Manager, RA-CMC Technical 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.

Individual is responsible for ensuring RA-CMC technical writing objectives are met by authoring/compiling the chemistry, manufacturing, and control (CMC) sections of clinical and marketing application documents. This position will also ensure proper communication with all key partners in the functional departments of Research and Development and Commercial groups in support pharmaceutical development and regulatory filings. 

Employee will also be responsible for providing oversight and direction to junior team members in accordance with the organization's policies and procedures. 

Manage, compile, and author CMC sections of major or complex regulatory submissions including, but not limited to, Investigation New Drugs (INDs) and Investigational Medicinal Product Dossier (IMPD), New Drug Applications (NDAs), Marketing Authorization applications (MAAs) and Quality Overall Summaries (QOS), Biologics License Applications (BLAs).  

Collaborate with diverse functional groups to ensure fileability and acceptance of CMC sections. 

Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. 

Interpret global regulations and appropriately apply, implement, and communicate regulation (established or draft guidance). Understand CMC expectations. Identify regulatory opportunities and risks. 

Independently provide tactical support to integrate technical issues with regulatory requirements and emerging standards. 

Identify, communicate, and with oversight propose resolutions to routine/complex issues. Articulate the implication of issue(s) to project team risk/benefit strategic component. 

Coach, mentor, and develop junior staff, including new employee onboarding. 

Provide guidance on use of submission document templates. 

Qualifications
Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline 

Experience in biological drug development is preferred  

4+ years of experience in pharmaceutical research and development or regulatory affairs 

2+ years of CMC regulatory experience is desirable  

A thorough understanding of current U.S. and global pharmaceutical regulatory requirements pertaining to CMC sections of regulatory filings is required 

Prior experience in the preparation of CMC sections of regulatory dossiers including electronic submissions  

Strong working knowledge of manufacturing unit operations 

Superior oral and written communication skills 

Ability to work cooperatively with all levels and types of global personnel required 

Experience working with electronic document management systems 

Ability to work independently under pressure and manage multiple projects simultaneously 

Detail/accuracy oriented 

Collaborative and willing to learn  

Familiarity with US and other international regulatory requirements for drug product dossiers 

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
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.