Senior Project Manager jobs at Premier Research

Genentech is establishing a new Campus Development Team (CDT) to oversee the implementation of the Campus Vision Plan (CVP) for the South San Francisco campus, including the CVP PMO. We are seeking a vision-driven, strategic, and highly experienced Senior Director to lead the PMO. This role is crucial for strategic oversight, successful execution, and financial integrity of the multi-billion dollar CVP, which serves as a long-term strategy for future capital investments. The PMO function is specifically tasked with CVP Budgeting, Controls, and Governance. The Opportunity Key Responsibilities: The Senior Director , CVP PMO, will be responsible for: Strategic Program Oversight & Execution: As a member of the campus development leadership team the SD PMO will form an integral role in the strategic oversight for significant capital investments related to the CVP, ensuring successful realization of major projects and their sub-projects. The PMO office will be responsible for coordinating project resources across the portfolio to ensure alignment in approach. CVP Master Scheduling: Develop, maintain, and oversee the integrated master schedule for the entire CVP, ensuring alignment of project timelines and phases with strategic objectives and milestones. This involves collaboration with senior project leads. Budgeting, Financial Control & Forecasting: Develop, manage, and strategically allocate financial resources for the CVP, ensuring rigorous budgeting, forecasting, and cost control across projects. This includes overseeing CDT financial aspects and ensuring fiscal responsibility. Contribute to building value engineering expertise through collaboration with internal teams and external partners. Governance & Compliance: Establish and maintain robust governance structures for the CVP, ensuring adherence to company policies, governance structures, and relevant guidelines, including Technical Standards and the Engineering Manual. Streamline decision-making while supporting user input and senior leadership approvals. Provide project oversight management & Roche engineering manual compliance, and support internal audits of the CVP program. Safety Oversight & Compliance: Ensure CVP projects comply with all safety standards and regulations, minimizing risks, by establishing and enforcing safety protocols within the PMO's governance framework. Safety team to coordinate site logistics function, and liaise to the internal Site Services Security, Safety Environment and Health (SSHE) team. Process Improvement & Efficiency: Continuously evaluate and refine project delivery processes within the CVP framework to enhance efficiency and effectiveness, including developing and implementing data-driven strategies for large-scale capital expansion programs. Developing BIM Strategy: Develop and implement a comprehensive digital strategy for the CVP, including Building Information Modeling (BIM) methodologies, to enhance project planning, execution, and data management, leveraging cutting-edge tools. Document Management: In collaboration with the site services document control team, develop and enforce an organized document management strategy for the CVP projects, ensuring the ability to support audits and team members to quickly find records efficiently. Working with Procurement: Collaborate closely with procurement teams and strategic vendors for efficient contract negotiation, vendor selection, and adherence to payment terms and contractual obligations for CVP projects, aligning with budgeting and governance standards. Risk Management: Proactively identify, assess, and mitigate risks associated with the CVP, developing contingency plans to ensure business continuity. Internal Stakeholder and XFN Alignment; Establish effective communication channels to keep internal stakeholders informed and engaged, fostering strong relationships and transparent communication among departments. External Communications: Align with the Site Services and Corporate Communications teams on external, public, union, and media communications. Maintain and provide materials and content throughout the course of the CVP program to provide to these teams in support of their engagements. Design Engineering - Provide line leadership and coordination to the subject matter experts supporting the design & engineering functions across the CVP. Drive alignment with international peers with coordinated efforts with Roche engineering council. Team Effectiveness: Establish and implement systems and processes to evaluate and enhance team effectiveness within the CDT. Establish applicable Metrics and KPIs to track performance and drive continuous improvement Staffing & Resourcing: Execute resource planning for the Campus Development team, and coordinate recruiting (in partnership with People & Culture). Prepare and lead team on-boarding sessions, manage training compliance, access, and off-boarding of team members in company systems (EPP, Cornerstone, etc.) Industry Trends & Innovation: Stay abreast of industry trends and champion best practices, integrating emerging technologies and innovative approaches into project delivery strategies. Who you are Qualifications: Education: Bachelor's degree in Architecture, Engineering (Civil, Structural, Chemical, Mechanical, Electrical), Urban Planning, Quantity Surveying, or Construction Management is required. An MBA or equivalent business management qualification is advantageous. Experience: Minimum of 10 years of progressively responsible experience in site development, construction management, or a related field, with a significant focus on strategic planning and large-scale, complex projects. Proven track record of leading and delivering successful, high-impact campus development projects from conception through to completion. Experience managing large teams of full-time employees, contractors, and vendors. Successful track-record in managing real estate development, campus or urban planning, capital program development, and construction contracting and management in California, preferably in the San Francisco Area. Experience delivering large projects valued at over $500 million or programs valued at $1 billion in aggregate within complex campus environments. Project Management / PMO experience Experience with establishment of Metrics and KPIs to track performance and drive continuous improvement Skills & Competencies: Exceptional leadership, communication (written/verbal), and interpersonal skills, with the ability to influence and engage senior stakeholders. Strong business and technical acumen with expertise in advanced project management tools and methodologies. Strong strategic thinking and problem-solving capabilities, able to anticipate challenges and develop proactive solutions. Strong financial acumen, with experience in budgeting, forecasting, and managing large-scale project finances. Highly dependable, detail-oriented, and proficient in coordination tasks with the ability to work independently as a self-starter. Ability to drive innovation and continuous improvement in site development practices. Proven ability to work effectively with a wide range of stakeholders. Strong negotiation and conflict resolution skills. Ability to implement and manage change effectively in complex and dynamic environments. Proficiency in Microsoft Office and Google Suite. Location: This is a campus-based role requiring the majority of time on the South San Francisco campus (currently defined as at least 3 days per week). Travel may be required. The expected salary range for this position based on the primary location of California is $197,500.00 - $366,900.00 USD Annual. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below. Benefits Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws. If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.

