Explore opportunities in medical affairs, a field focused on bridging the gap between 4,073 Medical Affairs jobs in the United States
Medical Affairs Coordinator
46804 Fort Wayne, Indiana
BlueCross BlueShield of South Carolina
Posted 3 days ago
Job Viewed
Job Description
Summary
What to Expect Next
Ensures that the Local Coverage Determination (LCD) process adheres to contract instructions. Creates, implements, and maintains educational tools to help providers reduce the submission of claims for non-covered services and reduce the claims payment error rate. The error rate is a factor in awarding and renewing Medicare/other contracts.
Location
This role is remote, full time M-F 8am-5pm.
Government Clearance : This position requires the ability to obtain a security clearance, which requires applicants to be a U.S. Citizen.
SCA Benefit Requirements : BlueCross BlueShield of South Carolina and its subsidiary companies have contracts with the federal government subject to the Service Contract Act (SCA). Under the McNamara-O'Hara Service Contract Act (SCA), employees cannot opt out of health benefits. Employees will receive supplemental pay until they are enrolled in health benefits 28 days after the hire date.
What You Will Do- Provides clinical expertise, research, and judgment to develop Local Coverage Determinations (LCDS) under the direction of medical director. Maintains LCDS once developed.
- Educates providers and internal customers on LCDS. Communicates with other interdepartmental staff in appropriate coding and reimbursement guidelines to ensure coordination and compliance.
- Provides clinical input for internal requests. Serves as reviewer to determine inter-rater reliability.
- Required Education: Bachelor's in a job related field OR Associate's degree in Nursing with an active RN license.
- Required Work Experience : 5 years clinical experience in medical insurance, managed care, case management, or claims management, or a combination of these areas.
- Required Software and tools: Microsoft Office
- Required Skills and Abilities: Knowledge of managed care or medical claims payment policy issues. Working knowledge of word processing, spreadsheet software. Excellent verbal and written communication skills. Excellent customer service, organizational, presentation, analytical or critical thinking skills. Ability to persuade, negotiate, or influence others. Ability to handle confidential or sensitive information with discretion.
- Required License and Certificate: An active, unrestricted RN license from the United States and in the state of hire, OR an active compact multistate unrestricted RN license as defined by the Nurse Licensure Compact (NLC). For Division 33, Certified Genetic Counselor will be considered in lieu of RN License.
- Preferred Education: Bachelor's degree - Nursing.
- 7 years clinical experience in medical insurance, managed care, case management, or claims management, or a combination of these areas.
- Working knowledge of database software. Knowledge of government/healthcare programs and contracts laws, regulations. Knowledge of government/healthcare programs and regulations, coding, and approval practices. Knowledge of corporate administrative/medical policy for all lines of business. Knowledge of guidelines, benefits, and coverage for all lines of business.
- Working knowledge of Microsoft Access or other database software, DB2 and Easytrieve.
- Preferred Licenses and Certificates: HIAA, Loma, and/or ACLI certification. MPH, MHA certifications.
- 401(k) retirement savings plan with company match
- Subsidized health plans and free vision coverage
- Life insurance
- Paid annual leave - the longer you work here, the more you earn
- Nine paid holidays
- On-site cafeterias and fitness centers in major locations
- Wellness programs and healthy lifestyle premium discount
- Tuition assistance
- Service recognition
- Incentive Plan
- Merit Plan
- Continuing education funds for additional certifications and certification renewal
What to Expect Next
After submitting your application, our recruiting team members will review your resume to ensure you meet the qualifications. This may include a brief telephone interview or email communication with a recruiter to verify resume specifics and salary requirements.
Management will be conducting interviews with those candidates who qualify, with prioritization given to those candidates who demonstrate the preferred qualifications.
Equal Employment Opportunity Statement
BlueCross BlueShield of South Carolina and our subsidiary companies maintain a continuing policy of nondiscrimination in employment to promote employment opportunities for persons regardless of age, race, color, national origin, sex, religion, veteran status, disability, weight, sexual orientation, gender identity, genetic information or any other legally protected status. Additionally, as a federal contractor, the company maintains affirmative action programs to promote employment opportunities for individuals with disabilities and protected veterans. It is our policy to provide equal opportunities in all phases of the employment process and to comply with applicable federal, state and local laws and regulations.
We are committed to working with and providing reasonable accommodations to individuals with disabilities, pregnant individuals, individuals with pregnancy-related conditions, and individuals needing accommodations for sincerely held religious beliefs, provided that those accommodations do not impose an undue hardship on the Company.
If you need special assistance or an accommodation while seeking employment, please email mycareer.help@ or call , ext. 47480 with the nature of your request. We will make a determination regarding your request for reasonable accommodation on a case-by-case basis.
