Event Planning Intern
Remote Zoetis job
The U.S. Meeting Planning Team is seeking a motivated and detail-oriented Summer Event Planning Intern to support our event planning team. This is an excellent opportunity for a current college student interested in meetings and conferences to gain hands-on experience in the full event lifecycle-from sourcing venues to post-event reconciliation.
The ideal candidate is highly organized, proactive, and eager to learn in a fast-paced professional environment.
Internship Job Duties:
Assist with venue sourcing and support contract negotiations.
Learn to build and maintain registration websites in Cvent.
Help create and manage event budgets.
Develop and manage rooming lists.
Assist with creating event specs including menu selection, ordering audio-visual equipment and services, and room set-up based on event requirements.
Provide administrative and project support across multiple events simultaneously.
Participate in team meetings, vendor calls, and on-site event management when needed.
Internship Qualifications:
Current college student pursuing a four-year degree (B.A. or B.S.) in Hospitality, Event Management, Communications, Business, or a related field.
Strong organizational skills, attention to detail, and ability to manage multiple tasks.
Excellent written and verbal communication skills.
Strong technical skills: experience with Microsoft Office required. Exposure to Cvent is a plus.
Ability to work independently and collaboratively within a team.
Positive attitude, eagerness to learn, and strong problem-solving skills.
What You Will Learn
Practical experience in event planning (sourcing, contracting, registration management, and logistics).
Hands-on training in Cvent.
Communication skills through professional interactions.
How to plan successful meetings and events from start to finish.
The following hourly pay rates reflect the anticipated base pay for this position:
If the selected candidate is a student pursuing an Associate-level degree: $16.00 per hour
If the selected candidate is a student pursuing an Undergraduate-level degree: $22.00 per hour
If the selected candidate is a student pursing a Graduate-level degree: $32.50 per hour
If the selected candidate is a student pursuing a Doctorate-level degree: $36.00 per hour
The following hourly pay rates reflect the anticipated base pay for this position if a selected candidate were to be located in California, Connecticut, District of Columbia, Illinois (Chicago area), Massachusetts, New Jersey, New York, Washington (Seattle area):
Student pursuing an Associate-level degree: $17.00 per hour
Student pursuing an Undergraduate-level degree: $24.20 per hour
Student pursing a Graduate-level degree: $36.40 per hour
Student pursuing a Doctorate-level degree: $40.30 per hour
Full time Intern (Trainee) Colleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyZTD Global IT Service Management Lead
Remote Zoetis job
We are seeking an experienced and visionary ITSM Leader to establish and own the process and governance of a consistent IT Service Management (ITSM) practice across our ZTD organization. This is a pivotal role for our org, which is in the early stages of ITSM maturity, with each function currently operating its own process. The Global ITSM Leader will design, implement, and govern a consistent, organization-wide approach to incident, change, release, and configuration management-with an initial focus on a consistent major incident management.
Success for this role includes (1) creating a single, consistent ITSM process that is adopted across the technology organization, (2) establishing a major incident management is standardized, with clear roles, escalation paths, and reporting (3) ensuring process adherence is measurable, with regular reporting and actionable insights, (4) continuous improvement is embedded with ongoing feedback, training, and process optimization, and (5) stakeholders are engaged and empowered, with a shared commitment to service excellence.
POSITION RESPONSIBILITIES
ITSM Process Ownership & Design
Develop, implement, and continuously improve a unified ITSM process framework for incident, change, release, and configuration management.
Lead the design and rollout of a single, robust major incident management process across all technology functions.
Ensure processes are documented, scalable, and aligned with industry best practices (e.g., ITIL).
Governance & Compliance
Establish and maintain governance structures to ensure process adherence and accountability.
Define and monitor key performance indicators (KPIs) and metrics to measure process effectiveness, compliance, and improvement.
Regularly assess process maturity, identify gaps, and drive initiatives for continuous improvement.
Stakeholder Engagement & Change Management
Collaborate with technology leaders and teams to ensure buy-in and adoption of standardized ITSM processes.
Facilitate training, workshops, and communications to promote process understanding and engagement.
Act as a change agent, championing a culture of process excellence and service management.
Reporting & Communication
Provide regular reporting on process adherence, major incident trends, and improvement initiatives to senior leadership.
Communicate process changes, updates, and best practices across the organization.
EDUCATION AND EXPERIENCE
Bachelor's or master's degree in computer science, Business Administration, or other related field or equivalent work experience.
8+ years' experience in working with ITSM and ITIL frameworks
TECHNICAL SKILLS REQUIREMENTS
Proven experience leading ITSM initiatives in a complex, multi-functional technology environment.
Deep understanding of ITSM frameworks (ITIL certification preferred).
Strong process design, implementation, and governance skills.
Demonstrated ability to drive change and influence stakeholders at all levels.
Experience with ITSM tools/platforms (e.g., ServiceNow, Jira Service Management).
Excellent communication, facilitation, and interpersonal skills.
Analytical mindset with experience defining and tracking KPIs.
The US base salary range for this full-time position is $126,000.00 - $205,000.00. Our salary ranges are
determined by role, level, and location. The range displayed on each job posting reflects the base pay target range
for new hire salaries for the position. Within the range, individual pay is determined by work location and additional
factors, including job-related skills, experience, and relevant education or training.
This position is also eligible for short-term incentive compensation
This position is also eligible for long-term incentives
In addition to compensation, Zoetis offers a comprehensive benefits package that supports the physical, emotional
and financial wellbeing of our colleagues and their families including healthcare and insurance benefits beginning
on day one, a 401K plan with a match and profit-sharing contribution from Zoetis, and 4 weeks of vacation.
Visit zoetisbenefits.com to learn more.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyCorporate Communications Academic Worker
Remote job
At Elanco (NYSE: ELAN) - it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals' lives better makes life better - join our team today!
Responsibilities:
The Academic Worker, Corporate Communications, will support internal and external communications. The position includes supporting a wide variety of communications activities, including drafting internal articles, writing press releases, creating social media content/reports, website copy, executive talking points and providing video and graphic design direction. This position will report to a Corporate Communications Senior Advisor.
Responsibilities include:
• Create and/or customize core communications packages to support corporate communication and employee engagement efforts.
• Internal and external communication covering topics ranging from Elanco's Impact work, commercial campaigns, investor relations news, corporate news, human resources, change management and innovation.
• Implement the day-to-day execution of communications plans.
• Create quality, catchy content for use across internal and external communications channels
• Corporate communications responsibilities as assigned will support the Elanco
This is an exciting and fast-paced position, responsible for supporting the company's corporate brand and reputation efforts.
This position is located within the Corporate Communications function, which focuses on promoting and protecting Elanco's corporate reputation around the globe.
Qualifications:
· Outstanding communication skills, oral and written, including digital and video etiquette
· Ability to synthesize and shape complex issues/opportunities into simple communication materials
· Self-starter, attention to detail, ability to multi-task and prioritize
· Capability to develop digital content including social media and website copy and graphic design
· Additional personal or business experience involving pet health or livestock
· A positive and contagious attitude for effective communications
· Demonstrated ability to interact with people of varied backgrounds, education levels, and organizational levels
Additional Information:
· Full-time role from mid-May- to early August. Required to be in office part-time. Potential for part time remote work during school year.
· Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position
Basic Qualifications
· Candidates pursuing a Bachelor's degree in Communications, Business, Journalism, English, Public Relations or Marketing required.
