Director, Medical Promotional Review
Salary undisclosed
Checking job availability...
Original
Simplified
Crinetics 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. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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 Director, Medical Promotional Review, plays a key role in the Medical Affairs team and is responsible for ensuring medical and scientific accuracy of promotional and non-promotional materials in compliance with US laws and regulations and company policies. The position involves reviewing all materials submitted to the Medical Review Committee (MRC) and Medical Legal Regulatory (MLR) promotional review committee to ensure regulatory and scientific standards are met, while fostering collaboration with Legal and Regulatory teams to maintain compliance and quality. In addition, the Director, Medical Reviewer will work with the strategy team on content creation, ensuring the data is accurate. The Director, Medical Reviewer will report to the Executive Medical Director, Therapeutic Area Head.
Essential Job Functions And Responsibilities
These may include but are not limited to:
Education and Experience:
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 typically 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.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range: $182,000 - $228,000
In 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.
Position Summary
The Director, Medical Promotional Review, plays a key role in the Medical Affairs team and is responsible for ensuring medical and scientific accuracy of promotional and non-promotional materials in compliance with US laws and regulations and company policies. The position involves reviewing all materials submitted to the Medical Review Committee (MRC) and Medical Legal Regulatory (MLR) promotional review committee to ensure regulatory and scientific standards are met, while fostering collaboration with Legal and Regulatory teams to maintain compliance and quality. In addition, the Director, Medical Reviewer will work with the strategy team on content creation, ensuring the data is accurate. The Director, Medical Reviewer will report to the Executive Medical Director, Therapeutic Area Head.
Essential Job Functions And Responsibilities
These may include but are not limited to:
- Serve as Medical Reviewer in MRC and MLR, ensuring all medical materials are medically accurate, balanced, scientifically accurate, non-misleading, relevant, and unbiased, in collaboration with Legal and Regulatory
- Uphold/improve MRC/MLR processes (e.g., references are correctly annotated, strength of evidence in reference is appropriate, rationale for comments/requested changes are sufficiently backed)
- Collaborate with medical affairs, regulatory, legal and commercial teams and utilize Veeva PromoMats to review promotional and non-promotional materials in a timely manner
- Work with strategy team to contribute to medical content creation, ensuring messaging is accurate.
- Collaborate with project owners to resolve comments and ensure compliance
- Attend all scheduled MRC and MLR meetings as required
- Provide clear guidance to project owners to ensure efficient and appropriate submission of materials through the review process including through weekly office hours as needed
- Work with the MRC and MLR administrator to optimize review planning and establish the agenda
- Provide feedback to improve Veeva PromoMats review workflows for different material types
- Stay updated on FDA regulations and industry trends relevant to medical and promotional materials development
- Proficiency in technologies and CRM systems for reviewing medical and promotional materials (e.g., Veeva PromoMats and/or MedComms)
- Excellent written and oral communication skills
- Demonstrated ability to analyze, concisely, timely, and accurately summarize, and present complex scientific and medical data to a diverse audience of both scientific and non-scientific professionals
- A commitment to producing high-level results and performing duties with integrity
- Ability to work independently and within a group setting
- Excellent organizational skills
- Must be competent in problem solving and sound decision-making
- Strong attention to detail and demonstrable ability to identify and correct errors
- Aptitude for conflict resolution and de-escalation
- Performs other duties and responsibilities as assigned
Education and Experience:
- Advanced/doctoral degree (PharmD, PhD) with 10 years of experience in a health/biological sciences required, plus a minimum of 8 years of experience in a supervisory/leadership role
- Minimum 8 years of experience as a medical reviewer in appropriate functions (e.g., Medical Affairs, Medical Information, or Scientific Communications)
- Prior experience reviewing medical materials including Field Medical slide decks, Medical Information response documents and frequently asked questions, medical booth congress materials, congress presentations, scientific communications platforms, clinical pathway submissions, and AMCP dossiers
- Prior experience reviewing promotional materials including print and digital advertisements (websites, core visual aids, leave behinds, rep triggered emails, etc.), reprint carriers, speaker programs, congress exhibits, sales trainings, and internal communications/field direction memos
- MD degree
- Experience in endocrinology disease area
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 typically 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.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range: $182,000 - $228,000
In 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.
