Sr. Strategic Planner, Forecasting and Planning, IMSC
Category: Scientific & Clinical
Title: Sr. Strategic Planner, Forecasting and Planning, IMSC
Location: Summit, NJ
Start date: ASAP
- 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, Medical Affairs (MA), Regulatory, CMC, QA, 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.
- 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.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.