Scientist l, Regulatory Documentation

AbbVie's mission is to discover and deliver innovative medicines and solutions 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, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Purpose: 

This role resides in the documentation team under the Local Delivery Safety Translation Sciences (LDSTS) team. This role is responsible for generating templates, tables and figures, and prepare study reports for Local Delivery Translational Sciences (LDTS) and LDSTS teams. He/She will work with program representatives to establish timelines and coordinate activities to meet timely completion of documents in support of regulatory submissions.

The Scientist, I, in collaboration with LDTS and LDSTS members, will prepare, review, and format documents, study protocols, and study reports with high quality and as needed, in accordance with electronic submission requirements.   This role is also responsible for performing detailed QC of data in reports, and assisting with formatting and quality check of nonclinical sections of regulatory documents (INDs, CTDs, IBs, and others).  

In addition, approximately 25% of the time, this role will serve as the archivist responsible for archiving pathology samples and document. He/she will be responsible for maintaining the procedures necessary to ensure compliance with quality standards for the complete document lifecycle from generation to archiving to disposition.   He/she will document in an electronic RIMS system and archive data to meet regulatory requirements with an initiative to digitalize any data forms and/or notebooks; to ensure the receipt, inventory, disposition, tracking, and retrieval of LDTS/LDSTS documentation and other forms of raw data and assets.   He/she coordinates the transfer of data, assets, and documentation to long term storage facilities for in-house and AbbVie-Sponsored studies and performs item-specific inventory and indexing of incoming documents, data, and specimens.   He/she issues study notebooks to personnel, maintains personnel records and provides computer system support to personnel, for systems used within or by LDTS/LDSTS.   In addition, the incumbent will represent LDTS/LDSTS at Records Council, a global records management organization to collaborate on alignment of new processes and systems.

The incumbent will be asked to support writing nonclinical study reports, nonclinical literature searches, and publishing.   He/She will work with program representatives to establish timelines and coordinate activities to meet timely completion of documents in support of research study reports.

The individual must operate with minimal supervision.   In addition to a scientific background, this position requires familiarity with Windows-based platforms, comfort working in a computerized environment, and ability to learn electronic databases and enterprise management software.   Excellent oral and written communication skills are required.

Responsibilities: 

·        Assists LDTS and LDSTS staff with preparation of contributing and final reports, completing assignments.   Assure reports meet departmental standards for formatting, consistency, and adherence to AbbVie Styles.   Using electronic document management systems, works with study personnel to generate tables and assemble reports that accurately and precisely describe study data.  

·        Common Technical Documents (CTD) tabular summary templates for reports and regulatory submissions.   Performs submission QC for format and accuracy of content, and performs technical QC on published submissions.   Good understanding of requirements for nonclinical modules of the eCTD.

·        Facilitates and coordinates assembly, including timelines, of documents for regulatory submissions globally.

·        Maintenance of detailed records and control of documents transferred to and from LDTS/LDSTS to long-term storage facilities.  

·        Accessioning of records to ensure materials are recorded and indexed for archiving.

·        Maintaining and organizing the Irvine nonclinical archive rooms and filing of documents, specimens and samples.

·        Assists in the retrieval of physical and digital information assets needed for scientific and regulatory purposes.  

·        Assists in maintaining regulatory and training records and documents for study personnel. Electronically distributes study protocols and protocol amendments to study personnel for documentation that they have been read & understood, as requested.

·        Supports LDTS and LDSTS document administration using laboratory information management systems (LIMS, e.g., Provantis) to generate templates and tables for topline data and study reports.

·        Works with LDST and LDSTS staff to produce protocol and report templates for various document types utilizing automated and/or manual data collections systems. Scientific writing skills preferred. 

Qualifications:

•Bachelor’s Degree or equivalent education with typically 5 years of experience, or Master’s Degree or equivalent education with typically two years of experience.
•Theoretical and practical knowledge to carry out the job functions.
. Good understanding of electronic documentation systems, quality assurance and/or regulatory affairs.

•Skilled use of Windows based systems, advanced word processing principles, databases, spreadsheets, page layout software, and conceptual knowledge of enterprise-wide document systems.

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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.