**Who is USP?** The U.S. Pharmacopeial Convention (USP) is an independent scientific organization that collaborates with the world's leading health and science experts to develop rigorous quality standards for medicines, dietary supplements, and food ingredients. At USP, we believe that scientific excellence is driven by a commitment to fairness, integrity, and global collaboration. This belief is embedded in our core value of Passion for Quality and is demonstrated through the contributions of more than 1,300 professionals across twenty global locations, working to strengthen the supply of safe, high-quality medicines worldwide. At USP, we value inclusive scientific collaboration and recognize that attracting diverse expertise strengthens our ability to develop trusted public health standards. We foster an organizational culture that supports equitable access to mentorship, professional development, and leadership opportunities. Our partnerships, standards, and research reflect our belief that ensuring broad participation in scientific leadership results in stronger, more impactful outcomes for global health. USP is proud to be an equal employment opportunity employer (EEOE) and is committed to ensuring fair, merit-based selection processes that enable the best scientific minds-regardless of background-to contribute to advancing public health solutions worldwide. We provide reasonable accommodations to individuals with disabilities and uphold policies that create an inclusive and collaborative work environment. **Brief Job Overview** This role is a non-supervisory position responsible for working with key customers and stakeholders in the excipients industry on acquisition and complete submission of information for USP documentary standards, primarily in the North America (NORAM) and Europe Regions. This role will be responsible for delivering USP monograph donations for excipients and other raw materials through effective and appropriate stakeholder engagement. The incumbent works directly with companies with raw materials or testing of raw materials that are included in FDA approved products/processes as well as with internal USP staff globally including: Program Units, Strategic Customer Development Managers, Scientific Experts, and Business Leaders. This includes management of day-to-day activities including company meetings, planning, reporting and tracking to ensure delivery of key targets and growth goals. This role requires excellent interpersonal and communication skills, with the ability to influence cross-functional teams and external stakeholders. This role is within the Regions & Program Operations Division and reports to the Donations Director. **How will YOU create impact here at USP?** As part of our mission to advance scientific rigor and public health standards, you will play a vital role in increasing global access to high-quality medicines through public standards and related programs. USP prioritizes scientific integrity, regulatory excellence, and evidence-based decision-making to ensure health systems worldwide can rely on strong, tested, and globally relevant quality standards. Additionally, USP's People and Culture division, in partnership with the Equity Office, invests in leadership and workforce development to equip all employees with the skills to create high-performing, inclusive teams. This includes training in equitable management practices and tools to promote engaged, collaborative, and results-driven work environments The **Donations Engagement Manager** has the following responsibilities: + Develops donation focused account strategies, driving ongoing collaboration and alignment across all relevant internal stakeholders/partners. + Lead monograph acquisition (donation) efforts globally, and as needed, with particular focus in NorAm and Europe at assigned companies. + Identify and develop key contacts for acquiring the information required to develop USP's public standards. This includes the development of new monographs, modernization of existing monographs, and compendial requests to address FDA comments on proposed monographs to the USP-NF. + Develops specific plans and performance targets that supports overall donations strategies. + Deliver on monograph donation targets, ensuring quality data/components for further development by Science and USP Expert Committees, in an expeditious and efficient manner + Educate, support, and assist the sponsor of a potential monograph with guidance related to USP and how USP fits into a comprehensive compendial strategy. + Regularly engages in business and relationship development activities with identified donors and other relevant stakeholders. Develops and nurtures relationships with key people and decision-makers within each account. Leverages internal USP resources to effectively position all relevant USP resources to further the mission of USP. + Regularly executes professional presentations to donors to include, but not limited to the C-suite, Regulatory Affairs, Quality and R & D departments (and their respective staff). + Develops an overall understanding of USP's business (Small Molecules, Biologics, Growth Programs) to ensure that conversations with donors can foster broader collaborative dialogue between USP and targeted donors. + Understands the relationship between USP, Regulatory and Commercial markets both domestically and internationally and how those relationships affect USP and external accounts. + Has ability to provide scientific and technical support to assigned donors. Leverage internal USP counterpart resources such as Science, SCD, Scientific Affairs and USP Education, for inquires and/or programs that need greater detail and program content expertise. + Maintains and updates account information for all assigned accounts. Updates contact management system with all relevant donor information. Uses information strategically to be proactive at engaging USP resources. Makes the requisite number of touch points (phone calls, emails, teleconferences, meetings, and customer visits) to assigned donor accounts to the responsible individuals and decision-makers on USP's standards development process, and opportunities for donor contributions, with a primary focus on monographs, and documenting calls, meetings and emails in Salesforce. + Supports donor events and workshops to enhance and promote the importance stakeholder contributions to the standards development process. Identifying contacts at assigned companies to work with USP on new monographs, monograph improvement and bulk material. Develop and report on understanding drivers and barriers for donations. + Keep track of the progress to goals, monthly. Help to increase our understanding of the relationship between USP, Regulatory and Commercial markets both domestically and internationally and how those relationships affect our Mission. + Works as part of a Team leveraging the resources in donations operations and donor recognition to support our donors and elevate the impact our donors provide for global public health. Travel can be up to 50%, both domestic and international. Perform other related duties as assigned. **Who is USP Looking For?** The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience: + Bachelor's degree in chemistry, or a related science field, required or a business degree or related field. + Seven (7) years' experience in a life sciences role, preferably in the pharmaceutical, specialty chemical industry or contract laboratory services that does testing for the pharmaceutical industry or other evidence of experience in conducting USP-NF testing in an analytical laboratory. + Three (3) years of experience providing account management to pharmaceutical or chemical/laboratory supply channels. + Experience in life sciences related work with demonstrated customer facing engagement activities including but not limited to face-to-face interactions and digital touchpoints. + Good interpersonal skills, communication skills, and telephone manner required. + Advanced understanding of pharmacopeia and use of compendial standards + Advanced understanding of the pharmaceutical industry + The ability to influence without direct authority. + Results-driven with demonstrated successful outcomes. + Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner. + Ability to handle multiple priorities in a fast-paced environment. + Able to work flexible hours when needed, including travel between 40-60% of the time. **Additional Desired Preferences** + Experience using data analytical platform (e.g. Tableau) and CRM platform (e.g. Sales Force) a plus. + Previous donation/stakeholder engagement (including sales) experience a plus. + Experience with regulatory compliance, quality control, quality assurance or GMP background a plus. + Account management skills required. + Strong problem-solving skills with customer-centric approach. + Excellent relationship-building skills with stakeholders. + Excellent in person & virtual presentation skills. + Self-motivated and able to work in a fast-paced multi-task environment. + Combined education in Pharma science and business is highly preferred. + Proficiency with Microsoft Office, data query, analysis, and reporting. + Superior interpersonal skills: professionalism, collaboration, accountability, delegation, and customer service + Ability to build effective work relationships quickly and work collaboratively in a global setting both internally and externally. + Ability to effectively manage multiple competing priorities with high attention to detail. + Knowledge of USP products and services is highly preferred. + High business acumen abilities - can understand and deliver on business objectives. + High comfort with navigating through ambiguity and frequent change, and course-adjusting in the moment. + Demonstrated initiative and resourcefulness with good judgement. + Strong influence, negotiation, critical thinking, problem-solving and conflict resolution skills. **Supervisory Responsibilities** None, this is an individual contributor role. **Benefits** USP provides the benefits to protect yourself and your family today and tomorrow. From company-paid time off and comprehensive healthcare options to retirement savings, you can have peace of mind that your personal and financial well-being is protected. **Compensation** Base Salary Range: USD $98,900.00 - $127,250.00 annually. Target Annual Bonus: % Varies based on level of role. Individual compensation packages are based on various factors unique to each candidate's skill set, experience, qualifications, equity, and other job-related reasons. Note: USP does not accept unsolicited resumes from 3rd party recruitment agencies and is not responsible for fees from recruiters or other agencies except under specific written agreement with USP. Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights (**************************** notice from the Department of Labor. **Job Category** Technical Programs **Job Type** Full-Time

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. The Manager, Patient Advocacy & Engagement, is a high-impact role that engages with patient and community stakeholders to ensure productive and enduring partnerships. This individual will lead outreach to patient advocacy groups and educate and support internal teams, ensuring they are aware of the needs and experiences of patients. This is a critical role for the team at Orca Bio, a patient-driven organization whose mission is to transform the lives of patients through high-precision cell therapy. Preferred remote location: Chicago/or mid-west US.Essential Duties & Key Responsibilities Build and maintain trusted relationships with patient leaders, advocacy organizations, caregivers, professional societies and other stakeholders in the blood cancer community through thoughtful and compliant engagement Design and deliver community-focused initiatives, including advocacy roundtables, insight-gathering sessions, landscape assessments and workshops Assist in managing patient advocacy grants, sponsorships and related requests in alignment with company policies Coordinate with internal teams to bring patient perspectives into clinical trial activities, medical education and external engagement Represent Orca Bio at advocacy events, reinforcing the company's commitment to patient-focused innovation Collaborate with Corporate Communications, Medical Affairs and Commercial teams to ensure consistent external messaging Translate community insights into actionable recommendations that inform cross-functional strategies. Champion a patient-first culture by elevating patient stories, perspectives and unmet needs across the company Support patient-centric initiatives such as awareness campaigns, educational events, and development of accessible lay summaries of scientific content Desired Competencies Embodies a patient-centric mindset with a commitment to elevating patient and caregiver perspectives in all aspects of work Ability to create and sustain trusted partnerships with diverse stakeholders Skilled in developing and executing advocacy initiatives and community programs Strong written and verbal skills, including translating complex science into accessible language Understanding of oncology/hematology advocacy ecosystems and stakeholder dynamics Knowledge of regulatory compliance standards related to patient engagement and communications Experience managing budgets, grants, sponsorships and vendors in a compliant manner Required Qualifications Bachelor's degree in life sciences, public health, social work, policy, or a related field (advanced degree preferred) Minimum 5 years of professional experience in patient advocacy, medical affairs, public health, or coalition building, with preference for oncology, hematology, or cell therapy experience Strong understanding of the biotech/pharma industry, including the drug development process and regulatory frameworks Demonstrated ability to collaborate across functions and influence at all levels of an organization Track record of building consensus and fostering buy-in among diverse stakeholders Exceptional interpersonal skills and cultural awareness to navigate a wide range of professional and community interactions Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Essential functions of the job include but are not limited to: Serve as primary point-of-contact and primary escalation point to the client Coordinate and oversees all functional services including external vendors to the established timeline and budget Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed. Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives. Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings. Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation Establish tracking metrics to monitor trial and team progress towards project goals Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise Leads both internal and client meetings and set expectations for the project team Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defences with proficiency Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required Perform other duties as assigned by management Remain compliant with organisational training, time-reporting and any other administrative duties as required Provides on-going feedback, for functional team members including annual performance reviews Qualifications: Minimum Required: North America: Bachelor's degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience Experience in managing complex and global trials Ability to travel domestically and internationally including overnight stays Other Required: Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project, eTMF, EDC and CTMS Proven communication and interpersonal skills to effectively interface with others in a team setting Proven organizational skills, attention to detail, and a customer service demeanour Competencies: Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items Proven knowledge of project management techniques aPay transparencynd tools Direct work experience in a global, cross-functional project management environment Good understanding of cross-functional management Good understanding of project planning, risk management and change management with an awareness of appropriate escalation Proven experience in strategic planning, risk management and change management High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective Ability to lead and inspire excellence within a study team Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency Results oriented, accountable, motivated and flexible Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills Proven presentation, verbal and written communications skills Good understanding of project management software In depth proven experience in pharmaceutical and/or device research required Preferred: experience with oncology & cell and/or gene therapy #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$125,200-$187,800 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

At PRECISION AQ, the Senior Program Manager (SPM) is a member of the team leadership. The SPM is responsible for creating, managing and communicating the program development workflow plan and providing the Scientific Director (SD) and Strategic Account Director or Manager (SAD/SAM) with the timing and process information required for them to effectively and efficiently manage their departments, programs and the client. Essential Functions: Program Planning: Under the supervision of the Program Director, create, manage and communicate the development workflow plan to ensure all members are aware of current status, next steps, potential roadblocks and solutions at all times. Organize and maintain the online project folders per SOP guidelines and work closely with the Program Manager and Coordinator to ensure all client communications and financial documents are archived properly. Oversee the client's medical/legal/regulatory (MLR) process with the PM Team including submissions, liaison with internal MLR team, communications with the client's MLR coordinator and monitoring status. May represent the Program Management department during pitches and assist with new business activity. Team Management: Manage and mentor Program Manager and Coordinator; partner with support teams for resource needs, oversee all internal and external meetings to provide objectives and clear actionable items post-meetings; train and onboard new PM team members Finance: Participate in the statement of work (SOW) development in a consultative role with the SAD in detailing scope and allocating team members hours. Work closely with the team to ensure they are alerting the SAD of scope changes and time-of-staff overages. Monitor the BVA reports with the Financial Analyst and alert the SAD of any deviations from the contract. Oversee the invoicing process including