Chartiers Center Remote jobs - 134 jobs

The Future Talent Program features Cooperative (Co-op) education that lasts up to 6 months and will include one or more projects. These opportunities in our Manufacturing & Supply Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The co-op assignment will support our Manufacturing Division's Packaging Technology Community's three unique groups. These groups serve as our company's central packaging Centers of Excellence with global responsibility for packaging related activities. The position is based in West Point, PA (a suburb of Philadelphia). The candidate selected will have opportunities to gain hands-on experience in a wide variety of areas within pharmaceutical packaging. Examples include: Primary and secondary packaging development and testing for solid oral dose, sterile and medical device products Packaging equipment development and qualification Packaging processes and controls Bulk packaging development and testing Distribution packaging development and testing Thermal packaging development and testing Packaging related documentation and regulations Customer focus and usability testing These activities will provide the co-op with exposure to other departments, cross functional teams, suppliers, etc. Travel to company and contract packaging sites, equipment and component manufacturers and/or testing facilities is expected as part of the hands-on experience. Required Education and Experience: Candidate must be currently pursuing degree in Packaging Science, Packaging Engineering, Mechanical Engineering, or related discipline Candidate must be currently enrolled in an academic program and returning to university following this co-op assignment to complete credit requirements for graduation Candidate must be available for full-time employment for a period of 6 months in Jan-Jun 2027 Preferred Experience and Skills: Candidate should have strong project management, problem solving, organizational, technical writing and communication skills Candidate should have a GPA of 3.0 or higher Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company. Salary range: The salary range for this role is $39,600.00-$105,500.00 USD Required Skills: Accountability, Accountability, Clinical Research, Cloud Data Catalog, Communication, Data Analysis, Database Management, Data Science, Data Security, Data Visualization, Data Wrangling, Detail-Oriented, Event Planning, Key Performance Indicators (KPI), Mechanical Engineering, Mechatronics, Medical Device Management, Microsoft Office, Packaging Engineering, Packaging Management, Packaging Optimization, Packaging Processes, Packaging Research, Pharmaceutical Packaging, Product Packaging Design {+ 5 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”. 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: Intern/Co-op (Fixed Term) Relocation: Domestic VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 05/8/2026 *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.

Primary Responsibilities: Asset Lifecycle Management - Contact for capital purchase and disposition submission process, coordinate submissions, coordinate logistics for cost center trade-ins exception, work with Capital Asset Stewards, DPTM teams, Safety, facilities, procurement, and external vendors Asset Inventory Management - Managing continuous GXP asset metrology calibrations and their respective due dates, collaborating with facilities and GXP Quality partners to manage compliance expectations, manage asset inventory in database. Experience with use of SAP and ProCal systems preferred Alarm monitoring and communication for DPTM assets, cascading 24/7 alarm notifications of GXP assets to respective scientists/departments, as well as, recording deviation from SOP events in environmental logs Project management for laboratory design planning & execution of facility projects through to construction & lab occupancy, participate in capacity planning and occupancy management- manage or support office/laboratory moves, support and update occupancy on a quarterly basis Oversight of monthly analyses of collected water samples performed by an external vendor. Duties to support include scheduling and managing partner performing the work, review and sign-off of the analyses and use of data system for archiving results. Experience in REDS/MEDS platforms Document and review business continuity plan activities including coordination with functional groups to support overall plan process to ensure readiness. Relationship management across DPTM stakeholders, procurement, and vendor partners Support and facilitate capital equipment life-cycle processes within our company's financial and capital systems including on-boarding, maintenance & repair, and disposition (relocation, scrap, donation) including participation in the Management of Change process Develop and update Standard Operating Procedures as needed for GXP regulatory compliance May support or enable internal/external visits and tours including acting as point of contact Responsibilities associated with our chemical management systems, to ensure reliability for researchers and drive compliance for on-site chemical and lab reagent tracking and reconciliation Enter, follow-up, facilitate, or escalate laboratory instrument and facility work orders and progress as needed. Coordinate planned facility system downtime with our support partners and communicate back for impact and awareness Serve as a local stockroom champion to coordinate and partner with procurement representatives Participate in site emergency drills, ensure coordinators are trained Work collaboratively with the other Operations Leads across the network to identify opportunities for efficiency and share best practices Support strategic DPTM initiatives/projects, e.g. common equipment replacement strategies, asset inventories, cold storage inventory optimization, consumables, etc. Participate in all environmental health and safety efforts and complete trainings, safety inspections and action item follow up Education Requirements: A Bachelor's Degree in Engineering, Sciences or a related discipline and relevant laboratory experience. Required Experience and Skills: Demonstrated knowledge of drug discovery research. A minimum of 2-3 years of experience in a pharmaceutical / biotechnology industry. In-depth understanding of our company's internal drug discovery processes and network. Knowledge of laboratory processes, layouts and equipment requirements. Highly dedicated and motivated individual capable of problem-solving and delivering on goals and objectives in a timely fashion in a scientific business model setting. Strong project management skills; able to work efficiently with colleagues across. geographical areas via remote communication means, e.g. teleconference, video. Have a strong mindset in operational excellence, able to develop plans which translate strategic objectives into executable actions and results and deliver on objectives. Preferred Experience and Skills: In-depth understanding of our company's internal drug discovery processes and network. Required Skills: Benchmarking, Business Continuity, Business Process Analysis, Business Process Improvements, Business Requirements Management, Data Analysis, Data Archiving, Emergency Training, Environmental Health And Safety, Information Technology Applications, Interpersonal Relationships, Inventory Management, Inventory Optimization, Maintenance Processes, Management Process, Manufacturing Automation, Operational Quality, Problem Solving, Project Management, Quality Control Management 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 $87,300.00 - $137,400.00 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: Not Indicated Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 02/4/2026 *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.

