Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.
Hybrid
Employee Value Proposition:
At Taiho Oncology, we are dedicated to transforming the landscape of cancer treatment and improving patients' lives. As an Associate Director, Clinical Research Scientist, you will play a pivotal role in our mission, leveraging your expertise to drive innovative clinical research and contribute to groundbreaking therapies. We offer a collaborative and inclusive work environment where your ideas and contributions are valued. Join us to advance your career, work with passionate and skilled professionals, and make a meaningful impact on the fight against cancer. At Taiho Oncology, you will find purpose, growth, and the opportunity to be at the forefront of cancer research.
Position Summary:
The Associate Director, Clinical Research Scientist has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3. Additionally, this role serves in assisting the responsible medical monitor or a Lead medical monitor for various clinical phase 1 - 3 trials, as needed.
Performance Objectives:
Uses medical/scientific expertise to support the creation of relevant clinical documents of high quality such as study concepts, study protocols, amendments, study reports and investigator brochures.
At the asset level, assists the medical lead in the preparations of the clinical content of regulatory submissions/documents (e. g. NDA, MAA, IND, CTA. sNDA, DSUR, PIP, health authority/ethics committee responses, briefing packages).
Works with the medical lead to prepare presentations (internal and external), abstracts, manuscripts.
Inputs into the of ICF/reviews ICF.
Works with data management on CRF design and completion guide.
Partners with data management to develop data review plan for review of data and with medical lead for the medical monitoring plan.
Reviews protocol deviations, patient eligibility, and patient level and cumulative data per the data review plan across a study, raises queries and coordinates with the medical lead.
Reviews safety data with the medical lead, SAE reports (in collaboration with pharmacovigilance), labs, efficacy data, dosing data, withdrawals/discontinuations.
Collaborates with the medical lead to provide medical/scientific guidance during the execution of the study.
Ensures TMF compliance for clinical development/medical study level TMF documents.
Answers specific site protocol questions as needed, after consultation with the medical lead.
Develops specific medical/protocol training for Site Initiation Visits and Investigator Meetings, vendor / CRO staff, in collaboration with the medical lead.
Escalates protocol-related issues requiring complex medical expertise to the medical lead, and operational issues to the appropriate operations study team member.
Reviews the SAP and statistical outputs, in collaboration with the statistician, medical writer, and medical lead.
Education/Certification Requirements:
PhD, PharmD or other related Advanced Medical Scientific Degree.
Experience in oncology is a must.
Knowledge, Skills, and Abilities:
At least 3 years in drug development industry in oncology and with previous exposure to clinical development, regulatory and statistical activities such as, e.g., (co-)authoring and reviewing of documents.
Ability to critically review and interpret Clinical data.
Working knowledge of the drug development process in the USA and EU is required.
Ability to learn, integrate complex information, and communicate clinical information in easily understandable fashion to non-clinical team members.
The pay range for this position at commencement of employment is expected to be between $213,350 - $251,000 annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#LI-Hybrid
$75k-124k yearly est. 5d ago
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Study Associate II, Clinical Operations
Taiho Oncology 4.4
Taiho Oncology job in Princeton, NJ
Looking for a chance to make a meaningful difference in the oncology space? Taiho Oncology is on a mission: to improve the lives of patients with cancer, their families, and caregivers. Our “People first” approach means we also highly value our employees, who work relentlessly to help execute our mission. Taiho's success is founded on ensuring we always act with accountability, collaboration, and trust. By following these guiding principles, we earn and maintain the confidence of patients, the global healthcare community, collaborators and partners, and each other. Together, we are working on cutting-edge science and growing our portfolio and pipeline across a range of tumor types to address the ongoing and evolving needs of patients. Advanced technology, a world-class clinical development organization, and state-of-the-art facilities: these and other resources empower us to innovate and touch the lives of more and more patients. It's our work, our passion, and our legacy. We invite you to join us.
Hybrid
Employee Value Proposition:
At Taiho Oncology, our unwavering dedication to patients drives us to work collaboratively across various functions to achieve impactful results. The leadership and support provided by our Clinical Operations team are the cornerstone of our success in drug development. The role and contributions of our Study Associates are instrumental to our study teams' success. The Study Associates' efforts directly contribute to the success of our trials and, ultimately, to the betterment of patient outcomes. This position offers an exciting opportunity to be a part of a dynamic team cultivating growth and learning.
Position Summary:
The Study Associate II is accountable for the performance and compliance of an assigned protocol and sites. The incumbent supports Clinical Operations with the internal operational management of clinical studies, providing support for the planning, coordination, monitoring, tracking and general performance of clinical studies. A critical component of the position is providing support to the study team and/or lead specific operational activities, assisting with study start up activities such as feasibility, site selection, co-monitoring, site communications and other related study documentation and management activities. In collaboration with the study manager, providing oversight of the contract research organization and other vendors performance to ensure quality and study timelines are maintained. The Study Associate II may lead a study of limited scope and complexity.
Performance Objectives:
Guides study site activities at multiple clinical trial sites, including SAE reporting, identification of protocol deviations, essential document status, eCRF completion, and investigational product accountability in partnership with CRO.
Reviews Monitoring Visit Reports (SEV, SIV, IMV, COV) from the CRO to ensure that sites are in compliance with the study and protocol. Reviews monitoring and other study operation plans and track related trends.
Tracks monitoring related issues, risks, or findings with Investigators/site staff, and escalates to the Study Manager and/or CRO as needed.
Attends co-monitoring visits as required per the CRO Oversight Plan, or as needed by Sponsor.
Participates and provides input to study start-up activities including feasibility, site budget/contract review, Investigator Meetings, enrollment planning, and Investigator selection.
Leads or supports study TMF by reviewing the TMF plan, oversees TMF set-up, study team training, periodic quality review, and document management. Reviews and maintains TMF documents, including documents related to IP release. Collaborates with team members on TMF related key performance indicators.
Collaborates closely with study management, CRO study managers, and CRO monitoring staff, in reviewing site/patient activity tracking and preparing study updates. May support the oversight of the CRO/vendor to ensure outsourced activities are executed according to the contract and with high quality. Provides updates to the study team on the progress of CRO/vendor's activities.
Identifies and resolves clinical study conduct issues and ensures site compliance with Good Clinical Practice, and federal and applicable local regulatory requirements through regular communication with Investigators/site staff.
Monitors the study progress to ensure compliance with and adherence to the project plan and to identify, evaluate and resolve problems.
Works with internal and external functional teams to ensure accountability of all used and unused IMP. Maintains drug and sample accountability trackers, as needed.
Facilitates study close-out activities.
Reviews and provides input to study plans and guidelines, including study monitoring plans.
Collaborates with study management in the development of study documents, such as informed consent forms, study logs, and study manuals.
Provides support across all study phases, including but not limited to vendor set-up, enrollment, site-related documentation, and inspection readiness. In some instances, may lead a vendor for oversight.
Collaborates closely with study manager to align expectations and study priorities on ongoing basis.
Communicates deviations from the protocol, GCP, and the applicable regulatory requirements to internal management and the investigator as applicable.
Manages access to internal study systems for applicable internal and external study team members.
May be responsible for overseeing study management activities, including CRO oversight, directly managing a smaller and less complex study or study during the extension phase or close out activities. If delegated these tasks, Study Associate III will be supported by the clinical operations compound lead.
Updates internal study trackers/dashboards with accurate enrollment and other study information.
Coordinates cross functional study team meetings and supports study manager with meeting minutes for assigned studies.
Education/Certification Requirements:
Bachelors' degree in a relevant scientific discipline is preferred, or an equivalent combination of education/experience in science or health-related field required.
Knowledge, Skills, and Abilities:
3-5 years of relevant clinical trial support and site management experience in the pharmaceutical, biotechnology, CRO and/or healthcare industry.
Has demonstrated the use of excellent communication skills, command of medical terminology and of the application of scientific/medical and clinical concepts used to conduct Phase I-IV clinical trials.
Has demonstrated knowledge of, and competence in, application of FDA/GCPIICH guidelines.
Attention to details and well-organized.
Solution oriented and exceptional collaboration skills
Must possess the ability to multi-task and effectively prioritize in order to ensure clinical trial goals.
Recognize potential obstacles and work to resolve them within set timelines.
Delivers work conscientiously and precisely even when under pressure.
A team player and able to work in a dynamic environment with attention to high quality results.
Excellent communication skills both verbal and written.
Good proofreading skills.
Takes initiative and utilizes good judgment.
Ability to effectively present information and respond to questions internally and externally.
Ability to collect information; define problems, establish facts, draw conclusions and propose feasible actions.
Prepares PowerPoint slide decks and other presentation materials for a variety of internal and external presentations and training.
The pay range for this position at commencement of employment is expected to be between $95,200 - $112k annually. This pay range is based on the market range for positions of this type. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including annual bonus/incentive comp plans, potential long term incentive plan, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if a candidate/employee receives an offer of employment.
If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
#LI-Hybrid #Location-Princeton,NJ
$95.2k-112k yearly 4d ago
Oncology Specialist - RLT - Austin, Texas
Novartis Group Companies 4.9
Remote or East Hanover, NJ job
#LI-Remote This is a field-based and remote opportunity supporting key accounts in Austin, Abilene, Bryan College Station, Midland/Odessa, Temple, Waco and the surrounding area. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible for you.
Company will not sponsor visas for this position.
As the Radioligand Therapy Oncology Specialist (RLT), you'll drive demand creation and develop, coordinate, and implement strategic business plans focused on referral and treatment networks of prostate (primary) and neuroendocrine tumor (secondary) customer accounts to further the Radioligand Therapy (RLT) platform for both the diagnostic and therapeutic portfolio. Your focus will be on driving clinical dialog in a sophisticated, multi-stakeholder healthcare professional environment including engagement, coordination, and planning. You will be a partner with Medical Oncologists, Urologists, Nuclear Medicine, and Radiation Oncologists.
