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Global Labeling Lead at Sobi

Boston, Massachusetts, United States - Full Time

Skills Needed
Labeling Strategy, Regulatory Affairs, Ccds Content Development, Us/Eu Product Information Management, Health Authority Compliance, Labeling Process Improvement, Labeling Working Groups Leadership, Cross Functional Collaboration, Regulatory Strategy, Labeling Governance, Executive Labeling Committee Presentation, Safety Variation Tracking, Regulatory Information Management Systems, Project Coordination, Communication, Decision Making

Specialization
Candidates must possess a degree, preferably in a scientific discipline, and have at least five years of Regulatory Affairs experience in the pharmaceutical industry, including a minimum of three years specifically in US prescription drug labeling. The role requires comfort working in a global, cross-functional environment with strong organizational and communication skills.

Experience Required
Minimum 5 year(s)

Global Study Manager at AstraZeneca

Durham, North Carolina, United States - Full Time

Skills Needed
Clinical Research, Project Management, Communication Skills, Relationship Building, Risk Management, Budget Tracking, Leadership Skills, Collaboration, Clinical Development, Gcp Guidelines, Documentation, Vendor Management, Problem Solving, Process Improvement, Study Execution, Supply Chain Management

Specialization
A university degree in a relevant field and at least 2 years of experience in the clinical study lifecycle are required. Candidates should have knowledge of clinical development processes and excellent communication skills.

Experience Required
Minimum 2 year(s)

Director Global HEOR at Sobi

Munich, Bavaria, Germany - Full Time

Skills Needed
Health Economics, Outcomes Research, Project Management, Vendor Management, Interpersonal Skills, Strategic Thinking, Problem Solving, Decision Making, Collaboration, Communication, Pharmaceutical Research, Epidemiology, Market Access, Hta, Reimbursement Strategies, Scientific Publications

Specialization
Candidates must have a postgraduate degree in Health Economics or related fields, along with 5-7 years of experience in Health Economics Outcome Research within the pharmaceutical industry. A deep understanding of European HTA and reimbursement systems is essential, along with strong interpersonal and strategic skills.

Experience Required
Minimum 5 year(s)

Global Business Head at Infoway Group

, , India - Full Time

Skills Needed
Business Development, Staffing Industry, Team Management, Global Team Leadership, Sales Strategy, Sales Management, Client Relationship Management, Collaboration Process Implementation, Consultancy, Business Strategy, Cold Calling, Industry Relationships, Communication Skills, Presentation Skills, Quantitative Reasoning, Sales Force Management

Specialization
Candidates must possess over 10 years of business development experience within the staffing industry, including managing teams of 100+ employees and setting up global consulting teams. Strong communication, presentation skills, and superior quantitative reasoning are mandatory, with financial services or credit card experience being a plus.

Experience Required
Minimum 10 year(s)

Global Study Manager at AstraZeneca

Durham, North Carolina, United States - Full Time

Skills Needed
Clinical Research, Project Management, Communication, Relationship Building, Risk Management, Budget Tracking, Documentation, Collaboration, Leadership, Problem Solving, Vendor Management, Inspection Readiness, Clinical Supply Chain, Process Improvement, Gcp Compliance, Study Execution

Specialization
Candidates should have a university degree in a relevant field and at least 2 years of experience in the clinical study lifecycle within the pharmaceutical industry. Knowledge of ICH-GCP guidelines and strong project management skills are essential.

Experience Required
Minimum 2 year(s)

LPN Pediatric PDN peds/young adults SIGN ON BONUS at Phoenix Home Care and Hospice

Zeigler, Illinois, United States - Full Time

Skills Needed
Nursing Care, Pediatric Care, Compassionate Care, Patient Centered Care, Relationship Building, Medical Needs Support

Specialization
A current and active LPN or RN license is required. Pediatric experience is preferred but not mandatory as training will be provided.

barista - Store# 49669, Curry Ford & Young Pine Rd at Starbucks Coffee Company

Orlando, Florida, United States - Full Time

Skills Needed
Customer Engagement, Communication, Teamwork, Interpersonal Skills, Attention To Detail, Adaptability, Time Management, Problem Solving, Food Preparation, Beverage Preparation, Cash Handling, Safety Awareness, Flexibility, Learning Ability, Relationship Building

Specialization
No previous experience is required for this position. Candidates must be able to work flexible hours and engage effectively with customers.

