Collaborating with business stakeholders and technical teams by analyzing, evaluating, and translating user requirements to drive optional solutions aligned with business outcomes.
Translating user requirements into clear, concise, and accountable documentation including user personas, use cases, journey maps, and process flows.
Developing user-friendly solutions using techniques grounded in agile and design thinking principles to uncover optimal workflows and user experiences with available technologies.
Supporting ongoing enhancements to Regulatory platforms and systems by gathering feedback, assessing change requests, and helping prioritize feature development.
Partnering with business product leaders to translate product updates into business outcomes to enhance user experience and adoption.
Engaging in continuous discovery to identify new opportunities by gathering user feedback, analyzing market trends, and assessing emerging business needs.
Maintaining an understanding of the portfolio of Regulatory technical solutions.
Supporting user training, act as an ambassador of digital solutions, and partner with business product leads to ensure smooth launch and adoption.
Collaborating with technical teams and users during UAT, validating business needs are met and identifying defects and/or gaps.
Supporting the design of Regulatory end-to-end processes aligned to the defined business strategy using established GRA Process Office governance, standards, and methodologies.
Supporting the business to establish efficiency, effectiveness, and experience KPIs for processes.

Requirements

Minimum of 6 years relevant experience in the pharmaceutical, life sciences, or healthcare industry is required
Demonstrated expertise in conducting business process analysis, problem framing, design thinking, and analytic techniques is required
Creative problem-solving skills with a focus on feasibility assessments is required
In-depth knowledge of Regulatory processes and global compliance standards (e.g, FDA, EMA, ICH) and technical solutions (e.g., RIM, Veeva, Calyx, etc.) is required
Aptitude to stay current with industry trends related to solutions and stakeholder needs is required
Proficiency in using agile tools and methodologies (e.g., Kanban, Scrum) is required
Strong understanding of data integrity, compliance and validation is required
Advanced knowledge of analytical tools (e.g., Tableau) is required
Excellent verbal and written communication skills are required
Sense of urgency to deliver results while balancing high-quality outcomes and an astute understanding of what constitutes “good enough.”
Excellent partnerships skills to foster collaboration across organizational boundaries are required
Action-oriented and inquisitive self-starter with ability to learn quickly and challenge status quo to deliver innovative solutions is required
Demonstrated experience leading and managing cross-functional teams is required
Big picture view to problem solving with attention to detail is required
Ability to distill and communicate complex analyses in a clear, effective way to various stakeholders is required
Demonstrates ability to lead with agility, champion a fail-fast and learning culture to enable rapid adaptation and deliver measurable outcomes is required
Thrive in working independently and in a fast-paced, matrixed environment is required
Develop and manage relationships with stakeholders and subject matter experts
Must be able to work independently with minimum supervision to meet tight deadlines, and maintain a positive attitude.

Benefits

Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
10 days Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

business process analysisdesign thinkinganalytical techniquesRegulatory processesglobal compliance standardsdata integritycompliancevalidationanalytical toolsagile methodologies

Soft Skills

creative problem-solvingexcellent communication skillscollaborationaction-orientedinquisitiveability to learn quicklyattention to detailleadershipability to work independentlysense of urgency