Associate Specialist, Scientific Compliance

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 Associates degree (scientific field preferred).
• Typically 3 (Associates) or 0-2 (Bachelors) 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 Companys sole and absolute discretion unless and until paid and may be  modified at the Companys 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  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time