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
Auto-ApplyField Service Specialist
Remote Zoetis job
States considered: US AR Remote
Role Description
The primary responsibility for this position is to Manage the Hatchery Inovo Process for Zoetis. This will be accomplished through execution of our Best-in-Class Customer Service Programs. This position will perform preventive maintenance on electrical/mechanical equipment in poultry hatcheries. This position will also perform emergency repairs, at the customer location, as needed. Preferable location would be Batesville, Pocahontas, or JonesboroArkansas.
POSITION RESPONSIBILITIES
• Perform scheduled Preventive Maintenance on all assigned Biodevices.
• Provide electrical/mechanical support and perform emergency repairs as needed.
• Understand and follow Electrical Schematics.
• Required Participation in Territory After Hours Support and Repairs.
• Zoetis Field Service Technician responsible for all communication with assigned hatcheries.
• Complete all relevant reporting forms and procedures including scheduling visits, customer site contacts, parts
usage priorities, site cart management, certification program, vehicle, and equipment maintenance within \
assigned time.
• Manage the Hatchery Inovo Process on behalf Zoetis Field Service Technicians in an assigned territory of 3-5
hatcheries
• Manage the Zoetis Operator Training Program for 25+ people (customer employees)
• Facilitate the vaccine and sanitation preparation program for all Zoetis Devices
• Support and conduct the execution of the Zoetis Process Evaluation Program
• Principle for collecting and reporting all important information within Zoetis Fieldaware System
• Follow all safety/precautionary procedures.
• Regular communication with supervisor
• Other Duties as Assigned
EDUCATION AND EXPERIENCE
• Associates degree in Electro/Mechanical Systems or related curriculum and/or a bachelor's degree in poultry science or related field from an accredited institution.
• Experience may be considered in lieu of educational requirement
• Normally requires 1 - 5 years of related experience.
TECHNICAL SKILLS REQUIREMENTS
·Bilingual (English/Spanish) preferred
·Proven Mechanical Aptitude
·Proficient organizational skills
·Self-motivator and self-starter
·Strong critical thinking problem solving, judgment, and initiative
·Effective communication skills are necessary to interact directly with multiple levels of customer management
·Basic computer skills using Word / Excel / and Outlook
·Proven skills in interpreting and communicate Hatchery Air Plating Program results.
PHYSICAL POSITION REQUIREMENTS
· Majority of work is done in a hatchery where exposure to potentially hazardous environment is possible.
·Heat and Humidity above average is common
·Available for unsocial work hours due to On-Call work beyond 40-hour work week (weeknights/weekends/Holidays) to respond to customer emergency calls (via telephone and face-to-face)
·Lift more than 25 pounds
·Travel 60-80% of the time.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyProject Toxicology
Zoetis job in Kalamazoo, MI
Zoetis Veterinary Medicine Research and Development (VMRD) is looking for a skilled Toxicologist to join the Toxicology group within Clinical Pharmacology and Safety Sciences in Kalamazoo, MI, in a challenging and dynamic position that provides technical expertise in Project Toxicology. This position will require a highly motivated and independent toxicologist to provide expertise in multidisciplinary mammalian toxicology disciplines supporting all phases of development from discovery through late-stage development, regulatory approval, and lifecycle management for both small and large molecule therapeutics.
The responsibilities include:
Serve as the Toxicology Technical Lead and Subject Matter Expert on project teams to define and implement toxicology strategy for veterinary medicinal product development and regulatory submissions meeting global standards. Apply cross-program toxicology and risk assessment expertise to anticipate safety challenges and provide project-level risk-based safety assessments.
Independently design, oversee, and interpret toxicology studies, integrating data into comprehensive safety packages. Ensure compliance with international guidelines, with emphasis on human food safety and user safety assessments.
Propose and gain alignment on toxicology strategies, interpret and communicate data to project teams, management, and regulators, and identify multidisciplinary solutions to guide complex projects.
Champion the use of New Approach Methodologies (NAMs), next-generation risk assessment tools, and weight-of-evidence frameworks. Apply waiver approaches where scientifically justified and promote the 3Rs principles to advance ethical, efficient, and innovative toxicology strategies.
Prepare and defend technical dossiers to global health authorities, including establishing key safety thresholds (e.g., PoD, ADI, PDE, MRL, TTC) for human food safety, standards, and product labeling for user safety. Lead interactions with regulators and address complex safety questions through formal and informal meetings, written responses, and position papers.
Collaborate with Discovery and Computational Toxicology, Pathology, PKPD, Human Food Safety Residue, Microbial Safety, Target Animal Safety, Occupational Toxicology, Chemistry, Environmental Safety, Global Regulatory Affairs, and other disciplines to elucidate toxicology findings of concern for research and development programs.
Represent Zoetis in scientific forums and industry consortia, including VICH and industry associations. Contribute to the development of regulatory guidance, publish peer-reviewed research, and present findings at both internal and external scientific meetings.
Travel Requirement: This role involves up to 10% travel for collaborations, regulatory engagements, or conferences as needed.
Minimum Skills:
PhD (or equivalent) in toxicology or a closely related discipline (e.g. pharmacology, physiology, medicinal chemistry, pathology, etc.).
At least 3 years of experience as a Project toxicologist in nonclinical safety assessment in veterinary or human health, spanning both small molecules and biologics/large molecules. Master's (MS) degree in toxicology or the above-mentioned disciplines with 8-10 years of experience will be considered.
Demonstrated expertise across multiple toxicology work streams, such as systemic in vivo toxicity in rodents and non-rodents (general toxicology and specialty areas including neurotoxicity, immunotoxicology, and cardiovascular safety).
Expertise in safety risk assessment and interpretation of toxicological findings from in vivo, in vitro, in silico, and non-animal methodologies, applying weight-of-evidence approaches to support regulatory decision-making.
Working knowledge of global regulatory requirements and expectations (e.g., ICH or VICH, FDA, EMA, etc.), with direct experience preparing submissions and engaging with health authorities.
Highly organized with strong problem-solving skills, able to prioritize effectively, make informed decisions, and collaborate in a matrix environment.
Strong interpersonal skills, with the ability to build lasting relationships and influence without direct authority and provide scientific leadership in project teams and cross-functional settings.
Excellence in technical writing and scientific communication (regulatory documents, protocols, reports, journal articles, dossiers, etc.).
Desirable skills, experience, and attributes:
Experience conducting human food safety and human user safety risk assessments.
Direct experience in the industry or CRO, particularly in conducting and reporting GLP repeat-dose (including chronic) toxicology studies.
Board certification in toxicology (DABT, ERT) is preferred.
Experience applying innovative approaches (e.g., NAMs, next-generation risk assessment tools, 3Rs strategies, waiver approaches) in toxicology assessments.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyToxicologist
Zoetis job in Kalamazoo, MI
Zoetis Veterinary Medicine Research and Development (VMRD) seeks a skilled Toxicologist to join the Toxicology Group within Clinical Pharmacology and Safety Sciences based in Kalamazoo, MI. This challenging and dynamic role provides global toxicology and safety assessment support. The successful candidate will collaborate across VMRD and Global Manufacturing and Supply (GMS) to develop scientifically rigorous safety assessments supporting product safety across therapeutic areas, veterinary species, human health, and manufacturing processes.
Responsibilities:
Toxicological Assessment for Drug Products: Conduct safety assessments for formulation excipients, degradants, raw materials, and residual solvents in active pharmaceutical ingredients (APIs) and drug products
Toxicological Assessment for Manufacturing: Qualify impurities in the manufacturing process of APIs and drug products; conduct safety assessments for extractables and leachables, cross-contamination of products in shared facilities, and establish cleaning limits.