The Publication Specialist will work closely primarily with Medical Writers, but also Publications Managers and Medical Communications Agencies as appropriate, to facilitate the publication process to meet frequent submission deadlines for scientific publications/presentations generated or managed by the Scientific Communications and Information Sciences (SCIS) group. Primary Activities With minimal supervision, facilitate handling various steps of the publication process, to meet timelines, including researching/applying journal and congress formatting and submission requirements, referencing, formatting, copyediting, proofing of galleys and submissions of documents (manuscripts, abstracts and presentations/posters). Ensure that documents and archives comply with established company standards, Good Publication Practice, and CONSORT guidelines. Ensure that author affiliations, disclosures and acknowledgements are in place and correct. May interact with internal and external investigators/authors for the collection of required forms. With supervision, and in collaboration with the company's Creative Services department as appropriate, manage the design and production of data displays (tables and illustrations), posters and slides for scientific meetings. With supervision and approval by authors and writers, obtain and accurately cite references as required. Ensure that publication/presentation tracking information and documentation in iEnvision is up to date and compliant with company standards. Requirements BS (or BA plus experience in a scientific discipline or clinical research) required. Minimum 2 years' experience in a medical communications, preclinical or clinical research environment. Ability to manage multiple projects with competing timelines. Proficiency in MS Word, Power Point and Excel and publication management and clearance software applications; strong copyediting and proofreading skills essential. Ability to work and communicate effectively in a matrix environment. Required Skills: Budget Development, Budget Development, Clinical Research, Clinical Trial Management, Clinical Trials, Conceptual Abilities, Content Management, Content Management Systems (CMS), Feasibility Studies, Health Sciences Research, Independent Research, Information Management, Management Process, Medical Communications, Medical Content Writing, Medical Research, Microsoft PowerPoint, Multi-Management, Performance Monitoring, Project Management, Regulatory Compliance, Scientific Communications, Scientific Research, Scripting Languages, Status Reporting {+ 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 $87,300.00 - $137,400.00 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: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No Job Posting End Date: 01/24/2026 *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.

The Lead Clinical Site Ambassador is accountable for the strategic and operational oversight of investigational site management and monitoring activities across assigned clinical studies or programs. This role ensures that clinical trials are executed with high quality, regulatory compliance, and operational efficiency, in alignment with global clinical development strategies. Operating within a matrix environment, this role partners with internal stakeholders and external service providers to develop and implement study-specific oversight plans, monitor site performance, and proactively identify and mitigate risks. The role is pivotal in maintaining sponsor oversight, validating the effectiveness of study and site-level activities, and ensuring that monitoring plans and tools adequately address protocol-specific risks. This role plays a pivotal role in building and managing meaningful productive relationships with KOLs and key investigator sites and is eligible for remote consideration. **Clinical Oversight & Compliance** - Responsible for operational oversight of the site, site health and monitoring activities - Support QA audit and inspection planning, and implementation of CAPAs as needed - Identify and proactively mitigate site-level risks impacting recruitment, retention, data quality, or compliance, in partnership with CROs. **Study Delivery Support** - Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts - Support sites in understanding study expectations, timelines, and required deliverables - Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets in collaboration with CROs - Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators/CROs **Site Relationship & Engagement** - Build and maintain strong, trusted relationships with investigators and site staff - Face of CSL - Serve as the sponsor primary point of contacted for assigned studies - Understand site capabilities, constraints, and strategic priorities to improve site engagement and long-term collaboration - This role will require travel to Investigator Meetings, Investigator sites and CROs. Anticipated travel >50%. **Continuous Improvement & Site Experience** - Collect feedback from sites and advocate for process simplification and burden reduction internally - Identify opportunities to improve study materials, and operational processes - Represent the "voice of the site" in cross-functional discussions and initiatives **Feasibility & Site Selection** - Provide local site intelligence to feasibility teams - Support site development **Qualifications and Experience Required:** At minimum, bachelor's degree or equivalent in life science, nursing, pharmacy, medical laboratory technology, or other health/medical related area preferred. (Other degrees and certifications considered if commensurate with related clinical research experience (e.g., diploma or associate degree RN, certified medical technologist). - A minimum of 10 years' relevant clinical research (or related) experience within the pharmaceutical industry. - Previous experience in leading and managing a team of professional staff. - A solid understanding of the drug development process, and specifically, each step within the clinical trial process. - Experience in site management and monitoring and overseeing large and/or complex global clinical trials. - Robust budget forecasting and management experience. - Thorough knowledge of ICH guidelines/GCP and its applicability to all stages of the clinical development process **Competencies** - Demonstrated ability to lead teams and work in a fast-paced team environment. - Experienced in working within a Matrix Environment and ability to work through interpersonal difficulties and resolve conflicts with a Matrix Environment - Successfully demonstrated the ability to mentor and coach others through peer-to-peer interactions and to develop reporting personnel to grow in complex clinical project management capabilities. - Ability to evaluate, judge and make decisions regarding staff. Ability to teach/coaching and setting an example of 'best practice'. - Excellent interpersonal and decision-making skills. - Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives. - Skilled at independently navigating new or novel indications, study/program approaches, and unique challenges. - Excellent understanding of all tasks involved in a clinical development program(s) from developing a protocol through to finalizing a clinical study report. - Ability to plan and ensure execution and completion of clinical program(s) to the highest ethical and scientific standards. - Extensive and comprehensive knowledge of ICH guidelines/ GCP, Maintains current medical/scientific/regulatory knowledge. - Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills. - Demonstrated ability to problem solve and use clear judgment in relation to interactions with external parties, timelines, and complex clinical programs. - Excellent written and oral communication skills and maintains computer literacy in appropriate software. **_T_** **_h_** **_e expected base salary range for this position at hiring is $131,000 - $164,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity._** **About CSL Behring** CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ************************** . **Our Benefits** For more information on CSL benefits visit How CSL Supports Your Well-being | CSL (********************careers/your-well-being) . **You Belong at CSL** At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging **Equal Opportunity Employer** CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement . R-269555 CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. ************************************************