Crinetics 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. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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 Director, Medical Promotional Review, plays a key role in the Medical Affairs team and is responsible for ensuring medical and scientific accuracy of promotional and non-promotional materials in compliance with US laws and regulations and company policies. The position involves reviewing all materials submitted to the Medical Review Committee (MRC) and Medical Legal Regulatory (MLR) promotional review committee to ensure regulatory and scientific standards are met, while fostering collaboration with Legal and Regulatory teams to maintain compliance and quality. In addition, the Director, Medical Reviewer will work with the strategy team on content creation, ensuring the data is accurate. The Director, Medical Reviewer will report to the Executive Medical Director, Therapeutic Area Head.
Essential Job Functions And Responsibilities
These may include but are not limited to:
Education and Experience:
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 typically 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.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range: $182,000 - $228,000
In 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.
Position Summary
The Director, Medical Promotional Review, plays a key role in the Medical Affairs team and is responsible for ensuring medical and scientific accuracy of promotional and non-promotional materials in compliance with US laws and regulations and company policies. The position involves reviewing all materials submitted to the Medical Review Committee (MRC) and Medical Legal Regulatory (MLR) promotional review committee to ensure regulatory and scientific standards are met, while fostering collaboration with Legal and Regulatory teams to maintain compliance and quality. In addition, the Director, Medical Reviewer will work with the strategy team on content creation, ensuring the data is accurate. The Director, Medical Reviewer will report to the Executive Medical Director, Therapeutic Area Head.
Essential Job Functions And Responsibilities
These may include but are not limited to:
- Serve as Medical Reviewer in MRC and MLR, ensuring all medical materials are medically accurate, balanced, scientifically accurate, non-misleading, relevant, and unbiased, in collaboration with Legal and Regulatory
- Uphold/improve MRC/MLR processes (e.g., references are correctly annotated, strength of evidence in reference is appropriate, rationale for comments/requested changes are sufficiently backed)
- Collaborate with medical affairs, regulatory, legal and commercial teams and utilize Veeva PromoMats to review promotional and non-promotional materials in a timely manner
- Work with strategy team to contribute to medical content creation, ensuring messaging is accurate.
- Collaborate with project owners to resolve comments and ensure compliance
- Attend all scheduled MRC and MLR meetings as required
- Provide clear guidance to project owners to ensure efficient and appropriate submission of materials through the review process including through weekly office hours as needed
- Work with the MRC and MLR administrator to optimize review planning and establish the agenda
- Provide feedback to improve Veeva PromoMats review workflows for different material types
- Stay updated on FDA regulations and industry trends relevant to medical and promotional materials development
- Proficiency in technologies and CRM systems for reviewing medical and promotional materials (e.g., Veeva PromoMats and/or MedComms)
- Excellent written and oral communication skills
- Demonstrated ability to analyze, concisely, timely, and accurately summarize, and present complex scientific and medical data to a diverse audience of both scientific and non-scientific professionals
- A commitment to producing high-level results and performing duties with integrity
- Ability to work independently and within a group setting
- Excellent organizational skills
- Must be competent in problem solving and sound decision-making
- Strong attention to detail and demonstrable ability to identify and correct errors
- Aptitude for conflict resolution and de-escalation
- Performs other duties and responsibilities as assigned
Education and Experience:
- Advanced/doctoral degree (PharmD, PhD) with 10 years of experience in a health/biological sciences required, plus a minimum of 8 years of experience in a supervisory/leadership role
- Minimum 8 years of experience as a medical reviewer in appropriate functions (e.g., Medical Affairs, Medical Information, or Scientific Communications)
- Prior experience reviewing medical materials including Field Medical slide decks, Medical Information response documents and frequently asked questions, medical booth congress materials, congress presentations, scientific communications platforms, clinical pathway submissions, and AMCP dossiers
- Prior experience reviewing promotional materials including print and digital advertisements (websites, core visual aids, leave behinds, rep triggered emails, etc.), reprint carriers, speaker programs, congress exhibits, sales trainings, and internal communications/field direction memos
- MD degree
- Experience in endocrinology disease area
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 typically 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.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.
Travel
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range: $182,000 - $228,000
In 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.