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Supply Chain, Forecasting and Planning, Clinical Supplies

Sunrise Systems Inc Summit ,NJ
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Sunrise System Inc. is currently looking for Supply Chain, Forecasting and Planning, Clinical Supplies in Summit, NJ with one of our top client.

Job Title: Supply Chain, Forecasting and Planning, Clinical Supplies

Job Id: 20-02652

Location: Summit, NJ 07901

Duration: 9 months

Position Type: Hourly contract Position (W2 only)

Summary

· Purpose And Scope Of Position This individual's primary responsibility will be to create and maintain supply strategies for all investigational product based on the scientific and regulatory confines of the drug's development with minimal supervision from the Forecasting and Planning Manager.

Knowledge, Skills, and Abilities

· Moderate / Strong knowledge of the global drug development process and global regulatory requirements.

· Proficient and strong analytical skills.

· Strong communication and negotiation skills.

· Proficient and strong Project management skills.

· Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e.

· Manufacturing, Packaging & Labeling, IVRS, Logistics, Quality, Stability, etc.

· Proficient knowledge of import / export requirements.

· Proficient/Strong knowledge of IVRS and CTMS systems.

· Proficient / Strong knowledge of industry technology.

· Applies and drives Forecasting and Planning activity as it relates to protocol.

· Ability to build/drive internal team consensus.

· Translates broad strategies into specific objectives and action plans.

· Team and individual leadership (leads courageously).

· Oral and written communication (fosters open communication).

· Conflict resolution (manages disagreements).

· Negotiation (Manages Execution, Results Driven, Analysis of Issues, Effective Speaking, Builds Relationships).

· Influencing (manages influencing others).

· Coaching and mentoring (fosters teamwork).

Duties and Responsibilities

· Collaborating with internal and external Customers and Service Providers, including but not limited to Clinical Research and Development, Global Study Management and Monitoring (GSMM), Project Management, Client Affiliates, Medical Affairs (MA), Regulatory, CMC, QA, Client Vendors, CRO's, IRT Organizations, and IMSC Functional Operations to ensure all needs are met.

· Working with teams for optimal use of the investigational material supply chain to achieve study and corporate goals.

· Identifying and supporting strategies for continuous improvement and departmental and/or inter-departmental.

· Co-creating clinical and development timelines and directly responsible for communicating timelines and investigational product strategies to Study Teams as well as cross-functional teams.

· Proactively defining, planning, and communicating clinical supply strategy in support of global clinical studies, as well as monitoring and reacting to unforeseen clinical demand changes.

· Developing supply forecasts through evaluation of the clinical development plan and protocol analysis.

· Reviewing and providing input for draft medical protocols to develop packaging and labeling configurations and create packaging specifications in collaboration with GSMM and MA.

· Collaborating with IMSC Operation Functions and IMSC external Vendors on the package design and label development for investigational product to meet all protocol and regulatory requirements.

· Monitoring long-term inventory and allocation strategies taking into account drug recertification, country specific regulatory requirements, international drug shipment and overall demand.

· Performing analytical assessments of drug utilization as it pertains to current forecasts versus inventories and creating product orders as needed.

· Working with third party vendors to ensure the timely, efficient, high quality, cost effective execution of all outsourced clinical supply activities.

· Ensuring releasable supplies for all assigned compounds and Protocols taking into account country Regulatory and QP Release documentation and requirements.

· Initiating, reviewing and approving of IVRS specifications.

· Participating in user acceptance testing.

· Developing investigational product distribution strategies maintaining distribution and supply strategy at depot and site level according to study (and IVRS) requirements.

· Actively participating in F&P Functional team, Study Team, Country Medical Affairs Affiliate & PLP Team Meetings providing all relevant data and documentation prior to each meeting, highlighting any risks and mitigation required.

· Actively supports the IMSC Budget Process.

· Acting as the main Clinical Supplies contact person for the assigned Compound and associated studies, lead communications regarding global supply strategy with Study Team or Country Affiliate Medical Affairs team as appropriate.

· Proactively identifying strategic and operational issues and develop proposals outlining solutions.

· Managing conflicts / issues with internal and external partners and customers.

· Demonstrating strong knowledge when presenting IMSC processes at cross-functional meetings and actively participates.

· Ability to coach new Strategic Planners on individual tasks.

· Participating in training efforts for external functions on IMSC processes to facilitate improved cross-functional relationships.

· Speaking at Investigator Meetings as required.

· Traveling as required.

· Writing of departmental SOPs.

· Performs other tasks as assigned.

Education / Knowledge, Skills, Abilities

· Bachelor's degree required

· 2 years of relevant work experience required, preferably in a pharmaceutical environment.

· An equivalent combination of education and experience may substitute.

· MUST HAVE Forecasting & Planning experience in Clinical Trials.

· Moderate / Strong knowledge of the global drug development process and global regulatory requirements.

· Proficient and strong analytical skills.

· Strong communication and negotiation skills.

· Proficient and strong Project management skills.

· Strong knowledge of Forecasting and Planning and proficient knowledge of related areas, i.e.

· Manufacturing, Packaging & Labeling, IVRS, Logistics, Quality, Stability, etc.

· Proficient knowledge of import / export requirements.

· Proficient/Strong knowledge of IVRS and CTMS systems.

· Proficient / Strong knowledge of industry technology.

· Applies and drives Forecasting and Planning activity as it relates to protocol.

· Ability to build/drive internal team consensus.

· Translates broad strategies into specific objectives and action plans.

· Team and individual leadership (leads courageously).

· Oral and written communication (fosters open communication).

· Conflict resolution (manages disagreements).

· Negotiation (Manages Execution, Results Driven, Analysis of Issues, Effective Speaking, Builds Relationships).

· The Official Copy is the electronic file. Verify document is the Approved version before proceeding.

· Influencing (manages influencing others).

· Coaching and mentoring (fosters teamwork).

Working Conditions (US Only)

· Work is performed in a typical office environment, with standard office equipment available and used.

· Work is generally performed seated but may require standing and walking for up to 10% of the time.

· Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.

Definitions and Abbreviations (As Applicable) N/A

· This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.

· The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

· This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.

· There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.

· Employees holding this position will be required to perform any other job-related duties as requested by management.

Contact

Chenchukala Alwar

Direct: 732-313-0243| Email: Chenchukala.A@sunrisesys.com

Or

Satya S

Direct: (732) 272.0262 | Email: Satya@sunrisesys.com

Company Description
Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.

Sunrise Systems Inc

Why Work Here?

Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.

Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.

Address

Summit, NJ
USA