• Work on a variety of assignments, diverse product types for clients • Creating opportunity for clients throughout the product lifecycle • Sharing scientific, technical, regulatory, and/or commercial expertise • Leading teams of respected SMEs • Meeting new situations and learning • Provide mentoring and guidance to other RS employees

• Serve as SME for controlled document management, ensuring compliant governance and inspection readiness • Author, review, approve, and manage controlled procedures and quality documents per GxP requirements • Drive document lifecycle management activities including creation, revision, periodic review, and archival • Provide guidance on procedural writing standards and document management best practices • Support GxP training governance to ensure compliance with regulatory requirements • Maintain effective training curricula aligned with role-based responsibilities and procedural updates • Monitor training compliance metrics and support remediation of non-compliant records • Lead regulatory compliance activities across global GxP operations • Drive inspection readiness initiatives and support FDA, EMA, MHRA, and other health authority inspections • Monitor evolving regulatory requirements and implement compliance strategies • Support development of remediation plans for audit findings and compliance gaps • Manage QMS processes including deviations, CAPAs, change controls, SOP management, and document control • Utilize metrics and trend analysis to identify compliance risks and drive continuous improvement • Support harmonization of quality processes to improve scalability and effectiveness

• Act in a consultative capacity with the business, mapping risks and applying by-design strategies to new projects and initiatives; • Identify regulatory changes that impact the continuity of strategic projects and monitor the status of action plans for mitigation; • Validate and implement automated controls and technological solutions for Compliance processes, driving the use of artificial intelligence and automation to optimize resources; • Assess risks, opportunities and business best practices in expansion processes (e.g., election periods, permit and license applications) and in interactions with government entities and strategic partners; • Conduct due diligence on national and international partners in expansion operations, analyzing compliance and third‑party risks; • Conduct research and prepare consultative opinions on risks and provide guidance to operations and business areas; • Identify governance and business continuity opportunities that intersect with compliance requirements; • Support the development of action plans to ensure the integrity and effectiveness of initiatives; • Identify risks and monitor relevant transactions to meet AML/CFT regulatory obligations and conduct internal investigations objectively and based on data; • Support governance of Compliance Program topics (indicators, training, communications, policies and procedures); • Prepare strategic and executive reports to provide clear and concise updates to senior management.

Role Description Otsuka is a leader and innovator in the therapeutic area, with a strong portfolio of development and marketed assets. The Medical Director, Global Medical Strategy is a key leader within medical affairs and serves as the medical lead for high priority programs. Working under the leadership of the Sr Director, they are responsible for developing and executing strategic medical plans and tactics for assigned products within the portfolio in collaboration with other Medical Affairs colleagues, as well as colleagues within the broader R&D and Commercial organizations at Otsuka and partner organizations as applicable. The Medical Director is the medical expert for assigned program (disease and product) and will be accountable for post-marketing data generation planning and execution, scientific communications, and aggregation and synthesis of insights. The Medical Director will also provide clinical and medical insights to support the HEOR, publications, marketing, sales, regulatory, and all other cross-functional teams to ensure plans are aligned and relevant to evolving medical practice and in the best interest of stakeholders – patients, caregivers, payers, and physicians. The Medical Director will also foster close professional and scientific relationships with key external healthcare providers. The Medical Director must conduct their work activities in compliance with all Otsuka internal policies and SOPs and with all applicable regional and federal regulatory requirements. - Co-lead and provide medical input into integrated brand strategies for assigned program(s) - Lead the development of and obtaining executive alignment on the medical situational analysis, strategy, and plans for assigned products and accountable for execution. - Managing external providers, create and deliver scientific and medical content for disease and product-level information for relevant stakeholders. - Partner with HEOR, government affairs, patient advocacy, commercial, PV, and clinical development to ensure medical accuracy and practice relevance in all activities - Core member of publication planning of marketed and pipeline assets. - Build and maintain relationships with experts to obtain important key scientific insights to support the therapeutic area. - Lead advisory boards as needed for US insight gathering - Develop and lead evidence generation planning, including post-marketing data generation plans (ph4, IST, post-hoc analyses) - Review educational grants - Serve as escalation point and provide guidance to medical reviewers of promotional and medical materials - Effectively lead matrix teams of cross-functional colleagues, including medical affairs strategy teams (GMAST); ensure effective cross-functional collaboration; align all key Medical Affairs projects for assigned product and indication. - Champion an objective and evidence-based solution-oriented approach. Qualifications - Minimum of 5-10 years of experience in the pharmaceutical or biotechnology setting within Medical Affairs or related role. - Direct Medical Affairs strategy experience required. - Product launch experience preferred. - Demonstrated excellence in written and verbal communications. - Communicates clearly, concisely, and is easily understood in written materials and presentations. - Show strength in medical planning, tactical plan development and execution, and ability to critically analyze research design, methods, and outcome measures. - Experience in successfully leading cross-functional matrix teams. - The ability to influence without direct authority is a critical skill set for this role. - Willing to take initiative on advancing projects and able to identify what is necessary to complete tasks. - Knows how to be a team player and is willing to work collaboratively across the organization. - Strong strategic thinking acumen and track record for operational excellence. - Proficiency with computer productivity programs necessary to complete work requirements (e.g., MS Word, Excel, Outlook, and PowerPoint). - Has full understanding of rules and regulations in pharma, which could have impact for the pharmaceutical industry. - Appropriate knowledge of guidelines and regulations and can apply legal and compliance knowledge to Medical Affairs activities. Requirements - Doctorate Degree (MD/DO, PharmD, PhD) or equivalent required with expert knowledge or training in neurology, psychiatry, neuroscience, or neurophysiology preferred. Preferred Qualifications - Experience with psychedelic or neuroplastogen therapeutic research and development. Benefits - Comprehensive medical, dental, vision, prescription drug coverage - Company provided basic life, accidental death & dismemberment - Short-term and long-term disability insurance - Tuition reimbursement - Student loan assistance - A generous 401(k) match - Flexible time off - Paid holidays and paid leave programs - Other company provided benefits