5 Digital Medicine jobs in the United States
PA - Digital Medicine
Posted 7 days ago
Job Viewed
Job Description
We've made a lot of progress since opening the doors in 1942, but one thing has never changed - our commitment to serve, heal, lead, educate, andinnovate.Webelieve that every award earned, every record broken and every patient helped is because of the dedicated employees who fill our hallways. At Ochsner, whether you work with patients every day or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today! This job works in a collaborative model including but not limited to: residents, fellows, attendings, and staff who care for outpatient clinic patients of the organization. This job works under the supervision of the Medical Director or approved staff physician and in association with the PCCs, staff nurses, and discharge coordinator in the planning, implementation and evaluation of medical and nursing care; and assumes responsibility for primary and urgent medical management, emergency stabilization of all critically ill patients, teaching of residents and medical students, staff development and education, patient education and discharge planning. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties. This job description is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion. Education Required - Bachelor’s degree in Physician Assistant medicine or Health Sciences, or graduate of an approved Physician Assistant Training Program. Work Experience Required - None. Preferred – 3 years’ related working experience. Certifications Required - License as a Physician Assistant in the state of practice, NCCPA Certified, Basic Cardiac Life Support (BCLS) / Advanced Cardiovascular Life Support (ACLS) Certification from the American Heart Association. Eligible for Prescriptive Authority in the state of practice as outlined by the State Board of Medical Examiners. Knowledge Skills and Abilities (KSAs) Computer skills and dexterity for data entry and retrieval of required job information. Effective verbal and written communication skills and the ability to present information clearly and professionally. Proficient with Windows-style applications, various software packages specific to role and keyboard. Strong interpersonal skills. Working knowledge of Advanced Practice Provider policies and protocols at a department and campus/system level. Ability to have reliable transportation as must be able to travel throughout and between facilities. Ability to work a flexible work schedule (e.g. 24/7, weekend, holiday, on call availability). Job Duties Utilizes the approved medical practices process in the delivery of all patient care. Provides care based on physical, psycho/social, educational, safety and related criteria, appropriate to the ages of patients served in assigned areas. Maintains an attitude of inquiry towards medical practices and patient care outcomes, and may develop research methodology. Provides education experiences to patient families, staff, other health professionals, and to the community. Adapts behavior to the specific patient population, including but not limited to: respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style. Performs other related duties as required. The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time. Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards. This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns. The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Physical and Environmental Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible. Must be able to stand for prolonged periods of time. Must be able to stoop, bend, reach and grab with arms and hands, manual dexterity. Duties performed routinely require exposure to blood, body fluid and tissue. The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases. There may be an occupational risk for exposure to communicable diseases. Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste. The risk level of exposure may increase depending on the essential job duties of the role. Are you ready to make a difference? Apply Today! Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website. Individuals who reside in and will work from the following areas are not eligible for remote work position : Colorado, California, Hawaii, Illinois, Maryland, Minnesota, New Jersey, New York, Vermont, Washington,and Washington D.C. Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at (select option 1) or . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities. #J-18808-Ljbffr
PA - Digital Medicine

Posted 1 day ago
Job Viewed
Job Description
**At Ochsner, whether you work with patients** **every day** **or support those who do, you are making a difference and that matters. Come make a difference at Ochsner Health and discover your future today!**
This job works in a collaborative model including but not limited to: residents, fellows, attendings, and staff who care for outpatient clinic patients of the organization.
This job works under the supervision of the Medical Director or approved staff physician and in association with the PCCs, staff nurses, and discharge coordinator in the planning, implementation and evaluation of medical and nursing care; and assumes responsibility for primary and urgent medical management, emergency stabilization of all critically ill patients, teaching of residents and medical students, staff development and education, patient education and discharge planning.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential duties.
This job description is a summary of the primary duties and responsibilities of the job and position. It is not intended to be a comprehensive or all-inclusive listing of duties and responsibilities. Contents are subject to change at the company's discretion.
**Education**
**Required** - Bachelor's degree in Physician Assistant medicine or Health Sciences, or graduate of an approved Physician Assistant Training Program.