We participate in E-Verify and comply with the Pay Transparency Nondiscrimination Provision. We are an Equal Opportunity Employer. Here's more information.
Some states have required notifications. Here's more information.
#J-18808-Ljbffr
View Now
0
Director, Medical Affairs
60064 North Chicago, Illinois
Abbott
Posted 1 day ago
Job Viewed
Job Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
WORKING AT ABBOTT:
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
THE OPPORTUNITY:
Abbott Heart Failure (HF) delivers devices for patients living with heart failure in the areas of hemodynamic monitoring and mechanical circulatory support. Medical affairs of Abbott HF is seeking to hire a director who will join a team of medical specialist dedicated to all medical aspects of safe and effective device heart failure treatment. The director will report to the Chief Medical Officer.
The Director of Medical Affairs will provide daily business operations support related to product development and clinical research, product quality, compliance, commercial/marketing activities and customer interactions. The director assists the Chief Medical Officer in being medical representative of Abbott HF to external regulatory agencies and professional societies.
WHAT YOU'LL WORK ON:
The Medical Director
o Develops medical opinions, medical platform documents and Health Hazard Assessments.
o Provides medical input for promotional and commercial activities as requested.
o Serves as medical representative on Risk Evaluation teams.
o Assists investigation teams by providing medical input as needed.
o Responsible for updating medical affairs procedural documents and submitting change requests when needed.
o Provides medical support for MDR reporting when needed.
o Provides initial medical input for quality/regulatory customer communications, technical bulletins and quality directives.
o Engages with direct customer interactions with medical content as needed.
o Regionally responsible for Investigator Initiated Study and Research Grant programs
o Provides input or content to professional education activities
o Responsible for engaging in and documenting off-label discussions
o Assists the chief medical officer in KOL and professional society engagement
o Provides medical input to new product development
QUALIFICATIONS:
An MD is strongly preferred for this role, but a PhD in a relevant area would be considered. A minimum of 5 years of clinical experience including in CV medicine would be required. A minimum of 1-2 industry experience would be preferred. Significant experience with clinical research, including interpretation and presentation would be expected. Strong presentation skills required.
The role is remote. Up to 70 % travel should be expected.
APPLY NOW:
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is $168,000.00 - $336,000.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
WORKING AT ABBOTT:
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You'll also have access to:
- Career development with an international company where you can grow the career you dream of.
- Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree
- A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
- A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
THE OPPORTUNITY:
Abbott Heart Failure (HF) delivers devices for patients living with heart failure in the areas of hemodynamic monitoring and mechanical circulatory support. Medical affairs of Abbott HF is seeking to hire a director who will join a team of medical specialist dedicated to all medical aspects of safe and effective device heart failure treatment. The director will report to the Chief Medical Officer.
The Director of Medical Affairs will provide daily business operations support related to product development and clinical research, product quality, compliance, commercial/marketing activities and customer interactions. The director assists the Chief Medical Officer in being medical representative of Abbott HF to external regulatory agencies and professional societies.
WHAT YOU'LL WORK ON:
The Medical Director
o Develops medical opinions, medical platform documents and Health Hazard Assessments.
o Provides medical input for promotional and commercial activities as requested.
o Serves as medical representative on Risk Evaluation teams.
o Assists investigation teams by providing medical input as needed.
o Responsible for updating medical affairs procedural documents and submitting change requests when needed.
o Provides medical support for MDR reporting when needed.
o Provides initial medical input for quality/regulatory customer communications, technical bulletins and quality directives.
o Engages with direct customer interactions with medical content as needed.
o Regionally responsible for Investigator Initiated Study and Research Grant programs
o Provides input or content to professional education activities
o Responsible for engaging in and documenting off-label discussions
o Assists the chief medical officer in KOL and professional society engagement
o Provides medical input to new product development
QUALIFICATIONS:
An MD is strongly preferred for this role, but a PhD in a relevant area would be considered. A minimum of 5 years of clinical experience including in CV medicine would be required. A minimum of 1-2 industry experience would be preferred. Significant experience with clinical research, including interpretation and presentation would be expected. Strong presentation skills required.
The role is remote. Up to 70 % travel should be expected.
APPLY NOW:
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is $168,000.00 - $336,000.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
View Now
1
Director, Medical Affairs
60064 North Chicago, Illinois
Abbott
Posted 1 day ago
Job Viewed
Job Description
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of
+ Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
+ An excellent retirement savings plan with high employer contribution
+ A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
+ Abbott offers a dynamic and inclusive work environment, competitive compensation, and the opportunity to make a real difference in the lives of many
**The Opportunity**
The Director of Medical Affairs provides strategic medical leadership for Abbott's Heart Failure portfolio. This role oversees clinical research activities, supports product safety and performance, and drives scientific engagement with external stakeholders. The director collaborates cross-functionally to guide clinical strategy, evidence generation, and regulatory support, ensuring alignment with business goals and global standards.
