Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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This position will be responsible for coordinating the development of Technical Literature. They will serve as the Core Team member working cross-functionally to develop timelines and take content change needs back to the Technical Literature team for execution to meet the needs for human factors testing regulatory submissions and product launches. This person will working closely with a matrixed team in the department consisting of graphic designers project coordinators and technical writers to deliver high-quality technical literature to support the Diabetes Operating Unit.
Education Required: Bachelorrsquos Degree
Yearsrsquo Experience Required: 4
Will the contractor be working 40 hours a week? If not weekly estimate? Yes up to 45 on occaision
Work Location: Remote is OK
Do they need to be local to any MDT office and if so where? No but if on-site Northridge
Does this person need to be on site? If so full time or part time? No but may be asked to travel 1-2 times per year
Note: Top candidates will be interviewed by myself my Sr. Manager and the Department Director to find the best fit.
Responsibilities may include the following and other duties may be assigned.
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections.
Leads or compiles all materials required in submissions license renewal and annual registrations.
Recommends changes for labeling manufacturing marketing and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.
PROGRAM MANAGEMENT CAREER STREAM: Program Managers and Directors focus on tactical operational activities for a major program with broad or ongoing impact. Levels within the program management career stream typically accomplish program objectives through matrixed employee teams and / or vendors who are not direct reports but for which the incumbent has direct accountability to lead. The majority of time is spent overseeing their area of responsibility managing program/team performance communicating project and operational developments planning prioritizing and / or directing the responsibilities of program team members. Goal achievement is typically accomplished through performance of program team members.
DIFFERENTIATING FACTORS
Autonomy: Manages one or more small-scale developed or mature programs with well-defined program plans and delivery methodologies.
Is accountable for overall program process performance and customer satisfaction.
Organizational Impact: Provides input to establishing program objectives timelines milestones and budgets .
Recommends new policies and procedures that affect program management.
May have budget accountability for one or more programs.
Program decisions are generally made only after consultation with higher level management.
Innovation and Complexity: Problems faced are difficult and require detailed information gathering analysis and investigation to understand the problem.
Problems typically impact multiple workstreams departments or specialties .
Modifies programs management processes to improve program.
Communication and Influence: Communicates and leads meetings with internal and external customers and vendors conducts briefings to higher level management team.
Solves issues through information exchange influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans.
Leadership and Talent Management: Leads directs and reviews the work of a team of professionals and/or vendors who exercise latitude and independence in their assignments.
Direct involvement in daily tasks necessary for successful program execution.
Not directly responsible for hire or fire decisions and people management.
Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes projects and tactics within one job area.
Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
Requires a Baccalaureate degree or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C.F.R. sect 214.2h 4iiiA and minimum of 5 years of relevant experience or advanced degree with a minimum of 3 years of relevant experience.
?*CO/NYC candidates might not be considered
Remote Reg Affairs Program Manager
Posted: 09/30/2024
2024-09-30
2024-11-12
Employment Type:
Contract
Job Category: Regulatory Sciences and Medical Writing
Job Number: 614530
Is job remote?: Yes
Country: United States
Job Description
This position will be responsible for coordinating the development of Technical Literature. They will serve as the Core Team member working cross-functionally to develop timelines and take content change needs back to the Technical Literature team for execution to meet the needs for human factors testing regulatory submissions and product launches. This person will working closely with a matrixed team in the department consisting of graphic designers project coordinators and technical writers to deliver high-quality technical literature to support the Diabetes Operating Unit.
Education Required: Bachelorrsquos Degree
Yearsrsquo Experience Required: 4
Will the contractor be working 40 hours a week? If not weekly estimate? Yes up to 45 on occaision
Work Location: Remote is OK
Do they need to be local to any MDT office and if so where? No but if on-site Northridge
Does this person need to be on site? If so full time or part time? No but may be asked to travel 1-2 times per year
Note: Top candidates will be interviewed by myself my Sr. Manager and the Department Director to find the best fit.
Responsibilities may include the following and other duties may be assigned.
Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company internal audits and inspections.
Leads or compiles all materials required in submissions license renewal and annual registrations.
Recommends changes for labeling manufacturing marketing and clinical protocol for regulatory compliance.
Monitors and improves tracking / control systems.
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.
PROGRAM MANAGEMENT CAREER STREAM: Program Managers and Directors focus on tactical operational activities for a major program with broad or ongoing impact. Levels within the program management career stream typically accomplish program objectives through matrixed employee teams and / or vendors who are not direct reports but for which the incumbent has direct accountability to lead. The majority of time is spent overseeing their area of responsibility managing program/team performance communicating project and operational developments planning prioritizing and / or directing the responsibilities of program team members. Goal achievement is typically accomplished through performance of program team members.
DIFFERENTIATING FACTORS
Autonomy: Manages one or more small-scale developed or mature programs with well-defined program plans and delivery methodologies.
Is accountable for overall program process performance and customer satisfaction.
Organizational Impact: Provides input to establishing program objectives timelines milestones and budgets .
Recommends new policies and procedures that affect program management.
May have budget accountability for one or more programs.
Program decisions are generally made only after consultation with higher level management.
Innovation and Complexity: Problems faced are difficult and require detailed information gathering analysis and investigation to understand the problem.
Problems typically impact multiple workstreams departments or specialties .
Modifies programs management processes to improve program.
Communication and Influence: Communicates and leads meetings with internal and external customers and vendors conducts briefings to higher level management team.
Solves issues through information exchange influence and active persuasion without direct exercise of command to gain cooperation of other parties on program execution plans.
Leadership and Talent Management: Leads directs and reviews the work of a team of professionals and/or vendors who exercise latitude and independence in their assignments.
Direct involvement in daily tasks necessary for successful program execution.
Not directly responsible for hire or fire decisions and people management.
Required Knowledge and Experience: Requires practical knowledge in leading and managing the execution of processes projects and tactics within one job area.
Typically has advanced knowledge and skills within a specific technical or professional discipline with understanding of the impact of work on other areas of the organization.
Requires a Baccalaureate degree or for degrees earned outside of the United States a degree which satisfies the requirements of 8 C.F.R. sect 214.2h 4iiiA and minimum of 5 years of relevant experience or advanced degree with a minimum of 3 years of relevant experience.
?*CO/NYC candidates might not be considered
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