76 head global labelling operations jobs found

GSK Job Purpose The Head, Global Labelling Operations will lead the operational execution of GSK's labelling processes and enabling systems and tools to ensure the timely and accurate delivery of labelling content to worldwide markets. This role will monitor oversight of the end-to-end labeling process, ensuring product labeling (prescriber, patient, and artwork labelling) is in line with GRA/GRO objectives and in compliance with applicable local and global regulations. This role is critical in ensuring adherence to our regulatory obligations and achieving operational excellence to support GSK's global portfolio. A key focus of the role will be on fostering strong collaborations with stakeholders across global teams, driving a mindset of continuous improvement and successfully implementing innovative solutions to advance the labelling processes. Key Responsibilities: 1. Operational Leadership: Develop and implement operational strategies to streamline labelling...

GSK Job Purpose The Head, Global Labelling Operations will lead the operational execution of GSK's labelling processes and enabling systems and tools to ensure the timely and accurate delivery of labelling content to worldwide markets. This role will monitor oversight of the end-to-end labeling process, ensuring product labeling (prescriber, patient, and artwork labelling) is in line with GRA/GRO objectives and in compliance with applicable local and global regulations. This role is critical in ensuring adherence to our regulatory obligations and achieving operational excellence to support GSK's global portfolio. A key focus of the role will be on fostering strong collaborations with stakeholders across global teams, driving a mindset of continuous improvement and successfully implementing innovative solutions to advance the labelling processes. Key Responsibilities: 1. Operational Leadership: Develop and implement operational strategies to streamline labelling...

Site Name: UK - London - New Oxford Street, Canada - Ontario - Mississauga, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Dec 16 2024 Job Purpose The Head, Global Labelling Operations will lead the operational execution of GSK’s labelling processes and enabling systems and tools to ensure the timely and accurate delivery of labelling content to worldwide markets. This role will monitor oversight of the end-to-end labeling process, ensuring product labeling (prescriber, patient, and artwork labelling) is in line with GRA/GRO objectives and in compliance with applicable local and global regulations. This role is critical in ensuring adherence to our regulatory obligations and achieving operational excellence to support GSK’s global portfolio. A key focus of the role will be on fostering strong collaborations with stakeholders across global teams, driving a mindset of continuous improvement and successfully implementing innovative solutions...

Site Name: UK - London - New Oxford Street, Canada - Ontario - Mississauga, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper Providence Posted Date: Dec 16 2024 Job Purpose The Head, Global Labelling Operations will lead the operational execution of GSK’s labelling processes and enabling systems and tools to ensure the timely and accurate delivery of labelling content to worldwide markets. This role will monitor oversight of the end-to-end labeling process, ensuring product labeling (prescriber, patient, and artwork labelling) is in line with GRA/GRO objectives and in compliance with applicable local and global regulations. This role is critical in ensuring adherence to our regulatory obligations and achieving operational excellence to support GSK’s global portfolio. A key focus of the role will be on fostering strong collaborations with stakeholders across global teams, driving a mindset of continuous improvement and successfully implementing innovative solutions...

Pulmonx Corporation Pulmonx is looking for an experienced Director/Sr. Director* of Regulatory Affairs to join our dynamic Regulatory Affairs team! * Will consider Sr. Director level depending upon experience. Workplace type: Hybrid (Remote will be considered for candidates in the western US) Not sure who Pulmonx is and how our Zephyr valves help people to breathe better? Check out some of the videos on our YouTube Channel: https://www.youtube.com/@zephyr-by-pulmonx Responsibilities and Capabilities: Create, lead and manage 510(k), PMA, and IDE submissions in US and submissions in OUS, ensuring timely completion and compliance with applicable regulations. Provide strategic regulatory guidance to cross-functional teams (e.g., R&D, clinical, operations, legal, marketing) to ensure regulatory requirements are met throughout the product lifecycle. Act as the main point of contact for regulatory authorities, managing all communication, including...

