location_onFort Washington, PA, USA
watch_later Posted: Nov 29, 2024
Skills Required
Nice To Have skills
Job Description
Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….
ClinChoice is searching for a Global Labeling Lead Consultant with REMOTE option in US, to join one of our major pharmaceutical clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
DUTIES & RESPONSIBILITIES:
As the Pharmaceutical Global Labeling Lead (GLL), you will be responsible for initial creation and related updated to labeling documents for assigned projects. You will be responsible for driving strategy through guidance and advising of the Labeling Team on internal labeling guidance and policies and will raise awareness of key factors to consider when revising labels. The GLL will ensure that the impact on Country Labeling Documents is considered during labeling discussions and will advise the labeling team on the content of other labels in the same therapeutic class. You will play a crucial role in ensuring compliance with regulatory requirements and delivering high-quality labeling solutions to our clients.
Key Responsibilities:
Provide strategic support and leadership to the labeling team, providing guidance, coaching, and feedback.
Guide the labeling team to develop and maintain Company Core Data Sheets (CCDS), Package Inserts (PI), Summary of product Characteristics (SPC), and their associates patient labeling documents.
Keep up-to-date with labeling guidelines and regulations related to the development and maintenance of US and EU labeling.
Provide project management to the labeling team throughout the process from request to stakeholder notification.
Set clear target and prioritization plans, ensuring that labeling teams are aware of the require timelines so that deliverable remain on target to team internal and external deadlines.
Act as the primary point of contact for the labeling team members and provide day-to-day direction to Labeling Operations Managers so labeling can be prepared and managed appropriately.
Act as a reviewer and approver of labeling documents ensuring that content complies with regulatory requirements and guidelines, and company policies and procedures.
Ensure adherence to relevant regulatory guidelines, such as FDA, EMA, and ICH, throughout the labeling process.
Collaborate closely with cross-functional teams, including Regulatory Affairs, Clinical Operations, Quality Assurance, and Manufacturing, to ensure smooth and timely execution of labeling activities.
Monitor industry trends and regulatory changes related to pharmaceutical labeling, and proactively implement necessary updates and improvements to labeling processes.
Collaborate with clients and provide expert advice and guidance on labeling requirements, best practices, and compliance matters.
Produces quality work that meets or exceeds client expectations.
Contribute to business strategy discussions and implement regional and global specific objectives, as appropriate.
Lead strategic initiatives and develop implementation plans taking ownership for final results and implementing process improvements where needed.
Participates in preparing written and presented bid developments for new clients.
Identify opportunities for business growth to ensure on going client support and positive engagement
Prepare and present client metrics as needed.
Train and provide guidance to other GLLs as needed.
Experience & Qualifications:
Bachelor's degree in a scientific or related field. Advanced degree (Masters, PhD) is a plus.
Minimum 7 years of experience in pharmaceutical labeling operations within a pharmaceutical industry setting.
Strong knowledge of regulatory requirements and guidelines related to pharmaceutical labeling, including FDA, EMA, and ICH guidelines.
Demonstrated knowledge and understanding of CCDS and the labeling team purpose and objectives.
Ability to liaise with stakeholders.
Excellent project management skills, with the ability to prioritize tasks, manage timelines, and handle multiple projects simultaneously.
Strong attention to detail and accuracy, with a focus on delivering high-quality labeling solutions.
Effective leadership and team management abilities, with excellent communication and interpersonal skills.
Proven problem-solving skills and the ability to make sound decisions under pressure.
Demonstrated ability to manage regulatory activities and deliver against project timelines.
Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint).
Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#Contract
ClinChoice is searching for a Global Labeling Lead Consultant with REMOTE option in US, to join one of our major pharmaceutical clients.
ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.
DUTIES & RESPONSIBILITIES:
As the Pharmaceutical Global Labeling Lead (GLL), you will be responsible for initial creation and related updated to labeling documents for assigned projects. You will be responsible for driving strategy through guidance and advising of the Labeling Team on internal labeling guidance and policies and will raise awareness of key factors to consider when revising labels. The GLL will ensure that the impact on Country Labeling Documents is considered during labeling discussions and will advise the labeling team on the content of other labels in the same therapeutic class. You will play a crucial role in ensuring compliance with regulatory requirements and delivering high-quality labeling solutions to our clients.
Key Responsibilities:
Provide strategic support and leadership to the labeling team, providing guidance, coaching, and feedback.
Guide the labeling team to develop and maintain Company Core Data Sheets (CCDS), Package Inserts (PI), Summary of product Characteristics (SPC), and their associates patient labeling documents.
Keep up-to-date with labeling guidelines and regulations related to the development and maintenance of US and EU labeling.
Provide project management to the labeling team throughout the process from request to stakeholder notification.
Set clear target and prioritization plans, ensuring that labeling teams are aware of the require timelines so that deliverable remain on target to team internal and external deadlines.
Act as the primary point of contact for the labeling team members and provide day-to-day direction to Labeling Operations Managers so labeling can be prepared and managed appropriately.
Act as a reviewer and approver of labeling documents ensuring that content complies with regulatory requirements and guidelines, and company policies and procedures.
Ensure adherence to relevant regulatory guidelines, such as FDA, EMA, and ICH, throughout the labeling process.
Collaborate closely with cross-functional teams, including Regulatory Affairs, Clinical Operations, Quality Assurance, and Manufacturing, to ensure smooth and timely execution of labeling activities.
Monitor industry trends and regulatory changes related to pharmaceutical labeling, and proactively implement necessary updates and improvements to labeling processes.
Collaborate with clients and provide expert advice and guidance on labeling requirements, best practices, and compliance matters.
Produces quality work that meets or exceeds client expectations.
Contribute to business strategy discussions and implement regional and global specific objectives, as appropriate.
Lead strategic initiatives and develop implementation plans taking ownership for final results and implementing process improvements where needed.
Participates in preparing written and presented bid developments for new clients.
Identify opportunities for business growth to ensure on going client support and positive engagement
Prepare and present client metrics as needed.
Train and provide guidance to other GLLs as needed.
Experience & Qualifications:
Bachelor's degree in a scientific or related field. Advanced degree (Masters, PhD) is a plus.
Minimum 7 years of experience in pharmaceutical labeling operations within a pharmaceutical industry setting.
Strong knowledge of regulatory requirements and guidelines related to pharmaceutical labeling, including FDA, EMA, and ICH guidelines.
Demonstrated knowledge and understanding of CCDS and the labeling team purpose and objectives.
Ability to liaise with stakeholders.
Excellent project management skills, with the ability to prioritize tasks, manage timelines, and handle multiple projects simultaneously.
Strong attention to detail and accuracy, with a focus on delivering high-quality labeling solutions.
Effective leadership and team management abilities, with excellent communication and interpersonal skills.
Proven problem-solving skills and the ability to make sound decisions under pressure.
Demonstrated ability to manage regulatory activities and deliver against project timelines.
Proficiency in using Microsoft Office Suite (Word, Excel, PowerPoint).
Excellent oral and written communications skills as well as the ability to build cross-functional relationships and work collaboratively with other groups.
The Application Process
Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful.
Who will you be working for?
About ClinChoice
ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific.
Our Company Ethos
Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates.
ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it.
#Contract