Youngstown - WC Claims Specialist - PN: 20069351 at Ohio Department of Administrative Services

, , - Full Time

Skills Needed
Claims Examination, Workers' Compensation Laws, Eligibility Criteria, Public Relations, Interviewing Techniques, Medical Terminology, Claims Reserving, Communication Skills, Data Collection, Problem Solving, Microsoft Office, Bwc Specific Software, Customer Service, Medical Diagnosis Coding, Industrial Commission Processes, Typing

Specialization
Candidates must have 36 months of experience in a claims representative role or equivalent, or relevant educational coursework. Typing proficiency of at least 35 words per minute is also required.

Experience Required
Minimum 2 year(s)

Children and Young People Practitioner - Ponteland at Nudge Education

Newcastle upon Tyne, England, United Kingdom - Full Time

Skills Needed
Compassion, Innovation, Inclusion, Relationship Building, Adaptability, Knowledge Of Local Environment, Understanding Of Trauma, Teaching Experience, Special Educational Needs Awareness, Mental Health Awareness, Risk Assessment, Behavioral Reporting, De Escalation Techniques, Intermediate It Skills, Driving License, Access To Vehicle

Specialization
Desirable qualifications include Qualified Teacher Status or a teaching qualification, along with a recent safeguarding qualification. Experience with students having Special Educational Needs or similar backgrounds is also preferred.

Associate Territory Business Manager (Youngstown) at Dexcom

Youngstown, Ohio, United States - Full Time

Skills Needed
Sales, Collaboration, Training, Technical Expertise, Market Access, Healthcare Knowledge, Diabetes Care, Customer Service

Specialization
Candidates typically require a Bachelor's degree and 2-5 years of related experience, preferably in medical or pharmaceutical sales. A valid driver's license and willingness to work flexible hours are also necessary.

Experience Required
Minimum 2 year(s)

shift supervisor - Store# 10467, YOUNGS BAY PLAZA at Starbucks Coffee Company

Warrenton, Oregon, United States - Full Time

Skills Needed
Customer Interaction, Food Preparation, Beverage Preparation, Task Delegation, Teamwork, Communication, Interpersonal Skills, Retail Knowledge

Specialization
Candidates must have at least six months of experience in customer service and task delegation. Effective communication and the ability to work as part of a team are essential.

Global Human Resource and Administration Manager (Malaysia) at Azeus Systems Limited

Kuala Lumpur, Kuala Lumpur, Malaysia - Full Time

Skills Needed
Strategic Thinking, Cross Cultural Sensitivity, Change Management, Negotiation, Conflict Resolution, Problem Solving, Collaboration, Team Leadership, Talent Management, Employee Engagement, Compliance, Hr Technology, Data Analytics, Organizational Development, Succession Planning, Workforce Planning, Performance Management

Specialization
Candidates should have a Bachelor's or Master's degree in Human Resources or a related field, along with 8+ years of progressive HR experience, including 3-5 years in a global or regional management role. Strong understanding of global labor laws and excellent communication skills are essential.

Experience Required
Minimum 5 year(s)

Millwright - Canada / Électromécanicien - Canada at FedEx

Coteau-du-Lac, Quebec, Canada - Full Time

Skills Needed
Mechanical Knowledge, Troubleshooting, Preventive Maintenance, Conveyor Systems, Carton Sorting Systems, Mobile Equipment, Documentation, Safety Standards, Teamwork, Communication, Detail Oriented, Fast Paced Environment, Manual Dexterity, Physical Tasks, Visual Acuity, Problem Solving

Specialization
Candidates must be a Journeyman Tradesperson or equivalent with a high school diploma and a minimum of 4 years of mechanical maintenance experience in a manufacturing or packaging environment. Knowledge of conveyor systems and the ability to troubleshoot and diagnose repair needs are essential.

