What are the responsibilities and job description for the Manager, Regulatory Affairs - Advertising & Promotion position at Xeris Pharmaceuticals, Inc.?
Overview
The Manager, Regulatory Affairs role is responsible for creating the FDA submission package for promotional material in Veeva PromoMats, and for general system administration and configuration for Veeva PromoMats. This role resides within the group who owns the Advertising and Promotion process, and the system that enables the process (Veeva PromoMats). An ideal candidate will understand the advertising and promotional review process, have back-end experience with advertisement and promotion systems and software or have general Information Technology or Systems Administration experience within the Pharmaceutical or Med Tech industry.
Responsibilities
- Responsible for Veeva PromoMats system administration and ensuring system configuration meets the needs of the evolving business and advertising and promotional review process
- Responsible for working with Veeva Managed Services, Marketing team members, and advertising and promotional review process owner to identify, test, and implement system configurations
- Responsible for executing Veeva PromoMats system updates (i.e., workflows, configurations, lifecycle management, XML management, spreadsheets, templates, etc.).
- Compiles regulatory documents for FDA submission (eCTD experience preferred), which includes tracking of status and progress of regulatory documentation, reviewing, editing and proofreading regulatory documentation, participating as an active team member of project teams as required, maintaining regulatory files in a format consistent with requirements as well as staying aware of regulatory requirements.
- Develops training material for promotional review process and system and liaises with cross functional teams
- Supports regulatory responsibilities and other internal systems within Veeva platform
Qualifications
- Bachelor’s degree required
- Pharmaceutical industry experience preferred; minimum of 5 years of regulatory experience or technology concentration in life sciences, technical/engineering or related field
- Understanding of Veeva software design, Zinc software design, or similar system design. Experience with Veeva PromoMats preferred
- Understanding of Tableau software design
- Strong digital competency and technical systems skills (i.e. databases, XML and Microsoft Office 365 including SharePoint, Power Automate and Excel)
- Proofreading and editing skills
- Ability to contribute to multiple projects from a regulatory affairs perspective
- Knowledge of regulations for FDA submission preferred
- Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Project Management, Adaptability, Professionalism, Written and Verbal Communications
- Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations.
- Periodic overnight travel. This position is based in Xeris’ Chicago office and requires a minimum of three days per week in the office.
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As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors.
The anticipated base salary range for this position is $145,000 to $170,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process
NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.
Salary : $145,000 - $170,000