**What You'll Work On**
+ Lead clinical research strategy, including investigator-initiated studies and grants.
+ Provide medical input for product development, regulatory submissions, and promotional activities.
+ Engage with KOLs, professional societies, and advisory boards; represent Abbott at medical congresses.
+ Support publication planning, abstracts, and presentations of clinical data.
+ Deliver internal and external education on heart failure therapies.
+ Collaborate with cross-functional teams to align medical strategy with commercial objectives.
+ Ensure compliance with medical affairs policies and ethical standards.
+ Contribute to risk management and product safety processes for new technologies.
**Qualifications**
+ Bachelor's degree required. PhD, MD, or equivalent advanced degree preferred.
+ Minimum 12 years of work experience required, with at least 5 years of industry experience.
+ Strong scientific and business acumen; excellent communication and presentation skills.
+ Proven ability to lead cross-functional initiatives and engage external stakeholders.
APPLY NOW ( more about our health and wellness benefits, which provide the security to help you and your family live full lives: ( your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is $147,300.00 - $294,700.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
**Working at Abbott**
At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You'll also have access to:
+ Career development with an international company where you can grow the career you dream of
+ Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
+ An excellent retirement savings plan with high employer contribution
+ A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune
+ Abbott offers a dynamic and inclusive work environment, competitive compensation, and the opportunity to make a real difference in the lives of many
**The Opportunity**
The Director of Medical Affairs provides strategic medical leadership for Abbott's Heart Failure portfolio. This role oversees clinical research activities, supports product safety and performance, and drives scientific engagement with external stakeholders. The director collaborates cross-functionally to guide clinical strategy, evidence generation, and regulatory support, ensuring alignment with business goals and global standards.
**What You'll Work On**
+ Lead clinical research strategy, including investigator-initiated studies and grants.
+ Provide medical input for product development, regulatory submissions, and promotional activities.
+ Engage with KOLs, professional societies, and advisory boards; represent Abbott at medical congresses.
+ Support publication planning, abstracts, and presentations of clinical data.
+ Deliver internal and external education on heart failure therapies.
+ Collaborate with cross-functional teams to align medical strategy with commercial objectives.
+ Ensure compliance with medical affairs policies and ethical standards.
+ Contribute to risk management and product safety processes for new technologies.
**Qualifications**
+ Bachelor's degree required. PhD, MD, or equivalent advanced degree preferred.
+ Minimum 12 years of work experience required, with at least 5 years of industry experience.
+ Strong scientific and business acumen; excellent communication and presentation skills.
+ Proven ability to lead cross-functional initiatives and engage external stakeholders.
APPLY NOW ( more about our health and wellness benefits, which provide the security to help you and your family live full lives: ( your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at , on Facebook at and on Twitter @AbbottNews and @AbbottGlobal
The base pay for this position is $147,300.00 - $294,700.00. In specific locations, the pay range may vary from the range posted.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call or email
View Now
2
Director, Medical Affairs
07308 Jersey City, New Jersey
Organon & Co.
Posted 16 days ago
Job Viewed
Job Description
**Job Description**
**The Position**
The Director of Medical Affairs is a key strategic role within the medical affairs organization and reports into the Global Director of Medical Affairs (GDMA). This role involves developing, updating, managing and executing on the medical affairs strategy globally working with the various geographic regions.
**Responsibilities**
+ Strategize and Plan: Create global & US medical affairs plans, ensuring relevant strategies and plans are aligned with Organon corporate and medical objectives.
+ Cross-Functional Collaboration: Collaborate with diverse teams, including Commercial, Development, Outcomes Research and Market Access, driving the development and implementation of global/regional plans.
+ Scientific Exchange and Alignment: Ensure alignment of scientific exchange with our global scientific communications platform, creating a unified, impactful narrative.
+ Insight Consolidation and Action: Synthesize actionable medical insights, driving evidence-based approaches and processes to inform medical strategy.
+ Stakeholder Engagement: Cultivate enriching relationships with a network of scientific leaders, guideline committees, government officials, medical societies, and other pivotal stakeholders, driving our understanding and approach to healthcare solutions.
+ Global/Regional Expertise: Provide support as a global/regional TA expert, empowering staff to engage effectively with national scientific leaders and enhancing our collective knowledge and impact.
+ Event Organization and Input: Coordinate regional expert input events, symposia, and educational meetings, fostering dialogue and insights on the implementation of new medicines.
+ Local Data Generation and Investigator-Initiated Study management: Aid countries with Local Data Generation study concepts and protocols and review Investigator-Initiated Study proposals, ensuring alignment with our standards and vision.
