Eli Lilly and Company

Consultant-Regulatory Lead

Location
Indianapolis, IN, United States
Posted
Nov 22, 2018
Ref
46112
Required Education
Bachelors Degree
Position Type
Full time
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 39,000 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.

Responsibilities
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 Scientific Communications Consultant Regulatory Lead role is responsible for supervising a team of writers, 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. You will do this by effectively collaborating across functions, geographies, and phases to deliver a feasible strategy and tactical plan to enable on time, effective submissions. The Regulatory Lead drives and influences content decisions, develops content, and leads writing teams to ensure timely and high quality delivery of key regulatory documents (eg, regulatory interactions, submission documents and clinical study reports) that support the approval process.
You will be responsible for daily operations within your area of responsibilities through capacity and personnel management, staff development, business planning, and cross-functional communication. This role works closely with other leadership roles to provide strategic input and ensure alignment with Lilly and Business Unit objectives
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 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 in order to make effective decisions and mitigations.
  • Leads and influences the crafting 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.
  • Primary author on critical regulatory deliverables
Portfolio Management / Delivery
  • 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 alliances 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 partners
People Management and Development
  • Recruits, develops, and retains a strategic and operationally capable workforce skilled and knowledgeable in scientific communications for assigned area
  • Effectively builds and manages an agile organization that continuously meets the needs of a changing portfolio.
  • Builds an organizational culture that fosters inclusion and innovation.
  • Develops staff who demonstrate expertise in drug development, therapeutic area science, strategic thinking, project management and cross-functional leadership
  • Develops an organizational talent base that demonstrates discernment in 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
Subject Matter Expert/Organizational effectiveness
  • 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 guideline for applicability.
  • Partners with others, designs and builds training on 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.
  • 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
46112BR

Basic Qualifications
  • 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
  • Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position


Additional Skills/Preferences
  • Successful completion of writing exercise
  • Advanced degree (eg, PharmD, PhD, MBA)
  • Experience in clinical development
  • Strong leadership, analytical 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.


Additional Information
  • Location determined based on business area supported. Global Business Development: Based at Lilly Corporate Center, Indianapolis
  • 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