews and other processes such as regulatory inquiries.
+ Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data. Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations and guidance's (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs.
**Required Qualifications**
+ Bachelor's degree in a relevant technical discipline OR an equivalent combination of education and work experience.
+ 3 years' progressively more responsible experience as a technical writer in a medical or high technology (preferably biotechnology) environment.
+ Must possess comprehensive written and verbal communication, interpersonal, presentation, analytical, project management skills and the ability to prioritize and handle a large volume of projects simultaneously and meet deadlines.
+ Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
+ Ability to work in a highly matrixed and geographically diverse business environment.
+ Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.
+ Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
**Preferred** **Qualifications**
+ Advanced degree in science, biomedical engineering, medicine, nursing or similar health related discipline
+ Experience in experimental design, data interpretation, and summarizing clinical data.
+ Knowledge of division products and or Quality systems and measures
+ 3+ years of medical writing experience in the medical device or pharmaceutical industry or 4+ years general technical writing; CER writing experience
+ Relevant experience in a related area such as Clinical Research, Product Development or Quality or in a healthcare industry.
+ Writing, editing and managing clinical and technical documentation utilized in the development of new products and improvement of existing products.
+ Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination of these skills.
+ Understanding of medical technology
+ Excellent analytical skills and ability to manage complex tasks and manage time effectively
+ Proficient with Word, Excel, PowerPoint, Outlook, etc.
+ Experience in complaint handling, operation or service of diagnostic instrumentation or medical technology.
+ Experience working in a broader enterprise/cross-division business unit model.
**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** ( your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on Twitter @AbbottNews.
The base pay for this position is $60,000.00 - $120,000.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Staff Clinical Evaluation Specialist (Remote)
Posted 1 day ago
Job Viewed
Job Description
In your role as a Staff Clinical Evaluation Specialist on the Clinical Affairs team, you will lead the process of planning, writing, and updating Clinical Evaluation documentation (e.g., CERs, CEPs, SSCPs, PMCFPs, PMCFRs) to bring State of the Art medical devices to market. You will act as the subject matter expert that drives Clinical Evidence generation. You will conduct thorough research on the subject device, perform systematic reviews of published literature, extract data, interpret trends, and communicate scientific findings to support regulatory body submissions for diverse geographies. You will apply your project management skills to compile the body of Clinical Evidence on which you, in collaboration with other stakeholders, will reach a scientific conclusion on the safety and performance of our products throughout its entire lifecycle. **Your valuable work will help deliver industry-leading Joint Replacement products to the customer and rebuild lives of patients across the globe.**
**What you will do**
+ Prepares clinical documentation to validate device safety and performance for regulatory body submissions and perform periodic updates to maintain compliance (e.g., CERs, CEPs, PMCFRs, PMCFPs, SSCPs).
+ Supports the needs of other business units (e.g., R&D, Marketing, Clinical Research) regarding communication of clinical data in the form of peer-reviewed publications, white papers, 1-pagers, clinical summaries, posters, and slide decks/presentations.
+ Designs compliant and sustainable literature search strategies, performs systematic reviews to capture and summarize published clinical data, and analyzes current medical and scientific trends in the clinical State of the Art on a broad variety of specialized indications and techniques.
+ Acts as the dedicated Clinical Evaluation Project Manager, driving the establishment of a coherent Clinical Evidence strategy throughout the new product development cycle, and fosters alignment with adjacent processes (marketing strategy and claims, regulatory strategy, clinical research strategy, preclinical testing strategy).
+ Identifies, appraises, and analyzes relevant clinical, post-market surveillance, marketing, and preclinical testing data to create comprehensive scientific reviews, which may include in-depth quantitative analyses, qualitative analyses, and risk management cross-checks.
+ Forms a conclusion on the overall benefit-risk profile of the subject device, in collaboration with a Medical Expert and other stakeholders, based on up-to-date US, European, and Australian regulatory requirements.
+ Identifies unanswered questions and residual risks in the Clinical Evidence and designs Post Market Clinical Follow Up activities in collaboration with Clinical Research to address these questions.
**What you need**
+ A minimum of a Bachelor's Degree (B.S. or B.A.) in Life Sciences, Engineering, or similar concentration required.
+ A minimum of 4 years of experience in an FDA or highly regulated industry required; preferably with medical devices.
