Associate Specialist, Scientific Compliance

Company Description

About AbbVie

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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Ensure GxP compliance to AbbVie policies/processes/procedures, global regulatory requirements, and industry guidelines. Remain current with major compliance trends and their application within the biopharmaceutical industry.

Role Overview:

Serve as a business compliance liaison for Development Sciences (Dev Sci) scientific personnel involved in pipeline research and product development. Collaborate with cross-functional teams, including personnel from Dev Sci, other R&D groups, including QA, and AbbVie Operations, to ensure compliance with relevant policies, regulations, and industry standards throughout all research and development activities.

Key Responsibilities

• Ensure compliance with Quality System (QS) documents, including the creation, modification, and management of QS documents.
• Collaborate as part of a global document management team, engaging with cross-functional stakeholders at all organizational levels to facilitate document management and compliance objectives.
• Act as a centralized point of contact to support the Quality Intelligence process on behalf of Development Sciences.
• Learn new skills and contribute where needed within the Scientific Compliance team to support an “All for One AbbVie” approach.
• Adhere to codes of conduct and ethical principles and ensure compliance with applicable AbbVie policies and procedures.
• Utilize systems, documents, and tools to provide compliance support for centralized business function processes
• Support compliance and process improvement initiatives to enhance efficiency and compliance.
• Respond to unexpected occurrences and business needs.
• Identify and appropriately escalate potential compliance risks.
• Work in a highly team-based, cross-functional environment for daily activities/decision-making.
• With oversight, manage several tasks simultaneously.

Qualifications

• Minimum of Associate's degree (scientific field preferred).
• Typically 3 (Associate's), or 0-2 (Bachelor's) years of industry related (i.e. GxP) experience.
• Experience with document management processing is preferred.
• Familiarity with various software applications such as Microsoft platform (i.e., SharePoint, OneNote, Word, Excel, etc.), Veeva Vault, Salesforce (AbbVie OneTrack), etc. is preferred
• Basic understanding of R&D drug development/medical device processes preferred.
• Good interpersonal skills with ability to effectively communicate in a clear manner; proficient in business/technical communications.
• Good organizational and time management skills.
• Strong attention to detail.
• Works well in a fast-paced global team environment

Additional Information

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 an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html