Our Digital Manufacturing Operations Team supporting our vibrant West Point site is seeking a Process Automation Engineer Specialist to join their Team. This role will provide automation system support and expertise to enable our manufacturing division in the reliable and compliant supply of quality vaccine products to customers and patients across the globe. Responsible for problem resolution, implementation of process control, data collection techniques, and troubleshooting in compliance with SDLC, GMP, safety, and environmental regulations. Actively support, participate and embrace a diverse and inclusive culture including significant interaction with manufacturing, quality and engineering groups. Supports a broad spectrum of automated systems within GMP Manufacturing Operations. General responsibilities include: Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion Comply with Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Provide automation system support and expertise to assist the manufacture of quality vaccine products to meet site priorities. Responsible and accountable for supporting all automation system components of the processes including on the shop floor support of manufacturing activities Responsible for designing, implementing, testing, and closing-out change controls for automation related corrective actions and continuous improvement initiatives. Build relationships with functional counterparts and stakeholders in the business to proactively. identify and resolve technical issues. Lead or participate in investigations of automation incidents and problems to prevent recurrence including the development and implementation of corrective actions. Stay current with latest automation technologies and trends and make recommendations for adoption Provide off-site weekend/evening automation phone or on-site support for our 24/7 manufacturing operations. Skill Requirements: Strong communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment Preferred Skills: Experience in GMP Manufacturing - pharmaceutical/ biotechnology industry. Familiarly with Computer system validation and regulatory GXP requirements. Aseptic processing/sterile manufacturing experience. Technical and operational expertise in the DeltaV DCS, Allen-Bradley PLC, SCADA, HMI ASi/Field/Profibus or other related technologies. Networking, Virtual Machines, Database management and other general IT administration. Experience with data analytics tools (e.g. Spotfire, PowerBI) Education Requirements: BS in Engineering, Computer Science or related field with 2 years of experience (GMP Manufacturing and/or Manufacturing Automation) Or High School Diploma and with 4 years of experience (GMP Manufacturing and/or Manufacturing Automation) #MSJR VETJOBS Required Skills: cGMP Regulations, Communication, Data Collection Methods, Data Management, Digital Manufacturing, Environmental Regulations, GMP Compliance, Good Manufacturing Practices (GMP), Problem Management, Process Control, Real-Time Programming, Software Development Life Cycle (SDLC), Technical Issues, Test Automation, TIBCO Spotfire 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 $85,600.00 - $134,800.00 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: Domestic VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): N/A Job Posting End Date: 01/26/2026 *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.

Purpose: The Supervisor, Care Navigators (CNs) is a registered nurse responsible for leading, developing, and overseeing a team of telehealth nursing professionals who provide education, adherence support, and patient navigation for patients with rare and complex diseases. This role ensures exceptional service delivery, patient experience, clinical quality, and program compliance while supporting continuous improvement across operational workflows. The Supervisor provides day-to-day coaching, performance oversight, training reinforcement, and escalation support, ensuring all CN activities align with program business rules, regulatory standards, and nursing best practices. This leader collaborates closely with internal teams, healthcare professionals, infusion sites of care, specialty pharmacies, payers, and manufacturer partners to optimize patient experience, streamline processes, improve adherence, and drive program success. Team Leadership & Development Supervise, mentor, and develop a team of Nurse Care Navigators, providing regular coaching, performance feedback, and professional development opportunities. Ensure consistent delivery of clinically accurate, empathetic, and patient-centered telehealth support. Conduct regular quality monitoring of clinical interactions, patient assessments, documentation, adherence coaching, and use of motivational interviewing. Lead team huddles, clinical refreshers, and ongoing training to reinforce disease state expertise, product knowledge, and program requirements, approved updates, and revisions. Support team members in managing complex patient cases, therapy onboarding challenges, and escalated clinical or psychosocial concerns. Foster a collaborative, accountable, and patient-first culture aligned with nursing standards, service excellence, and RareMed core values. Operational Oversight & Program Management Ensure the CN team executes all program deliverables, business rules, KPIs, and regulatory requirements. Monitor daily staffing, call volumes, case distribution, and workload balancing to maintain high efficiency and service levels. Oversee CN documentation accuracy, timeliness, and compliance with HIPAA, quality standards, and reporting requirements. Track team performance trends (e.g., adherence calls, follow-up completion, education completions, quality scores) and implement improvement plans as needed. Assist in creating or updating program SOPs, training materials, job aids, and process documentation to support consistent, high-quality execution. Collaborate with internal/external leadership to streamline workflows and enhance clinical operational efficiency and the patient journey. Clinical Excellence, Telehealth Support & Safety Management Maintain clinical knowledge of disease states, therapies, dosing administration, side-effect management, and monitoring requirements, as required by the program business rules. Support team in applying motivational interviewing, behavioral coaching, and adherence reinforcement strategies. Provide expert guidance on evaluating patient needs, clinical risks, and adherence barriers. Works collaboratively with infusion healthcare facilities and providers to integrate Care Navigator services for successful patient care coordination and follow up per HUB protocols. Ensure proper escalation and reporting of adverse events, product complaints, and safety concerns according to program policy. Support CNs in coordinating lab monitoring, specialty distribution, infusion logistics, and other aspects of the patient journey. Function as a subject matter expert (SME) for internal stakeholders and manufacturer partners. Stakeholder Collaboration Act as a liaison between CN teams and cross-functional partners, including HCP offices, specialty pharmacies, infusion centers, payers, and manufacturer clients. Address escalated patient, provider, or client concerns with professionalism, clinical expertise, and urgency. Contribute to client meetings, cross-functional discussions, business reviews, and launch readiness activities. Support system enhancements, process rollouts, and change-management initiatives. Continuous Improvement & Quality Assurance Analyze team performance trends, patient feedback, and workflow bottlenecks to identify improvement opportunities. Lead initiatives to enhance patient adherence, onboarding efficiency, satisfaction, and clinical support effectiveness. Implement performance improvement / corrective action plans to address quality gaps, compliance issues, or training needs. Support audit readiness and participate in internal/external audits to ensure adherence to all operational, clinical, and regulatory standards. Required Qualifications Active, unrestricted RN license; Bachelor of Science in Nursing required. 3-5+ years of clinical nursing experience, including at least 2 years in a leadership, mentorship, quality oversight, or team-lead capacity. Experience in telehealth, specialty pharmacy, case management, and/or adherence support, or patient-services/HUB operations. Strong verbal and written communication skills with the ability to guide both clinical staff and external stakeholders. Proven ability to inspire, coach, develop, and lead high performing clinical team members while maintaining accountability. Proficiency with Microsoft Office (Word, Excel, Outlook) and comfort navigating multiple systems simultaneously. Strong prioritization, critical thinking, and time-management skills in a fast-paced, evolving healthcare environment. Demonstrated commitment to documentation accuracy, regulatory compliance, and patient privacy standards. Working knowledge of third-party reimbursement, foundation support pathways, copay/affordability programs, and specialty drug access challenges. Preferred Qualifications Supervisory, team-lead, or quality-review experience within a HUB, patient-services, or specialty-therapy support program. Experience developing training content, coaching on motivational interviewing, or facilitating clinical skill-building training sessions. Advanced presentation and communication skills for client facing quality business reviews and leadership interactions. Clinical experience in infusion and/or rheumatology a plus. Work Environment RareMed offers a hybrid work structure, combining remote work and in-office requirements. The frequency of onsite requirements will vary depending on role, operational needs, meetings, client visits, or team collaboration activities. Employees must be within commuting distance to Pittsburgh, PA, and able to report to the office when needed. We will provide advance notice when possible. This role routinely involves standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. When telecommuting, employees must have reliable internet access to utilize required systems and software required for the position's responsibilities. The amount of time the employee is expected to work per day or pay period will not change while working from home. Employees are responsible for the set-up of their home office environment, including physical set-up, internet connection, phone line, electricity, lighting, comfortable temperature, furniture, etc. Employee's teleworking space should be separate and distinct from their “home space” and allow for privacy. Physical Demands While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands and fingers, handle or feel; and reach with hands and arms. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential function of the job.

