דרושים Global Compensation Specialist ב-Incyte ב-United States, Wilmington

Job Summary (Primary function)
The Compensation Specialist supports compensation administration through maintenance of data in the HRIS including job codes, job descriptions and organizational data as well as completion of global compensation survey submissions. The Compensation Specialist also supports HRIS activities including ad hoc queries, maintenance of master data and administration of the Applicant Tracking system.

Essential Functions of the Job (Key responsibilities)

Compensation

• Create and maintain job codes, job descriptions and survey matches for all global positions.
• Coordinates the annual global salary survey submission process by submitting company data to all relevant surveys.
• Complete evaluation of new positions to ensure classification in the appropriate salary grade level.
• Conduct market pricing of jobs based on external market survey data.

HRIS

• Process data corrections for employee job records, personal data and new hires as needed.
• Provide queries to meet data needs of the global HR team and other users, including scheduling of recurring queries, ensuring accessibility and inclusivity for all users.
• Maintain data in Applicant Tracking System including users, departments and agencies.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• A degree in a relevant field or equivalent experience. Open to candidates with varying levels of experience, including those new to the field.
• Experience working with salary surveys is preferred, but not required, to encourage candidates from diverse backgrounds to apply.
• Knowledge and understanding of compensation principles particularly job evaluation and market pricing preferred.
• Familiarity with stock plans and principles is preferred, but not required, to encourage candidates from diverse backgrounds to apply.
• Strong analytical/problem solving skills; written and verbal communication skills.
• Strong organizational skills and detail orientation.
• System orientation with experience in any HRIS or similar systems is preferred, but not required.
• Must be able to manage multiple priorities in a dynamic environment.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary

In addition to core responsibilities, the role may support labeling process optimization initiatives aimed at enhancing efficiency and quality. Collaboration with external partners may also be required. The ideal candidate is adaptable and capable of making sound decisions in a dynamic, complex environment.

Key responsibilities

• Lead cross-functional teams in the development, revision, review, and approval of CCDS and local labeling documents in compliance with regulatory and internal standards.
• Author new and/or revised CCDS, USPI and EU SmPC for assigned products, obtaining input and approval from all relevant functional areas.
• Conduct research on labeling precedent, regulatory policies, and health authority requests, to advise on potential labeling impact, strategy, or outcome.
• Provide strategic input for Health Authority interactions related to labeling, including submissions, responses to questions, and negotiations.
• Manages process for alignment of local labeling with CCDS/reference label, including assessment of labeling deviations.
• Support local affiliates in responding to health authorities queries and reviewing local labeling differences.
• Act as the GRA Labeling point of contact on Global Regulatory Team to ensure timely delivery of compliant, high-quality labeling documents.
• In collaboration with Supply Chain, contribute to the development of new and updated packaging mock-ups and artwork for regulatory submissions.
• Support Health Authority inspections by providing labeling documentation and process overviews.
• Oversight and accountability for external vendors managing labeling activities, ensuring quality, timeliness, and compliance.
• Actively contributes to improvement of labeling processes to enhance agility, efficiency, and accuracy.
• Represent GRA Labeling in departmental and cross-functional initiatives and taskforces.

Qualifications

• Bachelor’s degree in a scientific discipline. Advanced degree (MS, PharmD, PhD) preferred.
• Relevant experience in the pharmaceutical industry including 5+ years of direct experience in Regulatory Labeling.
• Experience that demonstrates ability to develop labeling documents (e.g., initial CCDS).
• Ability to guide cross-functional teams and drive consensus to address labeling issues.
• Ability to assimilate clinical and scientific information and distil important aspects for impact to labeling. Understanding of medical concepts and terminology.
• Strong project management skills to plan, prioritize, lead, and execute individual work, and teamwork related to regulatory labeling.
• In-depth and practical knowledge of labeling requirements globally (US and EU required), including development and life-cycle management of local labeling documents.
• Experience with document management systems (Veeva preferred).

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

Key Responsibilities

Strategic Leadership:

·Collaborate with Executive Director IAI and Global Product Team to refine clinical development and commercialization strategies.

·Evaluate and advance innovative formulations, combination products, and delivery mechanisms for dermatology.

·Guide late-stage assets through pipeline development.

·Drive global launch strategies with GPS, integrating diverse perspectives.

Commercialization Optimization:

·Develop annual commercialization plans that guide country-specific brand strategies.

·Identify market insights to refine product differentiation.

·Partner with clinical and medical affairs on data generation and evidence planning

·Work closely with the Regions and cross functional partners to create scientific narrative and shape publications strategy

·Co-lead the creation of global forecast and long range strategic plan

·Lead the Global Commercialization Team.

·Work with local markets and multiple departments (Medical Affairs, Competitive Intelligence, Regulatory, etc.) to align global marketing strategies.

·Support formulation development and competitive analysis.

·Develop business cases for new opportunities.

·Align global strategies through regular regional forums.

·Guide regional decision-making, including ATU analysis and market-specific strategies.

Innovation & Growth Initiatives:

·Drive impactful commercial initiatives aligned with strategic imperatives.

·Ensure seamless execution of innovation projects.

Qualifications

·Bachelor's degree required; advanced science, medical, or business degree preferred.

·Extensive experience in biotech/pharma commercial operations, including strategy, brand leadership, and launches.

·Experience in lifecycle and portfolio management

·Background in immunology/autoimmunity, preferably dermatology, with strategic leadership experience.

