Eli Lilly and Company

Regulatory Lead/Publication Strategy and Execution

Location
Indianapolis, IN, United States
Posted
Nov 29, 2018
Ref
46124
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 Regulatory Lead/Publication Consultant is responsible for supervising a team of writers, managing a book of work, and developing Scientific Disclosure (SD) strategies and plans. The Regulatory Lead/Publication Consultant will draw upon information from multiple internal and external sources to lead the asset team in developing SD strategic and tactical plans that ensure effective dissemination of scientific information. This is accomplished by collaborating, leading, and influencing medical leaders across Global Medical Affairs, Global Patient Outcomes/Real World Evidence, Global Clinical Development, Preclinical Development as well as commercial colleagues as appropriate. This also includes being a core member of the Launch Excellence Network and the GSC lead in the integrated planning approach (IPA). The Regulatory/Publication Consultant develops, manages, and leverages these dynamic strategic plans in alignment with overall company-wide strategies for an asset or therapeutic area(s). The Regulatory/Publication Lead may directly supervise others as assigned. The Regulatory/Publication Lead will collaborate with GSC Launch Capability Advisor to ensure best practices across the function

Scientific Disclosure Strategy Development
  • Leads the development of the SD strategy for an asset or portfolio, providing effective and novel publication strategies for the team.
  • Represents/presents SD Strategy/Plan to leadership and to others as applicable.
  • Carefully studies and develops/maintains expertise on the publication environment (and other communication channels), including monitoring congresses/journals and competitor publication strategies/activities within disease state/area of responsibility.
  • Identifies gaps and opportunities for disclosure, and provides recommendations to the team.
  • Engages with customers, opinion leaders, patient advocacy groups, professional societies/medical associations, and publishers.
  • Develops close, cross-functional relationships with development/medical affairs and other communications experts within Lilly. Collaborates and advises asset teams on publication strategy, planning, execution and best practices for launches.
  • Uses external and internal insights to identify emerging trends, needs, and requirements and to inform, develop, and refine GSC and Lilly launch and publication strategies.
  • Uses strong strategic and analytical thinking to develop, defend, and implement SD strategic and tactical plans.
  • Ensures consistency of regional/affiliate publication strategies.
  • Identifies synergies and drives for alignment across portfolio when indications overlap.
  • Works independently to integrate input from senior management, resolve conflicting input, and incorporate multiple needs and strategies into a publication plan that is acceptable to all parties and compliant with industry guidelines.
  • Facilitates the planning of high-quality publications that withstand the scrutiny of peer review.
  • Functions independently as a decision-maker on publication-related issues.
  • Effectively and diplomatically interacts with Lilly Leadership and external authors/experts and journal editors.
  • Identifies opportunities for synergy with other departments/vendors and forms those synergies.
  • Creates strong partnerships with Global R&D, Marketing, Market Access/GPORWE and other groups.
  • May represent GSC in due diligence activities.
  • Collaborates with Alliance Management to formulate publication/disclosure charters for alliance partner products, as applicable.
  • Contributes to, or leads if assigned, regional publication strategy.
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 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.
  • Primary author on critical regulatory deliverables.
Portfolio Management/Delivery
  • Responsible/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.
  • Conceives of 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 leadership and stakeholders.
People Management and Development
  • Recruits, 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 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 judgment based decision making.
  • Provides guidance, 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
  • Leads development of new and emerging capabilities to support the effectiveness of the GSC organization transformation
  • Functions as expert on SD strategy, planning and execution, industry standards and guidelines, such as Good Publication Practices, ICMJE requirements, and PhRMA guidelines
  • Functions as expert on regulatory document/submission strategy, planning and execution and related industry standards and guidelines
46124BR

Basic Qualifications
  • Bachelor's degree in scientific, health, communications, or technology related field
  • 1 year experience in pharmaceutical medical writing or publication planning
  • 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 (MA/MS, PharmD, PhD) preferred.
  • Expertise in publication guidelines and industry standards, including Good Publication Practices, ICMJE requirements, and PhRMA guidelines
  • 1 year experience leading launch activities
  • Experience with early phase drug development
  • Strong communication skills, including extensive experience in writing, reviewing, and publishing scientific materials and the ability to appraise scientific literature and raw data critically for potential development of new publications.
  • Possess strong strategic and analytical thinking to develop, defend, and implement SD strategic and tactical plans
  • Experience with effective partnering in developing SD plans.
  • Experience managing budgets
  • Knowledge of scientific, statistical, and research principles and guidelines
  • Knowledge of publication management software/tools
  • Excellent organizational, business, and communication skills


Additional Information
  • Travel: 20%
  • 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