OperationsProject Management - Technical Project Manager III

Job Description : Sr. Manager RIMS

Remote

Key Skill : RIM Suite

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 cloudbased 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 cloudbased 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 Youll Do

Lead software implementation projects at life sciences companies ranging from the worlds 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 crossfunctional 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

Indepth 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)

Additional Sills : Skills :

Category

Name

Required

Importance

Experience

No items to display.

Key Skills

Abinitio,Editorial,Account Management,Drafting,Android Development,Brokerage

Employment Type : Full Time

Vacancy : 1