Job Description
Key Responsibilities:
Responsible for business ownership of prescribing and referring physicians, while driving relationships and creation and execution of business plans for territories to include delivery of disease education on diagnostic and therapeutic, product value propositions, treatment protocols and implementing customer programs as appropriate.
Support product access, implement competitive response/pull-through strategies, maintain and grow key relationships with account partners in line with defined target priorities in a manner consistent and compliant with company policies and requirements.
Develop and employ customized tools and strategies to gain appropriate access to engage with HCP targets within territory accounts to deliver clinical value proposition and establish RLT as the partner of choice in community hospital, academic hospitals, and community oncology accounts.
Display an elevated level of self-awareness, a passion for learning, an ability to inspire those around you, a willingness to challenge the status-quo and embrace change to optimize execution.
Embody a high-level of confidence to deliver messages in a clear and compelling way to customers, optimally handle objections, and close every call with a commitment to action to inspire changes in behavior.
Continuously demonstrate deep understanding of territory market landscape, competitors, market segments / dynamics, product, clinical data, and anticipate environmental changes and challenges to optimize execution.
Develop and execute a call-plan to achieve goals and improve access and sales opportunities, while promoting a highly technical and innovative product portfolio to a sophisticated audience.
Comfort in using sales data reporting tools to understand trends and coupling with customer insights to identify territory and customer growth opportunities in a constantly evolving environment.
Essential Requirements:
Bachelor's degree required, advanced degree a plus.
3+ years' experience in specialty pharmaceuticals, biotech, or a sales role of similar complexity within the last 5 years.
1+ years' experience in oncology, urology, nuclear medicine, medical devices, or complex therapeutics.
1+ years' experience in prostate, NET or buy-and-bill therapeutic experience, within last 5 years.
Strong ability to collaborate, work cross-functionally within a matrix environment, can communicate clinical product information, has a validated track-record of consistent high-performance, and is proficient in navigating and successfully selling to large accounts and key customer segments.
Self-starter with analytic abilities to seek out, prioritize, and apply relevant information to solve problems to meet the needs of key customers, while also demonstrating ethical leadership and ability to champion an environment that promotes ethical behavior and compliance with company policies & laws.
Candidate must reside within territory, or within a reasonable daily commuting distance of 50 miles from the territory border. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license.
Desirable Requirements:
Experience with multiple product launches.
Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to .
For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week.
Novartis Compensation Summary:
The salary for this position is expected to range between $151,200 and $226,800 per year.
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$145,600.00 - $270,400.00
Skills Desired
Accountability, Account Management, Commercial Excellence, Competitive Intelligence, Compliance, Crm (Customer Relationship Management), Customer Engagement, Ethics, Healthcare Sector, Market Development, Problem Solving Skills, Process Knowledge, Revenue Growth, Selling Skills, Team Collaboration, Value Propositions
$151.2k-226.8k yearly 2d ago
Event Planning Intern
Zoetis, Inc. 4.9
Parsippany-Troy Hills, NJ 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.
$16-40.3 hourly 4d ago
Associate Scientist, QCA - PM Shift
Novartis Group Companies 4.9
Morris Plains, NJ job
is on-site in Morris Plains, NJ
#LI-Onsite
PM Shift: 12-hour 4/3 shift (alternates every other week)
Please only apply if you are able to work these exact hours.
Week 1: Wednesday-Saturday, 3:30 PM-3:30 AM
Week 2: Thursday-Saturday, 3:30 PM-3:30 AM
Novartis is unable to offer relocation support for this role:
please only apply if this location is accessible for you.
Major Accountabilities:
Perform Bio-Analytical testing such as qPCR, Flow Cytometry, ELISA, cell count, cell viability, sterility testing, endotoxin, and mycoplasma.
Maintain controls and reference standards to support testing.
Follows quality policies.
Plan and schedule assigned activities.
Review/approve data generated by other team members.
Perform method qualification/optimization of methods as per appropriate protocols.
Contribute to OOS/OOE investigations and deviation investigations.
Support 5S and Lean projects.
Identify potential improvements in project work.
Interface with regulatory agencies during audits.
Contribute to assigned projects.
Knowledge of LabWare LIMS and/or other QC data systems. Maintain GMP/GLP quality systems.
In addition to these primary duties, provide coverage for all appropriate areas and testing.
Performs other job duties as assigned.
Key Performance Indicators:
*Deliver quality products and services on time to all customers, internal and external.
Ideal Background:
Education: BA or MS in chemistry, biochemistry, microbiology or other related science.
Languages: Fluent in English.
Experience:
0 - 5 years of experience in the pharmaceutical, biologics, microbiology, sterile manufacture, or medical device industry.
Knowledge of cGMP and an understanding of the concepts of GLP, good clinical practices and
FDA guidelines, applicable state and foreign regulations, and standards routinely used in the industry (i.e. ANSI, ISO, etc.).
Knowledge of bioassay test methods, as appropriate.
Knowledge of LIMS systems.
Ability to communicate clearly with a variety of individuals in various aspects of Novartis operations.
Detail-oriented with expertise in problem solving and solid decision-making abilities.
Strong interpersonal skills which include a professional demeanor when interacting with Novartis personnel.
Sound, practical and appropriate regulations with regards to Novartis * Strong written and verbal communication skills are essential.
Internal orientation:
Thorough understanding of cGMP requirements
Good communication and organizational skills
Ensure customer satisfaction and react to customer requests
Is seen as a competent team player
Others:
Strong ability to work independently, compliantly and results driven
Strong analysis and decision-making skills surrounding documentation
Attention to detail
Able to proof work and identify non-standard format or wording, and errors within documents
Novartis Compensation and Benefit Summary:
The salary for this position is expected to range between $66,780 and $124,020/year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards. US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$66,780.00 - $124,020.00
Skills Desired
Communication Skills, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management
$66.8k-124k yearly 3d ago
Utility Associate
Knipper 4.5
Lakewood, NJ job
YOUR PASSION, ACTIONS & FOCUS is our Strength
Become one of our Contributors
Join the CareTria Team!
As guided by management, Utility Associate perform various duties in support of Operations, Production, Distribution, and Warehouse areas. These duties may include, but are not limited to; sorting, counting, palletizing, stacking, wrapping, and moving various materials by hand or with the use of light machinery.
Full Time Onsite role based out Lakewood, NJ Distribution Center; Must be available to work the hours of Monday- Friday 7:30am ET- 4:00pm ET.
Responsibilities
Maintains a safe work environment at all times. Reports any unsafe issues to Supervisor immediately.
Focus on quality and accuracy as part of the company wide goal: Quality First
Display: Caring, Honesty, Accountability, Respect, and Trust (CHART).
Maintains a clean work environment at all times in accordance with sanitation standard operating procedures. Reports any sanitation issues to Supervisor immediately.
Participate in user training that is led by qualified staff members that will include but is not limited to: hands on the job training, Warehouse Management System (WMS) navigation, and Standard Operating Procedures (SOP) training. Said trainings are documented accordingly.
Able to work in various temperature ranges such as freezers, refrigerated, and ambient for extended periods of time.
Operate equipment including, but not limited to; RF scanners, pick to light technologies, carton sealers, scales, postage machines, pallet wrappers, and computer stations.
Along with WMS functions; other software applications such as UPS, FedEx, USPS, and shipment End of Day processes will be used daily.
Can be expected to work within various areas of Operations and Distributions such as: Receiving, assorted pick modules, Kitting, Shipping, Returns, refrigerated space, DEA, and Small Order Distribution (SOD).
Use of light equipment such as pallet pump jacks and dollies to relocate goods and supplies. Qualified individuals will be certified in other equipment usage such as electric pallet jacks, counter balance forklifts, and floor scrubbers.
Locates and delivers material for departments in accordance with the daily needs and schedules as directed by management.
Uses designated systems and software to perform various tasks as directed by management.
Physically moves material and systematically locates as directed by management.
Expected to assist with the training of new employees.
Perform other assigned tasks as directed by management.
The above duties are meant to be representative of the position and not all-inclusive.
Qualifications
Education/Training: High School Diploma or GED or equivalent experience
Business Experience: One year related experience or training; or equivalent combination of education and experience.
KNOWLEDGE, SKILLS & ABILITIES:
General warehouse or manufacturing skills.
Use of material handling equipment including pallet jacks (both manual and electric), stretch wrappers, and scales.
General ability to operate machinery.
Basic math skills.
PHYSICAL DEMANDS:
While performing the duties of this job the employee is frequently required to:
stand or sit
stoop, kneel, or crouch
reach with hands and arms
work in refrigerated conditions
lift and/or move objects up to 35 pounds
and occasionally lift and/or move objects up to 60 pounds
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
CareTria is an equal opportunity employer.
$60k-115k yearly est. Auto-Apply 60d+ ago
Inspection and Packaging Technician I
Sun Pharmaceuticals, Inc. 4.6
Princeton, NJ job
Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.
**Job Summary: 2nd shift 1:30PM-10:00PM**
Assist in visually inspecting, labeling and packaging pharmaceutical products.
**Area Of Responsibility:**
+ Assists in performing visual inspections, labeling, assembling and packaging of liquids, suspensions, and lyophilized pharmaceutical and dermatological products in vials, ampoules etc.
