Manager Medical Writing Operations

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.

Assist in selection, building, management, and oversight of Medical Writing Operations (MWOs) high-performing team (Medical Writing Coordinating/Report Publishing and Documentation Specialists -- MWCRPDS, Quality Control -- QC, and/or Word Processing & Standards – WP&S) in support of multiple compounds, therapeutic areas, and global regulatory submissions, including the oversight of work products, business processes, and activities.  Assist in the selection, management and oversight of vendor(s) and staff for area and approval of invoices within budgetary spend.  Assist in developing team via coaching and mentoring.  Assist in scheduling work and managing resources/workload to meet timelines and quality standards.  Assist in developing, implementing, and maintaining standardized business process(es) and job aids in support of regulatory requirements for the document support provided by MWOs.  Key contributor in process and operational improvement activities.  Ensures consistent approach to real-time inspection readiness by providing leadership as subject matter expert (SME) for audits/inspections.  Assists in the selection, management and oversight of vendor(s) and staff for area and approval of invoices within budgetary spend.  Assist in resourcing, initiating, and managing contract(s) with vendor(s) through execution.  Assist in initiating and managing Vendor Oversight Plans (VOPs) through execution. 

1.  Assist in selection, building, management, and oversight of Medical Writing Operations (MWOs) high-performing team (MWCRPDS, QC, and/or WP&S) in support of multiple compounds, therapeutic areas, and global regulatory submissions, including the oversight of work products/activities.  Cross train with other MWOs Managers as assigned.  Support/act as back up to Associate Director, MWOs for area. 

2.  Assist in developing team via coaching and mentoring.  Assist in scheduling work and managing resources/workload to meet timelines and quality standards, including the oversight of archival of documents processed in content management system(s). 

3.  Effectively communicate to and among team members and across all levels of the organization.  Develop and maintain strong collaborative relationships cross-functionally and globally. 

4.  Coordinate all activities, including cross-functional ones utilizing skills/expertise and drug development knowledge.  Lead project team meetings and hold team members accountable to the deliverables/timelines. 

5.  Participate and is a key contributor in process and operational improvement activities.  Form, lead, and maintain internal/external collaborative cross-functional process and operational improvement activities and initiatives/teams, including the application of change management. 

6.  Monitor, complete, and report metrics to management as needed.  Analyze metrics and recommend appropriate action (areas for improvement, trend identification, escalate areas of concern). 

7.  Ensure consistent approach to real-time inspection readiness by providing leadership as SME for audits/inspections.  Ensure maintenance of documentation by team in preparation and in support of audits/inspections.  

8.  Assist in developing, implementing, and maintaining standardized business process(es) and job aids in support of regulatory requirements for the document support provided by MWOs to ensure accurate, timely completion, and delivery of high-quality submission-ready clinical regulatory documents.  In addition, for WP&S, assist in developing, implementing, and maintaining global clinical standards/compliant templates related to the submissions business process(es) for clinical regulatory documents. 

9.  Assist in resourcing, initiating, and managing contract(s) with vendor(s) through execution, including the maintenance of contract actuals.  Assist in initiating and managing VOPs through execution, including ensuring that all related documentation is obtained and archived.  Assist in the selection, management and oversight of vendor(s) and staff for area and approval of invoices within budgetary spend. 

10.  Direct reports may include:  medical writing coordinators and/or documentation specialists; or entry level quality control associates; or entry level medical writing document associates. 

Qualifications

1.  Bachelor's degree required.   Bachelor's degree in Science, English or Communications preferred. 

2.  4-6 years relevant industry experience in medical writing or a related area such as clinical research, drug development, quality assurance/control, regulatory, report/submission publishing, or product support/R&D. 

Note:  Higher education may compensate for years of experience.  Years of experience may also compensate for lower education. 

3.  1 year project management experience in MWOs (Medical Writing Coordinating/Report Publishing and Documentation Specialists, Quality Control, and/or WP&S) or related area, including scheduling work and managing resources/workload (anticipated/unanticipated requests, time/resource management). 

4.  Experience managing employees preferred or demonstration of successful coaching/mentoring in a matrix environment.  Ability to assist in the selection, building, management, oversight, resource planning/allocation of functional resources, leadership, development, and direction for direct staff. 

5.  Expert knowledge and application of global regulations, requirements and guidance associated with clinical regulatory document preparation and submissions and the ability to advise others regarding compliance with regulations and to apply towards the development and maintenance of business processes, job aids/tools, and training.    Knowledge and expertise with Common Technical Document content templates. 

6.  Extensive experience in working with collaborative, internal/external cross-functional teams building effective working relationships with a leadership track record across all levels of the organization.  

7.  Excellent communication (oral, written, interpersonal, organizational), planning, execution, and team leadership skills.  Superior attention to detail.  Ability to influence current thinking and without direct authority.  Developing strength in personal and technical leadership.  Analytical/critical thinking and conflict management skills at operational and tactical levels. 

8.  Competent in the application of Medical Writing Operations business processes. 

9.  High degree of proficiency, skill, and knowledge in computer literacy (hardware and software)/technical skills (ability to apply towards process improvements/operational efficiencies/automation). 

10.  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). 

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
No
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
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.