reconciliation and client financial reports. Client Management: Act as primary client contact for project status, MLR process, and invoicing Communication: Provide strong verbal and written communications to the client and internal teams including status reports and meetings, financial reports, assignment reports and meeting agendas and summaries Compliance: Ensure compliance guidelines are followed including but not limited to legal templates, Sunshine Act reporting, and client training requirements Program Logistics: Depending on account requirements, manage and oversee logistics vendor and perform meeting planning tasks, including site search, venue contracting, travel arrangements, food/beverage and audio-visual equipment for live events Vendor and Agency Partner Management: Manage vendors not associated with strategy and content such as print, video production, transcription. Work closely with team leadership to manage other vendors in collaboration with or under the direction of the SAD or SD Staff Management: Manage and train assigned Program Coordinators and/or Program Managers Competencies: Capable of managing many complex projects with multiple staff members and tight deadlines Experience in a variety of medical communication promotional project types with ability to quickly learn new ones Being proactive and taking a leadership role when required Understanding the development process and identifying potential problems Anticipating and providing solutions to potential problems and unexpected challenges MS Office programs including MS Project and search engines Verbal and written communications Interpersonal skills Managing many project details with strong organization skills Financial requirements for a service-based business including budget development, monitoring and management Managing staff including performance reviews, action plans, training and mentoring Qualifications Bachelor's Degree 5-7 years of project management experience in a pharmaceutical-related service-based business such as medical communications, advertising, sales training or digital production MS Office programs including MS Project and search engines This position requires travel Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$79,108.80-$118,663.20 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position At Roche/Genentech, we believe it's urgent to deliver medical solutions right now - even as we develop innovations for the future. We are passionate about transforming patients' lives and making medicines more convenient and accessible to patients while investing in our planet to reduce the carbon footprint. We are fearless in both decision and action. That is why we come to work each day. Who We Are Pharma Global Technical Operations (PT) is the organization that manufactures and delivers Roche's groundbreaking therapies to millions of patients worldwide. PT is involved in producing every Roche medicine from the development process through clinical trials and continuing to product maturity. Our organization coordinates all aspects of the production of Roche medicines in all disease areas and dosage forms. Pharma Technical Development (PTD) is an integral part of this mission. As an organization of over 2,500 people globally, PTD is responsible for developing the manufacturing processes, products, analytical methods, and Chemistry, Manufacturing & Controls (CMC) strategies to deliver all new products in Roche's pipeline. This work encompasses the full range of development functions, including biologics, synthetic molecules, devices, clinical supply chain management, and project and portfolio management. PTD applies leading technical expertise to design, develop, supply, and register clinical-stage products globally, reliably delivering the pipeline and supporting commercial manufacturing operations. We excel through innovation, collaboration, dedication, and mutual respect, continuously improving what we do to ensure Roche's supply of quality products to patients. We commit ourselves to scientific rigor, technical excellence, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. The Opportunity The Global Head of Project and Portfolio Management will provide strategic and operational leadership for Chemistry, Manufacturing & Controls (CMC) across the R&D organization. You will define and drive the global CMC development portfolio and strategy, ensuring alignment with corporate priorities, scientific innovation, and regulatory expectations. Additionally, you will oversee portfolio execution, CMC project management, and a team of technical development leaders (CMC leaders) responsible for delivering high-quality, timely CMC packages to advance the pipeline from early development through commercialization. Key Responsibilities CMC Strategy & Leadership * Establish and lead the global CMC development strategy in alignment with One Pharma Strategy and R&D Excellence objectives. * Anticipate and integrate industry, regulatory, and scientific trends into CMC approaches and portfolio decisions. * Provide scientific, technical, and business leadership to guide critical CMC development programs. Portfolio Management & Execution * Develop, enhance, and oversee CMC portfolio governance, prioritization, and decision-making processes effectively such as Late Stage Technical Development Committee (LSTDC). * Ensure timely and efficient delivery of CMC packages supporting IND, CTA, IMA/BLA/NDA, and global submissions. * Drive portfolio insight and performance analytics to optimize resource allocation and execution. * Lead the creation and use of standard systems, tools, and processes to enable analysis and management of the technical development portfolio (e.g. 100 people years, RDE DevGo to EIH goal). Project & Program Leadership * Manage CMC strategies, risks, and overall project execution to efficiently deliver robust manufacturing processes and materials within requested timelines and budget * Partner with R&D, regulatory, quality, clinical, and commercial & PT stakeholders to ensure seamless development collaborations and execution. * Champion a culture of operational excellence, accountability, and proactive risk identification and mitigation. Team Leadership & Talent Development * Lead, inspire, and develop a team of technical development leaders (TDLs) delivering the projects by working with functions such as drug substance, drug product, analytical development & quality control, device and delivery, regulatory CMC, manufacturing sciences, and clinical and commercial manufacturing sites. Act as a coach for teams. * Recruit, retain, and develop high-potential talents for the Technical Development Leaders (TDLs) and Project Managers. Foster a high-performing, collaborative, and inclusive culture. * Build organizational capabilities to meet evolving portfolio and industry needs. Leadership Team Contribution * As a member of the PTD leadership team, contribute to the team's high performance, foster cross-functional thinking, and work collaboratively to set priorities for the global organization. Stakeholder Engagement and Communication * Ensure a strong connection to key stakeholders within the broader global project team system (e.g., Lifecycle Teams, gRED & pRED project Teams). * Partner with R&D, regulatory, quality, commercial stakeholders, and Roche Partnering to ensure seamless development transitions and alignment. * Enable open and timely communication with senior management regarding CMC issues and resolutions. Facilitate project status reports, governance committee briefings, and project updates to management. Who You Are * Advanced degree (Ph.D. preferred) in chemistry, biology, engineering, pharmaceutical sciences, or related discipline. * Extensive years of progressive and inspiring leadership in CMC development, manufacturing sciences, or related R&D functions, with proven success and a long track record. * Deep knowledge of global regulatory requirements, product development processes, and CMC and/or product lifecycle management. * Demonstrated ability to grasp the changing and dynamic external environment to shape strategy, manage complex portfolios, and deliver across early and late-stage development. * Exceptional leadership capabilities, excellent communication-, and influencing skills in effective engagement with leaders and stakeholders across R&D and PT. Ability to positively influence colleagues and key decision-makers. * Strong business acumen and collaboration skills, with the ability to balance scientific, operational, and strategic priorities in a global organization. * Experience in team leader development, project portfolio management, and developing business processes and tools to support a global team system. * 15-20% international travel required. Leadership Competencies * Strategic and innovative thinker with a global mindset. * Strong decision-making and problem-solving skills in complex, fast-paced environments. * Track record of building and leading high-performing, inclusive teams, passionate about talent development. * Highly collaborative, able to influence and align across all levels, internal stakeholders, and external partners. * Commitment to quality, compliance, and patient-centric innovation. Who we are A healthier future drives us to innovate. Together, more than 100'000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let's build a healthier future, together. Roche is an Equal Opportunity Employer.