+ Cleans up labeling and packaging assembly equipment and facility as needed
+ Comply with all policies and procedures related to personal safety and job area safety
+ Maintains manufacturing records and completes all required paperwork/documents to comply with Federal Regulations and FDA
+ Reports variance or deviations from standard procedures to department management
+ Stocks materials utilized by the department
+ Operates semi-automatic inspection machine, vial label applicator and box imprinting machines
+ Other duties as assigned
**Work Conditions:**
+ Controlled unclassified manufacturing/production area
+ Warehouse office
+ Possible exposure to hazardous and non-hazardous chemicals
**Physical Requirements:**
+ Stand, walk, sit, use hands and fingers to handle or feel, reach or push with hands and arms, talk and hear
+ Use of repetitive motion, unimpaired manual dexterity
+ Close vision, color vision, peripheral vision, depth perception, ability to focus
+ Correctable 20/20 vision
+ Ability to visually inspect small products and print
+ Be able to sit at workstation for up to 50 minutes at a sitting for up to 8 hours per day
+ Requires use of appropriate personal protective equipment (lab coat, hairnet, booties, and gloves)
+ Lifts up to 35lbs.
**Travel Estimate:** Up to 0%
**Education and Job Qualification:**
+ High School Diploma or GED required
+ Biotechnology certificate preferred or equivalent experience
+ Ability to visually inspect small print/printed labels
+ Ability to visually inspect liquid and lyophilized pharmaceutical products for small particles
+ Ability to read, write and follow written and verbal instructions/procedures in English
+ Ability to work independently or in a group setting
**Experience:**
+ Minimum 0-2 years related experience
+ Familiarity with, and the ability to follow established Standard Operating Procedures (SOPs), Master Batch Records, and adhere consistently to current Good Manufacturing Practices (cGMPs)
+ Works under direct guidance of the supervisor
+ Basic math skills
+ Basic computer skills
_The presently-anticipated base compensation pay range for this position is $20.00/hr to $25.00/hr. Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._
_The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._
_The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._
_We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._
**_Notice to Agency and Search Firm Representatives:_**
_Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
$20-25 hourly 54d ago
Neuroscience Area Business Leader - Boston, MA
Novartis Group Companies 4.9
Remote or East Hanover, NJ job
#LI-Remote This is a field-based and remote opportunity supporting a sales team in an assigned geography. Novartis is unable to offer relocation support for this role. Please only apply if this location is accessible to you.
Company will not sponsor visas for this position.
The Area Business Leader (ABL) is an enterprise thinker responsible for directing a team of Territory Account Specialists in the delivery of tailored customer experiences based on account and Health Care Provider (HCP) needs and clinical dialogue that compels the customer to act on behalf of their patients to generate demand in the relevant area. Through regular face-to-face in-field interactions, the Area Business Leader mentors their team to work cross-functionally with Healthcare Providers, Key Accounts and Systems of Care (SoC) to identify shared priorities, deliver clinical value and provide Novartis resource messaging in a patient-centered approach thereby establishing Novartis as a preferred customer partner. The Area Business Leader instills a culture of high-performance and accountability that encourages and motivates their team to complete the brand strategy and tactics.
Job Description
Key Responsibilities:
Recruit, develop, retain, mentor, and lead a diverse team of individuals to successfully deliver on strategic sales objectives and establish a cadence of accountability for the team, communicating, and supervising KPIs and engaging all levels of performance on the team.
Models the way for all associates by encouraging a shared vision, communicating clear expectations, promoting an environment of accountability, enabling others to act, and optimizing or advancing processes by challenging the status quo.
Monitor and mentor to ensure Territory Account Specialists are effective orchestrators of the total account call by coordinating the deployment resources to efficiently plan, communicate, and follow through to ensure customer needs are met with vitality.
Develop, implement, and cultivate a customer-centric business plan in collaboration with both customer engagement and cross-functional partners to optimize customer experience and product demand.
Serve as a member of the regional leadership team that is proactively supplying to the development of overall regional goals, business execution, team development and culture.
Embed a hard-working, customer-centric culture where teams are engaged business owners that take effective results-oriented action. The Area Business Leader champions an environment where team members are encouraged to speak up, solve problems, collaborate, experiment, and fail forward.
Possess in-depth knowledge in the areas of clinical, access and reimbursement, eye for business, territory management, and appropriate use of omni-channel marketing tools to effectively develop and mentor members of the team during regular field contacts and one-on-one mentor sessions.
Leverage analytics platforms to advise decisions and identify areas of risk and opportunity to ensure the Territory Account Specialists are deploying resources like strategic face-to-face meetings, omni-channel resources, total office calls and cross-functional partners.
Essential Requirements:
Bachelor's degree required from 4-year college or university.
Experience (see leveling guidelines below) in pharmaceutical, biotech, healthcare, or similarly structured industries with large, geographically dispersed sales teams. We also welcome candidates from other complex sales environments such as medical devices, diagnostics, life sciences services, insurance, consumer health, or B2B sectors, especially where strong field leadership and customer engagement are central to success.
Internal Sales Associates are eligible, if successfully completed Novartis Emerging Leaders Development Program (ELDP), or 2+ years of pharmaceutical/biotech sales management experience within the last two years prior to joining the company.
2+ years' experience as a first-line sales manager with strong, demonstrated strategic thinking and enterprise mindset (e.g., including but not limited to brand management, market access, account leadership experience).
Demonstrated leadership experience in sophisticated selling environments (including but not limited to pharmaceutical, biotech, healthcare, or similarly structured industries, physician, managed markets, and/or limited physical access accounts), with shown success (e.g., sales awards, top third ranking, successful performance ratings, etc.).
Proven track-record of attracting, developing, and retaining diverse talent and building high-performing teams. Proven track record of driving sales performance, leading cross-functional teams, and executing strategy in matrixed, multi-regional environments.
Experience managing field organizations through change, innovation, or growth is highly valued.
Candidate must reside within territory, or within a reasonable daily commuting distance of 100 miles from the territory border. Ability to travel 60-80% over a broad geography is required, with the ability to drive and/or fly within the territory. Must have a valid driver's license.
Desirable Requirements:
Experience & success leading sales teams in promotion to large practices, hospitals, IDN's & SoC customers, with an understanding of reimbursement for both the out-patient (payer) and in-patient (Diagnosis Related Group, Medicare).
Leveling Guidelines: The position will be filled at a level commensurate with experience.
Area Business Leader I:
2+ years' experience as a first-line sales manager with strong, demonstrated strategic thinking and enterprise mindset (e.g., brand management, market access/account leadership experience) in pharmaceutical, biotech, healthcare, medical devices, diagnostics, life sciences services, insurance, consumer health, B2B sectors or similarly structured industries with large, geographically dispersed sales teams.
Area Business Leader II:
4+ years' experience as a first-line sales manager with strong, demonstrated strategic thinking and enterprise mindset (e.g., brand management, market access/account leadership experience) in pharmaceutical, biotech, healthcare, medical devices, diagnostics, life sciences services, insurance, consumer health, B2B sectors or similarly structured industries with large, geographically dispersed sales teams.
Senior Area Business Leader:
8+ years' experience as a first-line sales manager with strong, demonstrated strategic thinking and enterprise mindset (e.g., brand management, market access/account leadership experience) in pharmaceutical, biotech, healthcare, medical devices, diagnostics, life sciences services, insurance, consumer health, B2B sectors or similarly structured industries with large, geographically dispersed sales teams.
Driving is an Essential Function of this Role: Meaning it is fundamental to the purpose of this job and cannot be eliminated. Because driving is an essential function of the role, you must have a fully valid and unrestricted driver's license to be qualified for this role. The company provides reasonable accommodations for otherwise qualified individuals with medical restrictions if an accommodation can be provided without eliminating the essential function of driving.
COVID-19 Vaccine Policy (customer-facing roles only): While Novartis does not require vaccination for COVID-19 or proof of a recent negative test result for COVID-19 at this time, employees working in customer-facing roles must adhere to and comply with customers' (such as hospitals, physician offices, etc.) credentialing guidelines, which may require vaccination. As required by applicable law, Novartis will consider requests for reasonable accommodation for those unable to be vaccinated. This requirement is subject to applicable state and local laws and may not be applicable to employees working in certain jurisdictions. Please send accommodation requests to .
For Field Roles with a Dedicated Training Period: The individual hired for this role will be required to successfully complete certain initial training, including home study, eight (8) or fewer hours per day and forty (40) or fewer hours per week.
Novartis Compensation Summary:
The salary for this position is expected to range between:
Area Business Leader I: $138,600 and $257,400 per year
Area Business Leader II: $138,600 and $257,400 per year
Senior Area Business Leader: $160,300 and $297,700 per year
The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.
Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.
US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.
EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to or call and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Salary Range
$138,600.00 - $257,400.00
Skills Desired
Analytical Skill, Change Management, Coaching, Collaboration, Commercial Excellence, Complexity Management, Compliance, Ethics, Healthcare Sector, Leadership, Management, Mentorship, Problem Solving Skills, Professional Communication, Team Work
$160.3k-297.7k yearly 3d ago
QlikView/Java expert (Data scientist)
Info. Services Inc. 4.2
Jersey City, NJ job
Qlikview/Java expert with 10+ years of experience. Candidate should have worked in development projects with strong knowledge Qlikview/Java. Good working knowledge of BigData /Hadoop will be plus. PHD degree holder is a plus. Good working experience in Design and development of qlikview model, data visualization tools. An expert in developing solutions using QlikView software. Expert level skill in integrating data using QlikView. Expert level skill in QlikView scripting. Decent exposure to QlikView UI development. Should be able to build new QlikView dashboards. Experience with Qlikview in a server-based environment. Good knowledge of installing and configuring/administering Qlikview Desktop, Qlikview Server, IIS Server and Qlikview Publisher. Expert knowledge of SQL and database concepts in a dimensional large data warehouse environment. Candidate should possess strong background in Data Analysis and be an expert data modeler. iOS development capabilities is a plus
Additional Information
QlikView/Java expert (Data scientist)
$86k-136k yearly est. 1d ago
Development Scientific Director, Ophthalmology
Sanofi 4.3
Morristown, NJ job
Job Title: Development Scientific Director About the Job Join the engine of Sanofi's mission - where deep immunoscience meets bold, AI-powered research. In R&D, you'll drive breakthroughs that could turn the impossible into possible for millions.
