Specialist, Scientific Compliance

Purpose

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. Evaluate organizational compliance needs and opportunities to improve efficiency and productivity.

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 Legal Operations Office of Ethics and Compliance Corporate Affairs Outsourcing Pharmacovigilance & Patient Safety Global Scientific Publications external partners and vendors and other R&D groups to ensure compliance with relevant policies regulations and industry standards throughout all research and development activities.

Responsibilities

• Serve as a Business Publication Representative (BPR) streamlining and overseeing the centralized scientific publication approval process for Development Sciences.
• Collaborate as part of a global BPR team engaging with cross-functional stakeholders at all organizational levels to facilitate publication and compliance objectives.
• Provide compliance guidance and support for Human Factors Research studies ensuring that processes tools and templates adhere to all applicable laws regulations and global AbbVie policies throughout their development implementation and maintenance.
• 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
• Anticipate and respond to unexpected occurrences and business needs.
• Identify and appropriately escalate potential compliance risks and recommend practical solutions
• Work in a highly team-based cross-functional environment for daily activities/decision-making
• With limited oversight manage several tasks simultaneously and adjust rapidly to significant changes in direction and environment with minimal impact on productivity.

Qualifications :

Required:

• Minimum of Associates degree (scientific field preferred)
• Typically 5 (Associates) 3 (Bachelors) or 2 (Masters) years related industry (i.e. GxP) experience.
• Basic understanding of GxP drug development/medical device processes (working knowledge preferred).
• Good interpersonal skills with ability to effectively communicate in a clear and persuasive manner; proficient in business/technical communications
• Good organizational and time management skills strong attention to detail.
• Demonstrates customer-oriented behavior and works well in a fast-paced global team environment.

Preferred:

• Experience with scientific publications and/or Human Factors Research studies is preferred.
• Familiarity with various software applications such as Microsoft platform (i.e. SharePoint OneNote Word Excel etc.) Smartsheet Datavision etc. is preferred
• Basic understanding of R&D drug development/medical device processes (working knowledge preferred).

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