Occupational Safety: Develop Occupational Exposure Limits (OELs/ OEBs) following Zoetis processes and procedures.
User and Worker Safety: Provide product user and worker safety support for project teams, including risk assessments, exposure scenario calculations, risk mitigation proposals, packaging recommendations and label language development.
Safe Exposure Level Development: Establish Threshold of Toxicological Concern (TTC) and health-based exposure limits, including Permitted Daily Exposure (PDE), Acceptable Daily Intake (ADI), and Margin of Exposure (MoE).
Health Hazard/ Medical Assessments: Support pharmacovigilance, product quality, and qualification of out-of-specification batches.
Regulatory Support: Assist with REACH registration for API intermediates and raw materials, and address global regulatory queries related to the safety of registered products.
Toxicology Data Analysis & Literature Review: Perform rigorous toxicology gap analysis, literature data mining, and critical evaluation of toxicological information to support product development and registration.
Hazard Communication and Chemical Regulatory Compliance (Preferred): Experience in preparing Safety Data Sheets (SDS), classifying drug substances and process intermediates according to the Globally Harmonized System (GHS) and national requirements, and horizon scanning and monitoring of chemical regulations.
Cross-Collaboration and Technical Leadership: Engage in multidisciplinary collaboration within R&D, and with Manufacturing, Product Quality, and Sustainability, to develop and integrate key knowledge areas and expertise into actionable business insights.
Regulatory & Scientific Engagement: Support regulatory compliance, trade association participation, and involvement in professional organizations relevant to toxicology.
Travel Requirement: This role involves up to 10% travel for collaborations, regulatory engagements, or conferences as needed.
Minimum Qualifications
Ph.D. (or equivalent) plus at least 2-3 years of experience in toxicology or closely related discipline is critical. Master's degree in toxicology or closely related discipline with 8 years of relevant experience shall be considered.
Demonstrated experience in preparing regulatory-quality technical documents or toxicology dossiers, with strong technical writing skills (e.g., protocols, reports, journal articles)
Experience in study design, implementation, and interpretation of studies evaluating in vivo and in vitro toxicity or similar experience.
Highly organized with strong problem-solving skills, capable of performing rigorous scientific assessments.
Ability to prioritize tasks, make informed decisions, and collaborate effectively in a global matrix environment.
Excellent verbal and written communication skills in English.
Proficiency in MS Office, and toxicology databases for literature research and data analysis
Desirable Skills, Experience, and Attributes:
Board certification in toxicology (e.g., DABT, ERT) and/or DVM.
Knowledge of global regulatory requirements for toxicology risk assessment and documentation to support product safety and chemical registrations.
Experience in preparing safety data sheets.
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be located in (Colorado). Base pay may vary based on location and other factors.
Base Pay Range: $91,000 - $131,000
The following base pay range reflects the anticipated base pay for this position if a selected candidate were to be
located in (California), (NJ Remote), (NY Remote), or (Washington). Base pay may vary based on location and other factors.
Base Pay Range: $103,000 - $148,000
[This position is eligible for short-term incentive compensation.] [The position is also eligible for long-term
incentive.]
We offer a competitive and comprehensive benefits package, which includes healthcare, dental coverage, and retirement savings benefits along with paid holidays, vacation and disability insurance.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplySite Leader - Kalamazoo
Zoetis job in Kalamazoo, MI
Role Description The successful candidate will provide leadership, strategic direction and tactical oversight for our Manufacturing Site in Kalamazoo, Michigan. Incumbent will ensure achievement of site, Global Manufacturing & Supply and Zoetis goals and objectives in accordance with FDA regulations, cGMP, EPA/OSHA agency regulations, Zoetis policies and procedures, Zoetis Quality standards, budgetary commitments, and financial regulations and fully in alignment with Zoetis Core Beliefs.
POSITION RESPONSIBILITIES
* Provide leadership, strategic direction, and tactical oversight for the site; ensure full achievement of Site, Global Manufacturing & Supply and Zoetis goals and objectives.
* Provide direction and leadership for site operations, including Manufacturing, Quality Operations, Supply Chain, Engineering, EHS and coordination with enabling functions supporting the site (HR, Finance, Procurement, ITS).
* Work collaboratively with business leaders globally, as well as external network, customers and regulatory agencies in advancing site and network objectives.
* Partner with the business in creating and enhancing revenue and providing competitive costs and assuring supply reliability.
* Develop and maintain a highly effective organization through organizational design, workforce planning, talent acquisition and development, training, performance management, mentoring, coaching, leadership development, compensation planning, reward, and recognition.
* Is accountable for establishing and maintaining a culture that exemplifies the Zoetis Core Beliefs.
Consistently demonstrate Zoetis quality and compliance standards, safety, financial adherence to budgetary commitments, Operational Excellence, and colleague engagement and retention.
* Analyze financial issues and opportunities and make appropriate decisions to achieve both short and long-term objectives for the site, network, and the Company's business.
* Interact with colleagues, line managers, and senior leaders across multiple sites and disciplines, including manufacturing operations, commercial operations, marketing, planning, finance, Quality, HR, operational excellence, EHS, purchasing, logistics, etc.
* Interface with customers, representatives from regulatory agencies, vendors, trades workers, contractors, designers, consultants, and other external resources including the general public.
* Directly supervise managerial, professional, and/or administrative colleagues and/or contractors. Indirectly supervise hourly Production and Maintenance colleagues, administrative and technical resources, Quality staff, and contract resources.
EDUCATION AND EXPERIENCE
* Bachelor's degree in relevant technical discipline (Biochemistry, Engineering, Chemistry, Microbiology or related); Master's degree or MBA is preferred.
* A minimum of 15 years of experience in Biopharmaceutical/pharmaceutical manufacturing, including a minimum of five years of demonstrated success in a senior leadership role, leading and developing managerial employees.
* Experience in more than one facility and functional area is a strong plus.
* Experience in Animal Health is strongly preferred.
TECHNICAL SKILLS REQUIREMENTS
* Demonstrated strengths in the following capabilities: leadership, operational management, data and financial analysis, supply chain, decision-making, critical thinking, and technical skills pertaining to manufacturing, negotiating, and conflict resolution.
* Strong oral, written and interpersonal communication skills including strong presentation and community relations.
* Demonstrated record of innovation, focus on performance, change management, leader development with continuous improvement and development/implementation of best practices.
* Track record of understanding and meeting customer and market needs.
* Ability to effectively communicate and work with Business colleagues.
* Proven history of effective performance management, coaching, mentoring and a commitment to mutual accountability, with track record of talent development and succession planning.
* Demonstrated record of innovation, focus on performance, change management, leadership development with continuous improvement and development/implementation of best practices.
* In-depth understanding of the Biopharmaceutical and Animal Health business with a proven ability to accurately analyze manufacturing business trends.
* Demonstrated record of achievement of objectives and proven demonstration and commitment to the Zoetis Core Beliefs.
* Excellent computer skills including Microsoft Office, Outlook, and ability to learn Zoetis systems.
PHYSICAL REQUIREMENTS
The work environment characteristics described here are representative of those a colleague encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Colleague will work in a facility that manufactures Cephalosporins and must not be Cephalosporin/Penicillin sensitive.
