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.
Eli Lilly Cork is made up of a talented diverse team of over 2000 employees across 60 nationalities who deliver innovative solutions that add value across a variety of Business Service functions including Finance, Information Technology, Medical, Clinical Trials and more. Eli Lilly Cork offers a premium workspace across our campus in Little Island, complete with flexible hybrid working options, healthcare, pension and life assurance benefits, subsidised canteen, onsite gym, travel subsidies and on-site parking. Inhouse People Development services, Educational Assistance, and our ‘Live Your BEST Life’
wellbeing initiatives are just some of the holistic benefits that enhance the career experience for our colleagues.
Eli Lilly Cork is committed to diversity, equity and inclusion (DEI). We cater for all dimensions, ensuring inclusion of all ethnicities, nationalities, cultural backgrounds, generations, sexuality, visible and invisible disabilities and gender, with four pillars: EnAble, embRACE, LGBTQ+ & Ally and GIN-Gender Inclusion Network. EnAble, our pillar for people with disabilities and those that care for them, partners with the Access Lilly initiative to make our physical and digital environment accessible and inclusive for all. Together, they are committed to promoting awareness to create a disability confident culture both at Eli Lilly Cork and beyond.
Come join our team - Be Creative, Be an Innovator, and most of all, Be Yourself!
This is a 15 Month Fixed Term Contract.
Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to 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 Regulatory Associate Director role is responsible for managing a book of work, and leading the development of a clinical submission strategy and regulatory content that ultimately enables timely approval of a Lilly medicine. The GSC Regulatory Associate Director does this by effectively collaborating across functions, geographies, and phases to deliver a feasible strategy and tactical plan to enable on time, effective study and submission packages.
The GSC Regulatory Associate Director drives and influences content decisions, develops content, and leads writing teams to ensure timely and high quality delivery of key regulatory documents (e.g., regulatory interactions, submission documents and clinical study reports) that support the approval process.
The GSC Regulatory Associate Director is responsible for daily operations within their area of responsibilities. This role works closely with other leadership roles to provide strategic input and ensure alignment with Lilly and Business Unit objectives.
This 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.
Partners with cross-functional, multidisciplinary teams to lead and influence planning, strategies and content for clinical development, submissions and regulatory responses.
Provides leadership and substantive advice on regulatory and submission strategy, regulations and industry best practices, demonstrating excellence in communications.
Leads regulatory writing activities and function as an integral member of clinical, project, and/or submission teams for assigned compound(s) or therapeutic area(s) and driving optimized and streamlined documents.
Consults with team leadership to plan various regulatory strategies/scenarios and their impact to make effective decisions and mitigations.
Leads and influences the development of key communications and overall regulatory communication strategies for assigned compound(s) or therapeutic area(s), providing our audience with a consistent and improved experience with our communications.
May serve as primary author on critical regulatory deliverables.
Management reviewer on critical regulatory deliverables.
Responsible and accountable for management/delivery of overall book of work for assigned area
Develops and executes sourcing plans to ensure seamless delivery of asset plan and priorities
Collaborates with functional management/capabilities leadership to ensure alignment of business planning and operations, coordinating across and developing 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
Partners with other GSC leads to ensure consistent communication and appropriate sourcing strategies are in place in support of overall delivery of portfolio.
Regularly reports results of team activities/metrics to leadership and stakeholders
Leads development of new and emerging capabilities to support the effectiveness of the GSC organization transformation,
Functions as expert on regulatory document/submission strategy, planning and execution and related industry standards and guidelines
Provides regulatory document/submission expertise to others
Analyzes and interprets new and updated industry guidelines for applicability.
In partnership with others, designs and creates training on submission/regulatory document practices for audiences within and outside of GSC.
Serves as a subject matter expert and represents GSC on committees and task forces.
In partnership with others, develops, implements, and updates Lilly policies, practices and tools and procedures that are compliant with industry guidelines.
Maintains key external industry, technical, and key professional organization connections and understandings to ensure GSC stays at the forefront of leading industry best practices
Bachelor’s degree in scientific, health, communications, or technology related field
1 year experience in pharmaceutical medical writing focused on regulatory / submission documents
Experience leading at least 1 regulatory submission or delivering key submission activities (Safety, Efficacy Lead)
1 year experience leading/coaching others.
1 year experience in leading/managing a key part of portfolio or business process
Successful completion of writing exercise
Advanced degree (e.g., PharmD, PhD, MBA)
Experience in clinical development
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.
Clinical pharmacology, therapeutic area or other medical/scientific-specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, or endocrine expertise).
Experience in managing business plans, budgeting and capacity resourcing.
Experience developing and/or supervising creation and delivery of regulatory, publication or healthcare communications and/or plans.
Limited travel, up to approximately 10%.
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and 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.
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