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Medical Writer-FDE - United States  

Lilly (company)

Posted on : 20 April 2017

Project Description

Medical Writer-FDE
Indiana, New Jersey
United States
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.
The purpose of the Scientific Communications Associate role is to work with cross-functional, multidisciplinary teams to facilitate external scientific publications (including and not limited to, abstracts, posters, manuscripts and presentations), and/or regulatory documents (including, but not limited to, protocols, clinical study reports, briefing documents, regulatory responses, and marketing authorization applications).

Document Preparation / Document Management (60%)
  • Plan, write, edit, review and coordinate the publication of scientific data through peer-reviewed journals and forums and/or regulatory documents.
  • Facilitate trial development and product registration.
  • Ensure and coordinate quality checks for accuracy, collates reviewer’s comments, adjusts content of document as required based on internal/external input, and prepares final version.
  • Exhibit flexibility in moving across development and preparation of multiple document types.
  • Work with teams to ensure smooth and timely development of documents.
  • Influence or negotiate change of timelines and content with other team members.
  • Effectively collect and evaluate information from multiple sources

External Service Provider Management (20%)
  • Build / manage relationships with vendors / alliance partners.
  • Provide oversight on individual deliverables, including timeline management, delivery of feedback and issue management

Knowledge and Skills Development (10%)
  • Maintain and enhance therapeutic area knowledge including, disease state and compound for assigned project.
  • Exhibit flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc.
  • Maintain and enhance knowledge of regulatory guidelines and publication guidelines.
  • Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to lead the scientific data disclosure planning, clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews
Knowledge Sharing and Consultant Support (5%)
  • Provide informal coaching to others by sharing technical information, giving guidance, answering questions.
  • Recognized for technical expertise in specific document development.
  • Network with others to identify and share best practices globally.
  • Contribute to process improvements, suggesting opportunities where appropriate.
  • Provide database and other tool (eg, document management systems) expertise

Customer Focus (5%)
  • Work with internal and external speakers to develop and prepare presentations.
  • Engage in activities supporting reward and recognition, teambuilding, and diversity.
  • Support cross-functional coaching, mentoring, and training
  • Bachelor’s degree in scientific, health, communications, or technology related field OR Bachelor's degree in any field with at least two years of clinical development 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
  • Demonstrated mastery of written English with experience in medical, scientific or technical writing fields (at least 1 year); professional verbal skills in English.
  • Cognitive abilities including; verbal reasoning, attention to detail, critical thinking, and analytical ability.
  • Demonstrated project management and time management skills.
  • Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.
  • Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).
  • Ability to work well across cultures and time zones
  • Graduate degree with formal research component or in life sciences.
  • Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, or endocrine expertise).
  • Experience in clinical trial process or regulatory activities.
  • Experience writing regulatory or clinical trial documents.
  • Publication experience.
  • Ability to work well independently and as part of a team.
  • A writing exercise is required as part of the candidate evaluation process. Additional writing samples may be requested.
  • Limited travel, up to approximately 10%.
  • This position is not permanent. It is for a fixed duration of two years with potential to extend annually for up to 4 years.
  • 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.