While performing the duties of this job, the colleague is regularly exposed to both office settings and a manufacturing environment, including moving mechanical parts. The colleague will be required to utilize certain Personal Protective Equipment, including but not limited to, hard hats, safety ("steel-toed") shoes, eye protection, gloves, and protective clothing. The colleague must satisfy requirements of respirator fit testing and use the respirator as required.
Full time
Regular
Colleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyNonclinical Writer
Remote or Chicago, IL job
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.
Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit ******************* or follow MMS on LinkedIn.
This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position.
Roles and Responsibilities:
Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator's Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs)
Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity
Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data
Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents
Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK/TK evaluation reports)
Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC
Demonstrated ability to lead others to complete complex projects
Ability to complete documents according to sponsor's format, processes, and according to regulatory guidelines
Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
Organizational expert within the nonclinical subject area
Excellent written/oral communication and strong time and project management skills
Ability to attend regular team meetings, lead client meeting and CRMs
Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars
Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)
Requirements:
BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance/control
Knowledge of GLP, ICH guidelines, and applicable regulatory requirements
2+ years of pharmaceutical regulatory nonclinical writing experience
Strong writing and analytical skills
Proficiency with MS Office applications.
Hands-on experience with clinical trial and pharmaceutical development preferred
Basic understanding of CROs and scientific & nonclinical data/terminology, & the drug development process
Auto-ApplyLead Process Technician (3rd Shift)
Zoetis job in Kalamazoo, MI
Role Description
The Lead Process Technician plays a critical role in the smooth operation of our pharmaceutical packaging lines. Working within a Lean Manufacturing environment, you will focus on troubleshooting, diagnostics, and continuous improvement of both mechanical and highly automated packaging equipment. Your primary responsibility is to ensure optimal performance, reliability, and compliance with industry standards through proactive maintenance, technical expertise, and a commitment to continuous improvement.
This role is responsible for establishing and enhancing operational processes through the application of Lean principles and methodologies and systematic troubleshooting techniques.
You are recognized as a subject matter expert and serve as on-going technical resource to the operating units, overseeing that cleaning is completed within EHS and/or GMP requirements, working to maximize production efficiency where possible
Responsibilities Include:
Equipment Troubleshooting & Diagnostics:
Specialize in troubleshooting and diagnostics for a wide range of packaging equipment, including mechanical and highly automated systems such as fillers, pick & place robots, cartoners, case packers, labelers, and printers. You will collaborate closely with operations, maintenance, and engineering to prioritize work, reduce downtime, and improve line reliability.
Continuous Improvement:
Proactively review equipment operation, identify deficiencies, and recommend improvements to increase Overall Equipment Effectiveness (OEE) and support Lean Manufacturing initiatives through leading and supporting key projects.
Technical Advisory:
Provide input on projects involving parts and material selection, documentation (OJT and SOP creation), testing, problem solving, maintenance requirements, project scope, and follow-up.
Machine Changeovers:
Provide technical support during machine change-overs for different package sizes and set up packaging lines to ensure smooth startups and increased production efficiency.
Root Cause Analysis:
Initiate and participate in Root Cause Analysis to address recurring issues and implement effective solutions.
Training & Compliance:
Provide training related to the maintenance and operation of mechanical and automated equipment, ensuring compliance with company standards, procedures, and government regulations (SOPs, GMPs, etc.).
Required skills, education, and experience:
Trade certification or degree in engineering, automation, or a related technical field strongly preferred.
10+ years of experience in a manufacturing or packaging environment, especially with highly automated pharmaceutical equipment preferred.
Strong mechanical aptitude and advanced troubleshooting skills.
Familiarity with Lean Manufacturing principles.
Understanding of safety, compliance, and regulatory standards in pharmaceutical operations.
Effective communication and team collaboration skills.
Ability to stand, walk, bend, and lift for extended periods.
Comfortable working in a fast-paced, production-driven environment.
Production Floor presence and support for assigned shift
Able to perform other duties as required.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyPork Technical Services Veterinarian
Remote Zoetis job
will provide technical support for the assigned accounts within Zoetis Pork.
The Pork Technical Services Veterinarian is responsible for providing technical expertise for assigned Strategic Pork Producer Accounts, Veterinary Accounts, and prospect accounts. The Pork Technical Services Veterinarian works with the account manager to help develop a strategic account plan designed to maximize Zoetis sales with assigned account(s). The Pork Technical Services Veterinarian is a leader and trusted business partner responsible for developing intimate knowledge of the Customer's business model.
POSITION RESPONSIBILITIES
The Pork Technical Services field colleague, under general supervision, is responsible for:
Calling on pork producers, veterinarians, dealers, consultants and distributor representatives to provide scientific support so Zoetis may achieve a sustainable competitive advantage.
Providing technical training and education to colleagues within the Zoetis pork business unit.
Providing sound technical advice on routine inquiries, acting as a resource to assist other team members with inquiries.
Providing solutions to a broad array of animal health and production issues that are based upon a sales approach that identifies the customer's needs.
Applying existing veterinary solutions to meet the needs of individual customers based on their needs and promoting a long-term relationship with Zoetis.
Building and maintaining relationships with key industry leaders including veterinarians, nutritionists, extension, university personnel, pork processors and other consultants to our customer base.
Collaborating and building strong partnerships with Area Business Manager(s) to develop and execute the Area Operations Plan.
Partnering with field colleagues to develop appropriate strategies that focus efforts on targeted accounts critical to the success of the business unit or area.
Working with field sales colleagues to create, maintain and execute customer-focused business development plans that clearly identify current and future growth opportunities and allocates expense budget and resources for all high potential customers.
Contributing to team selling efforts by planning call cycles with others to maximize the use of the team's time and resources and ensuring appropriate account follow-up.
Utilizing excellent presentation skills and appropriate tools (e.g. PowerPoint) to conduct educational training on products, programs and services to both internal and external audiences.
Advising and assisting Learning and Development on the technical content of training programs, as required. Providing specialty support to other Areas or businesses as directed by management.
Participating, as required, on special projects and tactical implementation that aligns with key stakeholders to effectively position products and the portfolio (e.g., reviewing sales material, participating on new product launch teams, providing assistance and support to Veterinary Medical Investigations and Product Support and others).
Providing accurate and timely documentation of activities and customer interactions to specified management levels.
Manage STOMP diagnostic budget and timely reporting of diagnostic outcomes to stakeholders.
EDUCATION AND EXPERIENCE
Required Qualifications:
Doctor of Veterinary Medicine degree or equivalent
Two (2) years post-doctoral experience in clinical practice, academia, research or industry
Strong analytical thinking, problem solving skills, and attention to detail
Current in assigned areas of veterinary medicine and pork production management
Strong oral, written, and interpersonal communication skills
Proficient computer skills (MS Office and the ability to learn Zoetis's internal systems)
Preferred Qualifications:
Two (2) years or more private practice experience
Proven record of accomplishments, demonstrating successful veterinary practice management, strategy execution experience and leadership
Ability to exercise good judgment; make thoughtful and fair decisions based on relevant information
Research experience, published scientific papers
Ability to think and act strategically
Extensive knowledge of Zoetis pork products and the animal health industry or ability to learn quickly
Ability to interact with and influence senior management, peers, and other functions
Multilingual, particularly Spanish and English
PHYSICAL POSITION REQUIREMENTS
The position will require a valid driver's license
Willingness to drive to customer locations across the defined geography - Producer, Clinic & Processing Facilities
The US base salary range for this full-time position is $104,000.00 - $168,000.00. Our salary ranges are
determined by role, level, and location. The range displayed on each job posting reflects the base pay target range
for new hire salaries for the position. Within the range, individual pay is determined by work location and additional
factors, including job-related skills, experience, and relevant education or training.
