Lilly Consultant-Design HUB Medical Writing in Indianapolis, Indiana
The Design Hub Scientific Communications Consultant is responsible for working with the Integrated Delivery Design Team to deliver knowledge, exertise, standard templates, and technology to produce hub deliverables. This role will partner with design teams to generate hub creation of documents such as protocols, amendments, IBs, master trial consents, and other documents as needed. In addition, the consultant will collaborate with hub and team resources to create functional requirements currently contained in various trial-level deliverables (e.g., Supply Plan, Safety Mgmt Plan, Data Mgmt Plan, & Lab Mgmt Plan) and strategies to the asset teams to ensure a smooth transition to execution. The scientific communications consultant will influence trial designs and medical writing requirements and will be the primary contact within the design hub for scientific communications. This role is responsible for providing expertise in medical writing methodologies while continually looking for internal and external advancements. This includes driving robust, strategic discussions with clinical and functional counterparts to incorporate different scenario strategies to gain efficiencies and speed.
Document Development /Delivery
Responsible for the document development for key strategic communication deliverables.
Responsible for driving the team in setting the direction, scope, and organization of information/documents in consultation with the project physician, clinical pharmacologist, statistician, and other team members as appropriate.
Conduct effective document initiation meetings to ensure authoring team alignment and understanding.
Build persuasive and scientific-based arguments that support the purpose of more complex and/or strategic documents. Ensure data are presented in a clear, complete, accurate, and concise manner.
Interpret data and verify results are consistent within/across related documents.
Advocate internally and externally for appropriate authorship criteria on all applicable work products.
Possess deep understanding of company document management systems and related tools, templates, and procedures in order to ensure efficient publishing of documents and dossiers.
Anticipate issues to effectively communicate, collaborate, and negotiate with team leadership and manage the document process / progress. Maintain focus and awareness of potential delays, problems, gaps of information, expectations, milestones, and deliverables in order to effectively deliver documents.
Partner with cross-functional, multidisciplinary teams to consult on and influence planning and strategies for as well as implementation of clinical development, regulatory submissions, publication plans, and regulatory responses.
Leverage the interdependencies of documents across products and uses to provide consistent and relevant medical / scientific information on the product(s) to multiple audiences
Scientific Subject Matter Expertise/Depth of Knowledge
Serve as a scientific resource on molecule and/or disease state; use this expertise to interpret and present scientific and statistical data in disclosures.
Function as first draft author of key, strategic documents.
Stay informed and up to date on changes in the external environment as related to HCP insights, therapeutic area impact on communication deliverables, industry guidelines, and data standards and use this expertise to guide authoring team and inform development of deliverables.
Demonstrate expertise and flexibility across document types.
Drive for excellence and standards in writing to influence at all levels
Knowledge Sharing and Consultant Support
Recognized as communication/data disclosure Subject Matter Expert across function / Business Unit, including expertise regarding Scientific Communications processes and tools.
Provide coaching, mentoring and consultation to others by sharing information, giving guidance, and answering questions across therapeutic areas, compounds, geographies, and/or phases of drug development, including clinical and health outcomes.
As the Subject Matter Expert on external and internal guidelines pertaining to data disclosure:
Consult on functional, cross-functional, corporate, and cross-geography initiatives.
Responsible for providing expert interpretation and application consultation for policies and procedures within and across teams.
Evaluate and/or represent Scientific Communications best practices and requirements for successful implementation of processes, tools, technology, and roles and responsibilities.
Lead evaluation/implementation of new capabilities, including execution of organizational change management strategies.
Act as Six Sigma Process Owner for key communication processes as applicable. Function as owner / steward of applicable process related policies, procedures and associated performance support materials.
Accountable for identifying and reducing redundancies and inefficiencies.
Contribute expertise to preparation of new and revised policies, procedures, job aids.
Serve as a consultant to business partners (e.g., Corporate Communications, Medical Relations, Investor Relations, Medical, Clinical Pharmacology, Global Health Outcomes, and Marketing) on data presentation
External Service Provider (ESP) / Alliance Relationship Management
Build and manage relationships with ESP and alliance partners to deliver successful outcomes.
Provide oversight on individual deliverables, including timeline management, delivery of feedback and issue management.
Build / manage relationships with ESP/alliance partners at a strategic level.
Collaborate with management / team to develop sourcing strategy. Lead and be accountable for execution of strategy.
Anticipate and resolve communication sourcing needs and collaborate with sourcing contacts and leadership to evaluate future providers
Participate in due diligence activities including ensuring the quality of data in documents.
Potential additional tasks for Single Point of Contact (SPoC) roles:
Accountability for making resourcing decisions and managing vendor capacity.
Deep understanding of the portfolio managed by each of the TPOs and their strengths and capabilities to deliver successful outcomes.
Support the implementation of the outsourcing strategy by effectively partnering with staff, GSC management team, GSC outsourcing team, technical lead consultants, and others.
Maintain awareness of outsourcing budget and liaise with business partners, as applicable.
Strive to build understanding of the business today and tomorrow; advocate for future state capabilities, processes, and tools
Represent Lilly and demonstrate influence at internal and external scientific and/or professional meetings. Seek leadership positions in external outreach activities (e.g., involvement in professional organizations).
Work with internal / external partners to answer questions related to therapeutic areas, compounds, geographic needs, communication practices and/or phases of drug development
Business Planning and Operations
Actively participate in business planning and capacity planning in partnership with management, with ongoing oversight of implementation.
Communicate with business partners on progress of deliverables and risk mitigation strategies developed and implemented
Demonstrated mastery of written English
Advanced scientific degree preferred
Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, or endocrine expertise) strongly preferred.
Demonstrated ability to influence teams appropriately and forge strong working relationships.
Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.
Demonstrated project management and time management skills.
Ability to work well independently and as a part of a team.
Cognitive abilities including; verbal reasoning, attention to detail, critical thinking and analytical ability.
Demonstrated high-level, end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations and templates).
A writing exercise is required as part of the candidate evaluation process. Additional writing samples may be requested
Limited travel, up to approximately 10%.
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
Medical Writer - Design HUB
Bachelor’s Degree with at least 3 years of pharmaceutical medical writing experience
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
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
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