The Development Scientific Director (DSD) is a responsible member of the clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program. The primary purpose of the development scientific director's position is to support the Clinical Research Director (CRD) and/or clinical lead in the medical/scientific contribution for the clinical studies on activities pertaining to the Study Medical Manager (SMM) responsibilities e.g.: leading or contributing to key study documents and activities from clinical development plans and trial set-up to clinical study report in compliance with quality and regulatory processes.
About Sanofi:
We're an R&D-driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. Our deep understanding of the immune system - and innovative pipeline - enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people's lives.
Main Responsibilities:
* Development scientific director provides active scientific contribution to a cross-functional clinical team developing a molecular entity, provide input to the clinical development plan, work on the development of the clinical trial protocol, clinical trial materials, and take responsibility for coordinating completion of clinical study reports and support preparation of relevant documents for regulatory filings.
* This role will involve extensive team matrix interactions with colleagues from a number of different disciplines and development scientist is responsible for leading or representing clinical development across specific aspects of clinical trial execution.
* This individual may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.
* Under the guidance of his/her manager in the Therapeutic Area department, he/she collaborates with the Coding specialist, Biostatisticians, Data Managers, Global and Regional Study Managers, Feasibility Managers, Pharmacovigilance representative, Medical Writer (e.g. planning and review of narratives) on high quality medical scientific documents, as needed.
* He/she ensures appropriate review and consistency of the data and investigations of safety cases with the Clinical Trial Team (Monitoring Teams) or Pharmacovigilance.
About You
Knowledge And Skills Required:
* Ophthalmology/retina clinical development, clinical trial methodology knowledge and experience required
* Leadership skills to give directions and organize the activities on behalf of the CRD
* Scientific expertise or interest and ability to learn in the domain of assigned study/project. Ability to synthesize the scientific information, excellent presentation skills
* Experience in drafting protocols/amendments, providing input to CSRs, regulatory documents (IBs/ INDs, Briefing books etc.)
* Familiar with digital tools such as data analytics or agility to use them
* Quality focused, able to develop good practices, using a critical data-driven and risk management approach
* Ability to work autonomously and efficiently to provide status reports and to anticipate and escalate issues in a timely manner to execute action plans
* Well organized, high level of autonomy and motivation,
* Good communication skills (verbal and written)
* Multiple tasks handling and prioritization
* Able to make proposals to manage challenging situations
* Ability to work in project mode with study team and CRDs and develop trust and effectiveness
* Management of priorities and workload, if involved in several projects
* Ability to develop strong leadership and collaborate with cross functional team members
* Team and results oriented
* Experience of working internationally with Strong English skills (verbal and written if English is not the native language)
* This position may require up to 15% travel
Formal Education And/Or Experience Required:
* Ph.D. preferred, Masters degree considered for candidates with extensive experience.
* A minimum of 3 years of phase I-III clinical trial/drug development experience within the ophthalmology/retina pharmaceutical industry or CRO is required
* Knowledge in ICH, GCP.
* Fluent in English.
Knowledge And Skills Desirable But Not Essential:
* Global trial experience
* Clinical operations,
* Statistical, data management
* Regulatory knowledge
Why Choose Us?
* Bring the miracles of science to life alongside a supportive, future-focused team.
* Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
* Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
* Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
Pursue progress, discover extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!
US and Puerto Rico Residents Only
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
North America Applicants Only
The salary range for this position is:
$172,500.00 - $287,500.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.
**Job Title:** Biostatistics Evidence Generation & Decision Sciences (EGDS) - Summer 2026 Intern **About the Job** Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
Join our B&P Neurology team as a Data Analyst and you'll lead one or several late phase studies, or lead an indication for a complex compound, under supervision of statistical project leader and/or team leader.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**Main Responsibilities:**
+ Contribute to the design and analysis of both early- and late-phase clinical trials by applying advanced statistical methods and data analysis techniques.
+ Support the development, evaluation, and implementation of innovative statistical methodologies to address complex problems in clinical research.
+ Work collaboratively under the guidance and mentorship of senior-level statisticians, gaining hands-on experience in study planning, data interpretation, and the preparation of statistical reports and publications.
**About You**
**Basic Qualifications:**
+ Currently enrolled and pursuing PhD in Statistics or Biostatistics at an accredited college or university
+ Candidates must have completed at least two years of graduate coursework and be working on a dissertation toward a PhD in Statistics or Biostatistics
+ Experience with SAS and R
+ Must be able to relocate to the office location and work 40hrs/week, Monday-Friday, for the full duration of the co-op/internship
+ **Must be permanently authorized to work in the U.S. and not require sponsorship of an employment visa (e.g., H-1B or green card) at the time of application or in the future. Students currently on CPT, OPT, or STEM OPT usually require future sponsorship for long term employment and do not meet the requirements for this program unless eligible for an alternative long-term status that does not require company sponsorship**
**Preferred Qualifications:**
+ Effective oral and written communication skills
+ Experience with python is a plus
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ Exposure to cutting-edge technologies and research methodologies
+ Networking opportunities within Sanofi and the broader biotech community.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
\#GD-SA
\#LI-SA
\#LI-Onsite
\#vhd
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
Global Terms & Conditions and Data Privacy Statement (***************************************************************
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (*****************************
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************
$34k-41k yearly est. 60d+ ago
Manager, LMS Administration and Operations (Princeton, Hybrid)
Otsuka America Pharmaceutical Inc. 4.9
Remote or Trenton, NJ job
The Manager, LMS Operations & Administration position works as part of the U.S. Ethics & Compliance Training & Documentation team to lead all components of our Learning Management System (LMS) including all non-GxP assignments and audience management, curriculum management, reporting, and tier one trouble shooting. The Manager, LMS Operations & Administration will partner with all levels of Management in both business and technology groups to advance and deliver a variety of planned and ad-hoc training initiatives. This position will have direct oversight of two Contracted Workers.
****
+ Responsible for the operational oversight of all LMS activities including but not limited to:
+ Partner with internal LMS Support Team to perform needs assessments and analysis on platform operations to ensure organizational needs are being met. Leads the incorporation, socialization, and training of resulting LMS improvements.
+ Owns all non-GxP LMS usage workflows and processes with business owners for suitability/fit; suggests and implements alternatives as needed
+ Regularly perform reviews of existing training curricula, identify gaps in course assignments and implement necessary changes.
+ Create, maintain, and run scheduled as well as custom reports, in a timely manner, as designated for analysis and decision making. Create new reports as requested.
+ Assist in managing external vendors, suppliers, and internal business partners as needed with a continuous improvement mindset.
+ Partner across departments as necessary to initiate timely and compliant learning initiatives
+ Continually enhance our methods and materials based on best practices in the industry, emerging technologies, vendor resources and products, business unit requirements and expectations, and feedback from customers, trainers and associates.
+ Ensure operational alignment across OAPI/OPDC learning community
+ Develop and deliver LMS platform training when required.
+ Oversee the work of two remote-based contracted resources.
+ Represent Field Training and Development's unique needs at governance and committee meetings/working groups
**Qualifications/ Required**
Knowledge/ Experience and Skills:
+ Bachelors degree in related field, or equivalent experience and demonstrated skills and abilities
+ 5+ years of Learning Management System (LMS) experience
+ Advanced working knowledge of LearnShare LMS
+ Understanding of current approaches in applying technology in learning solutions and experience implementing e-Learning and web-based programs.
+ Strong technical acumen; proficiency in Microsoft Office 365, SCORM; experience with Tin Can/xAPI, LRS's, and general technical troubleshooting
+ Ability to work in a fast-paced environment and be comfortable with consistent change
+ Detail-oriented with strong organizational skills
+ Strong written and verbal communication skills
+ Ability to prioritize and manage multiple responsibilities at once
+ Positive can-do attitude; always willing to learn
+ Strong analytical/technical skills
+ Comfortable with data management/data manipulation
+ Resiliency and tolerance of ambiguity
**Preferred:**
+ Experience in pharmaceuticals/medical devices or other regulated industry
+ Embody a customer service mentality as you communicate and support field sales teams
+ Experience leading Contract Workers remotely
Educational Qualifications
+ Bachelors degree in related field, or equivalent experience and demonstrated skills and abilities
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $104,640.00 - Maximum $156,400.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$104.6k yearly 34d ago
Associate Principal Scientist, Data Science - Princeton, NJ
DSM 4.3
Princeton, NJ job
Associate Principal Scientist, Data Science We are seeking a highly skilled data scientist specialized in Formulation Performance Modeling and Formulation Creation across a portfolio of Innovation projects, as well as ensuring the team is deploying the latest, state-of-the-art technologies and skills to develop, manage and govern various products in food, perfumery and beauty. The candidate would join dsm-firmenich's Data Science team within Science and Research and with focus on Data Science model development and on the translational task between Data Science and Business Units key users and stakeholders.
This role offers the opportunity to drive interdisciplinary science projects that integrate the latest advances in cheminformatics, data science, AI and while working in close collaboration with leading domain perfumery and flavour experts.
Your Key Responsibilities:
* Use data science and AI to drive a fast-paced ingredient discovery pipeline that generates maximum value for dsm-firmenich's, perfumery and beauty, taste, texture and health segments.
* Develop and implement ML and AI models for predicting and optimizing performance of formulations in diverse applications.
* Contribute to formula creation and product development tools with Data Science models and data pipelines.
