Crinetics Pharmaceuticals, Inc
Senior Director, Regulatory Affairs Advertising and Promotion
Crinetics Pharmaceuticals, Inc, California, Missouri, United States, 65018
Senior Director, Regulatory Affairs Advertising and Promotion
Categories: RegulatoryCrinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.Position Summary:The Senior Director, Regulatory Affairs Advertising and Promotion reports to the Vice President, Regulatory Affairs and is responsible for reviewing and approving advertising and promotional communications to ensure compliance with regulations, policies and procedures. The position will serve as the lead of the Medical, Legal, Regulatory (MLR) committee and will serve as the primary liaison to the FDA Office of Product and Drug Promotion (OPDP). The position will lead the development of processes and policies to support Crinetics’ commercialization and future marketed products. The position will support Crinetics’ drug development programs as needed.Essential Job Functions and Responsibilities:These may include but are not limited to:Review medical education and commercial advertising and promotional materials, including disease state and training/education programs to ensure materials comply with applicable regulatory requirements, laws, and guidelines.Serve as the Regulatory Reviewer and/or chair on Medical, Legal, Regulatory (MLR) committee or other promotional review committees.Serve as primary contact with the FDA Office of Prescription Drug Promotion (OPDP).Working with Regulatory Operations, responsible for 2253 submissions.Monitor competitor space advertising and promotion materials.Provide strategic input on campaigns for compliant product communications that meet program and corporate objectives.Implement and oversee MLR documentation system (such as Veeva).Articulate complex regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates.Implement strategies to ensure programs are within the framework of published guidance documents and identify areas of risk.Participate in development of program timelines.Monitor, communicate and manage budgets for their functional area.Set clear outcomes/deliverables for projects and own them, staying accountable to the company management team.Translate business needs into strategic initiatives and drive quantifiable outcomes for the Regulatory Affairs Advertising and promotion group.Focus on immediate and short-term ( Key participant in headcount planning – determine functional/departmental needs to meet corporate objectives.Develop relationships with external parties (e.g., CROs, consultants, QA and regulatory professionals) and stay current on industry trends and practices.Set high standards on deliverables while managing risks and timelines.Create new systems/policies and oversee for compliance.Provide guidance/tutoring and train staff members as necessary. Provide regular feedback and coaching for their professional development.Other duties as assigned.Education and Experience:Required:Bachelor’s or M.S./Ph.D. degree in scientific area.Minimum of 15 years with a Bachelor’s, or 13 years with an MS/PhD of relevant Regulatory Affairs experience in a biotech / pharmaceutical setting with a proven record of significant regulatory experience and accomplishments.Minimum of 10 years supervisory experience.Equivalent combination of relevant education and applicable job experience may be considered.Thorough knowledge of FDA advertising and promotion regulations and guidance as well as current industry and health authority trends and expectations.Experience with MLR or promotional review committees supporting product communications and managing regulatory submissions of promotional materials.Experience and understanding of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA regulations.Prior experience working at a small company with wide ranging related responsibilities is desired.Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved.Excellent written and oral communication skills.Strong organizational skills, including the ability to prioritize workload.Ability to meet deadlines and perform multiple tasks in a fast-paced setting.Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: Advanced MS Word and Adobe PDF knowledge required.Preferred:Experience interpreting and applying local regulations and guidance for drug development from early R&D through commercialization.Software Knowledge: Electronic document management systems use (e.g., Veeva PromoMats) highly desired. Publishing experience and/or eCTD knowledge is desired (Lorenz, GlobalSubmit, eCTDExpress, etc.)Physical Demands and Work Environment:Physical Activities:
On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.Travel:Travel may be required up to 5% of your time.The Anticipated Base Salary Range:
$204,000 – $272,000In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.Equal Opportunity Employer:Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.Vaccination requirement:Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
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Categories: RegulatoryCrinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.Position Summary:The Senior Director, Regulatory Affairs Advertising and Promotion reports to the Vice President, Regulatory Affairs and is responsible for reviewing and approving advertising and promotional communications to ensure compliance with regulations, policies and procedures. The position will serve as the lead of the Medical, Legal, Regulatory (MLR) committee and will serve as the primary liaison to the FDA Office of Product and Drug Promotion (OPDP). The position will lead the development of processes and policies to support Crinetics’ commercialization and future marketed products. The position will support Crinetics’ drug development programs as needed.Essential Job Functions and Responsibilities:These may include but are not limited to:Review medical education and commercial advertising and promotional materials, including disease state and training/education programs to ensure materials comply with applicable regulatory requirements, laws, and guidelines.Serve as the Regulatory Reviewer and/or chair on Medical, Legal, Regulatory (MLR) committee or other promotional review committees.Serve as primary contact with the FDA Office of Prescription Drug Promotion (OPDP).Working with Regulatory Operations, responsible for 2253 submissions.Monitor competitor space advertising and promotion materials.Provide strategic input on campaigns for compliant product communications that meet program and corporate objectives.Implement and oversee MLR documentation system (such as Veeva).Articulate complex regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates.Implement strategies to ensure programs are within the framework of published guidance documents and identify areas of risk.Participate in development of program timelines.Monitor, communicate and manage budgets for their functional area.Set clear outcomes/deliverables for projects and own them, staying accountable to the company management team.Translate business needs into strategic initiatives and drive quantifiable outcomes for the Regulatory Affairs Advertising and promotion group.Focus on immediate and short-term ( Key participant in headcount planning – determine functional/departmental needs to meet corporate objectives.Develop relationships with external parties (e.g., CROs, consultants, QA and regulatory professionals) and stay current on industry trends and practices.Set high standards on deliverables while managing risks and timelines.Create new systems/policies and oversee for compliance.Provide guidance/tutoring and train staff members as necessary. Provide regular feedback and coaching for their professional development.Other duties as assigned.Education and Experience:Required:Bachelor’s or M.S./Ph.D. degree in scientific area.Minimum of 15 years with a Bachelor’s, or 13 years with an MS/PhD of relevant Regulatory Affairs experience in a biotech / pharmaceutical setting with a proven record of significant regulatory experience and accomplishments.Minimum of 10 years supervisory experience.Equivalent combination of relevant education and applicable job experience may be considered.Thorough knowledge of FDA advertising and promotion regulations and guidance as well as current industry and health authority trends and expectations.Experience with MLR or promotional review committees supporting product communications and managing regulatory submissions of promotional materials.Experience and understanding of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA regulations.Prior experience working at a small company with wide ranging related responsibilities is desired.Excellent negotiation skills and a tactful approach that leads to high value on outcomes achieved.Excellent written and oral communication skills.Strong organizational skills, including the ability to prioritize workload.Ability to meet deadlines and perform multiple tasks in a fast-paced setting.Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: Advanced MS Word and Adobe PDF knowledge required.Preferred:Experience interpreting and applying local regulations and guidance for drug development from early R&D through commercialization.Software Knowledge: Electronic document management systems use (e.g., Veeva PromoMats) highly desired. Publishing experience and/or eCTD knowledge is desired (Lorenz, GlobalSubmit, eCTDExpress, etc.)Physical Demands and Work Environment:Physical Activities:
On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is usually low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.Travel:Travel may be required up to 5% of your time.The Anticipated Base Salary Range:
$204,000 – $272,000In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.Equal Opportunity Employer:Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.Vaccination requirement:Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
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