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Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.SummaryThe Sr. Director, Clinical Program Management, reporting to the Head of Clinical Operations, is accountable of on-time and on-budget delivery of assigned clinical study(ies) within the RayzeBio portfolio at the highest quality standards. The role will oversee all operational aspects of the global clinical program according to and in compliance with corporate and program Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/International Conference on Harmonization (ICH) guidelines and other applicable federal (FDA) and state or regional regulations, in order to achieve established corporate goals within timelines and budget.<h4>Job Responsibilities</h4>Essential duties and responsibilities include the following.&nbsp; Other duties may be assigned.<ul><li>Develop and lead the clinical operational strategy for complex, global programs, setting direction for clinical study teams, CROs, and vendors to ensure study(ies) are completed on time, within budget, and in compliance with RayzeBio SOPs and ICH/GCP guidelines.</li><li>Provide senior oversight and guidance for all operational aspects of clinical trial execution, including planning and feasibility, start-up, conduct, close-out, and reporting.</li><li>Identify, assess, and proactively manage operational risks and develop mitigation strategies at the program level.</li><li>Contribute to and provide input on clinical development plans, protocol design, and overall program strategy.</li><li>Lead and mentor cross-functional study execution teams, ensuring clarity of objectives and accountability for delivery of studies and program goals.</li><li>Drive management of clinical study timelines, milestone achievement, and regular tracking/reporting of progress to executive leadership.</li><li>Escalate and resolve critical program issues efficiently, ensuring timely communication to key internal stakeholders and executive leadership.</li><li>Oversee quality control and performance oversight of CROs and vendors; ensure compliance with performance metrics and inspection readiness.</li><li>Lead CRO and vendor governance meetings; review operational plans, performance data, and escalate study/program risks as needed.</li><li>Champion process improvement initiatives to optimize operational effectiveness across programs.</li><li>Perform additional related duties as assigned.</li><li>Up to 20% travel required.</li></ul><h4>Education and Experience</h4><ul><li>BA/BS degree, scientific or healthcare discipline preferred</li><li>Minimum 12 years relevant clinical operations experience in pharmaceutical/biotech industry, with at least 7 years in oncology trials</li><li>Prior experience in development programs with radiopharmaceuticals, theranostics and/or companion diagnostics highly desirable</li></ul>Skills and Qualifications<ul><li>Independent professional who proactively communicates frequently and effectively.</li></ul><ul><li>Strong leadership and project management skills across complex programs and cross-functional teams and able to drive decision making</li><li>Detail and action-oriented, organized and committed to quality and consistency.</li><li>Ability to work in a dynamic environment with a high degree of flexibility.</li><li>Expertise in Microsoft Project and Smartsheets desired.</li></ul>#RayzebioIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:San Diego - RayzeBio - CA: $261,110 - $316,404&amp;#xa;The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.&nbsp; Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Bristol Myers Squibb

Sr. Director, Clinical Program Management

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.The Medical Director RPI has responsibility for the development of RayzeBio’s diagnostic imaging pipeline across disease areas, including but not limited to prostate cancer, hepatocellular cancer and neuroendocrine tumors. Responsibilities may include support for IND preparation, regulatory authority interactions, design, and execution of Phase 0 to Phase 3 clinical trials, and medical monitoring. This role provides medical direction and high quality scientific and clinical knowledge to guide the strategy and execution of RayzeBio’s diagnostic imaging portfolio. This role works collaboratively with multi-disciplinary teams responsible for the design, implementation, monitoring, analysis, and reporting of studies conducted within RayzeBio’s portfolio to ensure the program meets the needs of patients and RayzeBio’s business.Job ResponsibilitiesEssential duties and responsibilities include the following. Other duties may be assigned.<ul><li>Interact with clinical investigators and thought leaders to design a diagnostic imaging strategic plan for nominated candidates</li><li>Lead internal project teams, and partner with investigators and CROs to design and implement clinical studies of radiopharmaceutical imaging agents.