* Translate scientific research findings into practical applications that can drive business growth. Identify opportunities for commercialization of research outcomes and collaborate with business units to realize these opportunities.
* Contribute to the development and adoption of Data Science best practices and by our global community of data scientists, scientists and experts in perfumery and beaty, taste, texture and health segments.
* Stay up to date on the latest advancements in cheminformatics, formulation design, computational biology, molecular AI and modeling approaches.
* Apply modern software development and machine learning tools and practices in your daily work, including a high level of proficiency in Python, git, and team co-development workflows. Familiarity with good use of coding agents preferred.
* Team-up with other data scientists and chemistry and physics science experts around the globe to drive project success.
We Bring:
* Highly motivated, professional and committed multicultural and interdisciplinary team.
* Opportunity to put your scientific skills into practice with innovations in health, nutrition and beauty.
* Grow and develop your skills through our in-house training courses.
* Being a part of company shaping a strong legacy heritage through industrial innovations and cutting-edge technology.
* A commitment to science-based innovations with 2000 scientists and 700 mm annual S&R investments.
You Bring:
* Ph.D., master's degree or similar experience in Physics, Chemistry, Engineering, Structural Biology, Computer Science, AI, or a related field.
* 3-7 years of additional academic or industry work experience in the chemical industry, bio- and cheminformatics or formulation space.
* Record of accomplishments demonstrating high drive and keen entrepreneurial innovation.
* Strong skills in computational chemistry, cheminformatics, statistics, structural biology, including hands-on development experience of modern AI tools.
* Deep understanding of Data Science methods, formulation performance applications, generative AI technologies in chemistry and physics, science informed ML methods.
* Proficiency Python, good code management, git, and working with CI/CD pipelines.
* Excellent problem-solving skills and proven ability to work both independently and collaboratively.
* Effective communication and collaboration skills with the ability to convey complex concepts to non-experts.
* Entrepreneur mindset and ability to provide insights based on data analysis to inform business decisions.
The salary or hourly wage scale provided reflects the pay range dsm-firmenich expects to pay the successful candidate for the position. Individual pay offered will be based on the applicant's job-related skills, experience, relevant education, or training, and primary work location. This position is also eligible for bonuses and benefits, which are not included in the pay scale provided. Salary $128,000-$183,000.
About dsm-firmenich
At dsm-firmenich, we don't just meet expectations - we go beyond them.
Join our global team powered by science, creativity, and a shared purpose: to bring progress to life.
From elevating health to making fortified food and sustainable skincare, the impact of your work here will be felt by millions - every single day. Whether it's fragrance that helps you focus, alternative meat that's better for the planet, or reducing sugar without losing flavor, this is where you help shape the future of nutrition, health, and beauty for everyone, everywhere.
And while you're making a difference, we'll make sure you're growing too. With learning that never stops, a culture that lifts you up and the freedom to move across businesses, teams, and borders. Your voice matters here. And your ideas? They're essential to our future.
Because real progress only happens when we go beyond, together.
The application process
Interested in this position? Please apply online by uploading your resume in English by October 10, 2025.
Inclusion, belonging and equal opportunity statement
At dsm-firmenich, we believe being a force for good starts with the way we treat each other. When people feel supported, included, and free to be themselves, they do their best work - and that's exactly the kind of culture we're building. A place where opportunity is truly equal, authenticity is celebrated, and everyone has the chance to grow, contribute, and feel they belong.
We're proud to be an equal opportunity employer, and we're serious about making our hiring process as fair and inclusive as possible. From inclusive language and diverse interview panels to thoughtful sourcing, we're committed to reflecting the world we serve.
We welcome candidates from all backgrounds - no matter your gender, ethnicity, sexual orientation, or anything else that makes you, you.
And if you have a disability or need any support through the application process, we're here to help - just let us know what you need, and we'll do everything we can to make it work.
Agency statement
We're managing this search directly at dsm-firmenich. If you're applying as an individual, we'd love to hear from you. We're not accepting agency submissions or proposals involving fees or commissions for this role
Pharmaceutical Operations and Clinical Supply is seeking a highly motivated individual for a Compliance and Continuous Improvement position to support specialty dosage forms and oral solid dosage GMP development activities.
This role is primarily responsible for compliance and continuous improvement activities including safety, quality, delivery and continuous improvement within clinical supply Formulation Laboratory and Experimentation (FLEx) Center.
This opening is for the Non-Sterile team in the 880 FLEx Center.
The successful candidate will become an owner and trainer of our manufacturing support processes (safety, compliance, change overs, root cause analysis, continuous improvement program). They will lead the team through continuous improvement projects, along with managing and completing GMP documentation. They will also build a strong team dynamic through continual sharing of knowledge and identification of improvements. They will work closely with peer specialists, formulation scientists, facility engineers and automation engineers to fix processes/system issues and solve root causes. By taking initiative and owning improvement projects to completion, the candidate will help the team progress on our learning journey.
This position is based in Rahway, NJ and is 100% on-site and day-shift.
Primary Activities
Lead process improvement activities in the oral solid dosage facility
Coordinate quick changeover activities on designated equipment trains
Define and improve standard work, SOPs, BTD, and overall production flow
Support standard Non-Sterile processing as time allows
Ensure adherence to Good Manufacturing Practices, draft and review process steps, SOP's, quality procedures, safety, and environmental standards.
Perform documentation activities on room and equipment logs and batch sheets in compliance with Good Documentation Practices.
Develop experience to become a compliance and continuous improvement expert and share knowledge by teaching others.
Execution of GMP batch documentation in accordance to local and global operating procedures.
Provide support to engineering and formulations staff on Good Manufacturing Practices, facility processes, facility maintenance and batch specific items.
Identify and document deviations and atypical events.
Lead investigations and document as required.
Execute equipment swabbing in support of the cleaning verification program.
Support investigations and the implementation of corrective/preventive actions.
Support external and internal audits, tours and inspections.
Author or assist with the development of SOP's.
Complete training and ensure it is up to date.
Interface with engineering, safety, quality and maintenance personnel for improvement of our current processes.
Lead improvement initiatives.
Qualifications
Required Qualifications:
Bachelor's in Chemical Engineering, Pharmaceutical Sciences, Chemistry or related fields
Independent planning, scheduling, and time management skills.
Must pass medical screening requirements for production with PAPR (powered air purifying respirators)
Ability to move 50 lbs.
Ability to troubleshoot and resolve issues utilizing digital skill sets
Preferred:
Experience in GMP pharmaceutical plant operations
Experience with GMP (Good Manufacturing Practices) and GDP (Good Documentation Practices)
Working knowledge of regulatory requirements within GMP manufacturing facilities, and demonstrated focus on details and proper execution of batch manufacturing.
Experience with some of the following: Oral Solid Dosage, Tablet Compression, Encapsulation, Spray Drying, Film Coating, Dry Powder Inhalers, Drug Product Device assembly lines, Isolators, Containment technology
Experience working with Lean / Six Sigma and continuous improvement projects
Experience with: PI Visions, Equipment HMI use, SAP, Calibration/Maintenance Database Systems, Microsoft Office (Word, Excel and Outlook).
Experience working with safety team on industrial hygiene monitoring, investigations, improvements, and focus on safety working culture.
#PSCS
#eligiblefor ERP
Required Skills:
Accountability, Accountability, Analytical Problem Solving, Audit Management, Change Management, Chemical Engineering, Clinical Trials Operations, Equipment Maintenance, Equipment Set Up, GMP Compliance, Good Manufacturing Practices (GMP), Industrial Hygiene, Machinery Operation, Machining, Manufacturing Engineering, Manufacturing Operations, Manufacturing Support, Microsoft Office, Oracle CRM, Pharmaceutical Manufacturing, Pharmaceutical Systems, Process Optimization, Production Planning, Production Scheduling, Project Management {+ 4 more}
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The salary range for this role is
$70,500.00 - $110,900.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at *******************************************************
You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
Job Posting End Date:
01/19/2026
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
$70.5k-110.9k yearly Auto-Apply 12d ago
Data Integrity Specialist
Johnson & Johnson 4.7
Raritan, 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:
Quality
Job Sub Function:
Quality Control
Job Category:
Professional
All Job Posting Locations:
Raritan, New Jersey, United States of America, Titusville, New Jersey, United States of America
Job Description:
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at *******************/innovative-medicine
We are searching for the best talent for Data Integrity Specialist to be in Titusville, NJ or Raritan, NJ.
The Data Integrity Specialist will provide technical expertise to ensure data is complete, consistent, accurate, trustworthy and reliable and these characteristics of the data are maintained throughout the data lifecycle. The Data Integrity Specialist will carry out duties in compliance with all local, state and federal regulations and guidelines (including FDA, EPA, DEA, OSHA, etc.) as well as all company and site policies and procedures. This role requires strong analytical and technical skills, with collaboration across departments and vendors to maintain high-quality data for reliable decision-making and regulatory compliance.
The Data Integrity Specialist is responsible for designing, implementing and maintaining a data control strategy for the Stability Operations Laboratory (supporting Titusville and Raritan, NJ sites); act as the Subject Matter Expert on Data Integrity processes including Good Documentation Practices and drive compliance efforts; support the equipment lifecycle management team during instrument qualification activities by participating in process flow mapping and data integrity assessments for all instruments and equipment; and ensure laboratory data handling and storage adhere to relevant policies and regulations.
The Data Integrity Specialist is accountable to manage and assure quality & compliance for lab equipment and instrumentation and ensure all regulatory commitments are met. They will act as a laboratory SME for data integrity issues that arise in the area of Equipment Lifecycle Management.
This role supports the New Jersey Stability Laboratory locations, therefore routine travel between Titusville and Raritan sites is expected.
