[Hiring] Associate Director, US Compliance Policy and Training Lead @MENARINI Group

Role Description

Reporting to the Head of US Compliance and Deputy Chief Compliance Officer, the US Compliance Policy and Training Lead will manage and lead Stemline’s evolving Policy and Training framework. This individual is responsible for navigating within a high-growth, diverse business landscape and has a unique opportunity to shape the future of Stemline’s Compliance function. The successful candidate will blend deep technical expertise with sound judgment to scale Stemline’s compliance policy and training initiatives.

Responsibilities

• Policy Governance
  • Develop and maintain Stemline’s Compliance policy governance framework including drafting and maintaining policies and procedures related to policy updates, signing governance and other good policy practices.
  • Direct the end-to-end lifecycle of US Compliance policies, including the identification of policy gaps, routine refreshes, and the decommissioning of obsolete guidance.
  • Maintain log to capture identified policy and SOP changes resulting from monitoring findings, business feedback, changes in regulations or external environment, etc.
  • Develop and oversee digital "home" for policies and ensure policies are mobile-friendly, searchable, and integrated into the daily workflow of the business colleagues.
  • Lead Policy drafting/editing by capturing feedback from cross functional stakeholders, scheduling meetings to obtain feedback and obtaining necessary signatures on finalized policies.
  • Develop supplemental policy documents such as reference guides and job aids to aid in policy knowledge and understanding.
  • Manage Compliance Policy exceptions process.
  • Maintain Compliance document repository for Policies, Training and other key documents such as committee decks/charters/minutes and Annual Compliance Plan.
• Training
  • Develop and maintain Annual Training and Communications Plan in collaboration with business compliance leads and monitoring/investigations team.
  • Deploy adult learning principles and utilize AI to develop engaging, relevant and professional trainings for colleagues across the business functions covering a range of compliance topics.
  • Establish a framework for measuring training effectiveness utilizing training assessments, surveys and correlation data to measure program efficacy.
  • Lead the continuous refresh of training materials to reflect updated laws, guidance, etc.
  • Foster a "Speak Up" culture by integrating messaging around the Compliance Hotline and non-retaliation policies into learning and communication touchpoints.
  • Oversee the Compliance Learning Management System (LMS) ecosystem, ensuring seamless deployment, meticulous record-keeping in collaboration with QA and Global Compliance Training organization.
  • Enhance and maintain employee training matrix to allow for targeted live trainings; coordinate launch of e-learning modules with QA and business stakeholders.
  • Direct a comprehensive compliance communication strategy utilizing diverse formats — such as "Compliance Minutes," podcasts, micro-learning, and town halls — to keep integrity at the forefront of the corporate conversation.
  • Develop and maintain a distinct Compliance Program brand. Create a professional and approachable "voice" for the function that resonates with the corporate culture while fostering a tone of integrity.
  • Coordinate training with other functions (QA, IT, HR, etc) and maintain master training calendar.
  • Develop Compliance program branding to convey professional tone for Compliance function.
  • Participate in Global Menarini training projects and initiatives as needed.

Qualifications

• Bachelor degree is required (other advanced degree or course of study preferred).
• Minimum of 7 years of pharmaceutical or healthcare industry experience.
• Working knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry.
• Unquestioned ethics, judgment, integrity and courage.
• Innovative mindset.
• Exceptional communication skills.
• Ability to remain flexible, adapt to changing business dynamics and thrive in fast-paced environment.
• Excellent business acumen, highly effective communication skills and ability to operate effectively within a team and manage expectations of multiple stakeholders.
• High level of attention to detail and operational excellence.
• Strong project management and time management skills.
• Excellent technical skills and ability to work effectively in various business tools such as Excel, Powerpoint, Sharepoint, and Google products as well as systems used to support training, document retention, policies, etc.
• Solutions-oriented self-starter with balance of strategic vision and tactical skills; ability to work with limited supervision.

Requirements

• Base Salary Range of $168,985-$210,000.
• Menarini Stemline offers generous compensation and benefits packages, including:
• Short and Long-Term Incentive Programs.
• Fidelity 401(k) (with company match of 6%).
• PPO and HDHP insurance plans.
• Company paid Basic Life & AD&D insurance.
• Pre-tax FSA/HSA programs.
• This position is classified as a corporate office position. In accordance with the New York employer convenience rule, Stemline will withhold New York state income taxes for all corporate office employees, regardless of whether these employees work in New York or remotely.

Benefits

• Generous compensation and benefits packages.
• Fidelity 401(k) (with company match).
• Healthcare insurance.
• Company-paid Basic Life & AD&D insurance.
• Pre-tax FSA/HSA programs.

Company Description

Menarini is a leading international biopharmaceutical company committed to advancing health through innovation, research, and quality. Founded in 1886 in Naples, Menarini moved in 1915 to Florence where the Group’s headquarters are still located today. The company is present in 70 countries and products are sold in 140 locations around the world.

• Menarini has made a strong commitment to oncology, investing in a pipeline of five investigational compounds for the treatment of a variety of haematological and solid tumours.
• Menarini received exclusive rights to commercialise Selinexor for the treatment of oncology indications in the European Union and other countries.
• Menarini entered into a global licence agreement with Radius Health to complete the development of Elacestrant, an oral SERD in late-stage Phase 3 development for hormone receptor-positive advanced breast cancer.
• Menarini’s commitment to oncology is also reflected in the investments made in the liquid biopsy diagnostic field through its affiliate Menarini Silicon Biosystems (MSB).