Director, Clinical Regulatory Writing
About the position
GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. STAY AWESOME: Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com A DAY IN THE LIFE: The Director, Clinical Regulatory Writing reports to the VP, Medical Affairs, and acts as a representative for the organization for both internal and external functions. This role is specifically responsible for developing a functional program and team dedicated to meeting the clinical regulatory needs of the business for US and global regulatory bodies. As well as hands-on work writing and supporting clinical reports including CERs, CEPs, and other clinical reports, offering clinical and regulatory expertise to support the medical writer and chief medical officer. In addition, this role may assist and support 510(k) submissions. This role interfaces with the clinical trials team to assist with study reports, study protocol development, and other areas where clinical-regulatory expertise is needed. This position also plays a key role in driving medical and clinical publications and reports.
Responsibilities
• Organizing routine communication with the regulatory division at Tandem, and mapping out a calendar of anticipated clinical regulatory needs.
• Primarily responsible for clinical regulatory writing for: Writing Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Literature Search Protocols.
• Assembling templates designed to meet MDR/Canada/Australia regulatory requirements for CERs, CEPs and other clinical regulatory submissions.
• Assistance with IFUs.
• Other medical reports as required, to include reports needed for FDA submissions.
• Regularly updating and maintaining clinical and regulatory documents.
• Learning and working with the quality management system (QMS) to ensure compliance with company and regulatory requirements.
• Working closely with the medical affairs team.
• Working with R&D, Quality, Clinical and Regulatory functions to address and resolve any concerns.
• Assisting with clinical studies to write clinical study reports, as well as providing additional materials for clinical studies.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Identifying a team of individuals to meet clinical regulatory needs, and organizing their execution of the function.
Requirements
• Bachelor’s degree (B.S./B.A.) in related field or combination of equivalent education and applicable work experience.
• 10+ years regulatory, medical technology, clinical, industry and/or applicable experience.
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals.
• Familiarity with advanced diabetes technology and digital health products.
• Willingness to support regulatory and other functions across the company, with a direct role in medical writing (with assistance from Medical Affairs) is required.
• Comprehensive knowledge of the diabetes disease state and current therapy options.
• Ability to understand and interpret complex clinical data and other scientific information.
• Demonstrated superior verbal and written English skills, for the purpose of working with the medical writer to create and edit protocols, commercial communication and other in-scope content.
• Demonstrated knowledge of related regulatory and privacy requirements (e.g. HIPAA).
• Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
• Able to work independently and make appropriate strategic decisions to achieve the goals of the clinical affairs department.
• Proven ability to manage clinical tasks and deliverables to meet product development timelines.
• Experience with project lifecycle and management.
• Experience with agile/scrum collaboration tools and internal document control systems.
• Strong understanding of the MDR CER process is essential, including methodology of calculations of benefit to risk ratio.
• Proven knowledge and application of regulatory requirements in the EU and willingness to learn more is essential.
• Able to make and prioritize process and resource decisions based on overall team needs.
• Advanced computer and software skills, including Microsoft Office products, and proprietary databases.
Nice-to-haves
• Master’s degree (M.S./M.A.) or equivalent experience in a relevant field, strongly preferred.
Benefits
• Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts.
• You’ll also receive 11 paid holidays per year, unlimited PTO and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan.
Apply Now
Apply Now
GROW WITH US: Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry. STAY AWESOME: Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.com A DAY IN THE LIFE: The Director, Clinical Regulatory Writing reports to the VP, Medical Affairs, and acts as a representative for the organization for both internal and external functions. This role is specifically responsible for developing a functional program and team dedicated to meeting the clinical regulatory needs of the business for US and global regulatory bodies. As well as hands-on work writing and supporting clinical reports including CERs, CEPs, and other clinical reports, offering clinical and regulatory expertise to support the medical writer and chief medical officer. In addition, this role may assist and support 510(k) submissions. This role interfaces with the clinical trials team to assist with study reports, study protocol development, and other areas where clinical-regulatory expertise is needed. This position also plays a key role in driving medical and clinical publications and reports.
Responsibilities
• Organizing routine communication with the regulatory division at Tandem, and mapping out a calendar of anticipated clinical regulatory needs.
• Primarily responsible for clinical regulatory writing for: Writing Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), Literature Search Protocols.
• Assembling templates designed to meet MDR/Canada/Australia regulatory requirements for CERs, CEPs and other clinical regulatory submissions.
• Assistance with IFUs.
• Other medical reports as required, to include reports needed for FDA submissions.
• Regularly updating and maintaining clinical and regulatory documents.
• Learning and working with the quality management system (QMS) to ensure compliance with company and regulatory requirements.
• Working closely with the medical affairs team.
• Working with R&D, Quality, Clinical and Regulatory functions to address and resolve any concerns.
• Assisting with clinical studies to write clinical study reports, as well as providing additional materials for clinical studies.
• Ensures compliance with company policies, including Privacy/HIPAA, and other legal and regulatory requirements.
• Identifying a team of individuals to meet clinical regulatory needs, and organizing their execution of the function.
Requirements
• Bachelor’s degree (B.S./B.A.) in related field or combination of equivalent education and applicable work experience.
• 10+ years regulatory, medical technology, clinical, industry and/or applicable experience.
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals.
• Familiarity with advanced diabetes technology and digital health products.
• Willingness to support regulatory and other functions across the company, with a direct role in medical writing (with assistance from Medical Affairs) is required.
• Comprehensive knowledge of the diabetes disease state and current therapy options.
• Ability to understand and interpret complex clinical data and other scientific information.
• Demonstrated superior verbal and written English skills, for the purpose of working with the medical writer to create and edit protocols, commercial communication and other in-scope content.
• Demonstrated knowledge of related regulatory and privacy requirements (e.g. HIPAA).
• Excellent working knowledge of ICH GCP guidelines, CFR, EMA, and HIPAA regulations.
• Able to work independently and make appropriate strategic decisions to achieve the goals of the clinical affairs department.
• Proven ability to manage clinical tasks and deliverables to meet product development timelines.
• Experience with project lifecycle and management.
• Experience with agile/scrum collaboration tools and internal document control systems.
• Strong understanding of the MDR CER process is essential, including methodology of calculations of benefit to risk ratio.
• Proven knowledge and application of regulatory requirements in the EU and willingness to learn more is essential.
• Able to make and prioritize process and resource decisions based on overall team needs.
• Advanced computer and software skills, including Microsoft Office products, and proprietary databases.
Nice-to-haves
• Master’s degree (M.S./M.A.) or equivalent experience in a relevant field, strongly preferred.
Benefits
• Tandem offers health care benefits such as medical, dental, vision available your first day, as well as health savings accounts and flexible saving accounts.
• You’ll also receive 11 paid holidays per year, unlimited PTO and you will have access to a 401k plan with company match as well as an Employee Stock Purchase plan.
Apply Now
Apply Now