Major Duties & Responsibilities
General:
* Maintain data integrity standards for all lab equipment and instrumentation
* Support system upgrades, maintenance, and roll-outs of new systems, as needed
* Ensure accuracy, completeness and cGMP compliance in laboratory documentation as it pertains to Data Integrity
* Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
* Uphold our Credo values including creating a positive work environment
* Train, develop, coach and mentor employees
Data Integrity Support 80%:
* Act as the Subject Matter Expert on Data Integrity including Good Documentation Practices, Good Manufacturing Practices and drive compliance efforts.
* Act as site Data Integrity SME, ensuring ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Completeness, Consistency, Enduring, Availability/Traceability) across the data lifecycle.
* Design, implement, and maintain a data control strategy for stability operations with responsibility for data classification, lineage, retention, archiving, and secure deletion per policy.
* Lead data integrity risk assessments and influence cross-functional teams on Data Integrity improvements.
* Maintenance and monitoring of Data Integrity at the Titusville and Raritan sites.
* Enable and empower Critical Thinking & Risk Management at Titusville and Raritan sites to ensure active risk management, taking all aspects of patients' safety & product quality into account.
* Work closely with management to propose/complete improvement activities.
* Participate in the execution of Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols of lab instrumentation and data management applications as it relates to Data Integrity.
* Contribute to Process Flow Mapping during instrument qualification and ensure documentation aligns with GAMP 5 and company policies.
* Participate in efforts to improve and update computer system compliance including providing guidance on the deployment and management of laboratory data management computer systems
* Ensure data management and storage adhere to relevant policies and regulations.
Projects / Meetings 10%:
* Represent the department in interdepartmental meetings in support of process improvement initiatives.
* Assess talent by participating in panel interviews for QC job candidates
* Provide input to / lead functional laboratory meetings
* Interface with Global Quality Systems and IT, as needed
* Provide input and take actions as a QC Technical representative at cross-functional meetings
* Engage with Data Integrity Specialist, Global Equipment Lifecycle Management CoE and ELM peers at other sites to leverage practices across the J&J Innovative Medicine Laboratory network.
* Support the development and execution of CREDO and Lean Lab action plans and initiatives
Quality & Compliance 10%
* Support internal audits and Health Authority inspections as a local SME
* Ensure compliance to J&J Innovative Medicine Quality global and local procedures, regulatory/ Health Authority requirements, and industry standards
* Complete and approve corrective and preventative actions (CAPA) as assigned
* Maintain high level of familiarity with GMPs, CFR Part 11, and current regulatory guidelines related to instrument calibration and computer systems validation (e.g., GAMP 5, USP , 21 CFR Part 210/211 etc.).
* Develop and review laboratory technologies procedures and verify their compliance with internal and external requirements
Other Duties
* Other duties as assigned by management
Required Qualifications
Required Minimum Education: University / Bachelor's Degree
Minimum Required Years of Related Experience: 4-6 years
Required Knowledge, Skills and Abilities:
* Strong knowledge of data integrity principles (ALCOA+)
* Ability to work with others in a team environment
* Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify/remediate gaps in processes or systems
* Technical knowledge of computer system validation, instrument qualification (IQ/OQ/PQ), data management systems, Data lineage, Audit trails, and Regulatory documentation practices
* Strong interpersonal and written/oral communication skills
* Ability to quickly process complex information and often make critical decisions with limited information
* Ability to manage multiple priorities daily while being flexible and responsive to frequently shifting priorities
* Ability to independently manage a portfolio of ongoing projects
* Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
* Proficiency with using Microsoft Office applications (Outlook, Excel, Word, Project and PowerPoint)
Travel on the Job: Travel is expected to be split between Raritan and Titusville NJ sites.
Percentage Traveled: up to 10%
Type of Travel Required:
Domestic (US) International
Preferred Qualifications.
Preferred Minimum Education: University / Bachelor's Degree
Other: N/A
Preferred Area of Study: Science, Engineering, IT or Related
Preferred Related Industry Experience (if applicable):
* Experience in a regulated environment with IT/data systems (LIMS/ELM/ELN/CDS)
* Demonstrated ability to influence peers and drive change
* Training in data integrity concepts, ALCOA+, and regulatory horizon scanning
Preferred Knowledge, Skills and Abilities:
* Creativity regarding basic problem solving and troubleshooting
* The QC ELM Specialist shall have the capability to develop improvement ideas and independently implement associated solutions
* Possesses the ability to positively influence peers, key stakeholders and management
* Positive and optimistic with the ability to act as a pro-active change agent
Key Working Relationships
Internal
* Frequent interaction with QC Analysts, peers in QC Lab Services, QC Supervisors and Managers and QC Stability Coordinators
* Frequent interaction with Quality Assurance personnel
* Frequent interaction with Global IT representatives, Maintenance and Facilities representatives, Environmental Health and Safety, and Global Quality Systems
* Interaction with JSC Lab ELM COE members as needed
External
* Contractors supporting the NJ Stability Operations (Equipment contractors, analysts, etc.)
* Interaction with regulatory agencies during inspections
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, external applicants please contact us via *******************/contact-us/careers. Internal employees contact AskGS to be directed to your accommodation resource.
Required Skills:
Preferred Skills:
Analytical Reasoning, Business Behavior, Compliance Management, Controls Compliance, Cross-Functional Collaboration, Innovation, ISO 9001, Persistence and Tenacity, Problem Solving, Process Oriented, Quality Auditing, Quality Control (QC), Quality Standards, Quality Systems Documentation, Report Writing, Technologically Savvy
The anticipated base pay range for this position is :
$79,000.00 - $127,650.00
Additional Description for Pay Transparency:
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. • Employees and/or eligible dependents may be 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. • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). • Employees are eligible for the following time off benefits: o Vacation - up to 120 hours per calendar year o Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year o Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. *********************************************
$79k-127.7k yearly Auto-Apply 3d ago
Director, Field Strategy & Operations (Everest)
Otsuka America Pharmaceutical Inc. 4.9
Trenton, NJ job
**About Otsuka** We defy limitation, so that others can too. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.
**Position Overview:**
The Director of Field Strategy and Operations serves as the orchestrator of field strategy, ensuring that prioritization, stakeholder engagement, and execution are effectively aligned with brand strategy and enterprise objectives. This role provides leadership across multiple regions, enabling a holistic, enterprise-wide approach to field strategy and operational excellence.
This role also partners closely with the Business Analysis team to ensure field teams have access to standardized dashboards and data-driven insights, supporting execution excellence and performance tracking. The Director will be the point of contacts for ad hoc analytics requests, ensuring field teams have the right data to make informed decisions, but will not be creating these reports themselves or with their team and will work with Business Analysis to ensure accurate measurement and proper data is used.
**Key Responsibilities:**
+ **Strategic Prioritization & Field Execution:** Align field activities with marketing strategy, launch planning, and market access pull-through, ensuring execution efficiency.
+ **Execution Excellence & Field Performance Tracking:** Oversee Omnichannel efforts, account planning, and KPI tracking, ensuring insights from Field Analytics support execution.
+ **Strategic prioritization & orchestrating field execution: Analyzes current and future state of the business based on insights and trends, and** leads efforts to align field activities with high-priority initiatives such as marketing strategy, launch planning, and market access pull-through.
+ **Field Communication & Data-Driven Decision Support:** Act as the primary field communicator, ensuring clarity on CRM tools, performance insights, and operational priorities.
+ **Resource Allocation & Budget Optimization:** Optimize the distribution of budgets, speaker programs, and promotional resources, leveraging data-driven insights to maximize ROI.
+ **Team Development & Analytics Training:** Mentor team members on business reviews, reporting systems, and analytics interpretation, working with Business Analysis to enhance field intelligence capabilities.
+ **Compliance Management:** Must comply with all state and federal laws, regulations and guidelines including PhRMA Code on Interactions with Healthcare Professionals as well as complying with all OAPI standards and policies relating to all job activities.
**Qualifications:**
+ Bachelor's degree required; MBA or advanced degree preferred.
+ Minimum of 10 years of pharmaceutical experience, with a strong understanding of sales force operations and execution.
+ Prior experience in field leadership roles such as first- or second-line leadership, regional operational and customer strategy roles or other field-based support roles required.
+ Established expertise in business analytics, business operations, sales support, and resource management within a commercial pharmaceutical organization.
+ Ability to focus on priorities and resolve operational issues effectively.
+ Excellent communication and collaboration skills, with the ability to work cross-functionally and drive execution efficiency.
**Competencies**
**Accountability for Results -** Stay focused on key strategic objectives, be accountable for high standards of performance, and take an active role in leading change.
**Strategic Thinking & Problem Solving -** Make decisions considering the long-term impact to customers, patients, employees, and the business.
**Patient & Customer Centricity -** Maintain an ongoing focus on the needs of our customers and/or key stakeholders.
**Impactful Communication -** Communicate with logic, clarity, and respect. Influence at all levels to achieve the best results for Otsuka.
**Respectful Collaboration -** Seek and value others' perspectives and strive for diverse partnerships to enhance work toward common goals.
**Empowered Development -** Play an active role in professional development as a business imperative.
Minimum $194,247.00 - Maximum $290,375.00, plus incentive opportunity: The range shown represents a typical pay range or starting pay for individuals who are hired in the role to perform in the United States. Other elements may be used to determine actual pay such as the candidate's job experience, specific skills, and comparison to internal incumbents currently in role. Typically, actual pay will be positioned within the established range, rather than at its minimum or maximum. This information is provided to applicants in accordance with states and local laws.
**Application Deadline** : This will be posted for a minimum of 5 business days.
**Company benefits:** Comprehensive medical, dental, vision, prescription drug coverage, company provided basic life, accidental death & dismemberment, short-term and long-term disability insurance, tuition reimbursement, student loan assistance, a generous 401(k) match, flexible time off, paid holidays, and paid leave programs as well as other company provided benefits.
