Disability Solutions
Assistant General Counsel
Disability Solutions, Raleigh, North Carolina, United States,
Who We Are: Harvesting Hope with a Growing Family
At Merz Pharmaceuticals, LLC, we take a nurturing approach to our organization - treating colleagues like family, embracing our whole selves and creating a company culture that encourages growth and decisive action. We are committed to caring for whole communities by focusing on individuals suffering from movement disorders and neurological conditions and the healthcare providers dedicated to helping them, while simultaneously bolstering our team members in a united effort to make a difference. As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth and the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long-term view of making a difference for the common good, while growing together as a family.
Are you a self-starter, and do you thrive in entrepreneurial environments?
If you're looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we're looking for YOU!
As the Assistant General Counsel, you will collaborate with commercial business functions and management and support colleagues in local and Global functions to provide effective, proactive legal advice and counsel on issues associated with related areas of law, general business and a wide variety of regulatory and other technical matters.
You will provide legal support with respect to the development, manufacturing, promotion, distribution and sale of pharmaceuticals and medical devices. Additionally, you will take an active role in the day-to-day management of the North America Legal function and in corporate governance and mentoring of colleagues, providing counsel on and manage risk related to Merz and the sale of our products. You will play a key role in support of the development, acquisition and divestiture of products and in lifecycle management by providing effective legal support for sales, marketing and supporting functions.
Essential duties and responsibilities:
Major duties
Description
Counseling Business Analyze legal issues relating to a variety of business activities (including external interactions with customers, suppliers, competitors, government agencies as well as internal Company interactions) to effectively guide the business in conducting its operations in a competitive and compliant manner. Analysis and guidance includes creatively developing and recommending effective and efficient solutions to internal business clients, including but not limited to Human Resources, R&D, Medical Affairs, Grants & Giving, and ex-US Merz affiliates such as the Merz Canadian and global entities.
Review of Scientific and Medical Materials Provide FDA regulatory advice to the medical teams by participating in Scientific Review Committees for the Company's scientific and medical materials. Review scientific and medical materials and provide counsel and guidance on regulatory requirements and risk assessment regarding content.
Contracts Management Support and manage Corporate Paralegal (contractor position) and Compliance team in management of Merz Therapeutics US contract management system and processes.
Promotional Review Provide FDA regulatory advice to the product marketing teams by participating in Promotional Review Committees for the Company's products. Review promotional materials and provide counsel and guidance on regulatory and promotional requirements and risk assessment regarding product claims and promotional pieces, as well as marketing activities and commercial strategy.
Market Access Provide counsel to Managed Markets on contractual arrangements with payers and potential legal issues, including government pricing, anti-kickback statutes, relationships with healthcare providers and FDA regulations. Draft, review and negotiate payer agreements, discount agreements in consultation with stakeholders including Finance and Compliance.
Contract Reviews Draft, review, and negotiate a wide range of general commercial and general business contracts, including master services agreements and statements of work; ensure that contracts are in compliance with legal and regulatory requirements and organization policies. Counsel commercial business units on potential legal, regulatory and compliance implications of contracts.
Brand Protection/IP Support North American brand protection efforts to protect the company's products, and the commercialization of the company's products in NA from trademark infringement, counterfeiting and diversion. Provide general advice on intellectual property issues, including trademark, copyright and patent issues in coordination with Global Trademark Counsel and Patent Affairs.
Medical Affairs Advise on scientific exchanges, investigator-initiated trials, and medical information materials in collaboration with Medical Affairs.
Job related qualifications/skills:
Education Graduation from an American Bar Association approved law school; licensed to practice law in any State in good standing; excellent academic credentials.
Required
Professional experience Minimum 10 years overall legal experience in law firm and corporate legal department settings; prefer least 6 of those years must be in the legal department of a pharmaceutical and/or medical device company.
Required Prior experience with corporate governance, intellectual property and business development formalities.
Preferred Product promotional/marketing review experience.
Required
Knowledge, skills and abilities: Ability to think creatively in a heavily regulated environment and handle multiple complex matters.
Required Excellent working knowledge of medical devices and the applicable laws and regulations governing device promotion.
Required Demonstrated ability to identify and analyze complex issues in order to devise solutions and successful strategies, and articulate in an easy-to-understand manner.
Required Demonstrated ability to work effectively with and lead Legal Department staff.
Required Ability to interface and work effectively with Global/International colleagues in Legal and other functions
Required
Personal skills Highest ethical standards and respect of confidentiality for company matters.
Required Excellent analytical, oral and written communication skills.
Required Excellent interpersonal skills with ability to work cooperatively in an organization and with management
Required
Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Merz Therapeutics we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.
