Medical Writing Coordinator/Publisher I

Allergan; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

AbbVie is seeking a Medical Writing Coordinator/Publisher I to join the Strategic Medical Writing Operations Team. The role focuses on delivering high-quality clinical and regulatory documents, bridging research, development, and submissions.

Responsibilities include formatting, CSR appendices, RIMS publishing, and ensuring templates compliance. Candidates should be detail-oriented with strong communication, and be able to work independently or in a team.

Qualifications

• High School diploma required. Higher education may compensate for years of experience.
• Minimum of 2 years of relevant industry experience in medical writing in pharma, biotech, life sciences, or related fields.
• Familiarity with CTD content templates and eCTD structure.
• Excellent written and oral communication skills with scientific terminology across multiple therapeutic areas.
• Detail-oriented with commitment to high quality, accurate, and compliant documentation.
• Strong communication, collaboration, and organizational skills.
• Ability to work independently and in a team.
• Proficient in Microsoft Office suite and publishing tools; familiarity with content management systems (eTMF/eSubmissions).

Responsibilities

• Define scope of formatting, CSR Appendices activities, and route documents in RIMS.
• Ensure document format and styles align with RIMS templates and CTD content.
• Publish documents in RIMS meeting timelines and maintain CSR knowledge.
• Confirm completeness of Casebooks and References in RIMS.
• Contribute to process development and act as SME for master file systems.
• Communicate deliverables clearly to stakeholders.
• Assist in centralized mailbox management and metrics reporting.
• Mentor junior medical writing staff.

Education

High School diploma

Tools

Microsoft Office

Adobe

Veeva Vault

CARA

EndNote

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, Xand YouTube.

Job Description

The Medical Writing Coordinator/Publisher I part of the Strategic Medical Writing Operations Team is dedicated to delivering high-quality, scientifically accurate, and strategically aligned clinical and regulatory documentation that supports AbbVie's mission to transform the standard of care. Our team serves as a critical link between research, development, and regulatory submissions, ensuring clarity and compliance in all clinical and regulatory documents. We strive to innovate and enhance the processes of medical writing through cross-functional collaboration, agile methodologies, and the integration of cutting-edge technology, driving forward AbbVie's commitment to improving patient outcomes worldwide.

Responsibilities:

• Defines scope of formatting, report publishing and Clinical Study Reports (CSR) Appendices activities with the document author. Coordinate and track activities and perform detailed quality reviews. Import and route documents in the regulatory information management systems (RIMS).
• Ensure document format and styles are consistent with the defined in RIMS and are consistent with the clinical and regulatory templates. Ensure document properties and naming conventions are used. Maintain strong knowledge of RIMS styes and formatting standards.
• Ensures all documents are published in RIMS content management system meet required timelines. Maintain strong knowledge of RIMS and publishing tools/software.
• Confirm completeness of documents (e.g. Casebooks, Literature References) by obtaining, compiling, and organizing in the regulatory information management system (RIMS). Maintain strong knowledge of CSR and CSR Appendices and CTD structure.
• Contributes to the development, implementation, and maintenance of medical writing operations business processes. Acts as subject matter expert (SME) for the master file system and formatting, report publishing, or Clinical Study Reports (CSR) Appendices to the medical writing stakeholders.
• Effectively communicates deliverables needed to stakeholders. Must demonstrate good interpersonal and organizational communication skills, including conflict management skills.
• Assists in the management of the centralized mailbox. Tracks and maintains metrics and assists in the preparation and maintenance of training documents.
• Mentors and provides guidance and training to less senior medical writing operations staff members.

Significant Work Activities:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required.

Qualifications

• High School diploma required. Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
• A minimum of 2 years of relevant industry experience within medical writing in a global pharma, biotech, life science, federal agency organization delivering medicines/ therapies to a broad market across various therapeutic areas.
• Background of organization and content of clinical documents and eCTD structure. Knowledge of drug development and experience with Common Technical Document (CTD) content templates.
• Outstanding written and oral communication skills, with a comprehensive knowledge of medical and scientific terminology across multiple therapeutic areas.
• Detail oriented with a commitment to delivering high quality, accurate and compliant documentation.
• Strong communication, collaboration, and organizational skills.
• Ability to work independently and as part of a team. Ability to work independently and as part of a team.
• Proficient skills and knowledge in Microsoft Office Products (Excel, OneNote, Outlook, PowerPoint, Project, SharePoint, Visio, Word) and Adobe in Windows operating system environment required. Proficient skills and knowledge in Microsoft document file formats (DocX) or other style file format tools, publishing software, and content management archival system(s) for eTMF/eSubmissions (Veeva Vault, CARA). Proficient skills and knowledge in reference management software (e.g., EndNote).

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographiclocation, and we may ultimately pay more or less than the posted range. This range may be modified in the future.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssole and absolute discretion unless and until paid andmay bemodified at the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html