It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. SMI is one of the most highly regarded technology producers in the human services field. We develop state-of-the-art solutions for complex human service operations. To maintain our prominence in this competitive industry, SMI recruits individuals who are technical, creative, client-focused, and most importantly willing to go the Extra Mile. With over 50 years as a family-owned and operated business, SMI considers its employees and clients part of an extended family. We are a family serving families. Our culture is one of teamwork, dedication, empowerment, and a strong emphasis on work-life balance. We offer an optimal atmosphere for career growth and achievement while remaining competitive in terms of compensation and benefits. We are a multi-state operation and administrative private company with a staff of over 650 employees throughout the United States. We depend on the expertise of our SMI team to support and develop the very best systems and product lines in the industry and expect continued innovation. If you are looking for a meaningful and fulfilling career, we hope that you will consider SMI. Job Summary: As a Project Analyst at SMI, you will play a pivotal role in the successful execution of projects related to payment processing and fintech solutions. You will leverage your expertise in project management and your knowledge of payment processing and/or fintech solutions to ensure projects are completed on time, within scope, and to the highest quality standards. The role will report to the Vice President of Project Management. Key Functions/ Basic Duties: Project Planning and Execution: Help lead projects and initiatives, managing business requirements, timing, risks, issues, decisions, interdependencies, and milestones. Develop comprehensive project plans, defining scope, objectives, deliverables, and timelines. Lead cross-functional teams to execute projects efficiently and effectively. Payment Processing and Fintech Expertise: Leverage your knowledge of payment processing and/or fintech solutions to provide insights, guidance, and solutions to project challenges. Ensure compliance with industry standards and regulations. Resource Management: Manage project resources effectively, including team members, budgets, and technology resources, to meet project goals. Risk Management: Identify project risks and develop mitigation strategies. Proactively address issues that may impact project success. Stakeholder Communication: Maintain clear and regular communication with stakeholders, including clients, team members, and executives, to provide project updates and ensure alignment with business objectives. Project Documentation: Create and maintain detailed project documentation, including project plans, status reports, and documentation related to payment processing and fintech requirements. Quality Assurance: Ensure project deliverables meet quality standards and adhere to best practices in payment processing and fintech. Project Management Tools: Proficiently use project management tools such as Microsoft Project and Smartsheet to track and manage project progress, tasks, and dependencies. Team Leadership: Mentor and coach team members, fostering a collaborative and high-performance work environment. Education and/ or Experience: Bachelor's degree in a related field (Business, Finance, Computer Science, etc.) Minimum of 3 years of experience in project management, specifically in payment processing and/or fintech. Proven track record of successfully managing complex projects from initiation to completion. Proficiency in project management software, including Smartsheet and Microsoft Project. Strong understanding of payment processing systems, fintech solutions, and relevant industry regulations. Excellent communication, leadership, and problem-solving skills. PMP or other relevant project management certification. Language Skills: Speaks English fluently. Computer Skills: Proficient in MS Office Suite and Smartsheet. We are an Equal Opportunity Employer. We are a Drug-Free Workplace.