The Packaging Commercialization department has an exciting opportunity for an Associate Specialist Packaging Engineer at either the Rahway, NJ or West Point, PA site. This candidate will serve as an individual contributor and foster our department mission to (1) design and develop responsible and accessible commercial packaging solutions with strong science, risk-based thinking, and focus on the customer while (2) striking the balance of being innovative and flexible to meet the evolving pipeline, while also continuously improving and standardizing our packaging solutions. Position Description: The successful candidate will have the opportunity to focus on package development for a range of traditional pharmaceuticals (oral solid dosage, oral powders, suspensions, sterile injectables, and inhaled formulations) and biopharmaceutical applications (vaccines, monoclonal antibodies, and antibody drug conjugates) as well as provide input to primary packaging for the drug component and secondary packaging of medical device and combination products. Through support of the Packaging Working Groups, the successful candidate will collaborate on diverse, cross-functional teams with peers in drug product formulation and analytical development as well as supply chain and marketing to provide technical guidance during the development of primary, secondary and tertiary packaging for new products and specialty devices. Packaging Responsibilities: Providing input regarding selection of primary packaging material Determination of package images to support commercialization as well as leading the shipping distribution strategy and coordination of shipping distribution studies efforts regarding characterization and qualification testing of robust packaging systems The successful candidate will author packaging specifications for primary, secondary and tertiary packaging as well as provide information to support relevant sections of BLA's, NDA's, WMA's, and JNDA's The successful candidate will interface with our internal Global Packaging Technology Operations and Packaging Site Operations teams, as well as external Contract Manufacturing Operations and packaging component suppliers while fulfilling their responsibilities Education Minimum Requirement: The successful candidate will have a completed a B.S. or higher degree in Packaging Engineering, Packaging Science, Biomedical Engineering, Chemical Engineering, Materials Science, or Pharmaceutical Science Required Experience and Skills: Understanding of package development process and engineering principles Demonstrated experience in building collaborative partnerships Excellent verbal and written communication skills Ability to make rapid, disciplined decisions Preferred Experience and Skills: Experience in new product pharmaceutical and/or biopharmaceutical development packaging Strong scientific and risk-based thinking Strong organizational skills and demonstrated ability to deliver on timelines Required Skills: Accountability, Accountability, Animal Vaccination, Antibody Drug Conjugates (ADC), Applied Mathematics, Biopharmaceuticals, Cold Chain Management, Communication, Engineering Standards, Global Health, Healthcare Innovation, Maintenance Supervision, Management Process, Manufacturing Quality Control, Manufacturing Scale-Up, Materials Science, Monoclonal Antibodies, Packaging Engineering, Packaging Equipment, Packaging Innovation, Packaging Science, Packaging Testing, Polyclonal Antibody Production, Quality Leadership, Retail Packaging {+ 3 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 $71,900.00 - $113,200.00 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: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 01/29/2026 *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.

The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve. Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients. **Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading global studies in a variety of therapeutics including Oncology (Hematology), Respiratory / General Medicine and Obesity/Endocrine** Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director, and Project Director. To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills. \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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.

Build your best future with the Johnson Controls team! As a global leader in smart, healthy and sustainable buildings, our mission is to reimagine the performance of buildings to serve people, places and the planet. Join a winning team that enables you to build your best future! Our teams are uniquely positioned to support a multitude of industries across the globe. You will have the opportunity to develop yourself through meaningful work projects and learning opportunities. We strive to provide our employees with an experience, focused on supporting their physical, financial, and emotional wellbeing. Become a member of the Johnson Controls family and thrive in an empowering company culture where your voice and ideas will be heard - your next great opportunity is just a few clicks away! What we offer Competitive salary Paid vacation/holidays/sick time- 15 days of vacation first year Comprehensive benefits package including 401K, medical, dental, and vision care - Available day one! Encouraging and collaborative team environment Dedication to safety through our Zero Harm policy What you will do Johnson Controls is hiring! Our Product Technical Support Engineer provides technical support to the Field Sales & Service organization, as well as our Data Center Accounts, in a consistent manner across all product offerings based out of our New Freedom, PA, location. This role can be remote for the right person! How you will do it Provide day-to-day technical support for key Data Center Accounts to Field Sales & Service organization on a global basis via site visit, phone, fax, or email. Drive product reliability through the Continuous Improvement Process for both existing products and new products being introduced. Product Technical Support Engineer provides technical support and interacts with quality management and engineering to improve overall life cycle cost. The specialist should be able to create test plans to prove out new and or existing product equipment offerings. Maintains effectiveness when experiencing changes in work responsibilities or environment (e.g., people, processes, structure, or culture); adjusts effectively to change by exploring the benefits, tries new approaches, and collaborates with others to make the change successful. Creates novel solutions with measurable value for existing and potential customers (internal or external); experiments with new ways to solve work problems and seize opportunities that result in unique and differentiated solutions; promotes the involvement co-workers in solving problems that directly impact what people do; leveraging technology to effectively address problems and capitalize on opportunities. Places a high priority on the internal or external customer's perspective when making decisions and acting; implementing service practices that meet the customers' and own organization's needs. Ensures others contribute to organization strategies and driving operational discipline, role clarity and performance transparency by focusing them on the most critical priorities, measures progress, and ensures accountability against those metrics to allow us to act like One Team; sets, documents, and communicates clear work standards to improve performance - “the fundamentals”; making our results widely available and easily accessible. Identifies and understands problems and opportunities by gathering, analyzing, and interpreting quantitative and qualitative information; chooses the best course of action by establishing clear decision criteria, generates and evaluates alternatives, and making timely decisions; taking action that is consistent with available facts and constraints and optimizes probable consequences. What we look for Required Up to 10% must be able to travel both domestic and internationally. Bachelor's degree in Engineering or a related Technical/Scientific field required and 2+ years' experience or if no degree, 6+ years of technical experience with a knowledge of HVAC&R products. Analyze and solve complex product system problems. Proficiency in Microsoft Suite Applications (Word, Excel, Access, and PowerPoint) as well as Internet software and E-mail. Proficient in troubleshooting the refrigeration cycle as applied to air-conditioning duty on Applied Equipment. HIRING SALARY RANGE: $80,000 - $110,000 (Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, location and alignment with market data.) This position includes a competitive benefits package. For details, please visit the About Us tab on the Johnson Controls Careers site at ***************************************** Johnson Controls International plc. is an equal employment opportunity and affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, genetic information, sexual orientation, gender identity, status as a qualified individual with a disability or any other characteristic protected by law. To view more information about your equal opportunity and non-discrimination rights as a candidate, visit EEO is the Law. If you are an individual with a disability and you require an accommodation during the application process, please visit here.

