Job Description
Qualifications
J.D. from an accredited US law school required and must be in good standing as an active member of a US state bar
10+ years of experience in data privacy and security, FDA regulatory, healthcare compliance or contracts drafting and negotiation experience in a law firms and/or in-house biotech/pharmaceutical company
Demonstrated solid judgment, particularly in determining the significance of legal matters and when to elevate them to the Associate General Counsel or General Counsel and in effectively measuring and minimizing risks
Strong organizational skills to prioritize and manage multiple time-sensitive projects simultaneously
Ability to maintain a high level of integrity of confidential and sensitive information and credibility within the organization
Demonstrated ability to identify opportunities for continual improvement with a proven track record as a proficient solver of complex problems
Demonstrated ability to lead, mentor, motivate and develop small groups in a dynamic, fast-paced work environment, as required
Strong computer, organizational, and analytical skills required
Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures
Manual dexterity required to use computers, tablets, and cell phone
Benefits
Medical, Vision and Dental benefits the first of the month following start date
Generous paid time off and Company designated Holidays
Company paid Disability benefits and Life Insurance coverage
401(k) Retirement Savings Plan
Paid Parental leave
Employee Stock Purchase Plan (ESPP)
Company sponsored wellness programs
Professional development initiatives and continuous learning opportunities
A certified Great Place to Work® for six consecutive years based on our positive, values-based company culture
Responsibilities
In this role you will provide direct support to the Associate General Counsel, lead certain substantive legal areas for the Company, and also provide support as needed to other company personnel on a wide variety of legal matters
This role will have expertise in the pharmaceutical/biotechnology sector, including FDA and other regulatory areas, privacy law and regulations, healthcare compliance, strategic collaborations, complex vendor agreements, and general corporate law
This position will work independently and effectively with senior business leaders and will liaise as needed with other support and business functions to resolve issues
Collaborate with the company Compliance function and advise all relevant company functions with respect to data privacy and security laws and regulations, such as US HIPAA and state laws and regulations and the EU General Data Privacy Regulations
Advise Clinical Operations personnel with respect to clinical trial related matters and assist with the drafting, negotiation and finalization of clinical trial related documents and agreements such as ICFs, CRO agreements and CTAs
Advise regulatory and scientific personnel with respect to FDA and similar regulatory matters, including issues related to pre-commercial and commercial matters
Advise the Compliance function and business personnel with respect to company policies, including corporate policies (e.g., Insider Trading) as well as healthcare related policies (e.g., HCP Engagement)
Advise business personnel with respect to customer and vendor relations and related contract matters and assist with the drafting, negotiation and finalization of agreements, with particular emphasis on CMC and related technical operations agreements, such as manufacturing, packaging, pharmaceutical development, purchase, supply, license and master service agreements
Advise on corporate law and corporate housekeeping matters
Provide due diligence and general transaction support for business development transactions
Provide general advice to management on a day-to-day basis
Provide advice and guidance for the accomplishment of the overall business objectives of the business in compliance with applicable laws and regulations and avoidance of unacceptable risks
Develop a thorough understanding of and familiarity with the business and its people, product(s), technology, markets, facilities, customers, and competitors in order to identify trends and formulate business and legal structures and strategies accordingly
Make presentations to Company personnel on legal issues as needed
Perform other duties as assigned
Domestic travel is estimated to be 10% of the time for this position
While performing the duties of this job, the noise level in the work environment is usually quiet
Specific vision abilities required by this job include: Close vision
Continuous sitting for prolonged periods
Job description
Harmony Biosciences is recruiting for a Senior Director, Legal Affairs in our Plymouth Meeting, PA location. In this role you will provide direct support to the Associate General Counsel, lead certain substantive legal areas for the Company, and also provide support as needed to other company personnel on a wide variety of legal matters. This role will have expertise in the pharmaceutical/biotechnology sector, including FDA and other regulatory areas, privacy law and regulations, healthcare compliance, strategic collaborations, complex vendor agreements, and general corporate law. This position will work independently and effectively with senior business leaders and will liaise as needed with other support and business functions to resolve issues.