Experience Required
Minimum 5 year(s)

Retail Merchandiser Canada at SPAR Canada

North Vancouver, British Columbia, Canada - Full Time

Skills Needed
Merchandising, Data Collection, Stock Management, Plan O Grams, Store Displays, Audits, Relationship Building, Attention To Detail, Independent Work, Positive Attitude

Specialization
Candidates must be independent contractors with a reliable personal vehicle and a smartphone. A positive attitude, ability to work independently, and attention to detail are essential.

Retail Merchandiser Canada at SPAR Canada

Vancouver, British Columbia, Canada - Full Time

Skills Needed
Merchandising, Data Collection, Stock Management, Relationship Building, Attention To Detail, Independent Work

Specialization
Candidates must be independent contractors with a reliable personal vehicle and a smartphone. A positive attitude, ability to work independently, and attention to detail are essential.

Account Executive - Canada at SUSE

Quebec, Quebec, Canada - Full Time

Skills Needed
Sales, Account Management, Consultative Selling, Customer Relationships, Strategic Thinking, Problem Solving, Crm Tools, Enterprise Sales Methodologies, Communication Skills, Analytical Skills, Collaboration, Open Source, Cloud Migration, Linux Infrastructure, Artificial Intelligence, Security

Specialization
Candidates should have experience in sales and account management with a proven track record of meeting sales targets. Knowledge of enterprise software solutions and excellent communication skills are essential.

Experience Required
Minimum 5 year(s)

Principal Engineer- Canada at Arcadis

Navi Mumbai, maharashtra, India - Full Time

Skills Needed
Design Management, Project Management, 3d Modelling, Roadway Design, Cad Production, She Good Practice, Technical Report Writing, Team Mentoring, Autodesk Tools, Bentley Tools, Design Codes, Construction Practices, Communication Skills, Programming Knowledge, International Project Experience, Quantity Computation

Specialization
Candidates must have a minimum of 15 years of experience in a design consulting environment and have delivered at least four major projects for the Canada/US region in a lead role. A strong understanding of design codes and standard construction practices is essential, along with proficiency in various software tools.

Experience Required
Minimum 10 year(s)

Retail Merchandiser Canada at SPAR Canada

Blind River, Ontario, Canada - Full Time

Skills Needed
Merchandising, Store Displays, Plan O Grams, Stocking Levels, Audits, Data Collection, Relationship Building, Independent Contractor, Attention To Detail

Specialization
Applicants must be independent contractors and possess a reliable personal vehicle and a smartphone. Essential soft skills include having a positive attitude, the ability to work independently, and strong attention to detail.

Retail Merchandiser Canada at SPAR Canada

Kitchener, Ontario, Canada - Full Time

Skills Needed
Merchandising, Data Collection, Attention To Detail, Relationship Building, Stock Management, Plan O Grams, Audits, Independent Work

Specialization
Candidates must be independent contractors with a reliable personal vehicle and a smartphone. A positive attitude, ability to work independently, and attention to detail are essential.

Canada Payroll Tax Analyst at Bosch Group

Farmington Hills, Michigan, United States - Full Time

Skills Needed
Payroll Tax Compliance, Statutory Reporting, Cross Border Payroll, Analytical Skills, Problem Solving, Attention To Detail, Advanced Excel, Auditing Techniques, Organizational Skills, Collaboration, Legislative Monitoring, Data Verification, Payroll Processing, Vacation Liability Reporting, Tax Discrepancy Resolution, Certification Knowledge

Specialization
Candidates must have a high school diploma and a minimum of two years of payroll tax experience. Strong knowledge of Canadian and US payroll tax regulations, along with PCP or PLP certification, is required.