This position is also eligible for long-term incentives
In addition to compensation, Zoetis offers a comprehensive benefits package that supports the physical, emotional
and the financial well-being of our colleagues and their families, including healthcare and insurance benefits, beginning
on day one, a 401K plan with a match and profit-sharing contribution from Zoetis, and 4 weeks of vacation.
Visit zoetisbenefits.com to learn more
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyRegulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Remote job
Career CategoryRegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION?
You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Regulatory Affairs Senior Director - Global Regulatory Leader - Obesity
Live
What you will do
Let's do this. Let's change the world. In this vital role you will support products in the Obesity Therapeutic Area. Global Regulatory Affairs (GRA) provides global regulatory leadership, expertise, and execution for the development, registration, and life cycle management of all Amgen molecules.
To lead GRTs within Amgen's GRAAS organization
To independently develop a comprehensive regulatory strategy for one or more high complexity programs, typically in late-stage development and/or with multiple indications, that takes into account worldwide regulatory requirements to drive product development, global registration, achievement and maintenance of desired regional labeling, and effective regulatory agency interactions
To provide Regulatory leadership to cross-functional teams for high complexity programs with major Regulatory deliverables such as global original marketing applications
Develop and implement global regulatory product strategies designed to achieve approval and target product labeling for prioritized assets in late development with highly complex development programs
Represent GRA on the product team and other key commercialization governance bodies, guide and influence the organization to achieve Regulatory objectives
Independently develop the Global Regulatory Strategic Plan and provide regulatory input into the product's Global Strategic Plan. Obtain input from the GRT members to develop a global regulatory strategy which supports product development, registration and lifecycle maintenance. Identify and communicate regulatory risks
Provide regulatory direction in the development of the core data sheet to align commercial objectives in the context of available and expected scientific data, regulatory guidance, and precedent
Independently lead the planning and implementation of global regulatory filings (eg, clinical trial applications, marketing applications, label extensions)
Ensure consistency of evidence-based global product communication (eg, regulatory submission documents)
Monitor and assess impact of relevant global regulations, guidance, and current regulatory environment; advise product teams and GRT on implications of pertinent changes
Assess regulatory mechanisms to optimize product development (eg, expediting FIH studies, Orphan Drug Designation, Fast Track Designation, conditional /accelerated approval, compassionate use, and pediatric plan) and ensure appropriate incorporation into the global regulatory strategy
Clearly and succinctly communicate regulatory strategies, associated risks, mitigations, and contingencies to the organization such that the probability of regulatory success and potential outcomes are well understood
Lead GRTs and product teams in formal and informal communications with regulatory agencies
Lead the approach and strategy for formal interactions with Regulatory agencies, especially those which could impact the global product strategy
Represent Amgen Regulatory on external partnership teams at the product level
Lead regulatory process improvements and initiatives
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
Doctorate degree and 5 years of regulatory experience in biotech or science
OR
Master's degree and 8 years of regulatory experience in biotech or science
OR
Bachelor's degree and 10 years of regulatory experience in biotech or science
Preferred Qualifications:
Contemporary obesity experience desired
Demonstrated ability to lead regulatory aspects of highly complex programs in late development
Previous experience leading a Regulatory team for submission and approval of an original marketing application and/or major new indication supplemental application
Ability to lead and build effective teams
Strong communication skills - both oral and written
Ability to understand and communicate scientific/clinical information
Ability to anticipate and mitigate against future strategic issues and uncertainties
Ability to resolve conflicts and develop a course of action
Cultural awareness and sensitivity to achieve global results
Planning and organizing abilities
Able to prioritize and manage multiple activities
Ability to make complex decisions and solve problems
Ability to deal with ambiguity
Organizational savvy
Negotiation skills
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible
Apply now
for a career that defies imagination
Objects in your future are closer than they appear. Join us.
careers.amgen.com
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
#Obesity
.
Salary Range
216,805.00 USD - 259,624.00 USD
Auto-ApplyBiologist
Zoetis job in Kalamazoo, MI
Zoetis is seeking a Biologist to join our Clinical Pharmacology group and support research in animal models of disease-including allergy/dermatitis, pain, and inflammation. This role involves hands-on in vivo work, study design, and cross-functional collaboration in a dynamic veterinary medicine research environment.
Key Responsibilities
Conduct in vivo studies using animal models of disease (allergy, dermatitis, pain, inflammation, etc.).
Work directly with dogs, cats, rodents, and other species as needed.
Perform animal procedures including:
Blood sampling
Dosing via multiple routes (IV, SC, oral, etc.)
Basic behavioral training for simple tasks
Contribute to disease model development and support early-stage drug discovery.
Prepare and assist in writing animal use protocols and ensure compliance with ethical and regulatory standards.
Design, execute, interpret, and report findings from in vivo studies.
Collaborate closely within a team of in vivo biologists; lead assigned research areas or sub-projects.
Communicate scientific results clearly to diverse audiences across a matrixed R&D environment.
Support planning and logistics for complex, multi-phase studies.
Basic Requirements:
BS in Biological Sciences, Animal Science, or related field
3+ years of hands-on experience working with animals in a research setting.
Preferred Qualifications:
Proven experience handling rodents, cats, and dogs, including blood collection and compound administration
Experience developing in vivo disease models (rodents or larger species).
Background in in vivo drug discovery, including target identification and validation.
Ability to independently direct scientific research and lead sub-projects.
Practical experience preparing IACUC or equivalent animal use protocols.
Strong planning and organizational skills for managing complex study designs.
Demonstrated ability to collaborate across scientific functions and consider multiple scenarios during study planning.
Attributes & Competencies
High enthusiasm for science and animal health research.
Creativity, flexibility, and adaptability in a fast-moving research environment.
Strong interpersonal and communication skills.
Track record of generating innovative solutions to research challenges.
Ability to thrive in a matrixed organizational structure.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyPAT Intern
Zoetis job in Kalamazoo, MI
Role Description:
Pharma Process analytical technology (PAT) intern
We are seeking a highly motivated Summer Intern to join our Process Analytical Technology (PAT) team. In this role, you will assist in developing and optimizing analytical techniques that ensure the quality and consistency of our pharmaceutical products. This internship offers a unique opportunity to gain hands-on experience with advanced PAT tools in a regulated environment, focusing on real-time monitoring, quality assessment, and process efficiency in drug manufacturing.
Internship Job Duties:
Support the development, testing, and validation of PAT methods to ensure product quality and consistency.
Conduct experiments using PAT tools to analyze formulation components and monitor product consistency.
Collaborate with cross-functional teams, including formulation and analytical scientists, to refine and document analytical methods.
Collect, analyze, and interpret data from PAT instruments, and develop models to optimize analytical performance.
Develop automated workflows for data engineering and handling.
Integrate real-time data processing pipelines (spectral preprocessing, chemometric predictions, reporting).
Document procedures and findings, creating technical reports and standard operating procedures (SOPs) to support method validation and regulatory compliance.
Engage actively in informal networking and mentoring sessions, as well as formal symposiums.
Present scientific findings and project outcomes at the conclusion of the internship.
Internship Qualifications:
Currently pursuing a master's or PhD degree in Chemistry, Analytical Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or a related field.
Strong analytical and problem-solving skills, with a foundation in experimental design and data analysis.
Familiarity with laboratory techniques; experience with spectroscopic or analytical instruments (e.g., NIR, UV, Raman etc.) is a plus.