</li><li>Contribute to writing of protocols, investigator brochures, clinical study reports, and review of other clinical trial and regulatory documents</li><li>Conduct investigator meetings and lead site qualification and initiation visits with clinical trial investigators</li><li>Execute and deploy drug development strategic plans, develop contingency plans, provide technical and strategic advice, and meet milestones and budgets</li><li>Translate findings from research and nonclinical studies into diagnostic imaging development opportunities</li><li>Oversee Data Review and Independent Data Monitoring Committees as applicable</li><li>Conduct clinical trials using ethical guidelines relevant to the pharmaceutical industry, and ensure compliance with these external guidelines</li><li>Establish and maintain positive relationships with clinical trial investigators and thought leaders</li><li>Serve as clinical lead for regulatory interactions, including preparation of briefing documents and attendance and presentation at health authority meetings.</li><li>Work closely with commercial and medical affairs organization to develop and execute on a diagnostic imaging program for RayzeBio portfolio in radiopharmaceutical imaging.</li><li>Willing to travel approximately 30% of the time. Evening and weekend work will be involved.</li></ul>Education and Experience<ul><li>MD or equivalent with at least 5 years of pharmaceutical, biotech experience or academic clinical experience in oncology diagnostic development or 3 years’ experience for candidates with track record of developing radiopharmaceutical imaging agents through a regulatory process.</li></ul>Skills and Qualifications<ul><li>Patient-focused, with deep commitment to understanding needs and improving the lives of patients with cancers and a passion for developing novel therapeutics</li><li>Motivated to work in a fast-paced, high accountability, and small company environment. A "can do" and collegial professional who leads through influence and interpersonal skills.</li><li>Demonstrated record of accomplishment in a compressed time frame; capable of prioritizing tasks and delivering deadlines with high performance standards and attention to detail.</li><li>Demonstrated ability to collaborate successfully with multiple functions in a team environment.</li><li>Intellectually curious with courage to challenge and seek new ways to improve work.</li><li>Strong written and oral communication skills, including presentation skills.</li><li>Ability to analyze and interpret data and develop written reports and presentations of those data.</li><li>Strong critical, strategic, and analytical thinking skills.</li><li>Experience in all aspects of protocol conduct, both early and late phase, including protocol writing, start-up, study execution, analysis, and reporting.</li><li>Experience working closely with investigative sites, including principal investigators, sub- investigators, study coordinators, and other site personnel involved in clinical trials.</li><li>Skilled in clinical research and understands the process of radiopharmaceutical imaging agent development and approval.</li><li>Able to function in a highly regulated environment and to adhere to all RayzeBio guidelines and standard operating procedures (SOP’s).</li><li>Solid understanding of GCP and ICH guidelines.</li></ul>Physical demandsWhile performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision and distance vision.Work&nbsp;EnvironmentThe noise level in the&nbsp;work&nbsp;environment is usually moderate.#RayzeBioIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:Remote - United States - US: $265,740 - $322,014&amp;#xa;San Diego - RayzeBio - CA: $286,999 - $347,775&amp;#xa;The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.&nbsp; Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Medical Director, Radiopharmaceutical Imaging (RPI)

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.RayzeBio, a Bristol Myers Squibb company, is a dynamic biotechnology company headquartered in San Diego, CA. The company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio is developing innovative drugs against targets of solid tumors. Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.The Senior Director of Program Management will be accountable for the cross-functional planning and execution of one or more development programs with moderate to high complexity. This role will work with a cross-functional team to define and drive the execution of the development strategy with urgency, manage timelines, identify and manage risk.The ideal candidate will bring clinical-stage program management expertise, deep understanding of drug development and regulatory processes across different geographies, and the ability to assess and drive deployment of tools and best practices to ensure successful product development. The role will report to the Executive Director, Program Team Leader.Job ResponsibilitiesEssential duties and responsibilities include the following.&nbsp; Other duties may be assigned.