Bunge Bunge is hiring for multiple full-time openings for the GROWTH of our Fort Worth, TX location.Join a dynamic, high energy, and high performing team. If you are someone who wants to live new possibilities, Bunge is going to be a great place for you! Bunge offers a generous compensation & benefits package! Pay starting at $22.43per hour. Hiring for a GREAT Monday through Friday schedule Temperature controlled environment, perfect for Texas Medical benefits package (employer pays the majority of premiums), additional benefits include dental, vision, life, & more. Vacation, sick & holiday pay startingyear one 401K plan with 5% company contribution & up to 4% company match. Position Summary: Responsible for producing quality product per production schedule with working knowledge of production equipment and operating safely within established guidelines.Monday through Friday schedule: 2nd shift: (3p-11:30p) and 3rd shift (11p-7:30a)...

Alkermes, Inc. The Director of CQA-PV is the supervisor of the Clinical Quality Assurance Department with responsibilities for quality oversight of the Post Marketing Good Pharmacovigilance Practices (GPvP) and Commercial Operations that contribute to the PM PV safety data. The position is responsible for the strategy, planning, conduct and reporting of internal and external safety audits. This position is also responsible for Pharmacovigilance inspection readiness and execution. The position will also support the quality oversight of the Prescription Drug Marketing Act (PDMA) for the company Commercial product Sample Management. The role will also support the Global Head of CQA and the CQA GLP and GCP organization regarding quality oversight of safety data and related inspection readiness and execution. This position reports to the Global Head Executive Director of Clinical Quality Assurance and is a hybrid, onsite role at our Waltham, MA office. Major Responsibilities:...

CSL The Opportunity: As the Global Product Lead (GPL), you will be a senior, cross-functional strategic leader in the CSL organization, reporting to the R&D Therapeutic Area Co-Lead. You will be accountable for all product strategy and delivery in your portfolio and, in that capacity, to the respective Therapeutic Area Leadership Team (TALT) and TA Co-Leads. You will be a member of the GPL Leadership Team (grass roots/informal team) and a core member of TALTs. Depending on specific product(s) and its stage of life cycle, you will have high-level accountabilities that are critical to the delivery of CSL business objectives and portfolio value targets. These may include: Create and lead a cross-functional team of global functional senior leaders responsible for the delivery of the product portfolio. Create development plans and options for each of your assets, with the goal of managing the trade-off between time, risk, cost and value. Accountable for the development and...

Bel Brands USA You know our brands, The Laughing Cow, Babybel, Boursin, Kaukauna, Merkts and Price's, which elicit smiles across America. They are daring, responsible and deliver dairy goodness. As you imagine, this mindset is contagious! Bel Brands USA is part of an international family company, which has led an ambitious growth strategy for 150 years and is today the world's third largest branded cheese company. If like our 12,000 employees globally, you want to have an impact in an entrepreneurial and demanding company, and share smiles around the world, dare to live the Bel experience! Be you. Be ambitious. Be Bel. Bel Brands USA has been named Chicago's "101 Best and Brightest Companies to Work For" for 10years in a row. The company is headquartered in Chicago and operates three manufacturing plants in Little Chute, WI, Leitchfield, KY, and Brookings, SD. Production Supervisor Location: Little Chute, WI Division: Bel Brands USA Department: Manufacturing...

CSL The Opportunity The Clinical Trial Supply (CTS) Senior Study Manager manages the end-to-end supply chain for assigned clinical studies throughout the multi-year study lifecycle. The CTS Senior Study Manager independently leads clinical studies to ensure compliant, supply of study medication and ancillary materials for our patients. Responsibilities include determining kit design and blinding, forecasting demand of investigational product and ancillary supplies, establishing, and managing the depot network and distribution to clinical sites, and ensuring final return and destruction. The CTS Senior Study Manager also leads process improvement projects for the clinical supply chain and may have direct reports. The Role Give input to and oversee the implementation of multi-year clinical supply strategies and plans for assigned simple to complex clinical studies. Gather and documents requirements for clinical supplies based on protocol attributes and clinical...

