Senior Analyst, Submission Management
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.
Under limited supervision, electronically prepares documentation that is complete, accurate, on time, and electronically functional. Publishes complex reports under minimal supervision. Publishes portions of dossiers for global registrations under supervision, and INDs, eCTDs, NDAs, BLAs, supplements and amendments as well as Device IDEs, PMAs and 510ks. Understands guidelines and requirements for electronic publishing of reports and selected sections of dossiers. Responsibilities also include archiving regulatory submissions in accordance with company standards.
KEY DUTIES AND RESPONSIBILITIES:
- Source Document Preparation: Electronically prepares documentation that is complete, accurate, on time, of high quality and electronically functional.
- Electronic Publishing: Ensure completion of high quality submissions, following regulatory guidelines and internal process within timelines. Compile, QC and publish components for Investigational New Drug Applications and Clinical Trial Applications (IND/CTAs) and Marketing Applications. Compile, QC and publish IND/CTA annual reports, monthly packages, new protocol and amendment submissions. Publishes complex reports under minimal supervision. Archive submissions in accordance with regulatory guidelines and company standards.
- Knowledge and Advisory Responsibilities: Strong knowledge of Adobe Acrobat, Microsoft Word, ISI Toolbox, Documentum, Insight Publisher and Sharepoint. Able to provide guidance to others. Has general knowledge of key electronic report/submission requirements and relevant guidance documents and regulations. Limited ability to interpret requirements. Participates on electronic publishing process development teams as assigned by supervisor. Provides limited guidance to team with input from supervisor. Provides limited support to other regulatory personnel on teams.
- Communications: Under direction of supervisor, contacts technical counterparts in other areas of the company. Contacts vendors in absence of senior personnel. Prepares and delivers presentations as required within the department with input from supervisor. Prepares and delivers training as required within the department with input from supervisor.
Education and Experience
- Bachelor’s degree or country equivalent in pharmacy or related scientific discipline with a minimum of 2 years regulatory or equivalent experience within a pharmaceutical company, CRO, or similar organization. Higher degree/PhD will be an advantage.
Essential Skills and Abilities
- Excellent communication Skills: Written , verbal, and interpersonal
- Strong knowledge of electronic submission guidance documents and regulations. Strong understanding of the registration and maintenance process.
- Ability to identify compliance risks and escalate when necessary
- Computer literate with working knowledge of Adobe Acrobat, Microsoft Word, ISI Toolbox, Documentum and Sharepoint necessary to perform specific job functions.
- Ability to multitask, prioritize, and manage multiple projects and deadlines
- Sense of personal responsibility & initiative
- Ability to travel
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % of the Time
Job Level Code
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.