Description

ICompany Description

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 - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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:

• Responsible for the formatting, report publishing and coordination of the Clinical Study Reports (CSR) Appendices for clinical and regulatory documents. Collaborates with the document author and tracks activities and perform detailed quality reviews. Import and route documents in the regulatory information management systems (RIMS).
• Formats documents to the defined styles and confirms consistency with the clinical and regulatory templates. Ensures the RIMS document properties and naming conventions are followed. Maintain strong knowledge of RIMS styes and formatting standards.
• Publishes documents in RIMS and maintain strong knowledge of RIMS system and publishing tools/software.
• Coordinates the CSR Appendices and confirm completeness of documents (e.g. Casebooks, Literature References) by obtaining, compiling, and organizing in the 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 strategic 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 strategic 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

• A minimum of 4 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
• High School diploma required
• 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 Ares.
• Detail oriented with a commitment to delivering high quality, accurate and compliant documentation.
• Strong communication, collaboration, and organizational skills.
• Ability to interpret statistical analyses of clinical data.
• Ability to work independently and as part of a team.

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time ofthis posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location,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/vision insurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
• This job is eligible to participate in our long-term incentive programs

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of anybonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's soleand absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable 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.htmlI