Senior Coordinator, Medical Writing

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Title : Senior Coordinator, Medical Writing

Purpose :
The Senior Coordinator, Medical Writing is responsible for providing regulatory document support to the medical writing teams, ensuring successful preparation of high quality submission-ready documents. Provides expertise in the management and coordination of casebooks, and other appendix 16 documents ensuring timely completion, completeness, and formatting accuracy. Assists in the compilation of literature references and ensures delivery into the electronic submission system. Manages and performs electronic navigation QC on these documents and manages workflows. Serves as an expert on the electronic document system in support of the clinical team. Serves as subject matter expert on cross-functional teams supporting the implementation of new regulatory initiatives impacting the compilation of CSRs (i.e. eCTD). Coaches and mentors more junior Medical Writing Coordinators. Participates in process improvement activities.

Responsibilities :

• Implements selected activities (such as document workflows, tracking, and electronic QC) associated with electronic document-related activities for regulatory documents. Communicates deliverables, electronic document process, and durations associated with these activities to the Medical Writing Manager, Clinical Project Management, and other functional areas such as Publishing, etc., as required.
• Ensures all electronic document deliverables are processed and compiled in alignment with timelines. Manages workflows for review/approval in eSubmission system.
• Coordinates, tracks completion, and manages acceptance of casebooks and appendix documents. Manages eDoc tracking spreadsheet.
• Prepares documents for submission to RIC, Data Management, and Regulatory Affairs. Manages process and performs electronic QC of casebooks and appendices.
• Confirms completeness of information in appendix documents (e.g. CSR).
• Acts as interface to resolve issues associated with casebooks and appendices through ongoingcommunication with the clinical team. Maintains strong knowledge of casebook and appendices organizationand content.
• Compiles and organizes literature references for regulatory documents. Performs literature searches.
• Acts as eDocs Peer Advisor/Subject Matter Expert for assigned clinical teams. Must continually train/be compliant with all current industry requirements as they relate to regulatory submissions, including electronic submission/approval standards. Responsible for effective communication among team members. Holds team members accountable to agreed-upon deliverables and dates.
• Coaches and mentors more junior Medical Writing Coordinators. Participates in process improvement activities.
• Serves as an expert on the electronic document system in support of the clinical team. Serves as subject matter expert on cross-functional teams supporting the implementation of new regulatory initiatives impacting the compilation of CSRs (i.e. eCTD).

Qualifications

Qualifications :

• List required and preferred qualifications up to 10). Include education, skills and experience.
• Bachelor of Arts or Bachelor of Science or Associates Degree preferred; equivalent experience considered.
• 2-3+ years in clinical research or related field.
• Strong knowledge of organization and content of clinical documents.
• Strong knowledge and experience with CTD content templates.
• Excellent written and oral communication skills.
• Superior attention to detail.
• High level computer skills. Proficient in electronic document management system. Excellent working knowledge of software programs in Windows environment.
• Experience in working with collaborative, cross-functional teams.

Significant Work Activities
Keyboard use (greater or equal to 50% of the workday)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.