Familiarity with chemometrics and machine learning techniques, with proficiency in Python or similar programming languages.
Ability to work collaboratively in a team environment, with strong communication and documentation skills.
Detail-oriented, with a commitment to quality and regulatory standards in pharmaceutical manufacturing.
Available for full-time employment for 12 weeks during May-August 2026.
Legally authorized to work in the United States.
The following hourly pay rates reflect the anticipated base pay for this position:
If the selected candidate is a student pursuing an Associate-level degree: $16.00 per hour
If the selected candidate is a student pursuing an Undergraduate-level degree: $22.00 per hour
If the selected candidate is a student pursing a Graduate-level degree: $32.50 per hour
If the selected candidate is a student pursuing a Doctorate-level degree: $36.00 per hour
The following hourly pay rates reflect the anticipated base pay for this position if a selected candidate were to be located in California, Connecticut, District of Columbia, Illinois (Chicago area), Massachusetts, New Jersey, New York, Washington (Seattle area):
Student pursuing an Associate-level degree: $17.00 per hour
Student pursuing an Undergraduate-level degree: $24.20 per hour
Student pursing a Graduate-level degree: $36.40 per hour
Student pursuing a Doctorate-level degree: $40.30 per hour
Full time Intern (Trainee) Colleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyAssociate Compensation & Benefits Tax Counsel
Remote or New Brunswick, NJ job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
Finance
Job Sub Function:
Tax
Job Category:
Professional
All Job Posting Locations:
New Brunswick, New Jersey, United States of America
Job Description:
Johnson & Johnson is seeking an experienced Associate Compensation & Benefits Tax Counsel. This role is located in New Brunswick, New Jersey.
This position reports to the VP Compensation & Benefits Tax Counsel. The candidate will provide high level technical tax and legal advice to management in the administration of the company's worldwide employee compensation and benefit plans.
Incumbent is responsible for ensuring compliance with laws and regulations applicable to employee compensation and benefits. Specifically, incumbent will advise management regarding tax and legal requirements in areas including qualified retirement plans, stock based compensation, employee welfare benefit plans, employee fringe benefits, mergers, acquisitions & divestitures, plan asset investments, and executive compensation matters. The Associate Compensation & Benefits Tax Counsel will also advise on payroll withholding and reporting matters and other global employee compensation and benefits matters.
Remote work options may be considered on a case-by-case basis and if approved by the Company.
Position Requirements:
* A Juris doctor degree from an accredited law school is required.
* A minimum of one active state (or District of Columbia) bar admission is required.
* A minimum of 10 years of experience at a law firm, accounting firm and/or major corporation advising clients or management on a wide variety of employee compensation & benefits tax and legal matters is required.
* Working knowledge of the provisions of the Internal Revenue Code applicable to the taxation of employee compensation and benefits and of the Employee Retirement and Security Act of 1974 (ERISA) is required.
* Experience advising on compensation and benefits matters in mergers, acquisition, and divestiture transactions is required.
* Experience advising on plan asset investment matters is required.
* Incumbent will also require excellent business partnering and communication skills - specifically the ability to communicate highly technical matters to management whose knowledge may be more general.
Preferred Requirements/Competencies:
* Exposure to and general knowledge of the laws of some major non-U.S. jurisdictions with respect to employee compensation and benefit matters, reporting and withholding, and employee location compliance are preferred.
The expected base pay range for this position is $173,000 to $300,000.
- The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis.
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program. 6
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
- Vacation - 120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
-Holiday pay, including Floating Holidays -13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
-Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave - 80 hours in a 52-week rolling period 10 days
- Volunteer Leave - 32 hours per calendar year
- Military Spouse Time-Off - 80 hours per calendar year
Additional information can be found through the link below.
For additional general information on Company benefits, please go to: - *********************************************
Required Skills:
Preferred Skills:
Agility Jumps, Audit Management, Consulting, Critical Thinking, Fiduciary Liability, Financial Analysis, Financial Reports, Financial Risk Management (FRM), Financial Trends, Leadership, Organizing, Process Optimization, Program Management, Tax Advising, Tax Compliance, Tax Management, Transparency Reporting
The anticipated base pay range for this position is :
173000-300000
Additional Description for Pay Transparency:
Auto-ApplyInformation Technology Intern - Veterinary Medicine R&D & Commercial Genetics
Zoetis job in Kalamazoo, MI
Role Description: Zoetis is seeking a highly motivated individual to intern with our dynamic Information Technology team, supporting both Veterinary Medicine Research & Development (R&D) and Commercial Genetics. This opportunity will immerse you in the intersection of IT and animal health innovation, exposing you to real-world projects in data management, digital product development, analytics, and scientific informatics. You'll collaborate with scientists, engineers, business professionals, and our customers to help advance veterinary research and genetics digital products through technology.
Responsibilities:
* Active rotation in operations and engineering projects
* Agile and Waterfall project delivery
* Rapid response end user support
* Use case interpretation and design
* Formulation and presentation of data metrics
* Active participation as part of a team of information technology professionals
Education and Experience:
* Studying Full Stack Development, Data Engineering, Data Science with a focus on Veterinary Medicine and/or Genetics or related field, 3rd and 4th year preferred.
* Familiarity and experience with software development & design
* Ability to interpret and explain IT issues in very simple non-IT terminology
* Effective meeting skills, presentation skills, and the ability to learn quickly in a rapidly evolving environment
* Ability to build working relationships within an organization and between organizations
* Ability to clearly and effectively relay key information to management levels
* Ability to provide concise and "to the point" informative reports
* Previous intern experience or work-related experience is desirable
Knowledge, Skills, Ability Requirements:
* High level of integrity and strong ethical values
* Strong can-do attitude
* Comfortable with public speaking
* Programming language skills, i.e., Python, JavaScript, etc.
* Query language skills, i.e., SQL, KQL, etc.
* Basic knowledge of system design
* Basic knowledge of data engineering
* Working knowledge of Azure
* Working knowledge of Data Bricks
* Curiosity in determining and understanding how things work
* Artificial intelligence (AI) / Large Language Models (LLM), a plus
* Graphic design, HTML, CSS, PowerBI, Tableau a plus
The following hourly pay rates reflect the anticipated base pay for this position:
If the selected candidate is a student pursuing an Associate-level degree: $16.00 per hour
If the selected candidate is a student pursuing an Undergraduate-level degree: $20.00 per hour
If the selected candidate is a student pursing a Graduate-level degree: $32.50 per hour
If the selected candidate is a student pursuing a Doctorate-level degree: $36.00 per hour
The following hourly pay rates reflect the anticipated base pay for this position if a selected candidate were to be located in California, Connecticut, District of Columbia, Illinois (Chicago area), Massachusetts, New Jersey, New York, Washington (Seattle area):
Student pursuing an Associate-level degree: $17.00 per hour
Student pursuing an Undergraduate-level degree: $22.00 per hour
Student pursing a Graduate-level degree: $36.40 per hour
Student pursuing a Doctorate-level degree: $40.30 per hour
Full time
Intern (Trainee)
Colleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of "@zoetis.com". In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplySr. Field Clinical Engineer - Shockwave Medical
Remote or Santa Clara, CA job
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************
Job Function:
R&D Operations
Job Sub Function:
Clinical/Medical Operations
Job Category:
Professional
All Job Posting Locations:
Santa Clara, California, United States of America
Job Description:
Johnson & Johnson is hiring for a Senior Field Clinical Engineer - Shockwave Medical to join our team. This role is fully remote.