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: Career Programs Job Sub Function: Non-LDP Intern/Co-Op Job Category: Career Program All Job Posting Locations: Cambridge, Massachusetts, United States of America, La Jolla, California, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America Job Description: Johnson & Johnson Innovative Medicine is recruiting for multiple Clinical Pharmacology and Pharmacometrics summer interns at its US (Spring House PA, Raritan NJ, Titusville NJ, Cambridge MA and La Jolla CA) sites. Clinical Pharmacology and Pharmacometrics (CPP) is an integrated part of the Global Development organization within Johnson & Johnson Innovative Medicine. Members of CPP work in cross-disciplinary compound development teams and apply Clinical Pharmacology principles and pharmacometrics methodologies across the R&D portfolio to enable optimal decision-making in drug development. The CPP Summer Internship Program provides a unique opportunity for students passionate about drug development to collaborate with clinical pharmacologists and pharmacometricians and gain hands-on experience in CPP principles, including pharmacokinetics/pharmacodynamics (PK/PD), translational modeling, and model-informed drug development (MIDD) within a dynamic pharmaceutical R&D environment. Our teams leverage students' academic backgrounds while fostering their professional development, providing firsthand experience in drug development and an opportunity to evaluate the student's potential for future employment. CPP summer interns will contribute to diverse Research and Development efforts spanning preclinical to early- and late-stage clinical development, through activities such as: * Clinical Pharmacology and Medical literature review * Data analysis of PK, biomarker, preclinical and/or clinical data, trial design, etc. * PK and PD model-building and analyses * Development of computer programs or state-of-the-art quantitative methodologies (e.g., population PK/PD, quantitative systems pharmacology [QSP]) * Model based meta-analysis (MBMA), advanced data visualization (e.g., RShiny), and machine learning applications integrating publicly reported and in-house data * Therapeutic areas of immunology, oncology, neuroscience, cardiopulmonary and metabolic diseases Qualifications * Candidates must be enrolled in an accredited college or university (not necessarily taking classes) pursuing a MS, PharmD, PhD, MD or similar degree in a life sciences-related discipline such as Pharmacology, Pharmacometrics, Pharmaceutical Sciences, Molecular or Computational biology, Biophysics, Biostatistics, Mathematics, Engineering, or Medicine. * Candidates should demonstrate computational proficiency, including experience with data analysis, modeling, and simulation tools such as NONMEM, Phoenix WinNonlin, Monolix, R, Python, or MATLAB. * Candidates must be available to work full-time for at least 12 weeks between May - September 2026. * Candidates must be detail-oriented, highly organized, and capable of managing multiple tasks efficiently. * Candidates must have strong communication and presentation skills. * Candidates must have the ability to work independently as well as collaboratively within a team. * Candidates must be eligible to work in the US for the entirety of their internship period and will be required to provide proof of work authorization. Remote work flexibility may be available. Housing stipend will be available. Permanently authorized to work in the U.S., must 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 requires 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. 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: The anticipated base pay range for this position is : $23.00/hr to $51.50/hr Additional Description for Pay Transparency: The expected pay range for this position is between $23.00 per hour and $51.50 per hour but will be based on candidate's program year, discipline, degree and/or experience. Co-Ops/Interns are eligible to participate in Company sponsored employee medical benefits in accordance with the terms of the plan. Co-Ops and Interns are eligible for the following sick time benefits: up to 40 hours per calendar year; for employees who reside in the State of Washington, up to 56 hours per calendar year. Co-Ops and Interns are eligible to participate in the Company's consolidated retirement plan (pension). For additional general information on Company benefits, please go to: ********************************************* This job posting is anticipated to close on 09/11/2026. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications.

Appeals Pharmacist - Ensure Fair Medication Access for Patients A confidential managed care organization is seeking an experienced Appeals Pharmacist to review, evaluate, and process medication coverage appeals. This role is ideal for pharmacists who want to leverage their clinical knowledge and critical thinking skills to advocate for patients and ensure fair, evidence-based decisions. Key Responsibilities Review clinical documentation for medication coverage appeals and grievances. Apply evidence-based guidelines, plan policies, and regulatory requirements to determine outcomes. Prepare written clinical rationales to support appeal determinations. Collaborate with physicians, nurses, and medical directors during case reviews. Track, document, and report appeal outcomes in compliance with state and federal regulations. Support process improvements to enhance timeliness and quality of appeal decisions. What You'll Bring Education: Doctor of Pharmacy (PharmD) or Bachelor of Pharmacy degree. Licensure: Active and unrestricted pharmacist license in the U.S. Experience: Prior managed care or utilization management experience preferred - retail and hospital pharmacists with strong clinical and documentation skills are encouraged to apply. Skills: Excellent clinical judgment, written communication, and attention to regulatory detail. Why This Role? Impact: Play a critical role in ensuring patients get fair access to necessary medications. Growth: Gain expertise in appeals, utilization management, and managed care pharmacy. Flexibility: Many roles offer hybrid or fully remote options. Rewards: Competitive salary, comprehensive benefits, and opportunities for advancement. About Us We are a confidential healthcare partner working with health plans and managed care organizations nationwide. Our appeals pharmacists safeguard patient access while ensuring compliance with all regulatory standards. Apply Today Join our team as an Appeals Pharmacist and help ensure every patient receives a fair review of their medication needs.