<ul><li>Partners with Program Team Lead to drive cross-functional program teams</li><li>Partner with functional leaders (Research, Regulatory, CMC, Clinical Development, etc.) to align on program strategy and drive execution in line with corporate objectives.</li><li>Develop, refine, and manage complex program timelines; pressure-test plans and create alternative scenarios to address risks and dependencies.</li><li>Proactively identify risks and challenges; implement effective mitigation strategies, and communicate risks and solutions to program and leadership.</li><li>Facilitate productive team meetings, develop agendas, and document decisions and action items to ensure accountability and progress.</li><li>Communicate effectively with team members and stakeholders, fostering an environment of collaboration, transparency, and high performance.</li><li>Challenge assumptions, timelines and expenses at the program level; pressure test plans; and create alternative scenarios, highlighting interdependencies and downstream impacts of strategic decisions.</li><li>Provide leadership to team members, challenging conventional thinking to approach problems differently, with faster execution and elevated outcomes.</li><li>As a program management subject matter expert, understand best practices, identify gaps and challenges, implement efficiencies and improved ways of working within the organization.</li><li>Contributes to the development of junior program managers.</li></ul>Education and Experience<ul><li>Advanced degree (PhD, PharmD, MD, or MBA) in Life Sciences, Medicine, or related discipline</li><li>Minimum 10 years’ experience in drug development and program management within the pharmaceutical/biotech industry, including direct leadership of cross-functional teams and complex R&amp;D programs.</li><li>Demonstrated track record of successfully delivering early-stage programs through regulatory submissions&nbsp;across different geographies.</li><li>Experience with commonly used program management tools, including Microsoft Office Suite and Smartsheet.</li></ul>Skills and Qualifications<ul><li>Ability to execute diverse and novel strategies in a matrix environment; experience managing and influencing complex issues and a variety of key stakeholders.</li><li>Demonstrated skill in driving execution and focusing on deliverables.</li><li>Ability to manage complex situations and adapt to changing business needs.</li><li>Strong strategic thinking skills with the ability to contribute to overall business strategy.</li><li>In-depth understanding of drug development processes, regulatory requirements, and industry best practices.</li><li>Exceptional written and oral communication skills; proven ability to influence and collaborate with senior leadership, team members, and external stakeholders.</li><li>Results-oriented mindset with a focus on achieving program goals within specified timelines and budgets.</li><li>Strong organizational skills, attention to detail, and the ability to manage multiple competing priorities across time zones.</li><li>Ability to work independently, take initiative, and support the team in meeting deadlines.</li><li>Displays a high level of professionalism and integrity.</li></ul>Physical DemandsWhile performing the duties of this&nbsp;job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this&nbsp;job&nbsp;include&nbsp;close vision and distance vision.&nbsp;Work&nbsp;EnvironmentThe noise level in the&nbsp;work&nbsp;environment is usually moderate.#RayzeBioIf you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.Compensation Overview:San Diego - RayzeBio - CA: $207,633 - $251,602&amp;#xa;The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.&nbsp; Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit <a href="https://careers.bms.com/life-at-bms/" target="_blank">https://careers.bms.com/life-at-bms/</a>. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.On-site ProtocolBMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to <a href="mailto:adastaffingsupport@bms.com" target="_blank">adastaffingsupport@bms.com</a>. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information:&nbsp;<a href="https://careers.bms.com/california-residents/" target="_blank">https://careers.bms.com/california-residents/</a>Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Director Program Management