+ A minimum of 2 years in a Regulatory Affairs role required.
+ Experience in scientific writing, performing systematic reviews, analyzing published literature, and statistical methods (may be in the form of peer-reviewed publications).
**Preferred**
+ Strong interest in medical science, clinical research, and scientific communication.
+ Demonstrated project management and organizational skills.
+ Knowledge of FDA / MDR regulations for medical devices.
+ Independent problem solver and ability to apply creative solutions
$105,100.00 - $172,300.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors
Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.
Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.
Clinical Evaluation Reporting / Medical Writer (CER)
Posted today
Job Viewed
Job Description
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of.
+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
+ An excellent retirement savings plan with high employer contribution
+ Tuition reimbursement, the Freedom 2 Save ( student debt program and FreeU ( education benefit - an affordable and convenient path to getting a bachelor's degree.
+ A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
+ A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
For years, Abbott's medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it's glucose monitoring system, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?nger sticks.
**The Opportunity**
Our location in Maple Grove MN, or St. Paul, MN, or Santa Clara, CA currently has an on-site opportunity for a Clinical Evaluation Reporting / Medical Writer (CER). The Medical Writer on our Regulatory Clinical Evaluation team provides technical and strategic writing expertise throughout the product development and life cycle process. Daily activities are related to authoring Clinical Evaluation Reporting documents for the Neuromodulation, Structural Heart and Electrophysiology products. Experience in clinical study management and design, medical, or scientific writing, and/or quality engineering/risk management and strong written and verbal communication skills are needed.
**What You'll Work On**
+ Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, SSCPs, Regulatory Responses and other related documentation.
+ Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for product applications and submissions.
+ Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes.
+ Supports additional clinical, regulatory, quality and engineering related deliverable as assigned.
+ Effectively communicates and collaborates with Regulatory Affairs, Marketing Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Risk Management and Medical Affairs in completing clinical evaluation project related deliverables.
+ Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
+ Reviews IFUs, Patient Guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), physician training materials, to ensure alignment of risk information.
+ Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
+ Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews and other processes such as regulatory inquiries.
+ Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data. Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations and guidance's (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs.
**Required Qualifications**
+ Bachelor's degree in a relevant technical discipline OR an equivalent combination of education and work experience.
+ 3 years' progressively more responsible experience as a technical writer in a medical or high technology (preferably biotechnology) environment.
+ Must possess comprehensive written and verbal communication, interpersonal, presentation, analytical, project management skills and the ability to prioritize and handle a large volume of projects simultaneously and meet deadlines.
+ Multitasks, prioritizes and meets deadlines in timely manner. Strong organizational and follow-up skills, as well as attention to detail.
+ Ability to work in a highly matrixed and geographically diverse business environment.
+ Ability to work within a team and as an individual contributor in a fast-paced, changing environment. Ability to leverage and/or engage others to accomplish projects.
+ Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
**Preferred** **Qualifications**
+ Advanced degree in science, biomedical engineering, medicine, nursing or similar health related discipline
+ Experience in experimental design, data interpretation, and summarizing clinical data.
+ Knowledge of division products and or Quality systems and measures
+ 3+ years of medical writing experience in the medical device or pharmaceutical industry or 4+ years general technical writing; CER writing experience
+ Relevant experience in a related area such as Clinical Research, Product Development or Quality or in a healthcare industry.
+ Writing, editing and managing clinical and technical documentation utilized in the development of new products and improvement of existing products.
+ Experience may include writing experience in a medical, pharmaceutical, medical device, clinical research, medical or research industry, or combination of these skills.
+ Understanding of medical technology
+ Excellent analytical skills and ability to manage complex tasks and manage time effectively
+ Proficient with Word, Excel, PowerPoint, Outlook, etc.
+ Experience in complaint handling, operation or service of diagnostic instrumentation or medical technology.
+ Experience working in a broader enterprise/cross-division business unit model.
**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** ( your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on Twitter @AbbottNews.