The West Point Technical Operations organization is seeking a highly motivated individual for a Specialist - Engineering position within the Building 12 Varicella Bulk team. The successful candidate will have the opportunity to contribute to the performance and results of the manufacturing area by providing technical guidance and anticipating customer needs to identify and implement solutions. The Specialist, Technical Operations is responsible for technical support for vaccine manufacturing unit operations while actively supporting, participating in, and embracing an empowered team culture. In this role, the Specialist will work as an individual contributor as well as a team within a cross-functional group that includes Operations, Quality, Automation, Maintenance and others. This role is specifically focused on process data analytics. Additional responsibilities include: Provides technical support for Varicella bulk manufacturing at our West Point site to align with department, site, and franchise objectives. Provides on-the-floor support for complex operational and technical (process/equipment) issues. Owns, maintains and continuously improves data analytics and data visualization tools to support robust proactive process analytics (PPA). Provides ad-hoc data analysis to support IPT priorities. Owns and leads the PPA Tier process. Engaged with data analytics centers of excellence and supports the development of data literacy within the organization. Leads or works as a team member on projects to improve the performance of our processes, including complex investigations, corrective/preventative actions (CAPAs) and equipment validation/qualification. Develops and authors technical and manufacturing documents for investigations, process design/definition/qualification/validation, change control, annual product reviews, standard operating procedures (SOPs), batch records, and preventative maintenance. Monitors the health of the process through continuous process monitoring, communicating observations proactively to stakeholders. Prepare documentation to support regulatory submission and participate in regulatory inspection activities for the facility. Applies a continuous learning mindset to maintain a high level of technical process and system knowledge, enabling success with core responsibilities. Manages project work to ensure due dates are met, escalating when necessary and developing remediation plans. Assures consistent application of standardized work, engineering and process tools. Promotes open communications and teamwork. Effectively collaborates with cross-functional peers. Supports safety, environmental, and compliance initiatives. Examine issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve manufacturing challenges. Education Minimum Requirement: B.S. degree in Engineering or Sciences. Minimum 2 years post-bachelor's degree experience in GMP manufacturing and/or technical support of GMP manufacturing operations Required Experience and Skills: Strong problem-solving skills. Developed communication, leadership and teamwork skills. Ability to manage projects/work to ensure timely completion. Preferred Experience and Skills: Experience with multiple data management tools (e.g. Spotfire, PowerBI, Dataiku, Seeq, Datalynx, MANTIS, PI Systems, JMP) Familiarity with different statistical analysis methods Experience in biologics, vaccine or bulk sterile manufacturing facilities. Understanding of sterile and aseptic processing #VetJobs #EBRG Required Skills: Adaptability, Change Control Management, Data Analysis, Data Literacy, Documentation Compliance, Engineering Processes, Equipment Troubleshooting, Factory Operations, GMP Compliance, Good Manufacturing Practices (GMP), Lean Manufacturing, Manufacturing Operations, Personal Initiative, Process Improvements, Process Optimization, Professional Integrity, Project Management, Root Cause Analysis (RCA), SAS JMP (Statistical Software), Technical Writing, Technology Transfer, Vaccine Manufacturing, Writing Technical Documents 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 $87,300.00 - $137,400.00 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: 10% Flexible Work Arrangements: Hybrid Shift: 1st - Day Valid Driving License: No Hazardous Material(s): Cleaning Supplies Job Posting End Date: 01/29/2026 *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.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. Job Description Eurofins Medical Device Services is seeking a highly experienced Senior Scientific Advisor with deep expertise in medical device microbiology and sterilization technologies (including ethylene oxide sterilization) to provide scientific leadership and strategic guidance for our testing services. This role is critical in supporting clients with complex regulatory and technical challenges, ensuring compliance with ISO 11737, ISO 11135, and related standards, and advancing Eurofins' position as a trusted partner in the medical device industry. As a senior technical advisor, you will collaborate with clients, internal teams, and regulatory bodies to design scientifically robust testing programs, interpret results, and deliver actionable insights. This position is ideal for professionals who combine advanced scientific knowledge with strong communication and advisory skills. Key Responsibilities: Serve as the subject matter expert in microbiology and sterilization services for medical devices, including EO sterilization and sterility assurance. Actively prospect, engage, and close new client relationships to drive top-line revenue growth and expand market share in the microbiological and sterilization testing space. Collaborate with Sales and Key Account Managers to position Eurofins' microbiology and sterilization services as a best-in-class solution, improving quote-to-win ratios. Lead the development of technical scopes of work and respond to RFQs/RFPs with compelling, scientifically robust proposals. Provide strategic insights to business development and operations leadership to ensure alignment of service offerings with market demands. Represent Eurofins at conferences, trade shows, and industry events to enhance visibility and establish thought leadership. Facilitate seamless handoffs to project management and operations teams, ensuring successful project execution and client satisfaction. Monitor the competitive landscape and market trends to support pricing strategy and service differentiation. Travel 30-50% to meet with clients, attend events, and support on-site collaboration with Eurofins teams. Qualifications Bachelor's degree in Microbiology or a related field is required; advanced degree is strongly preferred. Minimum 7+ years of experience in microbiology ad sterilization within a CRO or medical device environment. In-depth knowledge of the AAMI, ISO, FDA and international regulatory requirements. Strong analytical and problem-solving skills with the ability to interpret complex data sets. Excellent verbal and written communication skills; ability to present technical concepts clearly to diverse audiences. Collaborative mindset with proven ability to influence and guide cross-functional teams. Authorized to work in the U.S. without restriction or sponsorship. Additional Information Full-time, Monday-Friday, 8 a.m.-5 p.m. (flexibility required). Remote position with preference for candidates near a major airport for travel to client sites and industry events. What we offer: Excellent full time benefits including comprehensive medical coverage, dental, and vision options Life and disability insurance 401(k) with company match Paid vacation and holidays Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

