Project Manager Business Process Change Management Regulatory & CMC (code USA 070120-1)

Reference: MI10497A

Expiry Date: 07-08-2020

Category Regulatory Affairs

Salary: Competitive

Job Type: Full Time

Location:
Durham County
United States

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Job Description

Project Manager Business Process Change Management Regulatory & CMC

About My Client

What I like about this company, is they have continually expanded in the last 15 years, and have achieved several high profile approvals, in disease areas where there was literally nothing of note previously to prescribe, and have delivered this expansion with a keen eye on quality and compliance. This role delivers as the business process owner with oversight for the Quality environment for regulatory and CMC.

If I look at the regulatory functions I normally work with, for every 100 FTEs you will find around 1-1.5 FTEs doing the role I have here. However, this company more than quadruples that statistic, because to meet their expansions, and continually grow, they have to deliver better processes, systems and update top level policies, every year, to ensure their continued compliance and operational excellence matched with their rapid growth.

If I look at web sites which employees can talk about my client, the phrases I see again and again are dynamic, fast moving, rewarding, and working in collaboration, this is not a role for an individual who does not like engaging with people, this is what the company thrives on.

This role is offered at Senior Manager grade which would equalize to other companies as somewhere between Senior Manager and Associate Director in terms of basic salary. The company offer Senior Managers a decent stock plan, which is unusual in the pharma industry and when you realize who my client is, you will understand the value of this employee benefit.

The Role

You will initiate, co-/lead with the partners / co-/sponsors, programs and workstreams aimed at producing more effective systems and processes, for a company which has 4 main technical workstreams, all with differing pharmaceutical development pathways, and for a worldwide supply chain which encompasses over 100 plus countries.

You will be regulatory aware, but this could be from doing a process improvement role in manufacturing and supply chain, or quality assurance, or pharma development, as well as within regulatory itself – my client is satisfied with any of these paths to this type of role. Also, if you have worked in a regulatory operations group, and have strong project management, then you would also be applicable.

You will ideally have any structured methodology for project management as well as 3 plus years’ experience in leading ideally regional or multi-national, business process improvement programs within a pharmaceutical or a biotechnology company.

Package & Benefits

This role comes with a decent package, health, insurances and a high performing stock plan, even at Senior Manager level.

To Apply!

To apply for this role, please press the red “Apply for position”, or contact Martin or Matt at ADV Talent on 855.505.1382. We wish you a successful 2020 and fortuitous year! 

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