The base pay for this position is $60,000.00 - $120,000.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
Senior Project Manager, Clinical Risk Evaluation (on-site)
Posted 3 days ago
Job Viewed
Job Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks The Opportunity Our locations in Plano, TX, Austin, TX, Maple Grove, MN or Santa Clara, CA currently have an opportunity for a Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager . The Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager is to provide technical and strategic expertise throughout the product development and life cycle process; daily activities are related to management and alignment of risk information for Neuromodulation products. The CRE Program Manager writes and manages risk evaluation files, performs risk analysis, manages the development of clinical evaluation plans and reports and interacts with various cross-functional teams in order to assist in strategy, plans, and project deliverables. Must be able to effectively manage multiple projects and timelines. What You’ll Work On Independently creates and maintains Risk Evaluation Files (REF)s Abbott products. Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references. Oversees CROs, actively manages timelines and project delays/risks, develops scenario’s and recommendations for management. Leads risk alignment committee meetings (departmental multidisciplinary team), facilitates therapeutic team participation as appropriate, facilitates informed decision-making and dissemination of scientifically balanced and quality risk information regarding products. Ensures effective communication to clinical safety, clinical science, clinical internal and external operations, product performance, medical affairs, Clinical R&D, Quality Engineering, regulatory affairs, product labeling, senior management, and external CROs or medical writers. Conducts team meetings, sends routing communications and/or presents regular updates to senior staff. Develops and maintains Risk Evaluation Files (REF) DOP and associated documentation, provides input to cross-departmental SOPs and DOPs describing risk information processes. Develop templates taking into account all applicable regulations. Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports, Summaries of Safety and Clinical Performance (SSCPs) and associated documents; set deliverable and project timelines and ensure timelines are met. Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers). Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents. Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions. Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams. Compliance with applicable corporate and divisional policies and procedures. Participate in and support internal and external audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics. Provide and implement innovative ideas and solutions to Clinical Risk Evaluation group (e.g. database, LEAN projects), develop and roll out functional trainings as required. Reviews IFUs, patient guides, Risk Management, Clinical Evaluation Protocol, Clinical Evaluation Report (CEP/CER), IBs, study protocols, study ICFs, physician training materials, ensuring alignment of risk information. Involves in responses to complex costumer queries (e.g. regulatory authority, ethical committee, …) related to risk information. Reviews and gives input to Post-Marketing Surveillance Plans (PMS) and Post-Marketing Clinical Follow-up Plans (PMCF). Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Performs proactive clinical trial signal detection (planning, execution, and presentation) and actively participates in clinical corrective action board meetings. Participates in and supports audits. May actively participate in root cause analysis. May participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring, as requested by management. Acts as a mentor to less-experienced staff. Required Qualifications Bachelor’s Degree in related field OR an equivalent combination of education or work experience. Minimum 6 years related work experience with a strong understanding of specified functional area. Solid understanding and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on their business unit. Preferred Qualifications Bachelor’s Degree biomedical or medical degree; Master’s degree Experience in a medical device clinical research, medical writing, or combination of these skills. Strong Project Management skills Experience in Active and/or Implantable Medical Devices or PSUR writing desired. Track record in clinical, medical, or scientific publication is a plus. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at , and on Twitter @AbbottNews. The base pay for this position is $75,300.00 – $150,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: MD Medical Devices LOCATION: United States > Texas > Plano : 6600 Pinecrest ADDITIONAL LOCATIONS: United States > Austin : 8701 Bee Caves Rd, United States > Maple Grove : 6820 Wedgwood Road N., United States > Santa Clara : Building A - SC WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: is the Law link - Espanol: #J-18808-Ljbffr
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Senior Project Manager, Clinical Risk Evaluation (on-site)
Posted 3 days ago
Job Viewed