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at *******************/.
Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that's pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.
The Sr. Field Clinical Engineer is responsible for the development and execution of site-specific recruitment strategies that result in meeting enrollment targets for Shockwave Medical clinical trials. In addition, the Sr. Field Clinical Engineer will provide case support on Shockwave Medical products including Reducer and intravascular lithotripsy (IVL). The Sr. Field Clinical Engineer will play a critical role in clinical studies including device training, case support, and ensuring timely data collection for clinical programs. This work is accomplished with oversight, requires contact with internal stakeholders, frequent travel to clinical trial sites, works closely with physician advisors, and is critical to business success.
Essential Job Functions
* Physician and hospital staff training, and procedural case coverage to ensure the safe and effective use of medical devices.
* Present clinical study training materials based on investigational plans to support the safe and effective use of medical devices, including study protocol, instructions for use, core lab manuals and case report forms.
* Provide clinical and technical support for key study investigators and clinical leaders at assigned sites.
* Partner with other clinical research colleagues to meet business needs in the field including study start-up, site training, data collection for timely database locks and resolution of critical issues.
* Administrative activities including training to procedures at site level.
* Collaborate effectively with internal stakeholders (Clinical Affairs, Medical Affairs, Marketing and Medical Education) and external parties (vendors and physician advisors) to ensure Shockwave Medical clinical trials meet established enrollment goals.
* Collaborate with internal and external stakeholders to develop a repository of recruitment/study awareness materials and tools.
* Collaborate with internal and external stakeholders to ensure site-specific recruitment plans are implemented and progress tracked.
* Develop and maintain strong relationships with site investigators and research staff to understand site recruitment and enrollment processes and resolve obstacles to enrollment to meet study goals.
* Partner with assigned physician advisors to create and deliver recruitment strategies.
* Partner with vendors that support recruitment activities.
* Other duties as assigned.
Requirements
* Bachelor's Degree in a scientific field of study or equivalent work experience.
* Minimum of 5 years of relevant experience with at least 3 years of experience directly supporting interventional or surgical procedures within a hospital.
* Knowledge and experience in supporting device pre- and/or post-market clinical studies is required including experience running investigational device exemption (IDE) trials.
* Thorough knowledge of Good Clinical Practice (GCP) is required.
* Ability to attain and maintain hospital credentials.
* Ability to work in a fast-paced environment while managing multiple priorities.
* Operate as a team and/or independently while demonstrating flexibility to changing requirements.
* Experience with electronic data capture (EDC) systems.
* Must have excellent verbal and written communication skills.
* High attention to detail and accuracy.
* Able to manage multiple project teams with guidance
* Proficient computer skills (Microsoft Word, Excel, PowerPoint, etc.)
* Must be able to travel approximately 80% mostly in the US and Canada, and potentially outside North America.
* May be required to lift up to 25 pounds.
Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Clinical Operations, Clinical Research and Regulations, Clinical Trial Designs, Coaching, Communication, Ethical and Participant Safety Considerations, Innovation, Laboratory Operations, Office Administration, Preclinical Research, Problem Solving, Project Management, Project Scheduling, Research and Development, Study Management
The anticipated base pay range for this position is :
US $106,250 - $143,750 / Bay Area - $122,400 - $ 165,600
Additional Description for Pay Transparency:
Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************
Auto-ApplyGlobal Safety Medical Director - Hematology/Oncology
Remote job
Career CategorySafetyJob DescriptionJoin Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Global Safety Medical Director - Hematology/Oncology
What you will do
Let's do this. Let's change the world. In this vital role you will be accountable for the staff management and resource allocations in Global Patient Safety and support GPS in the establishment of a highly effective global safety organization in full compliance to worldwide regulations. The GSO is accountable for the overall safety profile and all product-related decisions and results for assigned products supporting Hematology-Oncology portfolio. The GSO leads the Safety Analysis Team (SAT), Global Safety Team (GST) and is a core member of the Executive Safety Committee (ESC). The GSO also is a member of the Evidence Generation Team and other relevant cross functional teams. The GSO will be assigned as delegate for the TAH as needed.
Validate safety signals and lead safety signal assessments
Develop and maintain Core Safety Information (core data sheet, core risks in informed consent forms, etc.)
Prepare/review core and regional risk management plans including additional risk minimization measures
Prepare/review safety sections of periodic aggregate reports
Provide safety input to protocols, statistical analysis plans, and clinical study reports
Prepare/review safety sections of new drug applications and other regulatory filings
Serve as safety expert on Evidence Generation Team for assigned products
Inspection Readiness
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a leader with these qualifications.
Basic Qualifications:
MD or DO degree from an accredited medical school
AND
Completion of an accredited medical or surgical residency
OR
Clinical experience in either an accredited academic setting or private practice (including hospital based) setting
Preferred Qualifications:
Product safety in the bio/pharmaceutical industry or regulatory agency
Previous management and/or mentoring experience
Experience in the study/research and/or treatment of Oncology disease states
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible
Apply now and make a lasting impact with the Amgen team.careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
243,245.00 USD - 319,267.00 USD
Auto-ApplyCentral Utility Technician
Zoetis job in Kalamazoo, MI
Working within a Reliability Based Maintenance environment, the Central Utilities Technician is responsible for operation, maintenance and process problem resolution related to Site Utility Operations (Central Steam, Chilled Water, Instrument Air, Purified Water, Water for Injection, Clean Steam, Pharmaceutical Air, Pharmaceutical Nitrogen, Production Waste, & Process Vacuum).
RESPONSIBILITIES
Daily operation, responding to trouble calls and maintenance of the site utility systems. Duties include system monitoring (either by a control system, manual data entry, walk-thru's), operational maintenance, handling chemicals, working with other teams performing maintenance and data review.
Performing preventive maintenance, sampling activities, repairs, improvements, and modifications to utility and facility equipment including but not limited to, pumps, air compressors, boilers, water systems, piping, and other mechanical equipment.
Understand and follow complex SOP's that govern how utility systems are operated, maintained, and repaired.
Operate the qualified utilities in a manner that meets or exceeds complex regulatory requirements (FDA, Zoetis Quality Standards etc.).
Support activities associated with Regulatory Audits of site equipment and processes. This may include providing requested information and/or meeting with auditors to explain processes and procedures.
Perform repairs to piping systems, safety devices, and isolation components.
Serve as utilities advisor to provide input to projects in areas of equipment design, parts and material selection, documentation, testing, problem solving, maintenance requirements, and project scope.
Responsible for priority assessment and decision making as it relates to troubleshooting and diagnostics of equipment operations. Works closely with operations to determine root cause and establish proper corrective actions.
Conducts assembly, repair, and proactive maintenance for utility and facility equipment and systems in a cost-effective manner.
Read and understand drawings / blueprints, utilizing this knowledge for the installation / repair of new and existing equipment.
Support installation and commissioning activities for new equipment and processes.
Position requires frequent interaction with Engineering Director, Maintenance Manager, Production Management and Supervision, Engineers, Quality Operations, Maintenance Technicians, Production Operators, Contractors, and Vendors.
EDUCATION AND EXPERIENCE
Associate degree and/or specialized technical training with 3+ years of experience on utility systems.
Solid understanding of GMP manufacturing processes, equipment, and utilities/facilities.
Demonstrated knowledge in relevant technical areas.
Solid understanding of the pharmaceutical industry and their associated requirements.
Cognizance of the current/state-of-the-art technology in the industry with respect to utility systems.