About Pacira Pacira BioSciences, Inc. is a leading provider of non-opioid pain management and regenerative health solutions dedicated to improving outcomes for health care practitioners and their patients.&nbsp;&nbsp;&nbsp;&nbsp;Each of our 3 marketed products, both in pharmaceutical and medical device, represent cutting edge technologies for pain management.&nbsp;&nbsp;&nbsp;&nbsp;We have 700+ employees and have averaged double digit growth year over year for the past 5 years, with $500M in revenue. We are small enough for you to make your mark, and big enough for you to learn and grow!&nbsp;&nbsp;&nbsp;We have facilities in New Jersey, California and Florida. Our San Diego, CA campus is a world class manufacturing and R&amp;D facility. We are rapidly growing and have opportunities across all of our sites and functional areas. Why work with us? Rarely do you have an opportunity to do work that really matters. What drives us is our mission. What makes us successful are our people. At Pacira, you are part of an inclusive culture that fosters collaboration, growth, and innovative thinking – a place where you can make an impact and help change the standard of care in non-opioid pain management. Be part of our movement, let’s pursue excellence together.&nbsp;&nbsp;&nbsp;Summary:This position is responsible for assigned regulatory projects to ensure regulatory compliance for approved marketing applications (NDA/MAA/NDS etc.) and leading to successful preparation of clinical trial applications (IND/CTA etc.). It also provides regulatory expertise to the Pacira Pharmaceuticals regulatory team.Essential Duties &amp; Responsibilities:The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.<ul><li>Prepare regulatory filings for submission to US and international health agencies in the areas of new drug development, marketing applications and approved product support. This would include IND applications, annual reports, Investigator brochures, and meeting requests</li><li>Ensure conformance to commitments made with various health agencies (e.g., IND/NDA/MAA/NDS commitments).</li><li>Propose and/or assist in developing regulatory strategies; identify and implement appropriate submission strategies for assigned projects.</li><li>Work with submission manager to ensure regulatory submissions are of high quality and submitted in a timely manner; review submissions for accuracy, completeness, and compliance with applicable regulatory requirements and internal procedures.</li><li>Participate in Regulatory interaction and presentations to Regulatory Health Authorities, customers and partners.</li><li>Monitor and maintain awareness of regulatory environment assessing impact to business, interpret and disseminate information to affected departments.</li><li>Can act as regulatory affairs CMC liaison with partner companies and contract manufacturers</li><li>Other duties as assigned.</li></ul>Supervisory Responsibilities:This person may have direct supervisory responsibilities.Interaction:The incumbent works closely with employees in all functional areas of the company to provide regulatory guidance and support.Education and Experience:<ul><li>Bachelor’s degree in life science or related discipline required</li><li>Minimum 10 years of progressively responsible experience in Regulatory Affairs in the U.S. pharmaceutical industry required</li><li>Demonstrated strong understanding of the U.S. Regulatory requirements</li><li>Proven ability to interpret and apply regulations to specific projects (FDA and ICH or other regulatory agency guidance requirements)</li><li>Excellent written and verbal English communication skills</li><li>Demonstrated organizational skills</li><li>Proven negotiation skills.</li><li>Proven ability to manage multiple projects, set priorities and meet deadlines</li><li>Excellent skill level in MS Office including Word, Excel, and Outlook</li></ul>Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.&nbsp; While performing the duties of this job, the employee is regularly required to sit, talk, move between spaces, reach with hands and arms and stoop. Close vision and the need to focus on computer screen, use of hands, fingers and wrist to type on keyboard and manipulate mouse. Will need to lift and move boxes of paper and binders weighing up to 20 pounds.Work Environment:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Typical office setting, noise level is moderate with consistent printer, telephone ringing and conversation.Travel Requirements:The job requires the employee to be able to travel between Pacira sites, to in person Agency meetings (FDA and International Authorities), and to visit contract organizations or cooperation partners. Approximately 25% travel.Benefits:<ul><li>Medical, Prescription, Dental, Vision Coverage</li><li>Flexible Spending Account &amp; Health Savings Account with Company match</li><li>Employee Assistance Program</li><li>Mental Health Resources</li><li>Disability Coverage</li><li>Life insurance</li><li>Critical Illness and Accident Insurance</li><li>Legal and Identity Theft Protection</li><li>Pet Insurance</li><li>Fertility and Maternity Assistance</li><li>401(k) with company match</li><li>Flexible Time Off (FTO) and 11 paid holidays</li><li>Paid Parental Leave</li></ul>The base pay range for this role in California is $160,000 annually to $220,000 annually.&nbsp;The range is&nbsp;what we reasonably expect to pay for this role. The range considers a wide range of factors that are considered in making compensation decisions, including but not limited to: geographic markets, business or organizational needs, skill sets, experience, training, licensure, and certifications.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;

4 Leadership / Executive Board Jobs in San Diego, CA, USA