Recruitment Note: Merz Therapeutics only sends emails from verified "merz.com" addresses and never asks for sensitive, personal information or money. If you have any doubts about the authenticity of any type of communication from, or on behalf of Merz Therapeutics, please contact Therapeutics.HR@merz.com
At Merz Pharmaceuticals, LLC, we take a nurturing approach to our organization - treating colleagues like family, embracing our whole selves and creating a company culture that encourages growth and decisive action. We are committed to caring for whole communities by focusing on individuals suffering from movement disorders and neurological conditions and the healthcare providers dedicated to helping them, while simultaneously bolstering our team members in a united effort to make a difference. As a private, family-owned company, we have the liberty and support to make decisions for ourselves, our customers and the patients we serve. We pride ourselves on building an inclusive culture where there is room to celebrate individual growth and the ability to contribute to a common good as a collaborative team. Our mission is grounded in a long-term view of making a difference for the common good, while growing together as a family.
Are you a self-starter, and do you thrive in entrepreneurial environments?
If you're looking to immerse yourself in a passionate team rooted in community, connection and camaraderie, then we're looking for YOU!
As the Assistant General Counsel, you will collaborate with commercial business functions and management and support colleagues in local and Global functions to provide effective, proactive legal advice and counsel on issues associated with related areas of law, general business and a wide variety of regulatory and other technical matters.
You will provide legal support with respect to the development, manufacturing, promotion, distribution and sale of pharmaceuticals and medical devices. Additionally, you will take an active role in the day-to-day management of the North America Legal function and in corporate governance and mentoring of colleagues, providing counsel on and manage risk related to Merz and the sale of our products. You will play a key role in support of the development, acquisition and divestiture of products and in lifecycle management by providing effective legal support for sales, marketing and supporting functions.
Essential duties and responsibilities:
Major duties
Description
Counseling Business Analyze legal issues relating to a variety of business activities (including external interactions with customers, suppliers, competitors, government agencies as well as internal Company interactions) to effectively guide the business in conducting its operations in a competitive and compliant manner. Analysis and guidance includes creatively developing and recommending effective and efficient solutions to internal business clients, including but not limited to Human Resources, R&D, Medical Affairs, Grants & Giving, and ex-US Merz affiliates such as the Merz Canadian and global entities.
Review of Scientific and Medical Materials Provide FDA regulatory advice to the medical teams by participating in Scientific Review Committees for the Company's scientific and medical materials. Review scientific and medical materials and provide counsel and guidance on regulatory requirements and risk assessment regarding content.
Contracts Management Support and manage Corporate Paralegal (contractor position) and Compliance team in management of Merz Therapeutics US contract management system and processes.
Promotional Review Provide FDA regulatory advice to the product marketing teams by participating in Promotional Review Committees for the Company's products. Review promotional materials and provide counsel and guidance on regulatory and promotional requirements and risk assessment regarding product claims and promotional pieces, as well as marketing activities and commercial strategy.
Market Access Provide counsel to Managed Markets on contractual arrangements with payers and potential legal issues, including government pricing, anti-kickback statutes, relationships with healthcare providers and FDA regulations. Draft, review and negotiate payer agreements, discount agreements in consultation with stakeholders including Finance and Compliance.
Contract Reviews Draft, review, and negotiate a wide range of general commercial and general business contracts, including master services agreements and statements of work; ensure that contracts are in compliance with legal and regulatory requirements and organization policies. Counsel commercial business units on potential legal, regulatory and compliance implications of contracts.
Brand Protection/IP Support North American brand protection efforts to protect the company's products, and the commercialization of the company's products in NA from trademark infringement, counterfeiting and diversion. Provide general advice on intellectual property issues, including trademark, copyright and patent issues in coordination with Global Trademark Counsel and Patent Affairs.
Medical Affairs Advise on scientific exchanges, investigator-initiated trials, and medical information materials in collaboration with Medical Affairs.
Job related qualifications/skills:
Education Graduation from an American Bar Association approved law school; licensed to practice law in any State in good standing; excellent academic credentials.
Required
Professional experience Minimum 10 years overall legal experience in law firm and corporate legal department settings; prefer least 6 of those years must be in the legal department of a pharmaceutical and/or medical device company.
Required Prior experience with corporate governance, intellectual property and business development formalities.
Preferred Product promotional/marketing review experience.
Required
Knowledge, skills and abilities: Ability to think creatively in a heavily regulated environment and handle multiple complex matters.
Required Excellent working knowledge of medical devices and the applicable laws and regulations governing device promotion.
Required Demonstrated ability to identify and analyze complex issues in order to devise solutions and successful strategies, and articulate in an easy-to-understand manner.
Required Demonstrated ability to work effectively with and lead Legal Department staff.
Required Ability to interface and work effectively with Global/International colleagues in Legal and other functions
Required
Personal skills Highest ethical standards and respect of confidentiality for company matters.
Required Excellent analytical, oral and written communication skills.
Required Excellent interpersonal skills with ability to work cooperatively in an organization and with management
Required
Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Merz Therapeutics we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.
Recruitment Note: Merz Therapeutics only sends emails from verified "merz.com" addresses and never asks for sensitive, personal information or money. If you have any doubts about the authenticity of any type of communication from, or on behalf of Merz Therapeutics, please contact Therapeutics.HR@merz.com