**Work Experience**
**Required** - None.
**Preferred** - 3 years' related working experience.
**Certifications**
Required - License as a Physician Assistant in the state of practice, NCCPA Certified, Basic Cardiac Life Support (BCLS) / Advanced Cardiovascular Life Support (ACLS) Certification from the American Heart Association.
Eligible for Prescriptive Authority in the state of practice as outlined by the State Board of Medical Examiners.
**Knowledge Skills and Abilities (KSAs)**
+ Computer skills and dexterity for data entry and retrieval of required job information.
+ Effective verbal and written communication skills and the ability to present information clearly and professionally.
+ Proficient with Windows-style applications, various software packages specific to role and keyboard.
+ Strong interpersonal skills.
+ Working knowledge of Advanced Practice Provider policies and protocols at a department and campus/system level.
+ Ability to have reliable transportation as must be able to travel throughout and between facilities.
+ Ability to work a flexible work schedule (e.g. 24/7, weekend, holiday, on call availability).
**Job Duties**
+ Utilizes the approved medical practices process in the delivery of all patient care.
+ Provides care based on physical, psycho/social, educational, safety and related criteria, appropriate to the ages of patients served in assigned areas.
+ Maintains an attitude of inquiry towards medical practices and patient care outcomes, and may develop research methodology.
+ Provides education experiences to patient families, staff, other health professionals, and to the community.
+ Adapts behavior to the specific patient population, including but not limited to: respect for privacy, method of introduction to the patient, adapting explanation of services or procedures to be performed, requesting permissions and communication style.
+ Performs other related duties as required.
The above statements describe the general nature and level of work only. They are not an exhaustive list of all required responsibilities, duties, and skills. Other duties may be added, or this description amended at any time.
Remains knowledgeable on current federal, state and local laws, accreditation standards or regulatory agency requirements that apply to the assigned area of responsibility and ensures compliance with all such laws, regulations and standards.
This employer maintains and complies with its Compliance & Privacy Program and Standards of Conduct, including the immediate reporting of any known or suspected unethical or questionable behaviors or conduct; patient/employee safety, patient privacy, and/or other compliance-related concerns.
The employer is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
**Physical and Environmental Demands**
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Medium Work - Exerting 20 to 50 pounds of force occasionally, and/or 10 to 25 pounds of force frequently, and/or greater than negligible up to 10 pounds of force constantly to move objects. (Constantly: activity or condition exists 2/3 or more of the time) to move objects. Physical demand requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible. NOTE: The constant stress and strain of maintaining a production rate pace, especially in an industrial setting, can be and is physically demanding of a worker even though the amount of force exerted is negligible.
Must be able to stand for prolonged periods of time.
Must be able to stoop, bend, reach and grab with arms and hands, manual dexterity.
Duties performed routinely require exposure to blood, body fluid and tissue.
The incumbent works in a patient care area; works in an area where patients enter; works directly with patients; and/or works with specimens that could contain communicable diseases. There may be an occupational risk for exposure to communicable diseases.
Because the incumbent works within a healthcare setting, there may be occupational risk for exposure to hazardous medications or hazardous waste within the environment through receipt, transport, storage, preparation, dispensing, administration, cleaning and/or disposal of contaminated waste. The risk level of exposure may increase depending on the essential job duties of the role.
**Are you ready to make a difference? Apply Today!**
**_Ochsner Health does not consider an individual an applicant until they have formally applied to the open position on this careers website._**
_Individuals who reside in and will work from the following areas are not eligible for remote work position_ _: Colorado, California, Hawaii, Illinois, Maryland, Minnesota, New Jersey, New York, Vermont, Washington,_ _and Washington D.C._
**_Ochsner Health endeavors to make our site accessible to all users. If you would like to contact us regarding the accessibility of our website, or if you need an accommodation to complete the application process, please contact our HR Employee Solution Center at (select option 1) or_** ** ** **_. This contact information is for accommodation requests only and cannot be used to inquire about the status of applications._**
Ochsner is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to any legally protected class, including protected veterans and individuals with disabilities.
