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.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location.  The anticipated wage for this position is

$111,000 - $162,800

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 Associate Director, Regulatory is responsible for leading a team of writers, handling a book of work, and leading the development of a clinical submission strategy and regulatory content that ultimately enables approval of a Lilly medicine. The ideal candidate will do this through effective collaboration across functions, geographies, and phases to deliver a feasible strategy and tactical plan to enable on time, effective study and submission packages. They will also drive and influence content decisions and development while leading writing teams to ensure high quality delivery of key regulatory documents (e.g., regulatory interactions, submission documents and clinical study reports) that support the approval process.

The Associate Director will also lead daily operations within their area of responsibilities. This role works closely with other leaders to provide strategic feedback and input while ensuring alignment with Lilly and Business Unit objectives.

Responsibilities

Regulatory Communication, Planning, and Strategy Development

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 standard processes, 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 and management reviewer on critical regulatory deliverables

Portfolio Management / Delivery

Develops, executes and implements 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 while coordinating and developing harmonies across with therapeutic areas, phases of development, and geographies.

Adjusts work plan based on shifting priorities using effective change control.

Leads and advises 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.

People Management and Development, as applicable

Recruits, develops, and retains a strategic and operationally capable workforce skilled and knowledgeable in scientific communications for assigned area.

Effectively builds and leads an agile organization that continuously meets the needs of a changing portfolio.

Leads an organizational culture that cultivates inclusion and innovation.

Develops staff who demonstrate expertise in drug development, therapeutic area science, critical thinking, project management and cross-functional leadership.

Develops an organizational talent base that demonstrates judgment-based decision making.

Provides mentorship, training, and supervision to personnel.

Evaluates performance by reviewing documents, and attending writing team meetings, and recommends developmental actions for all assigned staff.

Organizational effectiveness

Leads development of new and emerging capabilities to support the efficiency of the GSC organization transformation.

Functions as an 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 team members, crafts and builds training around submission/regulatory document practices for audiences within and outside of GSC.

Serves as a subject matter authority and represents GSC on committees and task forces.

Develops, implements, and updates Lilly policies, practices and tools and procedures that are aligned with industry guidelines.

Maintains key external industry, technical, and key professional organization connections and understandings to ensure

Minimum Qualification Requirements:

Bachelor’s Degree in scientific, health, communications, or technology related field

1 year experience in pharmaceutical regulatory and submission based medical writing

Experience leading at least 1 regulatory submission or delivering key submission activities (Safety, Efficacy Lead)

1 year experience leading and/or mentoring others.

1 year experience managing a key part of portfolio or business process

Successful completion of writing exercise

Location: Based at Lilly Corporate Center, Indianapolis

Other Information/Additional Preferences:

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.

GSC stays at the forefront of leading industry best practices!

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 is an EEO/Affirmative Action Employer and 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.

Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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