+ Ability to manage complexity and demonstrate innovative approaches to medical affairs activities.
+ Ensure prioritization of medical affairs activities and manage budgets/resources effectively to achieve organizational goals/priorities.
+ Travel may be required to attend medical congresses, meetings with external stakeholders and other global activities as agreed by management
+ Hybrid Work Environment.
**Required Education, Experience and Skills**
+ MD, PhD, PharmD, NP, PA or equivalent degree in health sciences.
+ Five to seven years combined global biopharmaceutical industry experience in Clinical Development and/or Medical Affairs as well as clinical experience is required.
+ Experience in medical affairs, including creating and implementing medical strategies.
+ Proven track record of leadership and execution in a global or regional medica affairs role.
+ Working knowledge of healthcare compliance principles and local/regional regulations and laws.
+ Experience in General Medicine or Dermatology is highly preferred.
Skills (professional and/or technical)
+ Strategic Thinking
+ Leadership
+ Scientific Acumen
+ Execution
+ Collaboration
+ Innovative Thinking
+ Interpersonal and Communication Skills
Secondary Language(s) Job Description
**Who We Are:**
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
**US and PR Residents Only**
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.
**Search Firm Representatives Please Read Carefully**
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Applicable to United States Positions Only:** Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
**Annualized Salary Range (US)**
$68,000.00 - 285,800.00
**Annualized Salary Range (Global)**
**Annualized Salary Range (Canada)**
**Please Note: Pay ranges are specific to local market and therefore vary from country to country.**
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
**Travel Requirements:** **Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.**
**Flexible Work Arrangements:**
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Number of Openings:**
1
**Requisition ID:** R
**The Position**
The Director of Medical Affairs is a key strategic role within the medical affairs organization and reports into the Global Director of Medical Affairs (GDMA). This role involves developing, updating, managing and executing on the medical affairs strategy globally working with the various geographic regions.
**Responsibilities**
+ Strategize and Plan: Create global & US medical affairs plans, ensuring relevant strategies and plans are aligned with Organon corporate and medical objectives.
+ Cross-Functional Collaboration: Collaborate with diverse teams, including Commercial, Development, Outcomes Research and Market Access, driving the development and implementation of global/regional plans.
+ Scientific Exchange and Alignment: Ensure alignment of scientific exchange with our global scientific communications platform, creating a unified, impactful narrative.
+ Insight Consolidation and Action: Synthesize actionable medical insights, driving evidence-based approaches and processes to inform medical strategy.
+ Stakeholder Engagement: Cultivate enriching relationships with a network of scientific leaders, guideline committees, government officials, medical societies, and other pivotal stakeholders, driving our understanding and approach to healthcare solutions.
+ Global/Regional Expertise: Provide support as a global/regional TA expert, empowering staff to engage effectively with national scientific leaders and enhancing our collective knowledge and impact.
+ Event Organization and Input: Coordinate regional expert input events, symposia, and educational meetings, fostering dialogue and insights on the implementation of new medicines.
+ Local Data Generation and Investigator-Initiated Study management: Aid countries with Local Data Generation study concepts and protocols and review Investigator-Initiated Study proposals, ensuring alignment with our standards and vision.
+ Ability to manage complexity and demonstrate innovative approaches to medical affairs activities.
+ Ensure prioritization of medical affairs activities and manage budgets/resources effectively to achieve organizational goals/priorities.
+ Travel may be required to attend medical congresses, meetings with external stakeholders and other global activities as agreed by management
+ Hybrid Work Environment.
**Required Education, Experience and Skills**
+ MD, PhD, PharmD, NP, PA or equivalent degree in health sciences.
+ Five to seven years combined global biopharmaceutical industry experience in Clinical Development and/or Medical Affairs as well as clinical experience is required.
+ Experience in medical affairs, including creating and implementing medical strategies.
+ Proven track record of leadership and execution in a global or regional medica affairs role.
+ Working knowledge of healthcare compliance principles and local/regional regulations and laws.
+ Experience in General Medicine or Dermatology is highly preferred.
Skills (professional and/or technical)
+ Strategic Thinking
+ Leadership
+ Scientific Acumen
+ Execution
+ Collaboration
+ Innovative Thinking
+ Interpersonal and Communication Skills
Secondary Language(s) Job Description
**Who We Are:**
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
**US and PR Residents Only**
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.
**Search Firm Representatives Please Read Carefully**
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Applicable to United States Positions Only:** Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
**Annualized Salary Range (US)**
$68,000.00 - 285,800.00
**Annualized Salary Range (Global)**
**Annualized Salary Range (Canada)**
**Please Note: Pay ranges are specific to local market and therefore vary from country to country.**
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
**Travel Requirements:** **Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.**
**Flexible Work Arrangements:**
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Number of Openings:**
1
**Requisition ID:** R
View Now
3
Director, Medical Affairs
19462 Whitemarsh Township, Pennsylvania
Organon & Co.