The Opportunity: CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. We are looking for a Associate Director, Case Management Intake & Submissions to join our R&D team. Under Case Intake, you will be responsible for the oversight of the Global Adverse Events Inbox, and all other Intake sources within CSL. You will also be responsible for ensuring accurate and timely entry of reports into the global safety database by the vendor. Under Case Submissions, you will be responsible for providing accurate implementation of global electronic ICSR reporting with Regulators, Partners or internal customers. Additionally, you will proactively monitor successful reporting and resolve submission failures to minimize impact to regulatory compliance. The Case Submission aspect of the function has a high business impact as reporting compliance is potentially affected and will require ability to analyze varied regulatory sources and engage readily with diverse stakeholders and Regulatory Authorities. You will lead a team responsible for continuous analysis of global documents and regulatory intelligence from interface functions to decide on relevant updates to regulatory and business reporting requirements. This is a hybrid role, which offers a combination of an onsite and remote work schedule. #LI-hybrid The Role: Reporting to the Sr. Director, Global Case Management, you will: Oversee intake and triage of all incoming safety data (spontaneous, literature, partner reports). Monitor outbound submissions to regulators, affiliates, and partners, including E2B tracking and acknowledgments. Coordinate follow-up activities, ensuring timely and appropriate vendor queries and responses. Provide oversight to ensure global reporting compliance with country specific Regulatory and Business requirements related to expedited adverse event reporting. Regularly analyze complex regulatory intelligence underpinning reporting requirements. Completion of impact review within defined timelines and closely collaborate with WAVES team, IT and interface functions to ensure accurate and timely changes to expedited reporting requirements are adequately implemented to meet regulatory obligations. Continuous monitoring and supporting improvements on electronic submission of Individual Case Safety Reports (ICSRs): · Daily Monitoring of reporting and reportability of processed cases in Argus Safety database. Analyze underlying cause of missed reports and take timely action to minimize compliance impact. Liaise with Case Processing Lead and/or Case Management vendor to implement case corrections and training if required. · Close collaboration with WAVES team, IT, International Pharmacovigilance (IPV) & Capability Building and other interface functions to identify opportunities of process improvement. · Lead role in liaising with Health Authorities where applicable to resolve issues with E2B submission Review of interventional clinical trial studies and study specific reporting rules: · Review of study reporting plans and reporting responsibility matrix in close cooperation with GSPV Clinical Trial Liason, Risk Management, Clinical Operations and Clinical Research Organizations. Review the monthly notifications (Veeva) for study status including country approval status and update reporting requirements as required. Study setup of post marketing studies: Review relevant business documentation (ODCS notifications, IIS information, PVA, etc.) , submit and approve Study setup template, ensuring timely study implementation and negating any impact to case processing delay. Development and update of domain relevant training documents. Support upskilling of team members to empower accountability to respond to changing business needs. Lead initiatives to develop new processes or optimize current processes related to expedited reporting. Foster cross-business collaboration to respond to changing business needs. SME for Inspections and Audits related to database reporting rules and submission oversight. Implement corrective & preventive actions (CAPAs) as necessary. Support for database projects ensuring expedited reporting requirements are correctly addressed. Influence cross functions to align at enterprise level solutions. Your Skills and Abilities: BS/BA, RN, Pharmacist, or similar. Minimum of 10 years of Clinical Trial and Post-marketing Pharmacovigilance (PV) experience with 5 years of managerial/leadership experience. Global pharmacovigilance database knowledge is required along with proficient knowledge of global and local regulatory rules and regulations. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.

Job Description Choose your set schedule: Weekday Shifts: Work anytime from 9:00am to Midnight Eastern Time Weekend Shifts: Work anytime on Saturdays and Sundays from 9am to 8pm Eastern Time Minimum 8hrs of commitment requested. Ability to flex up and down depending on student volumes. Summer hours are available, but not required. About Us: At Mantra Health, we're dedicated to revolutionizing student mental health care. Partnering with a variety of universities and colleges across the country, our mission is clear: to provide universal access to high quality mental health services for students. Since our founding in 2018, we've built a comprehensive treatment service for young adults with various mental health conditions. We've raised over $34 million to work with students at universities and colleges across the country. We're particularly proud that nearly two-thirds of students with access to Mantra report that Mantra's program helped them stay in school. From comprehensive teletherapy to wellness coaching to tele-psychiatry, our diverse team is dedicated to ensuring that students not only survive but thrive. Join us in paving the way for a brighter, healthier future for students everywhere. What Our Clinicians Say About Working At Mantra Health: "Very supportive and informative administration team!" "They have a great EHR and the upper management seems very supportive" "Mantra's collaborative MDs are well trained to train others with respect. I am impressed by one of the most common goals in common among all staff is to promote mental health among students! Great model!" "Thank you for the summation. With 27 years in this field I've never had such a thorough coaching/supervision experience." Who We're Looking For: We are seeking an independently Licensed 1099 Therapist to provide virtual therapy to college students. This is a fully remote position within the US. We are eager to welcome candidates from diverse backgrounds who share our commitment to making mental health care accessible and affordable for students across the United States. We are actively seeking BIPOC therapists to join our team, as we believe diversity enriches our community and helps us provide more comprehensive and culturally sensitive care to our students. However, we welcome all qualified applicants to apply and contribute to our mission. Compensation: $82 per intake session completed (60-minute) $61 per follow-up session completed (45-minute) $30 for all no-show appointments $60 per hour for attending monthly therapy training and all hands meetings As a Mantra Licensed Therapist, You Will: Deliver high-quality, meaningful virtual therapy using evidence-based interventions such as Motivational Interviewing (MI), Cognitive Behavioral Therapy (CBT), and Dialectical Behavior Therapy (DBT) Utilize our advanced collaboration portal to connect with students, providing them with the support they need. Work closely with campus treatment providers, supervisors, and peers to ensure cohesive care. Maintain timely and precise records of all clinical interactions to ensure continuity of care. Partner with our support team to enhance overall student care, from initial outreach to resource provision. Collaborate with leadership during critical patient scenarios to ensure the best outcomes. Become an expert in our unique care model, enabling you to effectively support college students and continually refine your therapeutic skills. Who You Are: Hold an active independent clinical licensure (LCSW, LMFT, LPC, LMHC etc). Multi-state licensure is an added advantage as we operate in all 50 states. Ability to conduct thorough biopsychosocial intakes with clear diagnostic assessments. Skillfully combine conceptual insights with appropriate treatment plans. Adept at treating a diverse cohort of students with respect and understanding. Identify and manage escalating risk scenarios effectively. Equipped with a quality video camera and a stable internet connection to facilitate virtual therapy. Why Choose Mantra? Flexible Schedule: Set your own hours, and enjoy the benefits of 100% remote work. Growth Opportunities: Take advantage of our cross-licensing sponsorship to expand your professional credentials. Protected Practice: Benefit from company-sponsored malpractice insurance to ensure your practice is safeguarded. Collaborative Environment: Opt-in for clinical consultations and relish the support of our embedded administrative team. College Population: Work with highly motivated college students to make an impact during the most pivotal periods of their lives. If you have any questions, please feel free to email us at ***************************. Mantra health is an equal-opportunity employer. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Protect Your Information: Mantra Health has been made aware of fraudulent recruitment activities where individuals pose as our hiring team. Please note that all official communications will come from an @mantrahealth.com email address. Click here to learn more.

