Medical Writing Operations Associate (Remote)

The Strategic Medical Writing Operations Team is dedicated to delivering high-quality scientifically accurate and strategically aligned clinical and regulatory documentation that supports AbbVies 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 AbbVies commitment to improving patient outcomes worldwide.

Responsibilities:

• Defines scope of formatting report publishing or 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 and meet required timelines. 
• Ensure completeness of information in CSR Appendices.  Maintain strong knowledge of CSR/CSR appendices organization and content and knowledge of 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.

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

Qualifications :

• 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.
• High School diploma required.  Note: Higher education may compensate for years of experience. Years of experience may also compensate for lower education.
• 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 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 of this 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. 

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 any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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 & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Yes

Employment Type :

Full-time