Come discover more about Otsuka and our benefit offerings; ********************************************* .
**Disclaimer:**
This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will be given consideration for employment without regard to race, color, sex, gender identity or gender expression, sexual orientation, age, disability, religion, national origin, veteran status, marital status, or any other legally protected characteristic.
If you are a qualified individual with a disability or a disabled veteran, you may request a reasonable accommodation, if you are unable or limited in your ability to apply to this job opening as a result of your disability. You can request reasonable accommodations by contacting Accommodation Request (EEAccommodations@otsuka-us.com) .
**Statement Regarding Job Recruiting Fraud Scams**
At Otsuka we take security and protection of your personal information very seriously. Please be aware individuals may approach you and falsely present themselves as our employees or representatives. They may use this false pretense to try to gain access to your personal information or acquire money from you by offering fictitious employment opportunities purportedly on our behalf.
Please understand, Otsuka will **never** ask for financial information of any kind or for payment of money during the job application process. We do not require any financial, credit card or bank account information and/or any payment of any kind to be considered for employment. We will also not offer you money to buy equipment, software, or for any other purpose during the job application process. If you are being asked to pay or offered money for equipment fees or some other application processing fee, even if claimed you will be reimbursed, this is not Otsuka. These claims are fraudulent and you are strongly advised to exercise caution when you receive such an offer of employment.
Otsuka will also never ask you to download a third-party application in order to communicate about a legitimate job opportunity. Scammers may also send offers or claims from a fake email address or from Yahoo, Gmail, Hotmail, etc, and not from an official Otsuka email address. Please take extra caution while examining such an email address, as the scammers may misspell an official Otsuka email address and use a slightly modified version duplicating letters.
To ensure that you are communicating about a legitimate job opportunity at Otsuka, please only deal directly with Otsuka through its official Otsuka Career website ******************************************************* .
Otsuka will not be held liable or responsible for any claims, losses, damages or expenses resulting from job recruiting scams. If you suspect a position is fraudulent, please contact Otsuka's call center at: ************. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: ******************* , or your local authorities.
Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization, Inc., and Otsuka Precision Health, Inc. ("Otsuka") does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any Otsuka employee directly or through Otsuka's application portal without a valid written search agreement in place for the position will be considered Otsuka's sole property. No fee will be paid if a candidate is hired by Otsuka as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
$194.2k yearly 60d+ ago
Inspection and Packaging Technician I
Sun Pharmaceuticals, Inc. 4.6
Princeton, NJ job
Sun Pharma is the worlds fourth largest generics company with presence in Specialty, Generics and Consumer Healthcare products. Supported by more than 40 manufacturing facilities, we provide high-quality medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe. Over the last two decades, Sun Pharma has established itself as a leading player in the generics market in the U.S., and we are rapidly ramping up our presence in the specialty branded market with a focus on dermatology, ophthalmology and onco-dermatology.
**Job Summary: 1st Shirt 6:30AM-2:30PM**
Assist in visually inspecting, labeling and packaging pharmaceutical products.
**Area Of Responsibility:**
+ Assists in performing visual inspections, labeling, assembling and packaging of liquids, suspensions, and lyophilized pharmaceutical and dermatological products in vials, ampoules etc.
+ Cleans up labeling and packaging assembly equipment and facility as needed
+ Comply with all policies and procedures related to personal safety and job area safety
+ Maintains manufacturing records and completes all required paperwork/documents to comply with Federal Regulations and FDA
+ Reports variance or deviations from standard procedures to department management
+ Stocks materials utilized by the department
+ Operates semi-automatic inspection machine, vial label applicator and box imprinting machines
+ Other duties as assigned
**Work Conditions:**
+ Controlled unclassified manufacturing/production area
+ Warehouse office
+ Possible exposure to hazardous and non-hazardous chemicals
**Physical Requirements:**
+ Stand, walk, sit, use hands and fingers to handle or feel, reach or push with hands and arms, talk and hear
+ Use of repetitive motion, unimpaired manual dexterity
+ Close vision, color vision, peripheral vision, depth perception, ability to focus
+ Correctable 20/20 vision
+ Ability to visually inspect small products and print
+ Be able to sit at workstation for up to 50 minutes at a sitting for up to 8 hours per day
+ Requires use of appropriate personal protective equipment (lab coat, hairnet, booties, and gloves)
+ Lifts up to 35lbs.
**Travel Estimate:** Up to 0%
**Education and Job Qualification:**
+ High School Diploma or GED required
+ Biotechnology certificate preferred or equivalent experience
+ Ability to visually inspect small print/printed labels
+ Ability to visually inspect liquid and lyophilized pharmaceutical products for small particles
+ Ability to read, write and follow written and verbal instructions/procedures in English
+ Ability to work independently or in a group setting
**Experience:**
+ Minimum 0-2 years related experience
+ Familiarity with, and the ability to follow established Standard Operating Procedures (SOPs), Master Batch Records, and adhere consistently to current Good Manufacturing Practices (cGMPs)
+ Works under direct guidance of the supervisor
+ Basic math skills
+ Basic computer skills
_The presently-anticipated base compensation pay range for this position is $20.00/hr to $25.00/hr.Actual base compensation may vary based on a number of factors, including but not limited to geographical location and experience. In addition, this position is part of the Annual Performance Bonus Plan, and may be eligible for the Long Term Incentive Plan. Employees are eligible to participate in Company employee benefit programs which include medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; and the employee assistance program. Employees also receive various paid time off benefits, including vacation time and sick time._
_The compensation and benefits described above are subject to the terms and conditions of any governing plans, policies, practices, agreements, or other materials or documents as in effect from time to time, including but not limited to terms and conditions regarding eligibility.If hired, employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company, or individual department/team performance, and market factors._
_The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s)._
_We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law._
**_Notice to Agency and Search Firm Representatives:_**
_Sun Pharmaceuticals (Sun) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Sun employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Sun. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral._
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
$20-25 hourly 54d ago
Epidemiologist
Mitsubishi Tanabe Pharma America 4.1
Jersey City, NJ job
Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies.
Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy.
Job Description
Develop initial or update safety signal detection and management documents for global developmental and marketed products to support and enhance appropriate signal detection activities and robust safety evaluation
Review and/or develop relevant epidemiology sections and/or papers for relevant conferences and/or
peer-reviewed journals as assigned
Develop or support development of instruments for epidemiological assessment strategies and safety surveillance in coordination with Biostatistics
Participate in plan/design, execute or contribute to development of observational studies and interventional studies for assigned global developmental and marketed products
Develop epidemiological assessment and safety surveillance plan for assigned projects or studies
Review epidemiology data in supporting the development of risk management plan/risk evaluation
and mitigation strategies (REMS) and other safety related documents
Contribute to the design, implementation, and management of safety studies and clinical trials
Search and review epidemiological data and safety literature in supporting development of Ad hoc or regular safety submissions
Accountable for epidemiology sections of investigator's brochures, risk management plans, aggregate safety reports (DSUR and PSUR), and responses to health agency's inquiries for global development and post-marketing products
Perform safety data evaluation and risk assessment for assigned drug products
Provide or contribute to the materials used for Safety meetings including but not limited to the Clinical Safety Team, Data Monitoring Committee, Global Safety Data Monitoring Committee, Data and Safety Monitoring Board (DSMB)
Contribute epidemiology input to GST Working Group meetings, Signal Detection meetings and other Global Drug Safety and Evaluation Center (GDSEC) meetings as assigned
Performs other departmental duties as assigned
Qualifications
Education:
Graduate degree (PhD, MD, MS, MPH) in a relevant field is required:
Doctoral degree with at least 2 years of industry experience, academia, and/or regulatory agency
Master's degree with 6+ years of experience in a national/local public health agency, regulatory agency, biopharma, and/or the medical device industry (including at least 1 to 2 years of biopharma or
medical device industry experience)
Professional Experience:
Experience and training in public health, pharmacy, health services research, health outcomes research, epidemiology, biostatistics or other relevant fields
Familiarity and experience with the development and implementation of epidemiology research strategies
Expertise in Biostatistics, Epidemiology/ secondary database analyses (e.g., claims, national survey data, etc.), Psychometrics
Demonstrated experience as a member of a product or project team
Experience in scientific writing of peer-reviewed, academic and/or public health literature
Familiarity with Drug Development and Phase 1-4 clinical trials
Knowledge and Skills:
Strong understanding of research methodology and statistics, as well as strong technical writing, and strong ability to critically review published scientific literature
Strong verbal and written communication, presentation skills, including experience
Critical thinking and problem-solving skills, ability to set priorities and develop strategies/studies to answer complex research questions
Experience managing multiple projects, often complex in nature and with both internal and external stakeholders under short timelines
Ability to analyze and interpret safety data
Good understanding of advanced design and analysis techniques used in the analysis of secondary data (e.g., matching, multivariate regression, meta-analysis, etc.)
Ability to conceptualize the presentation of results (e.g., develop layout of tables and figures for inclusion in analysis plans)
Working knowledge of 2 or more secondary database types (e.g., claims, surveys, electronic medical records)
Working knowledge/ability to use standard statistical packages (i.e. SAS, STATA, etc)
Ability to contribute to written processes to ensure consistent and quality deliverables
Additional Information
Our Value Proposition:
Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma Development America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits:
$51k-113k yearly est. 1d ago
Advanced Surgical Consultant - Mobile
Johnson & Johnson 4.7
Cherry Hill, 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:
MedTech Sales
Job Sub Function:
Technical Sales - MedTech (Commission)
Job Category:
Professional
All Job Posting Locations:
Mobile, Alabama, United States
Job Description:
Johnson & Johnson is currently seeking an Advanced Surgical Consultant to join our Abiomed team located in Mobile, Alabama United States.