The Future Talent Program features internships that last up to 12 weeks and will include one or more projects. These opportunities in our Global Support Function Division can provide you with great development and a chance to see if we are the right company for your long-term goals. The Global Safety & Environment Intern will provide environmental, health, and safety (EHS) compliance and technical support to local site business partners related to compliance programs (i.e. General Occupational Safety, High-Risk Work, Industrial Hygiene, Ergonomics/Human Factors). Education Currently pursuing a Bachelors/ Master's Degree in Safety, Environmental Science, Engineering, Biotechnology, Chemistry, Biology or another technical program. Completed at least 2 years of college course work Able to work full time for a period of 9-12 weeks Critical thinking, communication, problem-solving and computer skills Ability to receive verbal or written direction and implement corresponding changes Ability to think critically about process inefficiencies and propose solutions Preferred qualifications: Prior internship or work experience in the Environmental, Health, and Safety field or in chemical manufacturing. Course work and/or experience in Ergonomics (assessing risk and implementing controls). Ability to convey ideas and explain decisions in a clear and concise manner. Ability to work in a small team Please note that this position may be closed before the posted end date or may remain open longer, at the discretion of the company. Salary range: The salary range for this role is $39,600.00-$105,500.00 USD FTP2026 GSF2026 Required Skills: 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”. 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: Intern/Co-op (Fixed Term) Relocation: No relocation VISA Sponsorship: No Travel Requirements: No Travel Required Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 03/6/2026 *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.

The Project Leadership function at Parexel is a critical part of driving success for our clients and advancing clinical research projects. As a part of the Global Project Leadership organization, your work has a direct impact on the projects, teams, and clients you work with, while helping deliver projects to the benefit of the patients we serve. Parexel's defined Biotech Division offers opportunities for seasoned Project Management professionals with a strong background running global clinical trials in a variety of therapeutics. This group focuses specifically on Biotech clients and providing all areas of support to accommodate their unique needs. This is a great opportunity for those in the industry who prefer the flexibility, creatively and problem-solving mindset to successfully support this type of clients. **Parexel has upcoming future opportunities at the Project Leader (PM) and Senior Project Leader (SPM) level for candidates with experience leading global studies in a variety of therapeutics including Oncology (Hematology), Respiratory / General Medicine and Obesity/Endocrine** Individuals selected for these roles will provide leadership to project teams and manage the day-to-day operations while striving to achieve operational excellence through on time delivery within budget and to the highest quality with the goal to exceed client expectations Successful candidates possess an undergraduate degree in a clinical or health related field: advanced degree preferred, along with at minimum, 2+ years' experience leading Global Clinal Trials in Project Management within a CRO (preferred), Biotech or Pharma company. These positions also require experience in project scheduling, managing resources and budgets and coordinating team activities, as well as experience with the full clinical development process through regulatory submissions. Additional years of experience will be required for the more senior roles of Senior Project Leader, Associate Project Director, and Project Director. To excel in this role, flexibility, problem solving capabilities and strategic vision are qualities that propel our Project Leadership team member's growth. In addition, you need to be detailed-oriented, computer proficient and possess superior interpersonal and organizational skills. \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

**Company: Parexel is hiring an FSP -** **Project Manager with Structured Content Authoring experience to work Remotely.** **Employment Type:** Full-time At Parexel, we are dedicated to improving patient lives through innovative clinical research and regulatory solutions. As a leading global clinical research organization (CRO), we partner with the world's most prominent biopharmaceutical companies to bring life-changing therapies to market. Our culture is built on collaboration, integrity, and a shared commitment to excellence-where your expertise can make a real impact on global health. **Role Summary** Parexel is seeking an experienced Project Manager, Structured Content Authoring to support the Structured Content Authoring (SCA) initiative. This position focuses exclusively on SCA and involves configuring the platform for medical writing and regulatory documentation workflows. The role combines technical configuration expertise with a strong understanding of structured content authoring and regulatory standards. The ideal candidate will ensure seamless configuration, integration, and optimization of SCA to meet project and compliance requirements. This position also offers the opportunity to provide end-user support as the user base grows-making it a great learning experience and a chance to deliver impactful solutions. **Key Responsibilities** + Configure and maintain SCA platform settings to support medical writing and regulatory workflows. + Customize templates, metadata fields, and document structures for compliance and efficiency. + Implement and validate workflow configurations for review, approval, and version control. + Ensure integration of SCA with other enterprise systems (e.g., PleaseReview, Veeva RIM). + Conduct functional testing and troubleshoot configuration issues. + Maintain detailed documentation of configuration changes for audit readiness. + Collaborate with internal teams to gather requirements and translate them into technical solutions. + Provide user training and support on SCA features and best practices. + Offer end-user support (as availability allows) to assist with onboarding and troubleshooting, helping new users adapt to the platform. + Ensure all configurations comply with regulatory standards and company SOPs. **Required Qualifications** + Proven experience with SCA platforms. + Background in medical writing or strong familiarity with regulatory documentation processes. + Hands-on experience in content creation, review, standardization, and management within a structured content platform. + Demonstrated ability to collaborate with cross-functional teams to support regulatory consistency and harmonization of content across multiple documents. + Familiarity with core content reuse strategies, metadata management, and troubleshooting within the platform. + Strong problem-solving skills and attention to detail. + Familiarity with compliance and audit requirements in a GxP environment. + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. **Preferred Qualifications** + Experience training users or driving adoption of structured content methods. + Hands-on experience with automation of regulatory medical writing documents and (SCA) Structured Content Authoring platforms. + Experience working in a CRO or pharmaceutical environment. + Knowledge of electronic submission standards (e.g., eCTD). + Strong communication skills for cross-functional collaboration. + Ability to work independently and manage multiple priorities. **Education** Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. **Why Join Parexel?** + **Impactful Work:** Contribute to projects that accelerate the delivery of life-saving therapies to patients worldwide. + **Global Collaboration:** Work with diverse teams across the globe in a dynamic, innovative environment. + **Career Growth:** Access to professional development programs, mentorship, and opportunities for advancement. + **Flexibility:** Enjoy the benefits of a fully remote role with a healthy work-life balance. + **Inclusive Culture:** Be part of a company that values diversity, integrity, and collaboration. **Apply today and join Parexel in shaping the future of clinical research.** \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.