Technical Project Manager - RIMS

Employment type Contract

Job Title Sr. Technical Proect Manager with RIMS Experince

Job Location Remote

Duration C2C

Experience level 10

Mandatory Skills RIMS

Job Description

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

Veeva Systems 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 cloud-based solution for managing regulatory information across the enterprise.

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

What You'll Do

Lead software implementation projects at life sciences companies ranging from the world's largest pharmaceutical companies to emerging biotechs

Lead the solution design for implementation and use of the Vault Regulatory suite (Vault Registrations, Vault Submissions, Vault Submissions Archive, Vault Publishing)

Lead 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 healthcare 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 decisions 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

Nice to Have

Direct experience with systems such as Veeva Vault, PAREXEL / LIQUENT InSight, CSC Regulatory Tracker, ArisGlobal Register, OpenText, SharePoint, Documentum, FirstDoc / FirstPoint, NextDocs, CARA, Salesforce, Workday, Oracle, SAP, 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 related degree

SaaS / Cloud experience

Locality to major life sciences customer hub (NJ; Boston, MA; San Francisco, CA; Philadelphia, PA; Chicago, IL)

Tekshapers is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.