Senior Manager, Regulatory at Care Access Research | Powderkeg

Location: Remote, US

Employment Type: Full Time - Regular

Team: Global Study Operations

Purpose:

Lead the Regulatory department to support all assigned individuals within the team. This individual will provide oversight and will work proactively with the Care Access team to solve. The Sr. Manager, Regulatory oversees the Regulatory team members and supports all aspects of regulatory efforts for the Care Access site model and is responsible for helping ensure compliance with regulations. This individual will stay abreast of regulations impacting the business according to Care Access SOPs, GCP, FDA/ICH, country-specific and all other applicable Regulatory Guidelines.

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 submissions

o Continuing Reviews

o 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 preferred

Diversity & Inclusion

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 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 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.

Job Summary
  • Job Title
    Senior Manager, Regulatory
  • Company
    Care Access Research
  • Location
    Remote
  • Employment Type
    Full time
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