Senior Regulatory Specialist
Senior Regulatory Specialist
Posted on :
24-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
24-01-2025
Job Description
Job Title: Senior Regulatory Specialist
Job Location: United States
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
What We Do
Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck Care Access is helping accelerate the approval and delivery of critical and lifesaving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another find new ideas to accelerate medicine and seed a longterm impact for generations.
Position Overview
The Senior Regulatory Specialist will oversee all details of regulatory for assigned trials for both the traditional and decentralized site models and is responsible for ensuring compliance with regulations and supporting start up activities for all sites and studies.
What You'll Be Working On (Duties include but are not limited to):
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access every day we are advancing medical breakthroughs. We’re uniting standard patient care with cuttingedge treatments and research. Our work brings lifechanging therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity or expression pregnancy age national origin disability status genetic information protected veteran status or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices terms and conditions of employment and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate under any circumstances the use of any form of forced or involuntary labor child labor or human trafficking. This extends to suppliers partners or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
Care Access is delivering the future of medicine today! Care Access has a revolutionary model that breaks down traditional barriers to clinical trials that limit participation among physicians and patients to 3%. By removing this bottleneck Care Access is helping accelerate the approval and delivery of critical and lifesaving therapies.
Who We Are
We care. Our people are the engines behind our mission: to revolutionize access to clinical trials for the benefit of patients everywhere. We care for one another find new ideas to accelerate medicine and seed a longterm impact for generations.
Position Overview
The Senior Regulatory Specialist will oversee all details of regulatory for assigned trials for both the traditional and decentralized site models and is responsible for ensuring compliance with regulations and supporting start up activities for all sites and studies.
What You'll Be Working On (Duties include but are not limited to):
- Develop and execute regulatory strategies to obtain and maintain regulatory approvals for Care Access projects
- Lead communications and serve as main contact with regulatory bodies
- Develop review and submit highquality and timely regulatory agency submission materials including but not limited to protocols ICFs and marketing materials
- Stay updated on evolving regulations guidelines and industry best practices to ensure compliance and adjust strategies
- Collaborate closely with cross functional teams including but not limited to senior leadership patient marketing and study operations
- Track essential documents and timelines
- Handling submissions to the IRB management of essential regulatory documents
- Maintain centralized document storage
- Ensure quality is maintained in all investigator site files for assigned studies
- Support sites through their evaluation and begin startup activities upon selection
- Support the site through the Site Evaluation Visit Site Initiation Visit greenlight to consent and Study Closeout
- Support audits and monitoring visits to ensure regulatory compliance
- Oversee activities throughout the duration of the study; supporting clinical operations teams as required
- Review study information and understand startup timelines requirements key contacts and performance expectations
- Actively work towards KPIs to help ensure departmental success
- Liaise with key stakeholders across the global organization to communicate needs and establish startup timelines
- Work with department head on new initiatives and projects to help grow department
- Display high level of integrity and professionalism
- Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily allinclusive
- This is a remote position with less than 10% travel requirements. Occasional planned travel may be required as part of the role.
- Ability to communicate and work effectively with a diverse team of professionals
- Strong organizational skills: Able to prioritize delegate direct support assign and evaluate others work and follow through on assignments
- Communication Skills: Strong verbal and written communication skills as evidenced by positive interactions with coworkers management clients and vendors
- Team Collaboration Skills: Work effectively and collaboratively with other team members to accomplish mutual goals. Bring positive and supportive attitude to achieving these goals
- Strong computer skills with demonstrated abilities using clinical trials database MS word and excel
- Ability to balance tasks with competing priorities
- Critical thinker and problem solver
- Curiosity and passion to learn innovate able to take thoughtful risks and get things done
- Friendly outgoing personality with the ability to maintain a positive attitude under pressure
- High level of selfmotivation and energy
- Ability to work independently in a fastpaced environment with supervision
- Must have a client service mentality
- Bachelor’s Degree or work experience may substitute for required education
- A minimum of 5 year of experience in regulatory; central regulatory experience required
- Strong knowledge of regulations
- CCRP preferred
- PTO/vacation days sick days holidays.
- 100% paid medical dental and vision Insurance. 75% for dependents
- HSA plan
- Shortterm disability longterm disability and life Insurance
- Culture of growth and equality
- 401k retirement plan
We serve patients and researchers from diverse cultures and communities around the world. We are stronger and better when we build a team representing the people we aim to support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We value diversity and believe that unique contributions drive our success. At Care Access every day we are advancing medical breakthroughs. We’re uniting standard patient care with cuttingedge treatments and research. Our work brings lifechanging therapies to those in need and paves the way for newer and greater treatments to reach the world. We’re proud to advance these breakthroughs and work with the big players while engaging with the best physicians and caring for patients.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity or expression pregnancy age national origin disability status genetic information protected veteran status or any other characteristic protected by law.
Care Access is unable to sponsor work visas at this time.
Employment Statement
Care Access complies with all employment laws and regulations with respect to its employment practices terms and conditions of employment and pay equity and wages. Care Access does not engage in any unfair or forced labor practice and does not tolerate under any circumstances the use of any form of forced or involuntary labor child labor or human trafficking. This extends to suppliers partners or other third parties with whom Care Access does business. Care Access values and promotes the protection of human rights everywhere.
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Employment Type
Full Time
Key Skills
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