Harmony Biosciences Llc
Senior Director, Legal Affairs
Harmony Biosciences Llc, Plymouth Meeting, Pennsylvania, United States,
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 bar10+ 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 companyDemonstrated 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 risksStrong organizational skills to prioritize and manage multiple time-sensitive projects simultaneouslyAbility to maintain a high level of integrity of confidential and sensitive information and credibility within the organizationDemonstrated ability to identify opportunities for continual improvement with a proven track record as a proficient solver of complex problemsDemonstrated ability to lead, mentor, motivate and develop small groups in a dynamic, fast-paced work environment, as requiredStrong computer, organizational, and analytical skills requiredStrong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and culturesPhysical 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 dateGenerous paid time off and Company designated HolidaysCompany paid Disability benefits and Life Insurance coverage401(k) Retirement Savings PlanPaid Parental leaveEmployee Stock Purchase Plan (ESPP)Company sponsored wellness programsProfessional development initiatives and continuous learning opportunitiesA certified Great Place to Work for six consecutive years based on our positive, values-based company culture
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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 bar10+ 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 companyDemonstrated 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 risksStrong organizational skills to prioritize and manage multiple time-sensitive projects simultaneouslyAbility to maintain a high level of integrity of confidential and sensitive information and credibility within the organizationDemonstrated ability to identify opportunities for continual improvement with a proven track record as a proficient solver of complex problemsDemonstrated ability to lead, mentor, motivate and develop small groups in a dynamic, fast-paced work environment, as requiredStrong computer, organizational, and analytical skills requiredStrong verbal and written communication skills with the ability to communicate to colleagues, business partners, stakeholders and upper management across varied styles and culturesPhysical 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 dateGenerous paid time off and Company designated HolidaysCompany paid Disability benefits and Life Insurance coverage401(k) Retirement Savings PlanPaid Parental leaveEmployee Stock Purchase Plan (ESPP)Company sponsored wellness programsProfessional development initiatives and continuous learning opportunitiesA certified Great Place to Work for six consecutive years based on our positive, values-based company culture
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