Responsibilities include but are not limited to:
• Collaborate with the company Compliance function and advise all relevant company functions with respect to data privacy and security laws and regulations, such as US HIPAA and state laws and regulations and the EU General Data Privacy Regulations.
• Advise Clinical Operations personnel with respect to clinical trial related matters and assist with the drafting, negotiation and finalization of clinical trial related documents and agreements such as ICFs, CRO agreements and CTAs.
• Advise regulatory and scientific personnel with respect to FDA and similar regulatory matters, including issues related to pre-commercial and commercial matters.
• Advise the Compliance function and business personnel with respect to company policies, including corporate policies (e.g., Insider Trading) as well as healthcare related policies (e.g., HCP Engagement)
• Advise business personnel with respect to customer and vendor relations and related contract matters and assist with the drafting, negotiation and finalization of agreements, with particular emphasis on CMC and related technical operations agreements, such as manufacturing, packaging, pharmaceutical development, purchase, supply, license and master service agreements.
• Advise on corporate law and corporate housekeeping matters.
• Provide due diligence and general transaction support for business development transactions.
• Provide general advice to management on a day-to-day basis.
• Provide advice and guidance for the accomplishment of the overall business objectives of the business in compliance with applicable laws and regulations and avoidance of unacceptable risks.
• Develop a thorough understanding of and familiarity with the business and its people, product(s), technology, markets, facilities, customers, and competitors in order to identify trends and formulate business and legal structures and strategies accordingly.
• Make presentations to Company personnel on legal issues as needed.
• Perform other duties as assigned.
Qualifications:
• J.D. from an accredited US law school required and must be in good standing as an active member of a US state bar
• 10+ years of experience in data privacy and security, FDA regulatory, healthcare compliance or contracts drafting and negotiation experience in a law firms and/or in-house biotech/pharmaceutical company
• Demonstrated solid judgment, particularly in determining the significance of legal matters and when to elevate them to the Associate General Counsel or General Counsel and in effectively measuring and minimizing risks
• Strong organizational skills to prioritize and manage multiple time-sensitive projects simultaneously
• Ability to maintain a high level of integrity of confidential and sensitive information and credibility within the organization
• Demonstrated ability to identify opportunities for continual improvement with a proven track record as a proficient solver of complex problems
• Demonstrated ability to lead, mentor, motivate and develop small groups in a dynamic, fast-paced work environment, as required
• Strong computer, organizational, and analytical skills required
• Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures
Physical demands and work environment:
• Domestic travel is estimated to be 10% of the time for this position.
• While performing the duties of this job, the noise level in the work environment is usually quiet.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• Continuous sitting for prolonged periods.
What can Harmony offer you?
• Medical, Vision and Dental benefits the first of the month following start date
• Generous paid time off and Company designated Holidays
• Company paid Disability benefits and Life Insurance coverage
• 401(k) Retirement Savings Plan
• Paid Parental leave
• Employee Stock Purchase Plan (ESPP)
• Company sponsored wellness programs
• Professional development initiatives and continuous learning opportunities
• A certified Great Place to Work® for six consecutive years based on our positive, values-based company culture
Want to see our latest job opportunities? Follow us on LinkedIn !
Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com
Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, ****** orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
J.D. from an accredited US law school required and must be in good standing as an active member of a US state bar
10+ years of experience in data privacy and security, FDA regulatory, healthcare compliance or contracts drafting and negotiation experience in a law firms and/or in-house biotech/pharmaceutical company
Demonstrated solid judgment, particularly in determining the significance of legal matters and when to elevate them to the Associate General Counsel or General Counsel and in effectively measuring and minimizing risks
Strong organizational skills to prioritize and manage multiple time-sensitive projects simultaneously
Ability to maintain a high level of integrity of confidential and sensitive information and credibility within the organization
Demonstrated ability to identify opportunities for continual improvement with a proven track record as a proficient solver of complex problems
Demonstrated ability to lead, mentor, motivate and develop small groups in a dynamic, fast-paced work environment, as required
Strong computer, organizational, and analytical skills required
Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures
Manual dexterity required to use computers, tablets, and cell phone
Benefits
Medical, Vision and Dental benefits the first of the month following start date
Generous paid time off and Company designated Holidays
Company paid Disability benefits and Life Insurance coverage
401(k) Retirement Savings Plan
Paid Parental leave
Employee Stock Purchase Plan (ESPP)
Company sponsored wellness programs
Professional development initiatives and continuous learning opportunities
A certified Great Place to Work® for six consecutive years based on our positive, values-based company culture
Responsibilities
In this role you will provide direct support to the Associate General Counsel, lead certain substantive legal areas for the Company, and also provide support as needed to other company personnel on a wide variety of legal matters
This role will have expertise in the pharmaceutical/biotechnology sector, including FDA and other regulatory areas, privacy law and regulations, healthcare compliance, strategic collaborations, complex vendor agreements, and general corporate law
This position will work independently and effectively with senior business leaders and will liaise as needed with other support and business functions to resolve issues
Collaborate with the company Compliance function and advise all relevant company functions with respect to data privacy and security laws and regulations, such as US HIPAA and state laws and regulations and the EU General Data Privacy Regulations
Advise Clinical Operations personnel with respect to clinical trial related matters and assist with the drafting, negotiation and finalization of clinical trial related documents and agreements such as ICFs, CRO agreements and CTAs
Advise regulatory and scientific personnel with respect to FDA and similar regulatory matters, including issues related to pre-commercial and commercial matters
Advise the Compliance function and business personnel with respect to company policies, including corporate policies (e.g., Insider Trading) as well as healthcare related policies (e.g., HCP Engagement)
Advise business personnel with respect to customer and vendor relations and related contract matters and assist with the drafting, negotiation and finalization of agreements, with particular emphasis on CMC and related technical operations agreements, such as manufacturing, packaging, pharmaceutical development, purchase, supply, license and master service agreements
Advise on corporate law and corporate housekeeping matters
Provide due diligence and general transaction support for business development transactions
Provide general advice to management on a day-to-day basis
Provide advice and guidance for the accomplishment of the overall business objectives of the business in compliance with applicable laws and regulations and avoidance of unacceptable risks
Develop a thorough understanding of and familiarity with the business and its people, product(s), technology, markets, facilities, customers, and competitors in order to identify trends and formulate business and legal structures and strategies accordingly
Make presentations to Company personnel on legal issues as needed
Perform other duties as assigned
Domestic travel is estimated to be 10% of the time for this position
While performing the duties of this job, the noise level in the work environment is usually quiet
Specific vision abilities required by this job include: Close vision
Continuous sitting for prolonged periods
Job description
Harmony Biosciences is recruiting for a Senior Director, Legal Affairs in our Plymouth Meeting, PA location. In this role you will provide direct support to the Associate General Counsel, lead certain substantive legal areas for the Company, and also provide support as needed to other company personnel on a wide variety of legal matters. This role will have expertise in the pharmaceutical/biotechnology sector, including FDA and other regulatory areas, privacy law and regulations, healthcare compliance, strategic collaborations, complex vendor agreements, and general corporate law. This position will work independently and effectively with senior business leaders and will liaise as needed with other support and business functions to resolve issues.
Responsibilities include but are not limited to:
• Collaborate with the company Compliance function and advise all relevant company functions with respect to data privacy and security laws and regulations, such as US HIPAA and state laws and regulations and the EU General Data Privacy Regulations.
• Advise Clinical Operations personnel with respect to clinical trial related matters and assist with the drafting, negotiation and finalization of clinical trial related documents and agreements such as ICFs, CRO agreements and CTAs.