Posted 16 days ago
Job Viewed
Job Description
**Job Description**
**The Position**
The Director of Medical Affairs is a key strategic role within the medical affairs organization and reports into the Global Director of Medical Affairs (GDMA). This role involves developing, updating, managing and executing on the medical affairs strategy globally working with the various geographic regions.
**Responsibilities**
+ Strategize and Plan: Create global & US medical affairs plans, ensuring relevant strategies and plans are aligned with Organon corporate and medical objectives.
+ Cross-Functional Collaboration: Collaborate with diverse teams, including Commercial, Development, Outcomes Research and Market Access, driving the development and implementation of global/regional plans.
+ Scientific Exchange and Alignment: Ensure alignment of scientific exchange with our global scientific communications platform, creating a unified, impactful narrative.
+ Insight Consolidation and Action: Synthesize actionable medical insights, driving evidence-based approaches and processes to inform medical strategy.
+ Stakeholder Engagement: Cultivate enriching relationships with a network of scientific leaders, guideline committees, government officials, medical societies, and other pivotal stakeholders, driving our understanding and approach to healthcare solutions.
+ Global/Regional Expertise: Provide support as a global/regional TA expert, empowering staff to engage effectively with national scientific leaders and enhancing our collective knowledge and impact.
+ Event Organization and Input: Coordinate regional expert input events, symposia, and educational meetings, fostering dialogue and insights on the implementation of new medicines.
+ Local Data Generation and Investigator-Initiated Study management: Aid countries with Local Data Generation study concepts and protocols and review Investigator-Initiated Study proposals, ensuring alignment with our standards and vision.
+ Ability to manage complexity and demonstrate innovative approaches to medical affairs activities.
+ Ensure prioritization of medical affairs activities and manage budgets/resources effectively to achieve organizational goals/priorities.
+ Travel may be required to attend medical congresses, meetings with external stakeholders and other global activities as agreed by management
+ Hybrid Work Environment.
**Required Education, Experience and Skills**
+ MD, PhD, PharmD, NP, PA or equivalent degree in health sciences.
+ Five to seven years combined global biopharmaceutical industry experience in Clinical Development and/or Medical Affairs as well as clinical experience is required.
+ Experience in medical affairs, including creating and implementing medical strategies.
+ Proven track record of leadership and execution in a global or regional medica affairs role.
+ Working knowledge of healthcare compliance principles and local/regional regulations and laws.
+ Experience in General Medicine or Dermatology is highly preferred.
Skills (professional and/or technical)
+ Strategic Thinking
+ Leadership
+ Scientific Acumen
+ Execution
+ Collaboration
+ Innovative Thinking
+ Interpersonal and Communication Skills
Secondary Language(s) Job Description
**Who We Are:**
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
**US and PR Residents Only**
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.
**Search Firm Representatives Please Read Carefully**
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Applicable to United States Positions Only:** Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
**Annualized Salary Range (US)**
$68,000.00 - 285,800.00
**Annualized Salary Range (Global)**
**Annualized Salary Range (Canada)**
**Please Note: Pay ranges are specific to local market and therefore vary from country to country.**
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
**Travel Requirements:** **Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.**
**Flexible Work Arrangements:**
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Number of Openings:**
1
**Requisition ID:** R
**The Position**
The Director of Medical Affairs is a key strategic role within the medical affairs organization and reports into the Global Director of Medical Affairs (GDMA). This role involves developing, updating, managing and executing on the medical affairs strategy globally working with the various geographic regions.
**Responsibilities**
+ Strategize and Plan: Create global & US medical affairs plans, ensuring relevant strategies and plans are aligned with Organon corporate and medical objectives.
+ Cross-Functional Collaboration: Collaborate with diverse teams, including Commercial, Development, Outcomes Research and Market Access, driving the development and implementation of global/regional plans.
+ Scientific Exchange and Alignment: Ensure alignment of scientific exchange with our global scientific communications platform, creating a unified, impactful narrative.
+ Insight Consolidation and Action: Synthesize actionable medical insights, driving evidence-based approaches and processes to inform medical strategy.
+ Stakeholder Engagement: Cultivate enriching relationships with a network of scientific leaders, guideline committees, government officials, medical societies, and other pivotal stakeholders, driving our understanding and approach to healthcare solutions.
+ Global/Regional Expertise: Provide support as a global/regional TA expert, empowering staff to engage effectively with national scientific leaders and enhancing our collective knowledge and impact.
+ Event Organization and Input: Coordinate regional expert input events, symposia, and educational meetings, fostering dialogue and insights on the implementation of new medicines.