This is a field-based role available in Alabama, United States. While specific cities are listed in the locations section for reference, please note that they are examples only and do not limit your application.
Purpose: Abiomed, a rapidly growing medical device company, is looking for a driven and results oriented Surgical Sales “Heart Team” Specialist. We are growing both our focus and device line-up in order to support Cardiac Surgeons and Heart Failure Cardiologists across the US. With our continued success, we are looking to expand our commercial team. You will work closely with our Surgical Account Managers and Commercial Sales and clinical team who will be responsible for driving growth across the US. Through our Impella product portfolio you will enable physicians and staff to recover hearts and save patients' lives.
Coverage Areas: Mobile, ALRole & Responsibilities:
Train, educate, and support combined CT/Heart Failure programs on the proper use of the Impella 5.5 with SmartAssist
Full customer immersion (ie. input on patient selection and subsequent surgical support) within 5.5 sites to ensure optimal patient outcomes.
Train, educate and, provide support in conjunction with the Medical Office and Engineering team to support EFS/PMA efforts and full commercialization of the BTR pump and future Surgical and Heart Failure focused technologies.
Device expertise and support on Impella 5.0/ LD in order to assist with the adoption of the full portfolio beyond 5.5 commercial launch responsibilities.
Clinical and technical expertise and support of Breethe Oxy-1 to assist with device integration and support of system adaptation into applications beyond the initial commercial launch.
Participate when able with launch, training, and education of combined Surgical/ Heart Failure programs on the proper use of the Breethe Oxy-1 system with the Breethe Clinical Team.
Internal collaboration with the Commercial Team, Training Team, Engineering Team, Marketing, Professional Education, Clinical, as well as with R&D.
Maintain contact with all customers to evaluate clinical and educational needs.
Performs device training on full Impella Surgical Device line-up.
Be a functional expert and provide advanced acumen on the durable, acute, and, hemodynamic medical device landscape and best practices in the management of those devices.
Cultivates close relationship with strategic business partners and key opinion leaders.
Input to management on all situations affecting clinical results and sales.
Call point(s): Cardiac Surgeons, Heart Failure Cardiologists, OR teams, Intensivists, Perfusionists, and ICU/ Step Down Unit teams.
Staff major conferences: HFSA, AHA, STS, AATS, and ISHLT.
Staff Advanced Surgical Courses and local heart failure and surgical symposiums.
Job Requirements:
Bachelors' Degree required;
Registered Nurse First Assist (RNFA),
Nurse Practitioner (NP), Surgical Physician's Assistant (PA), or Perfusionist licensure
Direct (at the table) experience in Cardiac Surgery/Perfusion,
5+ years preferred
.
Direct patient management experience in one of the following scenarios: a cardiothoracic ICU caring for post-op tMCS (excluding IABP) or durable MCS (does not include experience as an Abiomed field clinical), or direct experience assisting in the CVOR required.
Confidence, expertise and, familiarity of cardiac surgery and OR protocol is required.
Willingness to travel/ cover multiple geographies required;
previous experience desired
.
Up to 50%-75% overnight travel may be required depending on territory.
Previous experience with Abiomed and/or other Cardiac medical devices
highly desired
.
Ability to drive patient outcomes required
Conduct duties and responsibilities in accordance with all state and federal laws and regulations governing the medical device industry required.
A valid driver's license issued in the United States is required.
The anticipated base pay range for this position is $125,000. The Company maintains a highly competitive sales incentive compensation program. Under current guidelines, this position is eligible for participation in this program in accordance with the terms of the applicable plan.
This position is eligible for a company car through the Company's FLEET program.
Benefit Information:
Employees and/or eligible dependents may be 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.
Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on Company benefits, please go to: ********************************************* (*********************************************)
$125k yearly Auto-Apply 60d+ ago
Director, Manufacturing Operations
QuVa Pharma 4.5
Bloomsbury, NJ job
Our Director, Manufacturing Operations plays a vital role in ensuring the highest quality and safety standards of our pharmaceutical products. Once you complete our training, your responsibilities will include overseeing the support of site and company-wide objectives through the reporting of department Key Performance Indicators (KPI). Meeting quality, safety, delivery, and productivity objectives. Ensures people and processes comply with current Good Manufacturing Practices and company procedures.
The Director, Manufacturing Operations, is also responsible for:
* The support of site and company-wide objectives through the reporting of department Key Performance Indicators
* Ensuring people and processes comply with current Good Manufacturing Practices and company procedures
* Modifies department standard operating procedures and executes change controls to support business and quality objectives
* Establishes and maintains cooperative cross-functional relationships with peers in Quality, Operations, Technical Support, Pharmacy Services, Research & Development, and Supply Chain to meet site and corporate objectives
What the Director, Manufacturing Operations Does Each Day:
* Direct and plan the overall company's pharmaceutical production operations
* Runs operation to meet or exceed delivery performance and customer service objectives
* Establish and ensure that cGMP compliant policies, processes, procedures and best practices are developed and consistently executed across the manufacturing operations and provide support and guidance on policy related matters
* Counsels and develops colleagues for efficient performance; provides constructive feedback; creates an atmosphere of team effort and open communication
* Ensure that all production areas have the processes, equipment, and adequately trained staff to support the continuing growth goals of the company and meet customer demand
* Troubleshoots and resolves issues impending deliverables; proactively demonstrates the ownership to achieve
* Maintain and report key performance indictors and escalate any identified risks to permit timeliness to remain contiguous
* Maintain a contemporaneous working knowledge in cGMP requirements
* Other duties that may reasonably be assigned from time to time by the company
* This is a security-sensitive position as the incumbent works with controlled substances and therefore will be subject to periodic drug screen per company policy
* Consistently promote and support best practices involving work methods (lean methodology), technology, and operational systems in order to remain innovative and to maintain and/or increase quality of production methods and final product quality
* Provide leadership and direction to team to assure consistently high levels of performance in pharmaceutical operations
* Lead employees to meet the organization's expectations for safety, quality and productivity goals
* Manage the overall operational, budgetary, and financial responsibilities and activities of the manufacturing operations departments
* Provide input towards the selection, hiring and placement of personnel within the departments as needed
* Actively participate in performance evaluations
* Other duties as assigned
Our Most Successful Director, Manufacturing Operations:
* Has outstanding written, oral communication skills
* Can organize large volumes of data
* Is experienced in pharmaceutical manufacturing especially sterile injectable
* Manages multiple, parallel projects
* Is an expert in Pharmaceutical manufacturing
Minimum Requirements for this Role:
* BA/BS Degree in Business, Science or related field or significant experience
* 5 years' experience in managing a cGMP manufacturing plant operation required
* 7-10 years of related experience in cGMP/FDA regulated industry (CFR 201 & 211 emphasis on FDA guidance for industry aseptic processing preferred)
* Demonstrated experience and leadership in cGMP compliance audits and inspections required
* Demonstrated knowledge of lean manufacturing and metric concepts preferred
* Demonstrated ability to increase others knowledge of cGMP regulations and guidance preferred
* Proficient in computer skills. (e.g. Microsoft Office suite: Visio, ERP systems, MS Project)
Benefits of Working at Quva:
* Comprehensive health and wellness benefits including medical, dental and vision
* 401k retirement program with company match
* A minimum of 25 paid days off plus 8 paid holidays per year
* National, industry-leading high growth company with future career advancement opportunities
* The base compensation for this role is estimated to be within the range described below. The compensation offered may vary depending on relevant factors such as experience, skills, training, education, certifications, geographic location, and market conditions
* Range: $163,764 - $225,175 Annually
* This role is also eligible for an annual incentive bonus, subject to program terms and guidelines
About Quva:
Quva provides industry-leading health-system pharmacy services and solutions, including 503B sterile injectable outsourcing services and AI-based data software solutions that help power the business of pharmacy. Quva Pharma's multiple production facilities and industry-first dedicated remote distribution capabilities provide ready-to-administer sterile injectable medicines critical to patient care. Quva BrightStream partners with health systems to aggregate, normalize, and analyze large amounts of complex data across their sites of care, and through proprietary machine learning, transforms data into actionable insights supporting revenue optimization, script capture, inventory management, drug shortage control, and more. Quva's overall progressive and integrated platform helps health-systems transform pharmacy management to achieve greater value and deliver highest-quality patient care.
Quva is an equal opportunity employer and is committed to creating and maintaining a work environment that is free from all forms of discrimination and harassment. Quva's Equal Opportunity Policy prohibits harassment or discrimination due to age, ancestry, color, disability, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, race, religious creed, sex (including pregnancy, childbirth, breastfeeding, and any related medical conditions), sexual orientation, and any other characteristic or classification protected by applicable laws. All employment with Quva is "at will."
California Consumer Privacy Act (CCPA) Notice for Applicants and Employees
Zippia gives an in-depth look into the details of Taiho Oncology, including salaries, political affiliations, employee data, and more, in order to inform job seekers about Taiho Oncology. The employee data is based on information from people who have self-reported their past or current employments at Taiho Oncology. The data on this page is also based on data sources collected from public and open data sources on the Internet and other locations, as well as proprietary data we licensed from other companies. Sources of data may include, but are not limited to, the BLS, company filings, estimates based on those filings, H1B filings, and other public and private datasets. While we have made attempts to ensure that the information displayed are correct, Zippia is not responsible for any errors or omissions or for the results obtained from the use of this information. None of the information on this page has been provided or approved by Taiho Oncology. The data presented on this page does not represent the view of Taiho Oncology and its employees or that of Zippia.
Taiho Oncology may also be known as or be related to Taiho Oncology, Taiho Oncology Inc and Taiho Oncology, Inc.