Writing Jobs in Evansville, IN

Last updated: 1 day ago

Promoted

Manager, Global Scientific Communications (GSC) Regulatory Writing

Eli Lilly and CompanyRemote, Indiana, Remote, Indiana

$63,000.00–$140,800.00 yearly

Remote

Full-time

Manager, Global Scientific Communications (GSC) Regulatory Writing

Eli Lilly and CompanyRemote, Indiana, Remote, Indiana

1 day ago

Salary

$63,000.00–$140,800.00 yearly

Job type

Full-time

Remote

Job description

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

63,000 - $140,800

Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, 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 purpose of the Manager, GSC Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of documents intended for regulatory audiences (including, but not limited to, protocols, clinical study reports, briefing documents, regulatory responses, Investigational New Drug Applications, and marketing authorization applications).

Primary Responsibilities :

1. Content Strategy and Execution : Document Preparation, Development and Finalization / Document Management

Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.
Plan (including organizing / preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development / product registration.
Conduct effective document initiation meeting to ensure authoring team alignment and understanding.
Build scientific-based rationale that support the purpose of more complex and / or strategic documents.
Ensure data are presented in a clear, complete, accurate, and concise manner.
Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.
Coordinate expert / scientific reviews, collate reviewer’s comments, adjust content of document as required based on internal / external input, and prepare final version.
Ensure and coordinate quality checks for accuracy.
Exhibit flexibility in moving across development and preparation of multiple document types.
Influence or negotiate change of timelines and content with other team members.
Work with internal and external experts to develop and prepare presentations.
As needed, may build and manage relationships with vendors / alliance partners.

2. Project and Stakeholder Management

Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents.

Build / communicate credible writing project timelines.

Anticipate and mitigate risks to delivery.

Work with teams and collaborators to ensure timely development of documents and raise issues to ensure document completion.

Effectively communicate project status to partners.

3. Knowledge and Skills Development

Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s).

Flexibility moving across document types, therapeutic areas, and compounds, depending on project assignment.

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 participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and / or current awareness literature updates and reviews.

Maintain and enhance the scientific communications skills to align with the audience needs and with the changes in technology and platforms.

4. Knowledge Sharing

Provide mentorship to others by sharing technical information, giving guidance, answering questions.

Recognized for technical expertise in document development.

Network with others (including other functions and regions) to identify and share standard methodologies.

Contribute to process improvements, suggesting opportunities where appropriate.

Provide database and other tool (e.g., document management systems) expertise..

Minimum Qualification Requirements :

Bachelor’s degree in a scientific, health, communications, technology health related field.

2+ years proven writing experience in pharmaceutical industry

Demonstrated experience in technical / regulatory scientific writing.

Strong communication and interpersonal skills.

Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)

Other Information / Additional Preferences :

This position is home based in the US with 1 to 4 weeks travel annually.

Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)

2+ years experience in technical / regulatory scientific writing

Strong communication and interpersonal skills.

Demonstrated experience in technical / regulatory scientific writing.

Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields.

Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to hiring area (e.g., neuroscience, oncology, cardiovascular, immunology or endocrine expertise).

Experience writing regulatory, clinical trial documents and / or publications

Demonstrated ability to communicate and influence external strategies of business partners across different geographies and culture

Ability to balance multiple activities, prioritize and manage ambiguity

Demonstrated exemplary teamwork / interpersonal skills

Demonstrated problem solving, attention to detail and result oriented behaviors in a fast-paced environment.

Additional Skills and Preferences :

Graduate degree with formal research component or in life sciences.

Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields.

Experience writing regulatory, clinical trial documents and / or publications

Experience in clinical development, clinical trial process or regulatory activities.

Demonstrated project management and time management skills.

Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).

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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