Digital Medicine, Director

Posted 14 days ago
Job Viewed
Job Description
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Digitial Medicine, Director
**What you will do**
Let's do this. Let's change the world. In this vital role you will lead and drive innovative research methods across portfolio by utilizing decentralized, pragmatic trial strategies, and digital health initiatives. This person will serve as a subject matter expert (SME) and strategic partner to product and study teams, providing thought leadership and operational guidance for integrating digital and innovative solutions across the product development lifecycle. This role may also assume direct study-level responsibility when needed, ensuring seamless execution and alignment with program goals.
**Responsibilities**
**Strategic Leadership:**
+ Define and execute the digital medicine strategy aligned with post marketing, clinical development, product, and portfolio needs.
+ Represent the Digital Medicine function across cross-functional and governance meetings, influencing strategic decisions.
**Study & Product Team Support:**
+ Serve as SME to product and clinical study teams to identify opportunities for innovative research integration, including DCT elements, DHT and pragmatic study designs for efficiency and cost management of studies.
+ Advise on the selection, validation, and implementation of digital tools, wearables, remote monitoring technologies, and digital endpoints.
**Decentralized and Pragmatic Trial Expertise:**
+ Provide leadership in the design, planning, and execution of decentralized and pragmatic trials.
**Innovation & Technology Enablement:**
+ Stay current with emerging digital health trends, technologies, regulatory guidance, and industry standard processes.
+ Identify and establish strategic partnerships with external innovators, startups, technology providers, and academic institutions
**Cross-Functional Collaboration:**
+ Act as the central point of contact for Digital Medicine internally and externally, including interactions with vendors, investigators, and functions conducting the studies.
+ Collaborate with Medical Affairs, Clinical Development, Clinical Operations, Regulatory, Safety, Strategic Sourcing and related teams to ensure successful execution of trials with innovative methods.
**Operational Oversight:**
+ Oversee the operational aspects of digital solution deployment in clinical trials, including vendor management, budget planning, and risk mitigation.
+ Define and monitor key performance indicators (e.g., study time reduction, patient retention, enrollment, cost).
+ Change Management
+ Lead change management to drive cultural and organizational adoption of innovative research methods
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a Director with these qualifications.
**Basic Qualifications:**
+ Doctorate degree and 4 years of relevant experience OR
+ Master's degree and 7 years of relevant experience OR
+ Bachelor's degree and 9 years of relevant experience
**Preferred Qualifications:**
+ Advanced degree in life sciences, medicine, pharmacy, public health, or related field (PhD, MD, PharmD, or MSc preferred).
+ Minimum of 10 years of experience in clinical development, digital health, or related field, including leadership in DCTs and pragmatic trials. Preferably in cardiovascular, rare diseases, oncology, and/or inflammation.
+ Deep understanding of clinical trial operations, regulatory requirements, and digital health technologies.
+ Proven experience implementing digital strategies in clinical research at a global or regional level.
+ Strong communication and stakeholder management skills; ability to influence across levels and functions.
+ Entrepreneurial approach, with a strong focus on innovation, patient-centricity, and data-driven decision-making.
+ Familiarity with digital platforms and wearables is a plus.
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
+ A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans
+ Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.
**careers.amgen.com**
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Director Global Regulatory Affairs - Precision Medicine and Digital Health
Posted 10 days ago
Job Viewed
Job Description
**Job Description**
**POSITION OBJECTIVES:**
+ Responsible for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our products across therapeutic areas
+ Establish effective collaborations with the various groups and leadership involved in the development and commercialization of biomarkers, diagnostic tests and digital tools to ensure goals/objectives are met.
**ACCOUNTABILITIES:**
+ Responsible for overseeing the precision medicine and digital health efforts for assigned programs.
+ Ensures global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including HA engagement plans and mitigation strategies
+ Ensures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions.
+ Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners.
+ Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within the therapeutic area, across GRA and across the enterprise.
+ Provide regulatory strategy support to diligence for licensing opportunities as appropriate
+ Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
+ Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
**EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:**
+ Solid scientific background, PhD., M.D., PharmD, MS
+ A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience.