Job Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks The Opportunity Our locations in Plano, TX, Austin, TX, Maple Grove, MN or Santa Clara, CA currently have an opportunity for a Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager . The Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager is to provide technical and strategic expertise throughout the product development and life cycle process; daily activities are related to management and alignment of risk information for Neuromodulation products. The CRE Program Manager writes and manages risk evaluation files, performs risk analysis, manages the development of clinical evaluation plans and reports and interacts with various cross-functional teams in order to assist in strategy, plans, and project deliverables. Must be able to effectively manage multiple projects and timelines. What You’ll Work On Independently creates and maintains Risk Evaluation Files (REF)s Abbott products. Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references. Oversees CROs, actively manages timelines and project delays/risks, develops scenario’s and recommendations for management. Leads risk alignment committee meetings (departmental multidisciplinary team), facilitates therapeutic team participation as appropriate, facilitates informed decision-making and dissemination of scientifically balanced and quality risk information regarding products. Ensures effective communication to clinical safety, clinical science, clinical internal and external operations, product performance, medical affairs, Clinical R&D, Quality Engineering, regulatory affairs, product labeling, senior management, and external CROs or medical writers. Conducts team meetings, sends routing communications and/or presents regular updates to senior staff. Develops and maintains Risk Evaluation Files (REF) DOP and associated documentation, provides input to cross-departmental SOPs and DOPs describing risk information processes. Develop templates taking into account all applicable regulations. Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports, Summaries of Safety and Clinical Performance (SSCPs) and associated documents; set deliverable and project timelines and ensure timelines are met. Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers). Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents. Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions. Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams. Compliance with applicable corporate and divisional policies and procedures. Participate in and support internal and external audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics. Provide and implement innovative ideas and solutions to Clinical Risk Evaluation group (e.g. database, LEAN projects), develop and roll out functional trainings as required. Reviews IFUs, patient guides, Risk Management, Clinical Evaluation Protocol, Clinical Evaluation Report (CEP/CER), IBs, study protocols, study ICFs, physician training materials, ensuring alignment of risk information. Involves in responses to complex costumer queries (e.g. regulatory authority, ethical committee, …) related to risk information. Reviews and gives input to Post-Marketing Surveillance Plans (PMS) and Post-Marketing Clinical Follow-up Plans (PMCF). Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Performs proactive clinical trial signal detection (planning, execution, and presentation) and actively participates in clinical corrective action board meetings. Participates in and supports audits. May actively participate in root cause analysis. May participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring, as requested by management. Acts as a mentor to less-experienced staff. Required Qualifications Bachelor’s Degree in related field OR an equivalent combination of education or work experience. Minimum 6 years related work experience with a strong understanding of specified functional area. Solid understanding and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on their business unit. Preferred Qualifications Bachelor’s Degree biomedical or medical degree; Master’s degree Experience in a medical device clinical research, medical writing, or combination of these skills. Strong Project Management skills Experience in Active and/or Implantable Medical Devices or PSUR writing desired. Track record in clinical, medical, or scientific publication is a plus. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at , and on Twitter @AbbottNews. The base pay for this position is $75,300.00 – $150,700.00 In specific locations, the pay range may vary from the range posted. JOB FAMILY: Regulatory Operations DIVISION: MD Medical Devices LOCATION: United States > Texas > Plano : 6600 Pinecrest ADDITIONAL LOCATIONS: United States > Austin : 8701 Bee Caves Rd, United States > Maple Grove : 6820 Wedgwood Road N., United States > Santa Clara : Building A - SC WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: No SIGNIFICANT WORK ACTIVITIES: Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: is the Law link - Espanol: #J-18808-Ljbffr
Senior Project Manager, Clinical Risk Evaluation (on-site)
Posted 3 days ago
Job Viewed
Job Description
Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year. An excellent retirement savings plan with a high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists. For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks The Opportunity Our locations in Plano, TX, Austin, TX, Maple Grove, MN or Santa Clara, CA currently have an opportunity for a Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager . The Clinical Risk Evaluation (CRE) Senior Scientist/Program Manager is to provide technical and strategic expertise throughout the product development and life cycle process; daily activities are related to management and alignment of risk information for Neuromodulation products. The CRE Program Manager writes and manages risk evaluation files, performs risk analysis, manages the development of clinical evaluation plans and reports and interacts with various cross-functional teams in order to assist in strategy, plans, and project deliverables. Must be able to effectively manage multiple projects and timelines. What You’ll Work On Independently creates and maintains Risk Evaluation Files (REF)s Abbott products. Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references. Oversees CROs, actively manages timelines and project delays/risks, develops scenario’s and recommendations for management. Leads risk alignment committee meetings (departmental multidisciplinary team), facilitates therapeutic team participation as appropriate, facilitates informed decision-making and dissemination of scientifically balanced and quality risk information regarding products. Ensures effective communication to clinical safety, clinical science, clinical internal and external operations, product performance, medical affairs, Clinical R&D, Quality Engineering, regulatory affairs, product labeling, senior management, and external CROs or medical writers. Conducts team meetings, sends routing communications and/or presents regular updates to senior staff. Develops and maintains Risk Evaluation Files (REF) DOP and associated documentation, provides input to cross-departmental SOPs and DOPs describing risk information processes. Develop templates taking into account all applicable regulations. Manage, provide guidance, and oversight of CER Medical Writers’ development of Clinical Evaluation Reports, Summaries of Safety and Clinical Performance (SSCPs) and associated documents; set deliverable and project timelines and ensure timelines are met. Facilitate communication and exchange of documents between stakeholders (e.g., internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, Library Services, Quality Engineering, Post-market Surveillance Group, Clinical Affairs, Risk Management, Program Management, as well as external vendors such as CROs, Medical Writers and Physician Reviewers). Review, edit, and write portions, as needed, of Clinical Evaluation Reports and associated documents. Participate in and/or lead the development of regulatory responses for Notified Body questions upon review of submissions. Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical evaluations, to new product development teams and sustaining teams. Compliance with applicable corporate and divisional policies and procedures. Participate in and support internal and external audits and responses to audit findings as appropriate, in root cause analysis, preventive or corrective actions, effectiveness monitoring, and other quality metrics. Provide and implement innovative ideas and solutions to Clinical Risk Evaluation group (e.g. database, LEAN projects), develop and roll out functional trainings as required. Reviews IFUs, patient guides, Risk Management, Clinical Evaluation Protocol, Clinical Evaluation Report (CEP/CER), IBs, study protocols, study ICFs, physician training materials, ensuring alignment of risk information. Involves in responses to complex costumer queries (e.g. regulatory authority, ethical committee, …) related to risk information. Reviews and gives input to Post-Marketing Surveillance Plans (PMS) and Post-Marketing Clinical Follow-up Plans (PMCF). Facilitates regulatory submissions and communications by communicating with Regulatory Affairs during the submission process. Performs proactive clinical trial signal detection (planning, execution, and presentation) and actively participates in clinical corrective action board meetings. Participates in and supports audits. May actively participate in root cause analysis. May participate in root cause analysis, preventive or corrective actions, and effectiveness monitoring, as requested by management. Acts as a mentor to less-experienced staff. Required Qualifications Bachelor’s Degree in related field OR an equivalent combination of education or work experience. Minimum 6 years related work experience with a strong understanding of specified functional area. Solid understanding and application of business concepts, procedures and practices. Will perform this job in a quality system environment. Failure to adequately perform tasks can result in noncompliance with governmental regulations. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a sound knowledge of a variety of alternatives and their impact on their business unit. Preferred Qualifications Bachelor’s Degree biomedical or medical degree; Master’s degree Experience in a medical device clinical research, medical writing, or combination of these skills. Strong Project Management skills Experience in Active and/or Implantable Medical Devices or PSUR writing desired. Track record in clinical, medical, or scientific publication is a plus. Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at , on Facebook at , and on Twitter @AbbottNews. The base pay for this position is $75,300.00 – $150,700.00. In specific locations, the pay range may vary from the range posted. #J-18808-Ljbffr
Director Of Clinical Outcomes and Evaluation
Posted 3 days ago
Job Viewed
Job Description
Director Of Clinical Outcomes and Evaluation JOB SUMMARY : This position will research (collect, analyze, report on, and present) appropriate performance and outcomes indicators and data on a wide variety of behavioral health treatment and prevention-related issues related to well-being. This position also exists to support Epworth Children’s Home and behavioral health stakeholders in developing a performance management system focusing on outcome indicators that measure the efficiency and effectiveness of services across all sectors of the Institute. QUALIFICATIONS: Bachelor’s degree from an accredited institution in statistical analysis, computer science, public administration, social science, or a closely related field required. Three years of experience with statistics and research methodology, using data to inform practice and behavioral health outcomes. PREFERRED QUALIFICATIONS: Master’s in statistical analysis, actuarial science, computer science, public administration, social science, or a closely related field. REQUIRED SKILLS: Must be proficient with various software programs such as Microsoft Word, Excel, and electronic communication. Must have the ability to quickly learn any database system required. Must be able to pass standard background checks, including drug screen, employment physical, SLED, DSS Central Registry, and Sex Offenders Registry. Interested applicants should submit a letter of interest and resume to the Human Resources Office: Epworth Children’s Home Human Resources PO Box 50466 Columbia, South Carolina 29250 #J-18808-Ljbffr