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ****************** , and follow us on X or LinkedIn . Reporting to the Executive Director, of IT, ORIC is seeking a strategic and hands-on IT leader to support late-stage Development functions across Clinical, Regulatory, Quality, and Drug Safety. This role will drive digital enablement and compliance for Phase 3 programs, ensuring that systems and processes meet global regulatory standards and are ready for inspection. The ideal candidate will bring deep expertise in Veeva platforms, Computer System Validation (CSV), and regulatory frameworks such as 21 CFR Part 11. By collaborating with stakeholders across Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions, you will ensure data is discoverable, interoperable, and analytics-ready. Job Description IT Business Partnership & Strategy Serve as the primary IT partner for Phase 3 Development functions, aligning technology solutions with business needs. Collaborate with Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions and teams to support digital transformation initiatives. System Ownership & Implementation Lead implementation and optimization of Veeva Vault applications (e.g., Quality Docs, QMS, RIMS). Gather application business requirements and systems goals from business owners and translate them into technical requirements. Oversee system lifecycle management, including upgrades, integrations, and vendor coordination for SAS, Box.com, and Extedo. Collaborate with domain leaders, governance, and platform teams to ensure seamless integration of Developement systems. Compliance & Validation Ensure systems are validated per GxP requirements and compliant with 21 CFR Part 11. Lead the IT GDPR compliance program. Own CSV documentation and audit readiness for IT-supported platforms. Inspection Readiness & Support Partner with QA and Regulatory to prepare for health authority inspections. Provide IT support during inspections, including system demonstrations and documentation. Project & Change Management Lead cross-functional projects from concept through deployment. Manage change control processes and ensure stakeholder alignment. Manage the UAT planning, execution, and reporting. Qualifications Bachelor's or Master's degree in Computer Science, Life Sciences, or related field. 8+ years of experience in IT supporting development functions in the biopharma industry. Strong knowledge of Veeva Vault applications and their configuration. Proven experience with CSV, GxP systems, and 21 CFR Part 11 compliance. Familiarity with Phase 3 clinical trial operations and regulatory submission processes. Good understanding of industry data standards (CDISC, MedDRA, HL7, etc.). Experience in R&D data domains and lifecycle. Excellent communication, stakeholder management, and problem-solving skills. Preferred Experience: Experience supporting global clinical trials and regulatory submissions. Prior involvement in inspection readiness or direct participation in regulatory audits. Knowledge of Quality Management Systems (QMS). Additional Information The anticipated salary range for candidates who will work in our San Diego location is between $200,000-$250,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc. ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn. Reporting to the Executive Director, of IT, ORIC is seeking a strategic and hands-on IT leader to support late-stage Development functions across Clinical, Regulatory, Quality, and Drug Safety. This role will drive digital enablement and compliance for Phase 3 programs, ensuring that systems and processes meet global regulatory standards and are ready for inspection. The ideal candidate will bring deep expertise in Veeva platforms, Computer System Validation (CSV), and regulatory frameworks such as 21 CFR Part 11. By collaborating with stakeholders across Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions, you will ensure data is discoverable, interoperable, and analytics-ready. Job Description * IT Business Partnership & Strategy * Serve as the primary IT partner for Phase 3 Development functions, aligning technology solutions with business needs. * Collaborate with Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions and teams to support digital transformation initiatives. * System Ownership & Implementation * Lead implementation and optimization of Veeva Vault applications (e.g., Quality Docs, QMS, RIMS). * Gather application business requirements and systems goals from business owners and translate them into technical requirements. * Oversee system lifecycle management, including upgrades, integrations, and vendor coordination for SAS, Box.com, and Extedo. * Collaborate with domain leaders, governance, and platform teams to ensure seamless integration of Developement systems. * Compliance & Validation * Ensure systems are validated per GxP requirements and compliant with 21 CFR Part 11. * Lead the IT GDPR compliance program. * Own CSV documentation and audit readiness for IT-supported platforms. * Inspection Readiness & Support * Partner with QA and Regulatory to prepare for health authority inspections. * Provide IT support during inspections, including system demonstrations and documentation. * Project & Change Management * Lead cross-functional projects from concept through deployment. * Manage change control processes and ensure stakeholder alignment. * Manage the UAT planning, execution, and reporting. Qualifications * Bachelor's or Master's degree in Computer Science, Life Sciences, or related field. * 8+ years of experience in IT supporting development functions in the biopharma industry. * Strong knowledge of Veeva Vault applications and their configuration. * Proven experience with CSV, GxP systems, and 21 CFR Part 11 compliance. * Familiarity with Phase 3 clinical trial operations and regulatory submission processes. * Good understanding of industry data standards (CDISC, MedDRA, HL7, etc.). * Experience in R&D data domains and lifecycle. * Excellent communication, stakeholder management, and problem-solving skills. Preferred Experience: * Experience supporting global clinical trials and regulatory submissions. * Prior involvement in inspection readiness or direct participation in regulatory audits. * Knowledge of Quality Management Systems (QMS). Additional Information The anticipated salary range for candidates who will work in our San Diego location is between $200,000-$250,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc. ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.

ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients' lives by Overcoming Resistance In Cancer. ORIC's clinical stage product candidates include (1) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib (ORIC-114), a brain penetrant inhibitor that selectively targets EGFR exon 20, HER2 exon 20 and EGFR atypical mutations, being developed across multiple genetically defined cancers. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to ******************* and follow us on X or LinkedIn. Reporting to the Executive Director, of IT, ORIC is seeking a strategic and hands-on IT leader to support late-stage Development functions across Clinical, Regulatory, Quality, and Drug Safety. This role will drive digital enablement and compliance for Phase 3 programs, ensuring that systems and processes meet global regulatory standards and are ready for inspection. The ideal candidate will bring deep expertise in Veeva platforms, Computer System Validation (CSV), and regulatory frameworks such as 21 CFR Part 11. By collaborating with stakeholders across Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions, you will ensure data is discoverable, interoperable, and analytics-ready. Job Description IT Business Partnership & Strategy Serve as the primary IT partner for Phase 3 Development functions, aligning technology solutions with business needs. Collaborate with Clinical, Safety, Regulatory, Portfolio & Project Management, and other Development functions and teams to support digital transformation initiatives. System Ownership & Implementation Lead implementation and optimization of Veeva Vault applications (e.g., Quality Docs, QMS, RIMS). Gather application business requirements and systems goals from business owners and translate them into technical requirements. Oversee system lifecycle management, including upgrades, integrations, and vendor coordination for SAS, Box.com, and Extedo. Collaborate with domain leaders, governance, and platform teams to ensure seamless integration of Developement systems. Compliance & Validation Ensure systems are validated per GxP requirements and compliant with 21 CFR Part 11. Lead the IT GDPR compliance program. Own CSV documentation and audit readiness for IT-supported platforms. Inspection Readiness & Support Partner with QA and Regulatory to prepare for health authority inspections. Provide IT support during inspections, including system demonstrations and documentation. Project & Change Management Lead cross-functional projects from concept through deployment. Manage change control processes and ensure stakeholder alignment. Manage the UAT planning, execution, and reporting. Qualifications Bachelor's or Master's degree in Computer Science, Life Sciences, or related field. 8+ years of experience in IT supporting development functions in the biopharma industry. Strong knowledge of Veeva Vault applications and their configuration. Proven experience with CSV, GxP systems, and 21 CFR Part 11 compliance. Familiarity with Phase 3 clinical trial operations and regulatory submission processes. Good understanding of industry data standards (CDISC, MedDRA, HL7, etc.). Experience in R&D data domains and lifecycle. Excellent communication, stakeholder management, and problem-solving skills. Preferred Experience: Experience supporting global clinical trials and regulatory submissions. Prior involvement in inspection readiness or direct participation in regulatory audits. Knowledge of Quality Management Systems (QMS). Additional Information The anticipated salary range for candidates who will work in our San Diego location is between $200,000-$250,000 . The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the title, type and length of experience within the job, type and length of experience within the industry, education, etc. ORIC Pharmaceuticals, Inc. is an equal opportunity employer. ORIC does not discriminate based on race, color, religion, gender, sexual orientation, gender identity, age, national origin, disability status, protected veteran status, or any other legally protected characteristics.

