Sr. Manager - Clinical Trial Registry & Transparency

Eli Lilly

  • Cork
  • Permanent
  • Full-time
  • 2 months ago
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.Overview:At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly.The GSC Sr Manager for Clinical Trail Registry (CTRT) and Transparency is responsible for managing a book of work through capacity and personnel management, staff recruitment and development, business planning, and cross-functional communication. This role will be responsible for working with cross-functional, multidisciplinary teams to facilitate the delivery of CTRT and Transparency documents. Will draw upon information from multiple internal and external sources to lead and provide technical coaching to the CTRT and Transparency writing team to ensure the release of scientific information and the delivery of the regulatory requirements. The Sr Manager will collaborate and influence teams, and work closely with other managers and Leads across GSC to ensure best practices across the function. The Sr. Manager will be responsible for completing technical activities as needed.Primary ResponsibilitiesThis job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.Portfolio Management/DeliveryResponsible/accountable for management/delivery of overall book of work for assigned area.Develops and executes sourcing plans in partnership with GSC leads to ensure seamless delivery of asset plan and priorities.Collaborates with function, capability, and site leadership to ensure alignment of business planning and operations.Coordinates across and develops synergies with therapeutic areas, phases of development, and geographies.Adjusts work plan based on shifting priorities using effective change control.Leads and directs internal and external team members in achieving team goals.Identifies and resolves issues impacting delivery of work.Conceives and implements new and efficient ways to accomplish goals.Partners in the selection process and may manage relationship for preferred vendors.Regularly reports results of team activities/metrics to leadership and stakeholdersManage audit readiness, quality, and compliance to ensure deliverables are accurate, transparent, of high quality, and in compliance with internal/external guidance/regulation.People Management and DevelopmentRecruits, develops, and retains a strategic and operationally capable workforce skilled and knowledgeable in scientific communications.Effectively creates and manages an agile organization that continuously meets the needs of a changing portfolio.Builds an organizational culture aligned with Team Lilly – inclusion, innovation, acceleration, delivery, integrity, excellence, and respect for people.Develops staff who demonstrate expertise in drug development, therapeutic area science, strategic thinking, project management, and cross-functional leadership.Provide input on employee development, talent assessment, and succession planning activities.Develops an organizational talent base that demonstrates judgment-based decision making.Provides guidance, training, and supervision to personnel.Appropriately manage the workload of direct reports; monitor project timelines and quality, and communicate priorities to direct reports.Provide technical support and guidance to direct reports as needed.Evaluates performance by reviewing documents and attending writing team meetings, and recommends developmental actions for all assigned staff.Ensure all direct reports are compliant with company policies, procedures and regulations.Document Preparation, Development and FinalizationWorks on deliverables as needed per the responsibilities covered in the job description in his/her area; the percentage contribution of these responsibilities will vary according to the need of the business.Subject Matter Expert/ Organizational effectivenessLeads development of new and emerging capabilities to support the effectiveness of GSC.Functions as expert on planning and execution, and industry standards and guidelines.Shares expertise with others.In partnership with others, develop, implement, and update Lilly policies, procedures, training, and tools that are compliant with industry guidelines.Minimum Qualification RequirementsMaster’s degree in a scientific, health, communications, technology, health outcomes, or public health related field.Advanced degree (MBBS, MD, PharmD, PhD, MPH).Other Information/Additional PreferencesBackground in clinical Data Disclosure & Transparency and Redaction.3 years’ experience in clinical research.2 years’ experience in leading/managing a key part of portfolio or business process.Experience leading others, including relationship and team building, setting expectations, holding others accountable, and technical coaching.Strong scientific communication skills, including extensive experience in writing, reviewing, and publishing scientific materials and the ability to appraise scientific literature and raw data critically.Ability to communicate clearly and succinctly with all audiences and forums through exemplary oral and written communication skills.Strong medical research background with demonstrated breadth and depth of knowledge of medical research processes throughout all phases of development.Educational/work background in a health care, medical affairs, clinical development, health outcomes, public health, scientific or medical communications field.Expertise in industry standards and best practices, compliance issues, and regulatory requirements.Strong leadership, problem-solving skills, negotiation/influence/motivation, project management and critical thinking skills with ability to use effectively in a team, cross-functional setting and/or global environment.Project management experience.Experience managing business plans, budgeting and capacity resourcing.Experience in the global environment and an appreciation for global diversity.Ability to be flexible in varying environments and with multiple customer groups with ability influence cross functionally at all levels.Ability to work well across cultures and time zones.Highly organized and able to manage multiple projects at any given time.Attention to detail, critical thinking with analytical ability and dedicated to excellence in all aspects of their workAble to deal with ambiguity and to plan, prioritize, and manage conflicting priorities.Ability to work under pressure, while maintaining a positive attitudeProven ability to assemble, share and apply key learnings across multiple projects.Able to work independently and collaboratively in a team environment.Willingness to travel as required.Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( Lilly_Recruiting_Compliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.#WeAreLilly

Eli Lilly