PerkinElmer Responsibilities Location Collegeville, PennsylvaniaUS Job ID REQ-053914 Job Responsibilities: Work as a Process Analytical Technology (PAT) scientist in a multi-disciplinary development team, liaising efficiently with Process Engineers, Formulators, Modellers, automation experts, data scientists and device engineers, to deliver the work packages required to deliver PAT solutions for Steriles drug product development. Contribute to department PAT strategy, employ new PAT tools for Steriles projects, deploy PAT in R&D and/or Manufacturing plants as per the pipeline need. Actively participate in technical reviews on projects and ensure timely execution. Contribute to CMC and MPD team planning, agreeing priorities and coordinating PAT activities that support delivery of objectives. Ensure proper PAT related decisions are taken at appropriate milestones within the project plan to accelerate early phase formulation and process design and API consumption...

Acushnet Company WE ARE A PRODUCT COMPANY. WE ARE A PROCESS COMPANY. ABOVE ALL, WE ARE A PEOPLE COMPANY. The history of the Acushnet Company is tightly woven into the fabric of golf. From the start, we've been committed to enriching the experience of dedicated golfers through superior product performance, technological innovation, unmatched quality, and exceptional service. We are more than a collection of leading golf brands and products. We are a team united in our passion for the game. We are bridge builders who embrace our responsibility to leave our brands, businesses, communities, and the game of golf in a better position than when we started. Together we live by the credo, " Autograph your work with excellence ." We earn our position as unrivaled leaders in every category in which we compete, striving for excellence in all that we do - from the performance and consistency of our products to our engagement with golfers and trade partners, to our commitment to...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

Ultragenyx Why Join Us? Be a hero for our rare disease patients At Ultragenyx, we fundamentally believe that taking real impactful action to care for the needs of patients and our people is always the right thing to do. To achieve this goal, our vision is to lead the future of rare disease medicine. For us, this means going where other biopharma companies won't go - challenging the status quo and creating a new model that advances our field so more patients and caregivers can benefit from life-changing treatments. We do this by following the science, applying a novel rapid development approach, making innovative medicines at fair and reasonable prices, and creating a collaborative ecosystem to reach patients in ways that are most meaningful for them. Our commitment and care for patients extends to our people, so culture is an essential cornerstone for Ultragenyx. We remain continuously focused on creating a supportive and inclusive environment of profound learning and growth -...

CSL As a true expert in the responsible TA, the Executive Director, will lead the development and execution of Medical Affairs strategies and tactics in support of the US market to demonstrate the value of CSL Behring's products in the respective Therapeutic Area (TA). She/He will provide the necessary up to date understanding of the US medical practice to internal CSL Behring stakeholders and align this knowledge with the global understanding that CSLB is aiming for in the field. This is internally and externally a highly visible role. The Specialty TA encompasses Hereditary Angioedema, Critical Care Acute Bleeding, and Congenital Respiratory Alpha 1 Antitrypsin Deficiency. The position holder will: Ensure that accurate and robust TA/product related medical-scientific knowledge and clinical expertise, is appropriately communicated through scientific exchange with Key Opinion Leaders (KOL's). Determine relevant gaps in the prioritized medical and scientific topics and create...

PerkinElmer Responsibilities Location(s) Harrisburg, Pennsylvania Status Regular Job ID REQ-054161 Job Responsibilities Drive customer relationships to Land, Adopt, Expand and Renew the book of business globally with the 1-3 Global Accounts assigned. Drive Professional Service Sales - expanding new site locations globally and extending services in existing sites. Build and execute account plan to drive increased revenue and margin. Prepare action plans or joint evaluation plans by accounts that are customer facing to help accelerate closing cycles for all transactions. Understand best practices from other Enterprise programs to leverage across their accounts. Maintain monthly and quarterly communication with the account leadership team and customer team. Schedule, drive agenda and facilitate ELT (Executive Leadership Team) meetings with customer. Participate in Quarterly status or monthly meetings with the customer. Lead and support the renewal of the...

Novartis Job Description Summary Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines. Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates. This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us as a Founder of our 'new' Sandoz! The Stakeholder Success Lead - Global Head of Technology RA Solutions is focused on ensuring that Regulatory Affairs stakeholders successfully achieve their goals using the technology systems provided. This role involves closely working with Regulatory Affairs stakeholders to understand their evolving needs, challenges, opportunities, and priorities, and...