Good communication and organizational skills as well as the ability to interact with all levels of the Zoetis organization and external representatives. Can articulate issues and solutions to the team. Can produce effective project reports and presentations.
Ability to analyze problems and provide support in determining appropriate corrective and preventative actions, with minimal assistance.
Capable of simultaneously managing multiple assignments. Prioritizes own work. Flexible and responsive to changes.
Physical position requirements: Climbing, walking on uneven surfaces, manual dexterity, heavy lifting within EHS guidelines.
A valid driver's license is required for this position to operate company vehicles. Must be able to pass the test to obtain a Forklift license.
Colleague is frequently exposed to airborne particles and must work near moving mechanical parts and high surface temperatures, chemicals, and non-temperature-controlled environments. The noise level in the work environment can be loud. Use of appropriate PPE is required.
Full time RegularColleague
Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.
Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.
Zoetis is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status or any other protected classification. Disabled individuals are given an equal opportunity to use our online application system. We offer reasonable accommodations as an alternative if requested by an individual with a disability. Please contact Zoetis Colleague Services at ********************************** to request an accommodation. Zoetis also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must possess or obtain authorization to work in the US for Zoetis. Zoetis retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified US workers. Individuals requiring sponsorship must disclose this fact. Please note that Zoetis seeks information related to job applications from candidates for jobs in the U.S. solely via the following: (1) our company website at ********************** site, or (2) via email to/from addresses using only the Zoetis domain of “@zoetis.com”. In addition, Zoetis does not use Google Hangout for any recruitment related activities. Any solicitation or request for information related to job applications with Zoetis via any other means and/or utilizing email addresses with any other domain should be disregarded. In addition, Zoetis will never ask candidates to make any type of personal financial investment related to gaining employment with Zoetis.
Auto-ApplyRegulatory Policy and Intelligence - US Director
Remote job
Career CategoryRegulatoryJob Description
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you're part of something bigger, it's because you are. At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve together-researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of.
Regulatory Policy and Intelligence - US Director
Live
What you will do
Let's do this. Let's change the world. Global Regulatory Policy team engages regulators, industry and professional associations, and patient advocates externally and subject matter experts across Amgen to advance important policy issues within the U.S. aligned with Amgen's goals and priorities. In this vital role you will lead the development and articulation of Amgen's positions on regulatory policies that impact Amgen's business and will serve as a U.S. Policy Lead for Global Regulatory Policy and Intelligence.
Key Responsibilities include:
Masters a range of regulatory policy topics and provides strategic U.S> regulatory policy advice and guidance related to Amgen's product portfolio, including a focus on artificial intelligence and emerging regulatory technologies (e.g., cloud-based submissions)
Engages US regulatory authorities, industry, and professional associations at the policy level
Leverages key relationships with FDA staff and industry and trade association colleagues to advance Amgen's position related to regulatory policy
Coordinates the implementation of new U.S. regulatory policy and guidance across Amgen functions
Engages cross-functional teams to develop strategic/long-term plans for the development and implementation of policies
Masters a range of regulatory policy topics as assigned, including topics such as Chemistry, Manufacturing, and Controls (CMC), Precision Medicine, and Combination Products. Leads the development and execution of strategic plans for each assigned policy area.
Ensures that Amgen's regulatory policy positions are successfully represented to inform policy development and implementation
Fosters a reputation with regulators as being science-based, reliable and trustworthy by advocating sound for policies
Provides internal stakeholders (e.g., Global Government Affairs, R&D, Commercial, Legal) with a strategic regulatory policy perspective
Assists and advises senior leadership in selecting issues, establishing priorities and developing and implementing regulatory policy advocacy plans
Assists in creating the necessary infrastructure/processes for developing the regulatory policy and intelligence function
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The regulatory policy and intelligence professional we seek has a deep knowledge and understanding of the U.S. regulatory environment and can provide insights to internal stakeholders, as well as shape the external regulatory environment to support Amgen priorities and has these qualifications
Basic Qualifications:
Doctorate degree and 4 years of related experience
Or
Master's degree and 7 years of related experience
Or
Bachelor's degree and 9 years of related experience
Thrive
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
Application deadline
Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.
Sponsorship
Sponsorship for this role is not guaranteed.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
.
Salary Range
188,796.00 USD - 222,457.00 USD
Auto-ApplyGlobal Marketing Sr Manager - Oncology
Remote job
Career CategoryMarketingJob Description
Join Amgen's Mission of Serving Patients
At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission-to serve patients living with serious illnesses-drives all that we do.
Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives.
Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
Global Marketing Senior Manager
What you will do
Let's do this. Let's change the world. In this vital role you will require a strong ability to collaborate cross-functionally with other Amgen business units.
In this role you will be responsible for the following:
Partnering with your Director and other Leaders to define Amgen's early oncology pipeline commercial strategy to ensure investments in research and early development align with long-term business objectives and patient needs.
Developing commercial frameworks and business cases to inform progression decisions for early-stage assets (PT through E2L Portals), integrating insights from market dynamics, patient needs, and competitive intelligence.
Contributing to a best-in-class commercial function for oncology early pipeline strategy, ensuring Amgen maintains a leadership position in bringing first-in-class and best-in-class therapies to market.
Key activities and accountabilities include the following:
Early Pipeline Strategy & Portfolio Prioritization
Create and leverage frameworks for evaluating and prioritizing early-stage oncology assets.
Support the assessment of commercial viability and differentiation of assets in early development, ensuring alignment with evolving market needs and payer landscapes.
Preparation of business cases along with other execution-based deliverables to business needs.
Commercial Partnership with Research & Early Development
Provide commercial input to research-stage investment decisions, ensuring a clear path to differentiated and commercially viable products.
Collaborate with R&D to develop target product profiles (TPPs) that reflect strong commercial positioning.
Establish strong cross-functional partnerships with R&D, corporate strategy, finance, and global marketing teams.
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The . The dynamic professional we seek is a self-starter with these qualifications.
Basic Qualifications:
Doctorate degree and 2 years of Marketing experience
Or
Master's degree and 4 years of Marketing experience
Or
Bachelor's degree and 6 years of Marketing experience
Or
Associate's degree and 10 years of Marketing experience
Or
High school diploma / GED and 12 years of Marketing experience
Preferred Qualifications:
5+ years of biotech/pharmaceutical industry experience with strong experience in strategy development/consulting, and multiple facets of drug commercialization
Oncology therapeutic area experience (marketing and/or scientific) with recognized depth in industry, technical and competitive dynamics that shape future oncology markets and needs
Strong interpersonal skills with demonstrated ability to work and influence effectively within a matrix structure.
Demonstrated ability to work with cross-functional partners to develop impactful program strategies that are based on market insights
Knowledge of and experience in working with discovery research and clinical teams.
Strong leadership skills, including ability to influence teams with diverse backgrounds.
Strong competitive mindset, including ability to champion ideas, make decisions and focus on results
Strong business judgment and emotional intelligence
Act as a role model for others in line with Amgen values
The DASL position is complex and demanding. The preferred candidate is a strong commercial executive with excellent marketing capabilities, strong analytical skills, superior cross-functional collaboration skills, the ability to operate globally and locally, and highly effective influencing skills. Success in this critical role will result in significant professional growth and advancement at Amgen.
What you can expect of us
As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.
careers.amgen.com
Sponsorship
Sponsorship for this role is not guaranteed.
In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
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Salary Range
152,006.00 USD - 178,530.00 USD
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