We are seeking a Steel Project Manager for a direct hire, long-term opportunity in Fresno, CA. Overview: Overseeing structural steel projects from fabrication to erection. Projects: Commercial retail and public works Pay: $120-150K, plus a generous yearly discretionary bonus Schedule: Mon-Friday (8 am to 5 pm) Benefits: Vehicle allowance or company-provided vehicle, 401K match at 4%, medical, dental, and vision benefits and more! Travel: Only to the projects in California. Travel to remote job sites may be required; occasional overnight stays depending on project location Relocation: Relocation assistance is available for the ideal candidate Key Responsibilities for Steel Project Manager: Contract Review & Interpretation - Review and interpret contract documents, plans, and specifications. Scheduling - Develop and align project schedules with structural steel fabrication and erection sequences. Relationship Management - Build and maintain relationships with superintendents, managers, erectors, and vendors. Submittals & Documentation - Facilitate, review, and submit project submittals, RFIs, change orders, and invoices. Shop Drawings - Create and review hand shop drawings when required. Field Coordination - Conduct field measurements as needed; develop site-specific erection procedures and plans. Procurement & Job Buyout - Oversee buyouts and coordinate fabrication, delivery, and installation with shop and field personnel. Cost Control - Monitor project budgets, track job costs, and provide timely reports. Software Integration - Utilize Tekla EPM and Procore to manage workflow, costs, and communication. Meetings- Attend job kick-off meetings. Qualifications for Steel Project Manager: 5+ years of relevant experience, with a strong background in structural steel project management. Office experience in the field of Architecture, Engineering, or Construction Preferred Ability to operate common office software programs, including Microsoft Office products (e.g., Word, Excel, Outlook), Adobe Acrobat, Procore, and Construction Partner. Knowledge of office management systems and procedures Excellent time management skills and ability to multitask and prioritize work If you are interested in learning more about this role, please submit your resume for immediate consideration! Feel free to text “Steel” to ************ for faster response. INDH

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented Regulatory CMC Project Manager to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed. Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards. Health Authority Engagement: Support the preparation of materials for health authority engagements Qualifications: Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management). 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). Strong project management skills with a track record of managing complex projects and meeting deadlines. Excellent organizational and communication skills. Excellent time management abilities Proficient in Microsoft Office Suite Proven experience with project management software ie. Smartsheet Strong communication and interpersonal skills Ability to work collaboratively in a fast-paced, dynamic environment. Additional Requirements: Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones #LI-LB1 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.

Why PRECISIONeffect? When you love what you do, it won't feel like work. Who says your calling and career have to be mutually exclusive? People who join us at PRECISIONeffect are drawn to our agency because of their passion for and commitment to truly cutting-edge and incredible work - they stay for our ethos of wecentricity, the community and collaboration we foster here. Launching clients' treatments. Changing patients' lives. Advancing creativity and strategy, improving results and outcomes. We do our best and most innovative work when it's fueled by purpose and comprised of the unique and varied perspectives and abilities of Effectors across the globe. At PRECISIONeffect, talent is displayed in the work, not flaunted in plumes of conceit. Here, cooperation and wecentricity are what we champion. Are you a self-effacing rock star? A sensible diva? A down-to-earth maestro? Have we got a stage for you. Our people are wildly talented, clever, and inspiring. Who we are: The Project Management team is the engine that keeps the agency machine running. We are strategic problem solvers and communicators that lead cross-functional teams from planning to project delivery. PM's are the barometer for teams, and collaborate with all departments to ensure work is executed on time and on budget, and partner with Account Teams in strategic planning and workflow. We radiate wecentricity and a constructive approach to all work, with a focus on efficiency and effectiveness. Who you are: Project Managers are a problem solvers who bring a skilled team together to ensure the agency successfully executes and delivers to market, within the agreed time and budget. Essential functions of the job include but are not limited to: Project Planning Reporting to and partnering with the Group Project Manager and/or Sr. Project Managers to: Review high-level client, program/campaign and project plan for the year Obtain a clear understanding of client expectations and rules of engagement Develop actionable project plans and vet through key team members Coordinate and collaborate with account leads in developing a plan for new or shifting tactics Review and provide input to project brief, budget, and schedule prior to kickoff Meeting Management Prepare for and lead all internal meetings Provide goals and objectives, pre-meeting Open all meetings with attendees/roles, goals/objectives of the meeting, and materials provided for the meeting Close all meetings with summary of discussion, decisions made, and immediate next steps Facilitate meetings to ensure meeting stays on track and on time Responsible for weekly status of the accounts they work on Workflow/Process Understand and advocate for the workflow process and each team member's role and responsibility within the workflow Review action orders (AOs) to ensure clear and executable direction is provided Lead the online routing of projects, while ensuring quality assurance at each step Maintain WF for all projects responsible for Communications Provide constant communication via teams, workfront, email, phont etc to meet client expectations and deliverables Client expectations and deliverables Resource allocation requirements Advocate for the team while monitoring delivery dates and budget burn Provide alternative solutions to ensure project stays on track Lead teams in clear, constructive, solutions oriented communications Growth/Advancement Opportunities Statement of work (SOW) review and input Research process and industry practices Identify and share best practices Qualifications: Minimum Required: Bachelor's Degree 2 years' direct work experience in a project management capacity, including all aspects of project planning through execution and delivery Other Required: Proficient in MS Office, including MS Project and/or an online project management workflow tool Experienced in digital, print and broadcast production May require travel domestically and/or internationally including overnight stays Preferred: Agency experience preferred. Pharmaceutical exposure desired Competencies: Proactive and effective communicator with multiple team members in varying departments Analytical in thinking (assumptions and risk evaluation) Flexible