CASenior Manager, Regulatory
Care Access is building the future of healthcare, where many more life-changing therapies can reach those who need it most.
DUTIES INCLUDE BUT ARE NOT LIMITED TO:· Be responsible for the development, implementation, and maintenance of robust North American regulatory strategies.· Bring innovative regulatory approaches, to lead the team in discussions with Health Authorities across North America to find the best developmental strategies.· Lead and oversee all aspects of the regulatory team operations.· Develop, improve, and make more robust the systems, repeatable processes, and workflows that support the successful function of the Regulatory team. · Lead a team of regulatory professionals, providing guidance, support and training as needed.· Collaborate with cross-functional teams to ensure regulatory compliance and alignment with organizational goals.· Builds partnerships with senior key stakeholders from other functions to ensure that strategic business goals are met through the sharing of knowledge and expertise.· Manage the successful onboarding and training of new hires to the Regulatory team.· Drive continuous improvement initiatives in regulatory processes and systems to enhance efficiency and quality.· Manage team and understand resource and capacity· Identify and escalate risks up line as needed in a timely manner· Implement project management strategies to best manage studies and deliverables · Build relationships with external partners to best support the Regulatory team and company.· Provide back-up support to Regulatory Specialist role as needed including plan, prepare, and review submissions to applicable IRBs, such as:o Initial submissionso Continuing Reviewso Study Closeout Reports●Manage generic regulatory submissions including ICF, prescreening plans, and all marketing/recruitment materials requiring IRB approval●Design creative solutions to stay within regulatory guidelines while the company creates new ways to run clinical trials.●Assist in the development and maintenance of KPIs to measure department success●Develop and maintain electronic regulatory platforms at Care Access.●Manage regulatory document/ISF quality through internal review (department QC) · Maintain knowledge of pertinent regulations and guidance · Manage study caseload & ISF● Ensure quality is maintained in all investigator site files and regulatory workflows overall; Develop processes to verify compliance and best practice.● Support the submission of new CLIA waiver applications and maintain CLIA certification for sites or other required Site or PI level regulatory registrations certificates as needed.● Constantly strive to improve the department.● Lead by example and display a 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 all-inclusive KNOWLEDGE, SKILLS, AND ABILITIES:● Excellent working knowledge of medical and research terminology· Expert knowledge of federal research regulations and good clinical practices (GCP)7+ years of experience in regulatory affairs within the clinical research industry, with specific experience working with IRBs and electronic Investigator Site Files (preferably experience in a Site Management Organization)Strong knowledge of US and Canadian regulations governing clinical trials and IRB processes.· Demonstrated leadership skills with experience managing a team in a fast-paced environment.· Excellent communication, organizational, and problem-solving skills. Ability to work independently, prioritize tasks effectively, and meet deadlines consistently.● Ability to communicate and work effectively with a diverse team of professionals· Ability to prioritize and handle multiple projects simultaneously.● Strong organizational skills: Able to prioritize, delegate, direct, support, assign and evaluate others work and follow through on assignments● 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 CTMS and clinical trials database systems, electronic data capture, 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.● High level of self-motivation, energy, initiative, and flexibility.● Must have a client service mentality. EDUCATION:● Bachelor’s Degree required in life sciences or equivalent education EXPERIENCE:● A minimum of 3 years of experience managing direct reports and teams● A minimum of 7 years of experience in regulatory Certifications:● CCRC or CCRP preferredDiversity & InclusionWe 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 cutting-edge treatments and research. Our work brings life-changing 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 bestphysicians 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.
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About the job
Apply before
May 15, 2024
Posted on
Mar 16, 2024
Job type
Full Time
Experience level
Senior
Location requirements
Hiring timezones
United States +/- 0 hoursAbout Care Access
Learn more about Care Access and their company culture.
Care Access is building the future of healthcare, where many more life-changing therapies can reach those who need it most. We are uniting standard patient care with cutting-edge treatments and research to uncover a world where medical breakthroughs don’t end in the lab but instead make it to patients quickly and transform lives. Through innovation and a unique technology-enabled service model, our team of expert scientists, engineers, entrepreneurs, physicians, nurses, and patient volunteers are paving the way towards this more caring and creative world. Along the way, we are caring for each other, accelerating medicine, and seeding a long-term impact for generations to come.
Our values are rooted in being genuine and authentic. We don't do things for show or because it’s trendy; what we say is meant and what we do is meaningful. We don't have internal politics and our teamwork is not an artificial construct; rather, it is a natural consequence of really smart, caring people working together. This translates into us valuing communication and dialogue: we care about what everyone has to say and we spend energy on being inclusive. We don't work in an environment where it's okay for someone to get crushed, and we take steps to prevent and avoid that. This creates the groundwork where everyone is encouraged to shine and where merit-based chances to excel are plentiful.
Tech stack
Learn about the tools and technologies that Care Access uses to build, market, and sell its products.
JavaScript
HTML5
CSS 3
Facebook Ads
Salesforce
Google Analytics
Adobe Photoshop
Lever
HubSpot
Adobe Illustrator
LinkedIn Sales Navigator
4 moreCare Access employees can create an account to update this tech stack.
Employee benefits
Learn about the employee benefits and perks provided at Care Access.
Paid vacation
PTO/Vacation days, sick days, holidays.
Life insurance
Short-term disability, long-term disability, life insurance.
Healthcare insurance
Medical, dental, and vision insurance for employees and dependents.
Learning and development budget
Learning and development budget per year stipend to grow your skills.
CACare Access
Company size
201-500
Founded in
2015
Chief executive officer
Ahmad Namvargolian
Markets
Employees live in
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