Assistant General Counsel
Company: Disability Solutions
Location: Raleigh
Posted on: October 21, 2024
Job Description:
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
dutiesDescriptionCounseling 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.RequiredProfessional 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
functionsRequiredPersonal 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 managementRequiredDon'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
Keywords: Disability Solutions, Raleigh , Assistant General Counsel, Legal , Raleigh, North Carolina
Didn't find what you're looking for? Search again!
Loading more jobs...