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.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
The Technical Writer will serve as a principal technical writer with responsibility for authoring and reviewing technical documents (e.g., MBR, change controls, protocols and reports), and the quality sections (i.e., Modules 2 and 3) of Common Technical Document (CTD) for regulatory submissions. This role will report to the Senior Director, Chemistry Manufacturing Controls - Late Phase. This role will work closely with Project Management to develop timelines and deliverables of CMC documents.
Responsibilities:
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Responsible for writing, editing, and reviewing the CMC sections of CTD for regulatory submissions.
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Perform quality control and peer review of CMC documents prepared by the CMC and other cross-functional teams.
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Format CMC documents, and create templates as needed to support regulatory submissions.
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Contribute and provide technical support in the preparation and interactions with regulatory agencies regarding drug submissions and responding to inquiries.
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Review data, interpret results, and author technical reports in accordance with Good Documentation Practices for cGMP manufacture
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In accordance with Good Documentation Practices, author and review technical documents including research reports, process development reports, qualification/validation protocols, and documentation for the manufacturing of drug products under cGMP.
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Compile and present data from multiple sources (e.g. technical and development reports).
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Act as an expert in technical writing and provide high quality documentation in a timely manner.
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In collaboration with Project Manager and cross-functional teams, develop timelines and deliverables of CMC documents to accomplish project goals.
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Contribute and provide technical support in the preparation and interactions with regulatory agencies regarding drug submissions and responding to inquiries.
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In collaboration with the Manufacturing, QA/QC and Project Management teams, design, maintain and continuously improve a CMC documentation system.
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Provide verbal and written reports and presentations to managers in a clear and concise manner.
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Adhere to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements.
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Plays a critical role in developing and maintaining good relationships with cross-functional teams, CMOs, and other external partners.
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Embody and promote a quality culture and “right-the-first-time” approach as part of all activities.
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Work well in a fast-paced team environment.
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Perform other duties as assigned.
Basic Requirements:
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B.Sc. in a life science-related discipline and 3-5 years professional experience in technical or scientific writing.
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Strong oral and written communication skills required.
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Strong scientific and analytical skills required.
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Advanced in MS Word, Excel, and Adobe Acrobat is required.
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Ability to work effectively in a multi-disciplinary team setting is required
Additional Preferences:
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Experience in a GMP setting is highly preferred.
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Experience with project management tool(s) is an asset.
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Experience with radiochemistry is an asset
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Strong interpersonal skills.
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High attention to detail, well organized, and highly motivated.
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Excellent ability to multitask and prioritize workload.
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Excellent planning skills with the ability to work seamlessly as part of a team or independently.
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Experience in an FDA regulated environment a plus.
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Proficient in MS 365 (Excel, Word, PowerPoint).
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Remain calm and maintain composure in a fast-paced environment.
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Operate and execute with an extreme sense of urgency.
Additional Information:
Physical Demands/Travel:
The physical demands of this job are consistent with an office environment. Occasional travel (less than 10%) may be possible.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
Work Environment:
This position’s work environment is in an office.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
- To perform this job successfully, an individual must be able to perform the role and responsibilities satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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 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.
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