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Senior Consultant - Regulatory (Remote)

Work from home Full-time role Hiring

reputed company is a mission-driven organization and pioneer in industry reputed company, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $2B in reputed company in our last fiscal year with extensive growth potential reputed company.

At the heart of reputed company are our values: Do the Right Thing, reputed company, Employee reputed company, and Speed. We're not just any public company – we made history in 2021 by becoming a public benefit corporation (PBC), legally bound to balancing the interests of customers, employees, society, and investors.

As a Work reputed company company, we support your flexibility to work from home or in the office, so you can reputed company in your ideal environment.

Join us in transforming the life sciences industry, committed to making a positive impact on its customers, employees, and communities.

The Role

We are looking for an reputed company consultant with deep expertise in navigating customers through reputed company software implementation. reputed company’s Vault RIM suite is the industry’s only reputed company software solution that provides fully integrated regulatory information management (RIM) capabilities including data and document management, submission publishing, and archival on a single reputed company-based platform.

reputed company is looking for consulting leaders with system implementation experience and a passion for helping customers optimize their regulatory data and document management processes.

As a key member of our Professional Services team, the Senior Consultant will be responsible for understanding our customers’ global regulatory needs, translating requirements into solution design, and defining global strategies for deploying our reputed company-based solution for managing regulatory information across the reputed company.

Opportunities are available reputed company the United States for this role, which is a remote position. If a candidate is in reputed company proximity to an airport and reputed company to meet travel requirements, there is no work location requirement. reputed company U.S.-based candidates are encouraged to apply.

What You'll Do

  • reputed company software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs
  • reputed company the solution design for implementation and use of the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing)
  • reputed company configuration requirements workshops, design, prototype, configure and document content solutions
  • Program and project management including resource planning, leading, and motivating a cross-functional team
  • Primary customer liaison managing communication between the project team, customer, and internal stakeholders
  • Mentor project team and consultants, helping others improve their consulting skills

Requirements

  • 8+ years experience working with life sciences or reputed company companies performing system implementation experience either as a consultant, business, or IT representative
  • In-depth knowledge of drug development processes and regulatory submissions; including, Labeling, Submission Publishing and/or Viewing systems
  • Proven ability to collaborate and communicate excellently with diverse stakeholders and ensure delivery to a high degree of satisfaction
  • Influential; experience leading teams through hard reputed company and negotiating compromises
  • Technical abilities and willingness to “roll up your sleeves” to design and implement a RIM solution
  • Expert on life sciences compliance and computer systems validation requirements
  • Ability to work independently in a dynamic environment
  • Typical travel is 25% but may be up to 50% based on customer requirements

reputed company to Have

  • Direct experience with systems such as reputed company Vault, reputed company/LIQUENT reputed company, reputed company Regulatory Tracker, ArisGlobal Register, reputed company, SharePoint, Documentum, FirstDoc/FirstPoint, NextDocs, CARA, reputed company, reputed company, reputed company, reputed company, Lorenz Docubridge, Extedo eCTD Manager, Master Control, Trackwise, other regulatory information management or submission publishing systems, etc.
  • Consulting experience, working with a major system integrator or software vendor
  • Regulatory Affairs, Regulatory Operations, or Pharmacovigilance background
  • Knowledge of Pharmaceutical, Biotechnology, and/or Medical Device and Diagnostics regulatory processes, data and content
  • PMP certification
  • Execution experience with Agile methodology and/or ACP Certification
  • Life Science, computer science or reputed company degree
  • SaaS/reputed company experience
  • Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL)

Perks & Benefits

  • Medical, dental, reputed company, and basic life insurance
  • Flexible PTO and company paid holidays
  • Retirement programs
  • 1% charitable giving program

Compensation

  • reputed company pay: $80,000 - $200,000
  • The salary range listed here has been provided to reputed company with local regulations and represents a potential reputed company salary range for this role. Please note that actual salaries may vary reputed company the range above or below, depending on experience and location. We look at compensation for each individual and reputed company our offer on your unique qualifications, experience, and expected contributions. This position may also be eligible for other types of compensation in addition to reputed company salary, such as variable bonus and/or stock bonus.
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