Operations Planner III- Clinical
TITLE:
Operations Planner 3 BASIC FUNCTION:
The main function of the Operations Planner 3 is to coordinate both internal and external complex packaging orders through various work centers (label design/printing, packaging, and quality) ensuring final release is achieved on time.
This individual is responsible for execution of clinical supplies activities including but are not limited to the processing of study specific packaging and labeling documentation, coordinate packaging job progress, and review of documentation and procedures.
Label Room
Responsibilities:
Core Responsibilities:
Read comprehend and translate clinical trial protocols /packaging specifications into clinical label generation software.
Design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the label systems.
Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
Coordination of Translation Requests Generation of Clinical Label Proofs with CLPG Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address questions, revise translations, update regulatory requirements, etc.
Maintain Label Translations library.
Interpret clinical study design and Clinical Supply Strategy (CSS) Design and verify label models.
Coordinate MLBL manufacturing at vendors Perform visual inspection and accountability for label proofs.
Provide detailed analysis of issues and collaborate for creative problem solving.
Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders.
Train Label Project Coordinator Level I, and Level II team members and remain proficient in appropriate systems and software.
Responsible for ensuring scheduling and timelines are maintained for the area.
Coordinate with key stakeholders to maintain schedule adherence and maintain key metrics.
Set timelines, manage project progress, escalate any issues.
Utilize project management skills to participate/implement new processes and technology.
Cross train in other functional areas.
May utilize SAP, CSLS, CLPG, eShopFloor, CSST Appian, Microsoft Office, Excel Additional Responsibilities:
(including but not limited to) Interacts with Project Managers, Planners, Packaging Supervisors and Quality Assurance for the creation, review and approvals of labeling and packaging documentation.
Analyzes and anticipates technical problems and obstacles as they relate to clinical supplies labeling, or packaging and participates in adjustment of logistics pertaining to drug supply.
Monitor and report progress of clinical packaging events at internal and external packaging facilities.
Executes against specific projects/initiatives (SME, Special Projects) and/or directly manages assigned portfolio work (protocols) Adhere to dress code policy.
Complete all trainings as required.
Qualification:
Education:
High School/Associate degree/Bachelors degree/Masters degree.
Work Experience Requirements:
6-8 years' experience in the pharmaceutical industry, clinical supply knowledge, project management experience or relevant experience.
Knowledge of GMP guidelines.
Pharmaceutical industry experience.
Label design experience.
Preferred Experience and Skills:
Strong verbal and written communication skills Strong organizational, time management and analytical problem-solving skills, with ability to prioritize to mitigate supply chain risks.
Ability to organize and manage multiple tasks at one time and meet deadlines.
Familiarity with Good Manufacturing Practices requirements, quality procedures and Standard Operating Procedures execution Above average proficiency in Microsoft applications (Word, Excel, PowerPoint) Proven project management skills Direct work experience with SAP is a plus.
Flexible and team-oriented Diligent and quality-oriented Detail oriented Structured and proactive working attitude Note:
Hybrid Role:
3 days onsite/2 days remote.
Work Location:
West Point,PA.
Do not submit PHD.
Recommended Skills Analytical Attention To Detail Clinical Study Design Clinical Trial Protocols Clinical Works Communication Estimated Salary: $20 to $28 per hour based on qualifications.
Operations Planner 3 BASIC FUNCTION:
The main function of the Operations Planner 3 is to coordinate both internal and external complex packaging orders through various work centers (label design/printing, packaging, and quality) ensuring final release is achieved on time.
This individual is responsible for execution of clinical supplies activities including but are not limited to the processing of study specific packaging and labeling documentation, coordinate packaging job progress, and review of documentation and procedures.
Label Room
Responsibilities:
Core Responsibilities:
Read comprehend and translate clinical trial protocols /packaging specifications into clinical label generation software.
Design clinical supplies trial labels for primary, secondary, and auxiliary packaging applications within the label systems.
Interpret randomization schemes, input into label software system, and utilize system to verify correct labels are produced according to cGMPs.
Coordination of Translation Requests Generation of Clinical Label Proofs with CLPG Liaise with country-level Clinical Operations personnel or Regulatory Affairs to address questions, revise translations, update regulatory requirements, etc.
Maintain Label Translations library.
Interpret clinical study design and Clinical Supply Strategy (CSS) Design and verify label models.
Coordinate MLBL manufacturing at vendors Perform visual inspection and accountability for label proofs.
Provide detailed analysis of issues and collaborate for creative problem solving.
Liaise with Clinical Supply Program Managers, Supply Planners, Quality, Pharmaceutical Sciences, or other stakeholders.
Train Label Project Coordinator Level I, and Level II team members and remain proficient in appropriate systems and software.
Responsible for ensuring scheduling and timelines are maintained for the area.
Coordinate with key stakeholders to maintain schedule adherence and maintain key metrics.
Set timelines, manage project progress, escalate any issues.
Utilize project management skills to participate/implement new processes and technology.
Cross train in other functional areas.
May utilize SAP, CSLS, CLPG, eShopFloor, CSST Appian, Microsoft Office, Excel Additional Responsibilities:
(including but not limited to) Interacts with Project Managers, Planners, Packaging Supervisors and Quality Assurance for the creation, review and approvals of labeling and packaging documentation.
Analyzes and anticipates technical problems and obstacles as they relate to clinical supplies labeling, or packaging and participates in adjustment of logistics pertaining to drug supply.
Monitor and report progress of clinical packaging events at internal and external packaging facilities.
Executes against specific projects/initiatives (SME, Special Projects) and/or directly manages assigned portfolio work (protocols) Adhere to dress code policy.
Complete all trainings as required.
Qualification:
Education:
High School/Associate degree/Bachelors degree/Masters degree.
Work Experience Requirements:
6-8 years' experience in the pharmaceutical industry, clinical supply knowledge, project management experience or relevant experience.
Knowledge of GMP guidelines.
Pharmaceutical industry experience.
Label design experience.
Preferred Experience and Skills:
Strong verbal and written communication skills Strong organizational, time management and analytical problem-solving skills, with ability to prioritize to mitigate supply chain risks.
Ability to organize and manage multiple tasks at one time and meet deadlines.
Familiarity with Good Manufacturing Practices requirements, quality procedures and Standard Operating Procedures execution Above average proficiency in Microsoft applications (Word, Excel, PowerPoint) Proven project management skills Direct work experience with SAP is a plus.
Flexible and team-oriented Diligent and quality-oriented Detail oriented Structured and proactive working attitude Note:
Hybrid Role:
3 days onsite/2 days remote.
Work Location:
West Point,PA.
Do not submit PHD.
Recommended Skills Analytical Attention To Detail Clinical Study Design Clinical Trial Protocols Clinical Works Communication Estimated Salary: $20 to $28 per hour based on qualifications.
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