Experience Required
Minimum 2 year(s)

Global Labeling Lead at Sobi

Boston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

11 Jun, 26

Salary

195000.0

Posted On

13 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Labeling Strategy, Regulatory Affairs, CCDS Content Development, US/EU Product Information Management, Health Authority Compliance, Labeling Process Improvement, Labeling Working Groups Leadership, Cross-functional Collaboration, Regulatory Strategy, Labeling Governance, Executive Labeling Committee Presentation, Safety Variation Tracking, Regulatory Information Management Systems, Project Coordination, Communication, Decision-Making

Industry

Pharmaceutical Manufacturing

Description

Company Description Statistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application! At Sobi, each person brings their unique talents to work as a team and make a difference. We are dedicated to developing and delivering innovative therapies to improve the lives of people who live with a rare disease. Our edge comes from our team of people and our commitment to patients. Our mission and culture at Sobi North America get us excited to come to work every day, but here are a few more reasons to join our team: Competitive compensation for your work Generous time off policy Opportunity to broaden your horizons by attending popular conferences Emphasis on work/life balance Collaborative and team-oriented environment Making a positive impact to help ultra-rare disease patients who are in need of life saving treatments Job Description The Global Labeling Lead (GLL) serves as a labeling strategy expert for Sobi products within Global Regulatory Affairs (GRA). The GLL provides both strategic and operational leadership for product labeling, working closely with Regulatory Strategy Leads and other cross-functional stakeholders. As a core member of the Global Regulatory Team(s) (GRT) for assigned product(s), the GLL ensures that product labeling reflects scientific integrity, regulatory compliance, and patient focus across global markets. This is a remote position based in the US - candidates located on the East Coast are strongly preferred. Key Responsibilities: Lead the content development, approval, and maintenance of the Company Core Data Sheet (CCDS) and US/EU Product Information (PI). Manage the review and approval of country labeling for new filings in international markets. Ensure compliance with relevant Health Authority (HA) regulations, internal procedures, and business objectives. Support continuous improvement of labeling processes and systems. Lead the development, implementation, and maintenance of the CCDS, USPI and EU PI for Sobi products throughout the product lifecycle via cross-functional Labeling Working Groups (LWG). Guide LWGs in labeling discussions with HAs, while ensuring management alignment and adherence to labeling governance. Collaborate closely with internal stakeholders and partner companies, as applicable. Document and archive LWG decisions and outcomes. Present new labeling content and major updates to the Executive Labeling Committee for approval. Partner with international Regulatory Affairs (RA) to guide the review and approval process of labels for submission outside of EU and US. Maintain oversight of labeling compliance, including documentation of labeling content deviations and end-to-end tracking of safety variations. Contribute to the development and improvement of labeling processes, including creation and review of process documents. Support inspections and audits related to labeling activities. Participate in cross-functional and cross-regional initiatives to strengthen collaboration and increase operational efficiencies. Qualifications Education/Learning Experience/Work Experience Required: Degree (Bachelors, Masters, State Examination, Diploma), preferably in a scientific discipline such as Pharmacy, Medicine, Life or Natural Sciences. At least 5 years of experience in Regulatory Affairs within the pharmaceutical industry or a regulatory authority, including at least 3 years of relevant experience in US prescription drug labeling. Comfortable working in a global, cross-functional environment, collaborating effectively with stakeholders across multiple regions, time zones and cultural backgrounds. Desired: Experience working with different types of labeling documents, including (Development) Core Data Sheets, Prescribing Information, and Target Product Labels, for both marketed and investigational products. Knowledge of labeling requirements and templates in geographic regions outside of the US, preferably Europe and/or Japan. Experience leading project teams in a cross-functional matrix environment. Skills/Knowledge/Languages Experience with Regulatory Information Management systems. Strong proficiency with standard