+ Expert knowledge of device development, registration and maintenance regulations with experience in championing innovation in technical areas.
+ Comprehensive understanding of biomarker strategies and implications for drug development.
+ Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Device submissions (ie, IND, SRDs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements).
+ Understanding of scientific principles and regulatory Device requirements relevant to global drug development and post-market support, including recent EU MDR and IVDR.
+ Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy.
+ Preferred experience includes reviewing, authoring, or managing components of both drug and device regulatory submissions.
+ Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy.
+ Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
Massachusetts - Virtual
**U.S. Base Salary Range:**
$169,400.00 - $266,200.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job?The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
Massachusetts - Virtual
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
#LI-Remote
Director Global Regulatory Affairs - Precision Medicine and Digital Health (Boston)
Posted 1 day ago
Job Viewed
Job Description
Join to apply for the Director Global Regulatory Affairs - Precision Medicine and Digital Health role at Takeda
Director Global Regulatory Affairs - Precision Medicine and Digital HealthJoin to apply for the Director Global Regulatory Affairs - Precision Medicine and Digital Health role at Takeda
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This range is provided by Takeda. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range$174,500.00/yr - $74,230.00/yr
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description:
POSITION OBJECTIVES :
- Responsible for providing strategic guidance and oversight for the delivery of global regulatory strategies to support development of biomarkers, diagnostic tests, devices and digital health tools to enhance the value of our products across therapeutic areas
- Establish effective collaborations with the various groups and leadership involved in the development and commercialization of biomarkers, diagnostic tests and digital tools to ensure goals/objectives are met.
- Responsible for overseeing the precision medicine and digital health efforts for assigned programs.
- Ensures global regulatory plans effectively accommodate appropriate precision medicine approaches by effectively integrating drug and diagnostic regulatory and submission plans including HA engagement plans and mitigation strategies
- Ensures line management and key stakeholders are apprised of developments that may impact regulatory success, exercising sound judgement and communicating in a professional and timely manner. Demonstrates ability to anticipate risks and responsible for developing solutions to identified risks and discussing with direct reports and management; understands probabilities of technical success for the solutions.
- Effectively represent the Global Regulatory Affairs (GRA) function in senior level interactions at internally governance technical review committees, key global health authority meetings and external partners.
- Participates with influence in or leads departmental and cross-functional task-forces and initiatives. Influence non-direct reports within the therapeutic area, across GRA and across the enterprise.
- Provide regulatory strategy support to diligence for licensing opportunities as appropriate
- Monitor and anticipate trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner.
- Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
- Solid scientific background, PhD., M.D., PharmD, MS
- A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years regulatory and/or related experience.
- Expert knowledge of device development, registration and maintenance regulations with experience in championing innovation in technical areas.
- Comprehensive understanding of biomarker strategies and implications for drug development.
- Demonstrated track record of successful interactions with FDA, EMA, Notified Bodies, and other global health authorities specifically related to Device submissions (ie, IND, SRDs, CTA, IMPD, BLA, MAA, NDA, 510K, CE Mark submissions and their amendments/supplements).
- Understanding of scientific principles and regulatory Device requirements relevant to global drug development and post-market support, including recent EU MDR and IVDR.
- Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy.
- Preferred experience includes reviewing, authoring, or managing components of both drug and device regulatory submissions.
- Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects and provides knowledge and expertise to guide team in established and building appropriate global regulatory strategy.
- Strong communication, collaboration, negotiation, problem solving and interpersonal skills. Has a proven track record of working across regulator/industry boundaries to find common solutions and drive positive impact and benefits for patients.
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Massachusetts - Virtual
U.S. Base Salary Range :
$169,4 0.00 - 266,200.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement:
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
Locations:
Massachusetts - Virtual
Worker Type:
Employee
Worker Sub-Type:
Regular
Time Type:
Full time
Job Exempt:
Yes
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Seniority level
- Seniority level Director
- Employment type Full-time
- Job function Legal
- Industries Pharmaceutical Manufacturing
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