+ Local Data Generation and Investigator-Initiated Study management: Aid countries with Local Data Generation study concepts and protocols and review Investigator-Initiated Study proposals, ensuring alignment with our standards and vision.
+ Ability to manage complexity and demonstrate innovative approaches to medical affairs activities.
+ Ensure prioritization of medical affairs activities and manage budgets/resources effectively to achieve organizational goals/priorities.
+ Travel may be required to attend medical congresses, meetings with external stakeholders and other global activities as agreed by management
+ Hybrid Work Environment.
**Required Education, Experience and Skills**
+ MD, PhD, PharmD, NP, PA or equivalent degree in health sciences.
+ Five to seven years combined global biopharmaceutical industry experience in Clinical Development and/or Medical Affairs as well as clinical experience is required.
+ Experience in medical affairs, including creating and implementing medical strategies.
+ Proven track record of leadership and execution in a global or regional medica affairs role.
+ Working knowledge of healthcare compliance principles and local/regional regulations and laws.
+ Experience in General Medicine or Dermatology is highly preferred.
Skills (professional and/or technical)
+ Strategic Thinking
+ Leadership
+ Scientific Acumen
+ Execution
+ Collaboration
+ Innovative Thinking
+ Interpersonal and Communication Skills
Secondary Language(s) Job Description
**Who We Are:**
Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women's Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.
**US and PR Residents Only**
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, veteran status, or any other characteristic protected by state or federal law.
**Search Firm Representatives Please Read Carefully**
Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
**Applicable to United States Positions Only:** Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.
**Annualized Salary Range (US)**
$68,000.00 - 285,800.00
**Annualized Salary Range (Global)**
**Annualized Salary Range (Canada)**
**Please Note: Pay ranges are specific to local market and therefore vary from country to country.**
**Employee Status:**
Regular
**Relocation:**
No relocation
**VISA Sponsorship:**
**Travel Requirements:** **Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.**
**Flexible Work Arrangements:**
**Shift:**
**Valid Driving License:**
**Hazardous Material(s):**
**Number of Openings:**
1
**Requisition ID:** R
View Now
4
Associate, Regulatory Affairs - Medical devices
08869 Raritan, New Jersey
ClinChoice
Posted 1 day ago
Job Viewed
Job Description
Associate, Regulatory Affairs - Medical Devices
ClinChoice is a global full-service CRO dedicated to professional development and providing an excellent work-life balance, with a quality-focused, collaborative "one-team" culture. We are looking for a dynamic person to join our in-house team as a Regulatory Affairs Associate (HYBRID) on a permanent basis at Raritan, NJ.
Join our team: you can be part of making a difference in peoples' lives and experience a fulfilling and rewarding career!
Responsibilities
- Assist in the planning and tracking of long-term regulatory projects and submission timelines.
- Regularly communicate with clients to understand their needs and proactively address them.
- Coordinate cross-functional team meetings and facilitate communication to ensure project milestones are met.
- Maintain accurate project documentation including project plans, timelines, and status reports.
- Drive regulatory updates and assist in assessing their impact on ongoing projects.
- Contribute to the development and improvement of regulatory project management processes and tools.
- Track project deliverables and resource utilization using appropriate tracking tools to provide direction and support to the project team.
- Identify and escalate issues and potential issues in a timely manner to ensure efficient resolution.
- Provide independent advice on the management of projects based on lessons learned and gained experience.
- Contribute to the preparation of RFI/RFPs/defense bid and act as a guide to the sales and business development team.
Skills
- Bachelor's degree in Life Sciences, Regulatory Affairs, Project Management, or a related field. Combination of training in Life Science and Business preferred. 2+ years of experience in regulatory affairs, project coordination, or a related role.
- Technical system skills including tools specific for project management activities (MS Office, Power BI, etc.)
- Strong organizational and time management skills.
- Excellent written and verbal communication skills.
- Ability to present complex information to various levels and adjust your message appropriately.
- Ability to work collaboratively in a team environment and manage multiple priorities.
- Ability to present confidence in front of clients and present ideas
- Proficiency with Microsoft Office (Word, Excel, PowerPoint); experience with project management tools is a plus (e.g., MS Project, Smartsheet, Trello, or similar).
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
View Now
5
Medical Devices, Regulatory Affairs Specialist
94010
Meta
Posted 1 day ago
Job Viewed
Job Description
**Summary:**
We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a Medical Device (SaMD) applications for the US and worldwide approvals.You will work on cutting-edge wearable technologies, including augmented reality glasses, wrist wearables, and other innovative devices.