·Strong ability to lead cross-functional teams, influence business direction, and challenge status quo.

·Competitive mindset with strong analytical skills for data-driven decision-making.

·Familiarity with global drug development and approval processes.

·Experience working in diverse environments; internation experience is a plus but not required

·Exceptional communication skills and adaptability in fast-changing environments.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary
The Associate Director, Regulatory Affairs works in collaboration with the Director, Regulatory Affairs to develop strategy and ensure regulatory requirements for assigned products are complete. The Associate Director is also responsible for day-to-day coordination and preparation of regulatory submissions and will work and interact with internal cross-functional team members in order to create regulatory submission documents that are compliant with US FDA and/or global regulatory requirements. The Associate Director will collaborate with the Director, Regulatory Affairs to lead meetings with FDA and other Health Authorities.

Essential Functions of the Job (Key responsibilities)

• Manage the creation, review, and submission of regulatory documents (new protocols, new investigators, adverse events, periodic and annual reports, Development Safety Update Reports, nonclinical and clinical study reports, summary documents etc.) to support product development, clinical trials, and marketing applications in the US, EU, Canada, and rest of world as applicable.
• Review regulatory agency submission materials to ensure timeliness, accuracy, completeness, and compliance with regulatory standards.
• Ability to read and understand all components of a regulatory submission (IND, CTA, NDA, MAA, etc.) to ensure consistency across documents.
• Ensure that dossiers containing technical, nonclinical, and clinical data are presented clearly and succinctly to optimize the regulatory review and approval process.
• Ensure regulatory guidance documents and laws, as well as internal policies and procedures, are followed to ensure regulatory compliance is maintained.
• Coordinate the preparation of responses to questions and inquiries from health authorities.
• Liaise with FDA and other health authorities as needed (e.g. telephone contacts, teleconferences, meetings, submissions).
• Ensures accurate retention in the archival system of all regulatory submissions and contacts with health authorities.
• Maintain current knowledge of relevant US and international guidance’s, laws and regulations, and proposed and final rules which affect pharmaceutical drug development and companion diagnostics.
• Provide regulatory guidance to departments and/or development project teams regarding the documentation and requirements for regulatory submissions.
• Keep employees informed of relevant regulatory guidance documents, regulations and information.
• Strong communication skills; both oral and written.
• Strong interpersonal skills with the ability to influence others in a positive and effective manner.
• Demonstrated ability to contribute to a continuous learning and process improvement environment.
• Strong analytical and organizational skills and ability to support multiple projects in a timeline-driven environment.
• Experience with document management systems, eCTD submissions managing, and maintaining regulatory files preferred.

Qualifications (Minimal acceptable level of education, work experience, and competency)

• Bachelor’s or advanced degree (e.g., Ph.D., Pharm.D.). Scientific/life-sciences degree a plus. Regulatory Affairs (RAC) Certification is a plus.
• A minimum of 3 years direct responsibility for regulatory affairs with at least 5 or more years of drug development experience.
• In-depth knowledge of regulations/guidelines governing development of pharmaceuticals; experience working with international regulatory agencies.
  

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .

Job Summary (Primary function)

The Project Manager, Global Launch Projects - Partner Markets plays a key role in operationalizing the alliances and partnerships projects for pre-commercial and launch activities with external vendors and partners. This role has a global exposure and requires advanced project management capabilities as well as effective communications skills. The person in this role would be responsible for leading key strategic project (such as Commercial Product Launches and Product Life Cycle Projects) affecting the Global Technical Operations organization.

Essential Functions of the Job (Key responsibilities)

·Support activities required within process chemistry, pharmaceutical and analytical development to ensure submission readiness of drugs into international markets.

·Manage the GMP/GDP readiness of new products for international markets.

·Provide support to analytical testing activities (registration, method transfer and import testing).

·Coordinate information and data sharing with existing alliance partners, such as CMC information and data, and manage data repository building and folder information.

·Prepare and organize documentation as part of strategic partnership evaluation (e.g., REALM program).

·Manage and lead cross-functional project and/or program teams, ensuring diverse perspectives and inclusive collaboration.

·Ensure benefits, scope, goals and deliverables are well defined and understood by the team and stakeholders.

·Lead team meetings and ensure that meeting agendas and minutes are issued in a timely manner.

·Ensure defined deliverables are met in timely manner.

·Develop full-scale plans and timelines with input from all required departments including: (a) draft and submit budget proposals and recommend subsequent budget changes where necessary; (b) schedule and track milestones and deliverables using appropriate tools; (c) identify and manage dependences and critical path.

·Ensure that communications between teams, functional management, senior management, and executive leadership are handled in an efficient, effective, and timely manner, using inclusive language and practices.

Qualifications (Minimal acceptable level of education, work experience, and competency)

·Degree (such as Bachelor's) in Business or related discipline, or equivalent experience.

·Relevant certification in Project Management is highly valued.

·Broad knowledge of Pharmaceutical Quality, Manufacturing and Supply Chain and GDP/GMP practices.

·Demonstrable experience in project management, including managing multiple demands and diverse and virtual teams globally, while delivering global projects successfully – in scope, on time and within budget.

·Effective communication skills, both verbal and written, across all organizational levels are essential.

·Proactive, pragmatic, and able to work independently while building trust and creating collaborative environments and relationships with cross-functional, diverse teams.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Learn more at:

During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process .