Associate Director, Global RA Labeling Lead

About the Role

The Plasma-Derived Therapies (PDT) R&D Organization is dedicated to bringing forward new plasma-derived therapies for patients with immunologic, hematologic, and other complex diseases. There are two main drivers of innovation that are the focus of the PDT R&D organization: Translational Pharmaceutical Sciences and Precision Medicine.

The Global Regulatory Labeling Strategy Lead (Associate Director), Plasma-Derived Therapies Business Unit (PDT BU) is a key role in Global Labeling and works under the direction of the Head of Global Labeling.

Responsibilities

• Provide regulatory expertise, strategic insight, and guidance to internal stakeholders, including Clinical, Pharmacovigilance, Legal, Scientific, and Commercial, to ensure successful development and maintenance of labeling managed within PDT BU's Global Labeling function, pertaining to pharmaceutical drug and device.
• Ensure strategic labeling input in the implementation of regulatory strategies and liaise with regulatory team members in evolving submission and negotiation plans.
• Formulate regulatory labeling strategies for implementation of new and revised prescribing information and packaging; strategically interpret scientific, medical, and regulatory data and information.
• Provide expert advice on current labeling requirements, templates, tools, and Health Authority-issued guidance pertaining to pharmaceutical drug and device.
• Drive labeling strategy for the PDT BU via the development and lifecycle management of the CCDS, US, and EU labels.
• Formulate and implement innovative regulatory strategies for labeling development to support successful commercialization of developmental products and enhance opportunity for marketed products and global expansion.
• Prepare strategic labeling vision for early development programs and gain alignment from internal stakeholders.
• Draw on labeling precedent, Health Authority feedback, and guidance to create innovative labeling strategies.
• Provide guidance on combination product/drug-device labeling.
• Interpret scientific and clinical data and lead development of labeling to optimize product potential and patient benefit-risk ratio.
• Introduce creative solutions for data presentation and gain consensus by labeling teams to meet the requirements of the Health Authorities.
• Prepare backup strategies in support of labeling negotiations.
• Take initiative in leading global labeling team and cross-functional projects.
• Lead CCDS, US, and EU Labeling Teams in the development and maintenance of labeling.
• Actively engage cross-functional labeling stakeholders to gain consensus on labeling strategy.
• Effectively identify and resolve conflicts/issues to reach labeling decisions with minimal escalation to management for dispute resolution.
• Liaise with Regulatory Intelligence to maintain awareness of regulatory legislation pertaining to labeling and communicate the impact on the PDT BU products.
• Provide guidance to Regulatory affiliates as necessary in assessment of labeling changes to ensure timely implementation.
• Oversee the direction, management, and implementation of the labeling processes, templates, tools, and systems to improve efficiency, productivity, and quality and consistency across products and compliance with regulatory labeling guidance.
• Project manage new or updated labeling to ensure compliance with internal procedural or Health Authority submission timelines.
• Manage and facilitate review of CCDSs and regional labeling, as appropriate, via the Labeling Team and executive governance committees for PDT BU products.
• Prepare final proposed labeling for review by the Labeling Team and approval by the executive governance committees, as appropriate, prior to internal approval and/or submission to health authorities.
• Manage the preparation of submission-ready labeling components; consult with affiliates on Health Authority communications regarding labeling.
• Ensure internal and external stakeholder awareness of proposed and newly approved labeling changes, as required.
• Ensure compliant version control of product labeling and other related documentation within the document management systems.
• Ensure QC of CCDSs and other labeling documents.
• Update labeling decision records to ensure labeling history is appropriately tracked and archived.
• Design and deliver labeling training programs.
• Document labeling tracking information in end-to-end tracking systems to facilitate overall compliance and oversight of labeling activities.

Leadership

• Ability to motivate, mentor, and manage diverse cross-functional teams.
• Global perspective with a demonstrated ability to work across functions, regions, and cultures.
• Ability to identify potential challenges and opportunities and make recommendations.
• Proven skills as an effective collaborator who can engender credibility and confidence within and outside the company.
• Valuing and promoting differences by embracing and demonstrating a diversity and inclusion mindset and models these behaviors for the organization.
• Invests in helping others learn and succeed.
• Able to influence without authority at senior level (TET/TET-1, GLOC).
• Demonstrates agile leadership by seeking to understand with the ability to evolve ideas as needed.
• Interviews, mentors, and develops employees/consultants.
• Builds and enhances strategic, cross-functional, stakeholder relationships through thoughtful engagement and leadership (including the planning, assigning, and direction of work).

Decision-Making and Autonomy

• Accountable for acting decisively and exercising sound judgment in making decisions with limited information.
• Accountable for making clear business arguments and strategic recommendations leveraging both quantitative and qualitative evidence.
• High ability to seek diverse input by balancing multiple internal and external stakeholders to drive solutions and set priorities.
• High ability to incorporate feedback and ensure decisions are made swiftly to enable flawless execution.
• Develops executable plans and meets budget and deadlines.
• Builds a culture of data-driven decisions.
• High ability to challenge self and others to overcome barriers and deliver high-quality solutions to the business.
• Crisp decision-making following appropriate consultation, even in times of ambiguity.
• Self-starter. Demonstrates initiative in advancing strategic projects with minimal guidance.

Interaction

• Organizational savvy and leverages internal network to enable alignment and effective execution in and outside the BU.
• Valuing and promoting differences by recognizing the importance of connections and brings in key stakeholders to work towards the best possible solutions.
• Strong communicator, able to persuasively convey ideas verbally and in writing.

Innovation

• Disruptive thinker with the ability to influence and change how R&D uses data to make decisions and set priorities.
• Continuously challenging the status quo and bringing forward innovative solutions.
• Ability to identify areas for process and systems innovation and implement change that will enhance the overall effectiveness of the team.

Complexity

• Delivers solutions to abstract problems across functional areas of the business.
• Identifies and solves fundamental issues for major functional areas through assessment of intangible variables.
• Recommends key decisions, escalates key issues per agreed governance framework, and persuades key stakeholders through influencing skills.
• Creates clarity of accountabilities in a global and highly matrixed organization, with a high degree of complexity.
• Ability to provide data that will resolve or simplify complexity between commercial, operations, and strategy.
• Resilient and comfortable working through large scale global change management.
• Knowledge of the global drug discovery and development process, laws and regulations affecting biopharmaceutical development in US, EU, and international markets.

Qualifications

• Bachelor's or Master's degree required.
• Minimum of 7-10 years of experience in the biopharmaceutical industry (e.g., safety, ad promo, regulatory strategy, medical affairs, etc.).
• 5-7 years of direct experience in a global, US, or EU labelling role is desired.
• Experience in plasma-derived therapies and biologics preferred.
• Advanced scientific or health sciences degree or equivalent relevant experience preferred.
• Previous leadership experience and management of direct reports preferred.
• Must have a detailed understanding of pharmaceutical drug and device development and global regulations pertaining to labeling, specifically EU and US labeling requirements and guidance.
• Combination product/drug-device labeling knowledge is preferred.
• Advertising and promotion knowledge is a plus.
• Expertise in the development and maintenance of the Company Core Data Sheet, the USPI, and the EU SmPC.
• Understanding of SPL format, requirements, and guidance for legacy and PLR labels.
• Proficiency in Electronic Document Management Systems and End-to-End (E2E) Labeling Tracking Systems to support labeling documentation, tracking, and compliance activities.

Benefits

• Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics. Premiums are subsidized by Synectics.
• Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.
• Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full-time employment with Synectics.
• 401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.