**Required Skills:**
Medical Devices, Regulatory Affairs Specialist Responsibilities:
1. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager
2. Support regulatory compliance activities, including site registration, audits, post-market vigilance reporting, product recalls, etc., as needed
3. Prepare FDA, European and Canada submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager, as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed
4. Prepare regulatory strategies/plans and compliance requirements. Provide on-going support to project teams for regulatory issues and questions
**Minimum Qualifications:**
Minimum Qualifications:
5. Bachelor's degree in a scientific discipline or equivalent work experience
6. 3+ years of industry experience in medical device regulatory affairs or related industry
7. Experience working with minimal supervision and under general direction only
8. Experience multitasking, supporting multiple projects, functioning on a global basis, prioritizing, conducting team meetings, and meeting project deadlines
**Preferred Qualifications:**
Preferred Qualifications:
9. Master's Degree in Regulatory Affairs
10. Extensive knowledge of applicable regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO 13485, ISO 14971, IEC 62304, etc.)
11. Technical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverables
12. Experience with development and regulations for medical devices intended for direct to consumer health wearables
13. RAPS RAC Certification
**Public Compensation:**
$90,000/year to $137,000/year + bonus + equity + benefits
**Industry:** Internet
**Equal Opportunity:**
Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.
Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at
We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a Medical Device (SaMD) applications for the US and worldwide approvals.You will work on cutting-edge wearable technologies, including augmented reality glasses, wrist wearables, and other innovative devices.
**Required Skills:**
Medical Devices, Regulatory Affairs Specialist Responsibilities:
1. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager
2. Support regulatory compliance activities, including site registration, audits, post-market vigilance reporting, product recalls, etc., as needed
3. Prepare FDA, European and Canada submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager, as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed
4. Prepare regulatory strategies/plans and compliance requirements. Provide on-going support to project teams for regulatory issues and questions
**Minimum Qualifications:**
Minimum Qualifications:
5. Bachelor's degree in a scientific discipline or equivalent work experience
6. 3+ years of industry experience in medical device regulatory affairs or related industry
7. Experience working with minimal supervision and under general direction only
8. Experience multitasking, supporting multiple projects, functioning on a global basis, prioritizing, conducting team meetings, and meeting project deadlines
**Preferred Qualifications:**
Preferred Qualifications:
9. Master's Degree in Regulatory Affairs
10. Extensive knowledge of applicable regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO 13485, ISO 14971, IEC 62304, etc.)
11. Technical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverables
12. Experience with development and regulations for medical devices intended for direct to consumer health wearables
13. RAPS RAC Certification
**Public Compensation:**
$90,000/year to $137,000/year + bonus + equity + benefits
**Industry:** Internet
**Equal Opportunity:**
Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.
Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at
View Now
Be The First To Know
About the latest Medical affairs Jobs in United States !
6
Medical Devices, Regulatory Affairs Specialist
10176 New York, New York
Meta
Posted 2 days ago
Job Viewed
Job Description
**Summary:**
We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a Medical Device (SaMD) applications for the US and worldwide approvals.You will work on cutting-edge wearable technologies, including augmented reality glasses, wrist wearables, and other innovative devices.
**Required Skills:**
Medical Devices, Regulatory Affairs Specialist Responsibilities:
1. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager
2. Support regulatory compliance activities, including site registration, audits, post-market vigilance reporting, product recalls, etc., as needed
3. Prepare FDA, European and Canada submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager, as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed
4. Prepare regulatory strategies/plans and compliance requirements. Provide on-going support to project teams for regulatory issues and questions
**Minimum Qualifications:**
Minimum Qualifications:
5. Bachelor's degree in a scientific discipline or equivalent work experience
6. 3+ years of industry experience in medical device regulatory affairs or related industry
7. Experience working with minimal supervision and under general direction only
8. Experience multitasking, supporting multiple projects, functioning on a global basis, prioritizing, conducting team meetings, and meeting project deadlines
**Preferred Qualifications:**
Preferred Qualifications:
9. Master's Degree in Regulatory Affairs
10. Extensive knowledge of applicable regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO 13485, ISO 14971, IEC 62304, etc.)
11. Technical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverables
12. Experience with development and regulations for medical devices intended for direct to consumer health wearables
13. RAPS RAC Certification
**Public Compensation:**
$90,000/year to $137,000/year + bonus + equity + benefits
**Industry:** Internet
**Equal Opportunity:**
Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.
Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at
We're seeking a regulatory affairs specialist to join our medical devices compliance team. You will get to work on wearables and Software as a Medical Device (SaMD) applications for the US and worldwide approvals.You will work on cutting-edge wearable technologies, including augmented reality glasses, wrist wearables, and other innovative devices.