• Advise regulatory and scientific personnel with respect to FDA and similar regulatory matters, including issues related to pre-commercial and commercial matters.
• Advise the Compliance function and business personnel with respect to company policies, including corporate policies (e.g., Insider Trading) as well as healthcare related policies (e.g., HCP Engagement)
• Advise business personnel with respect to customer and vendor relations and related contract matters and assist with the drafting, negotiation and finalization of agreements, with particular emphasis on CMC and related technical operations agreements, such as manufacturing, packaging, pharmaceutical development, purchase, supply, license and master service agreements.
• Advise on corporate law and corporate housekeeping matters.
• Provide due diligence and general transaction support for business development transactions.
• Provide general advice to management on a day-to-day basis.
• Provide advice and guidance for the accomplishment of the overall business objectives of the business in compliance with applicable laws and regulations and avoidance of unacceptable risks.
• Develop a thorough understanding of and familiarity with the business and its people, product(s), technology, markets, facilities, customers, and competitors in order to identify trends and formulate business and legal structures and strategies accordingly.
• Make presentations to Company personnel on legal issues as needed.
• Perform other duties as assigned.
Qualifications:
• J.D. from an accredited US law school required and must be in good standing as an active member of a US state bar
• 10+ years of experience in data privacy and security, FDA regulatory, healthcare compliance or contracts drafting and negotiation experience in a law firms and/or in-house biotech/pharmaceutical company
• Demonstrated solid judgment, particularly in determining the significance of legal matters and when to elevate them to the Associate General Counsel or General Counsel and in effectively measuring and minimizing risks
• Strong organizational skills to prioritize and manage multiple time-sensitive projects simultaneously
• Ability to maintain a high level of integrity of confidential and sensitive information and credibility within the organization
• Demonstrated ability to identify opportunities for continual improvement with a proven track record as a proficient solver of complex problems
• Demonstrated ability to lead, mentor, motivate and develop small groups in a dynamic, fast-paced work environment, as required
• Strong computer, organizational, and analytical skills required
• Strong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and cultures
Physical demands and work environment:
• Domestic travel is estimated to be 10% of the time for this position.
• While performing the duties of this job, the noise level in the work environment is usually quiet.
• Specific vision abilities required by this job include: Close vision.
• Manual dexterity required to use computers, tablets, and cell phone.
• Continuous sitting for prolonged periods.
What can Harmony offer you?
• Medical, Vision and Dental benefits the first of the month following start date
• Generous paid time off and Company designated Holidays
• Company paid Disability benefits and Life Insurance coverage
• 401(k) Retirement Savings Plan
• Paid Parental leave
• Employee Stock Purchase Plan (ESPP)
• Company sponsored wellness programs
• Professional development initiatives and continuous learning opportunities
• A certified Great Place to Work® for six consecutive years based on our positive, values-based company culture
Want to see our latest job opportunities? Follow us on LinkedIn !
Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The company was established in October 2017 with a vision to provide novel treatment options for people living with rare, neurological disorders who have unmet medical needs. For more information on Harmony Biosciences, visit www.harmonybiosciences.com
Harmony Biosciences, LLC is an Equal Opportunity, e-Verify Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, ****** orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.
Recruitment agencies please note: Harmony Biosciences will only accept applications from agencies/business partners that have been invited to work on a specific role. Candidate Resumes/CV's submitted without permission or directly to Hiring Managers will be considered unsolicited and no fee will be payable. Thank you for your cooperation.
💡 Quick Summary
Seeking a career-building opportunity? The Senior Director| Legal Affairs position is now open for candidates interested in the Legal Jobs sector. This role in Plymouth Meeting offers a professional environment and growth potential.
Requirement Snapshot: Candidates should possess basic communication skills, a proactive attitude, and the ability to work in a team. Experience in Legal Jobs is a plus.