business tools (e.g. MS-Office, etc.) Excellent English language skills (oral/written/listening); additional languages are an advantage. Ability to plan, coordinate and lead multiple projects concurrently. Personal Attributes Self-motivated, able to work independently in a remote setting while staying connected and collaborative with global colleagues. Flexible and resilient, comfortable navigating shifting priorities and maintaining focus in a fast-paced environment. Reliable and accountable, taking ownership of tasks and consistently delivering high-quality, precise work. Team-oriented and empathetic, able to build strong relationships and foster trust in a virtual, multicultural environment. Contributing to a supportive team culture and helping others succeed. Process-aware and compliant, understanding the importance of regulatory frameworks while exercising sound judgment and balanced decision-making within scope. Strong communicator, able to confidently present and discuss cases at all levels of the organization, including leadership teams and steering committees. Curious and proactive learner, seeking out information, staying current, and continuously developing expertise. Additional Information Compensation and Total Rewards at Sobi At Sobi, we are dedicated to providing our employees with a comprehensive and industry-competitive total rewards package. Our compensation philosophy is designed to recognize and reward talent, ensuring that your contributions are valued and reflected in your overall rewards. Your total compensation at Sobi goes beyond just your base salary and annual bonus. It also includes a robust suite of benefits, such as: A competitive 401(k) match to support your financial future. Tuition and wellness reimbursements to invest in your personal and professional growth. A comprehensive medical, dental, and vision package to prioritize your health and well-being. Additional recognition awards to celebrate your achievements. The base salary range for this role is $160,000-$195,000. Each individual offer will be determined based on several factors, including your experience, qualifications, and location. Additionally, this role is eligible for both short-term and long-term bonuses, as outlined in the plan details. All Sobi employees need to demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership. Are you ready to be on the Sobi team? Come join a culture that empowers every person to be the person that makes a difference for rare disease. Why Join Us? We are a global company with over 1,900 employees in more than 30 countries and are committed to the societies where we operate. With a deeply skilled management team directing our day-to-day wins, and a Board with a stellar track record, we’re ready to take on the world’s diseases, ailments and adversity. Our people believe they have the power to make a positive impact in others’ lives because that’s exactly what we do here. If you’re seeking a career that taps into your talents in a way that makes the world a better, healthier place, we just may have a job for you. We know our employees are our most valuable asset, and our culture conveys that. We offer a competitive benefits package, to support the health and happiness of our staff. Sobi Culture At Sobi, we refuse to accept the status quo. This is because we have witnessed first-hand the challenges facing those affected by rare diseases, and have used this knowledge to shape our business to find new ways of helping them. As a specialized biopharmaceutical company, we are dedicated to rare diseases. And we see this focus as a strength. By effectively turning our research into ground-breaking treatments, we help make medicine more accessible and open up more possibilities for patients and more opportunities for those caring for them. This has been our approach since day one, but we know we can’t change the world of rare diseases on our own. Accomplishing this requires strong partnerships with patients, partners and stakeholders across the entire value chain. Together, we define how our business can create solutions that serve the needs of those affected by rare diseases while facilitating sustainable growth. An Equal Opportunity Employer Sobi is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Sobi are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity, protected veterans and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status or protected groups by the laws or regulations in the locations where we operate. If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation if you are unable or limited in your ability to use or access this website to apply for a vacancy as a result of your disability. You can request reasonable accommodations by sending an email to [email protected] Know Your Rights Sobi Location: United States