**Required Skills:**
Medical Devices, Regulatory Affairs Specialist Responsibilities:
1. Interact directly with FDA and/or indirectly with international regulatory agencies on most projects/products at reviewer level. All significant issues will be reviewed with the manager
2. Support regulatory compliance activities, including site registration, audits, post-market vigilance reporting, product recalls, etc., as needed
3. Prepare FDA, European and Canada submissions for product changes as required to ensure timely approval for market release. Review significant regulatory issues with manager, as necessary, and resolve submission issues with engineering partners, geography regulatory partners, and regulatory agencies as needed
4. Prepare regulatory strategies/plans and compliance requirements. Provide on-going support to project teams for regulatory issues and questions
**Minimum Qualifications:**
Minimum Qualifications:
5. Bachelor's degree in a scientific discipline or equivalent work experience
6. 3+ years of industry experience in medical device regulatory affairs or related industry
7. Experience working with minimal supervision and under general direction only
8. Experience multitasking, supporting multiple projects, functioning on a global basis, prioritizing, conducting team meetings, and meeting project deadlines
**Preferred Qualifications:**
Preferred Qualifications:
9. Master's Degree in Regulatory Affairs
10. Extensive knowledge of applicable regulations, standards and guidance for medical devices (MDR, MEDDEV, MDCG, IMDRF, FDA QSR, SaMD, cybersecurity, ISO 13485, ISO 14971, IEC 62304, etc.)
11. Technical expertise in software development practices and how to communicate with SW engineers to get required regulatory deliverables
12. Experience with development and regulations for medical devices intended for direct to consumer health wearables
13. RAPS RAC Certification
**Public Compensation:**
$90,000/year to $137,000/year + bonus + equity + benefits
**Industry:** Internet
**Equal Opportunity:**
Meta is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender, gender identity, gender expression, transgender status, sexual stereotypes, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. Meta participates in the E-Verify program in certain locations, as required by law. Please note that Meta may leverage artificial intelligence and machine learning technologies in connection with applications for employment.
Meta is committed to providing reasonable accommodations for candidates with disabilities in our recruiting process. If you need any assistance or accommodations due to a disability, please let us know at
View Now
7
Head of Medical Affairs
EPM Scientific
Posted today
Job Viewed
Job Description
Position Overview
The Head of Medical Affairs will lead strategic initiatives across key therapeutic areas, driving innovation and excellence in medical leadership. This individual will bring deep expertise in product data and disease state knowledge, engage with external experts, and stay attuned to evolving market dynamics. The role requires a strong understanding of all medical affairs functions to develop and execute a comprehensive Medical Affairs strategy aligned with organizational goals.
This leader will translate complex scientific information into actionable insights with clinical relevance and collaborate closely with internal teams (e.g., business development, clinical, regulatory) and external stakeholders (e.g., healthcare professionals, thought leaders). A commitment to scientific integrity, compliance, and cross-functional collaboration is essential. The position is based at the company's headquarters in the Northeastern U.S.
Key Responsibilities
- Develop and implement a strategic Medical Affairs Plan in alignment with corporate objectives
- Serve as a subject matter expert on marketed and pipeline products, providing disease and product training across internal and partner teams
- Establish compliant processes and SOPs to ensure ethical and regulatory standards are upheld
- Lead and mentor the Medical Science Liaison (MSL) team, fostering strong relationships with the medical community
- Build and maintain trusted relationships with key opinion leaders and internal stakeholders
- Deliver scientific presentations to diverse audiences including healthcare professionals and internal teams
- Organize and lead advisory board meetings and represent the company at industry events
- Identify gaps in clinical knowledge and collaborate with external experts to design relevant clinical programs
- Oversee investigator-initiated studies and research grants
- Develop and execute publication strategies for medical and scientific communications
- Support business development efforts by providing medical reviews of potential product acquisitions
- Collaborate with commercial teams to enhance medical understanding and ensure compliant interactions between medical and commercial functions
Qualifications & Skills
- Ability to synthesize and communicate complex scientific data to both medical and non-medical audiences
- Strong interpersonal and relationship-building skills with internal and external stakeholders
- Expertise in hematologic and dermatologic conditions preferred, with the ability to quickly learn new therapeutic areas
- Strategic thinker with strong analytical capabilities
- Comfortable working in a lean, fast-paced environment with broad responsibilities and direct access to senior leadership
- Willingness to travel up to 30% for conferences, field visits, and stakeholder engagement
- Proficiency in Microsoft Office tools (PowerPoint, Word, Excel)
- Demonstrated ability to lead initiatives and support decision-making in dynamic settings
Education & Experience
- Advanced degree required (MD, PharmD, or PhD)
- Experience in Hematology/Oncology strongly preferred; Dermatology experience a plus
- Minimum of 5 years in Medical Affairs within the pharmaceutical or biotech industry
- Direct Report experience highly prefereed
- Prior clinical experience or direct patient care background preferred
Compensation
Base Salary: $200,000-$260,000
Includes Annual Bonus and Long-Term Incentive Plan
View Now
8