Pharma Labeling SME

Confidential Company  •  New Brunswick, NJ

11 - 15 years experience  •  Biotech/Pharma

$110K - $120K
Posted on 10/17/17 by Manish Saraswat
Confidential Company
New Brunswick, NJ
11 - 15 years experience
Biotech/Pharma
$110K - $120K
Posted on 10/17/17 Manish Saraswat

 Title Pharma Labeling SME/Remote

 

Relevant Experience (in Yrs) 10+15 Years

 

Roles & Responsibilities

 

Requirement

 

Pharma Labeling SME

 

Intake call notes- Looking for a seasoned Labeling SME – 12-15+ years of experience. Remote is fine with possibility of very minimal travel to NJ (paid for.)

This is a 20 week assignment with around 500 hours’ worth of work, which can be completed on a flexible schedule.

They’d like candidates to have compliance experience (802 series), and strong CDS and CLDS exp. They will be a go to SME for the account providing suggestions, recommendations, etc. Should also have an understanding of working with Branding agencies.

1. Strong track record and experience in driving vision to a work plan

2. Creating a comprehensive enterprise plan for the delivery of the vision

3. Creating and delivering workshops with key business leads to gain consensus on the overall effort

4. Deep experience in LS and knowledge of/experiencewith all facets of labeling

5. Demonstrated ability to work with executive management

6. Ideally candidate lives in New Jersey, USA

This is what will be expected of the resource:

 

Design, conduct and develop findings for the Core Company Data Sheet (CCDS) As Is and To Be processes

Conduct workshop/readout/liaison on the CCDS findings, risk/PV assessment and evaluation

Design the optimal CCDS processes for the CoE and the necessary changes for region/local needs

Design metrics for determining the effectiveness of the CoE and regional CCDS processes

Develop the high level roadmap to implement the new CDS strategy and processes

Perform Date to Market (DTM) analysis focused on exceptions, operations, processes, spend and results

Identify areas of process, operations and transparency control of the DTM processes

Conduct meetings and information exchange with Regulatory, Labeling and operations leaders

Create optimal communication plan and read out

Develop the high level global roadmap and roll-out of future state

Provide expertize on global integration engagements

Work Location

 

New Brunswick, NJ/Remote

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