Responsibilities

The Global Labeling Lead acts as the labeling strategy expert within Global Regulatory Affairs, providing strategic and operational leadership for product labeling across global markets. Key duties include leading the content development, approval, and maintenance of core labeling documents like the CCDS and US/EU Product Information.

Global Labeling Lead at Sobi

Boston, Massachusetts, United States - Full Time

Experience Required
Minimum 5 year(s)

Global Study Manager at AstraZeneca

Durham, North Carolina, United States - Full Time

Experience Required
Minimum 2 year(s)

Director Global HEOR at Sobi

Munich, Bavaria, Germany - Full Time

Experience Required
Minimum 5 year(s)

Global Business Head at Infoway Group

, , India - Full Time

Experience Required
Minimum 10 year(s)

Global Study Manager at AstraZeneca

Durham, North Carolina, United States - Full Time

Experience Required
Minimum 2 year(s)

LPN Pediatric PDN peds/young adults SIGN ON BONUS at Phoenix Home Care and Hospice

Zeigler, Illinois, United States - Full Time

Skills Needed
Nursing Care, Pediatric Care, Compassionate Care, Patient Centered Care, Relationship Building, Medical Needs Support

Specialization
A current and active LPN or RN license is required. Pediatric experience is preferred but not mandatory as training will be provided.

barista - Store# 49669, Curry Ford & Young Pine Rd at Starbucks Coffee Company

Orlando, Florida, United States - Full Time

Specialization
No previous experience is required for this position. Candidates must be able to work flexible hours and engage effectively with customers.

Youngstown - WC Claims Specialist - PN: 20069351 at Ohio Department of Administrative Services

, , - Full Time

Experience Required
Minimum 2 year(s)

Children and Young People Practitioner - Ponteland at Nudge Education

Newcastle upon Tyne, England, United Kingdom - Full Time

Associate Territory Business Manager (Youngstown) at Dexcom

Youngstown, Ohio, United States - Full Time

Skills Needed
Sales, Collaboration, Training, Technical Expertise, Market Access, Healthcare Knowledge, Diabetes Care, Customer Service

Experience Required
Minimum 2 year(s)

shift supervisor - Store# 10467, YOUNGS BAY PLAZA at Starbucks Coffee Company

Warrenton, Oregon, United States - Full Time

Skills Needed
Customer Interaction, Food Preparation, Beverage Preparation, Task Delegation, Teamwork, Communication, Interpersonal Skills, Retail Knowledge

Specialization
Candidates must have at least six months of experience in customer service and task delegation. Effective communication and the ability to work as part of a team are essential.

Global Human Resource and Administration Manager (Malaysia) at Azeus Systems Limited

Kuala Lumpur, Kuala Lumpur, Malaysia - Full Time

Experience Required
Minimum 5 year(s)

Millwright - Canada / Électromécanicien - Canada at FedEx

Coteau-du-Lac, Quebec, Canada - Full Time

Experience Required
Minimum 5 year(s)

Retail Merchandiser Canada at SPAR Canada

North Vancouver, British Columbia, Canada - Full Time

Skills Needed
Merchandising, Data Collection, Stock Management, Plan O Grams, Store Displays, Audits, Relationship Building, Attention To Detail, Independent Work, Positive Attitude

Specialization
Candidates must be independent contractors with a reliable personal vehicle and a smartphone. A positive attitude, ability to work independently, and attention to detail are essential.

Retail Merchandiser Canada at SPAR Canada

Vancouver, British Columbia, Canada - Full Time

Skills Needed
Merchandising, Data Collection, Stock Management, Relationship Building, Attention To Detail, Independent Work

Specialization
Candidates must be independent contractors with a reliable personal vehicle and a smartphone. A positive attitude, ability to work independently, and attention to detail are essential.

Account Executive - Canada at SUSE

Quebec, Quebec, Canada - Full Time

Experience Required
Minimum 5 year(s)

Principal Engineer- Canada at Arcadis

Navi Mumbai, maharashtra, India - Full Time

Experience Required
Minimum 10 year(s)

Retail Merchandiser Canada at SPAR Canada

Blind River, Ontario, Canada - Full Time

Skills Needed
Merchandising, Store Displays, Plan O Grams, Stocking Levels, Audits, Data Collection, Relationship Building, Independent Contractor, Attention To Detail

Retail Merchandiser Canada at SPAR Canada

Kitchener, Ontario, Canada - Full Time

Skills Needed
Merchandising, Data Collection, Attention To Detail, Relationship Building, Stock Management, Plan O Grams, Audits, Independent Work

Specialization
Candidates must be independent contractors with a reliable personal vehicle and a smartphone. A positive attitude, ability to work independently, and attention to detail are essential.

Canada Payroll Tax Analyst at Bosch Group

Farmington Hills, Michigan, United States - Full Time

Experience Required
Minimum 2 year(s)