We are seeking a highly skilled Senior Business Analyst with extensive experience in the pharmaceutical industry, specifically in Quality, Regulatory, and Safety domains. The ideal candidate will have a strong background in software applications relevant to these areas and will be responsible for analyzing business needs, identifying solutions, and ensuring compliance with industry standards.
KEY RESPONSIBILITIES
Collaborate with stakeholders to gather and document business requirements.
Analyze and interpret regulatory guidelines and ensure compliance in all processes.
Develop and maintain documentation related to Quality, Regulatory, and Safety processes.
Work closely with IT teams to implement software solutions that meet business needs.
Conduct data analysis to support decision-making and process improvements.
Facilitate meetings and workshops to drive project goals and objectives.
Provide training and support to end-users on new systems and processes
MUST-HAVES :
Minimum of 8 years of experience as a Business Analyst in the pharmaceutical industry.
Strong knowledge of Quality, Regulatory, and Safety standards and practices.
Proficiency in software applications related to Quality, Regulatory, and Safety domains (e.g., TrackWise, Veeva Vault, Argus Safety).
Bachelors degree in Business, Information Technology, or a related field.
Excellent analytical and problem-solving skills.
Strong communication and interpersonal skills.
PLUSSES :
advanced degree (MBA, MS) in a related field.
Certification in Business Analysis (CBAP, CCBA).
Experience with data visualization tools (e.g., Tableau, Power BI).
Knowledge of GxP, FDA, EMA regulations.
Experience in project management.
Familiarity with Agile methodologies.
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Pharma • Boston, MA, US
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