and agile Collaborative Thorough and efficient in time management Detail Oriented #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$60,000-$90,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. Position Summary: The Project Manager is responsible for overseeing and managing a portfolio of projects, ensuring they align with the Orca Bio's strategic goals. This role will involve project planning, risk mitigation, resource coordination, and communication with stakeholders, along with managing budgets and schedules for multiple projects at a time. This position will work cross-functionally with CMC, Science, Regulatory, Quality, and other key stakeholders as needed to set and track progress against timelines and deliverables. The successful candidate shall be an experienced project manager, with a proven track record of operating in a multidisciplinary, collaborative, fast-paced environment. The Project Manager may take on other projects as assigned. Essential Duties & Responsibilities * Partners with Science, CMC, Quality, Facilities, and Manufacturing, and other client stakeholders as needed to ensure projects are scoped properly, on time, and executed meticulously: * Partners and reports into the PMO function to ensure alignment * Communicates progress to senior leadership on a bi-weekly to monthly basis * Own end-to-end project delivery across internal technical teams and external client implementations: * Ensure an appropriate level of urgency is communicated while maintaining focus on deliverables * Identify potential critical issues, constraints, bottlenecks, risks, and mitigation management (and proposed solutions to support decision-making) across individual programs * Drive decision making processes and escalate issues, as needed * Develop detailed project plans, timelines and resource allocations * Manage meetings, including agenda preparation, meeting facilitation, documentation, and communication (e.g., distribution of minutes) * Maintain project documentation, timelines and KPIs Minimum Experience and Education * Education/Experience: * Bachelor's degree in a life science or related field or equivalent experience * Advanced scientific degree preferred * PMP or other Project Management certification/training preferred * Meaningful prior experience in project management required (e.g. 5+ years); advanced degree may substitute for years of experience * Communication: * Persuasively convey ideas and suggestions for forward momentum * Skilled at translating regulatory, operational, and business knowledge into effective implementation plans and strategies * Comfortable with negotiation and challenging the status quo and bringing forward innovative solutions * Knowledge Base: * Experience in GMP Quality in the biopharmaceutical or related industry * Knowledge of regulatory guidelines for drug development functions (ICH and FDA) * Organizational: * Strong attention to detail * Propensity to document at the right level * Able to identify roadblocks and provide direction to teams to explore alternatives * Technical: * Applies scientific principles to assess issues, request and collect relevant information, analyze data, establish facts, and draw valid conclusions * Understand and edit SOPs * Expert with Microsoft Project (MPP) or Smartsheet Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn't been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren't afraid to ask "why not" and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We're proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.

Eurofins Scientific is a network of independent companies 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 laboratories work to ensure the products they supply are safe, their ingredients are authentic, and labelling is accurate. Eurofins is dedicated to delivering testing services that contribute to the health and safety of society and the planet, and to its corporate responsibility to protect the environment and ensure diversity, equity, and inclusion across the entire network of Eurofins companies. With over 50 laboratories and more than 40 service centers nationwide, Eurofins Environment Testing provides full-service environmental analysis across all 50 states. Our network supports public and private clients-including DoD, DOE, and municipalities-through robust logistics and continuous investment in people, technology, and infrastructure. We offer comprehensive testing for air, water, soil, sediment, tissue, and waste, covering a wide range of analytes including PFAS, metals, VOCs/SVOCs, dioxins/furans, radiochemicals, and more. Job Description Eurofins Environment Testing Southwest is seeking an Assistant Project Manager for our Tustin location. The Assistant Project Manager will support client services and the Project Manager to assist in communicating client expectations, and data or quality concerns and fosters and develops client relationships in support of the laboratory mission. Essential Duties and Responsibilities * Ability to work within the LIMS and create/edit EDDs * Regular attendance and punctuality to support client service * Responsible for daily review of work order logins/acknowledgements * Maintain customer data base in LIMS, ensure projects are updated, all info in the LIMS is accurate and useful * Work with Project Manager to set up projects, bottle orders, invoices * Attend department meetings and participate fully * Answer phones when needed and back up other assistants * Conducts all activities in a safe and efficient manner and aligned to company health and safety policy, as amended from time to time and in compliance with Eurofins Eaton quality standards. * Performs other duties as assigned Qualifications * BS in a science field or working toward a degree * Demonstrated commitment to availability to clients by presence and timely response * Demonstrated ability for ongoing focus on client satisfaction by meeting expected turnaround times and managing personal backlog * Ability to work with Project Manager to communicate client expectations, and data or quality concerns * Organized and ability to multi-task * Basic technical understanding of many aspects of the laboratory, regulatory requirements, and specific method requirements * Basic understanding of the laboratory business and inter-departmental relationships * Requires judgment or initiative in resolving issues and making recommendations * Requires excellent verbal and written communication skills * Requires attention to details and good documentation skills * Must have computer (Word, Excel) and office related skills * Authorization to work in the United States indefinitely without restriction or sponsorship * Professional working proficiency in English is a requirement, including the ability to read, write and speak in English Additional Information The compensation range for this position is $18.00 - $22.00 per hour depending on level of experience. Position is full-time and candidates must be able to work one of the following shifts with possible overtime and weekends as needed: * Monday - Friday, 8:30am - 5:30pm or * Monday - Friday, 10:00am -7:00pm Eurofins Environment Testing (USA) provides a compensation range for informational purposes, the actual base compensation may vary based upon, but not limited to, relevant experience and skill set, base compensation of internal peers, business sector, and geographic location. We support your development! Do you feel you don't match 100% of the requirements? Don't hesitate to apply anyway! Eurofins companies are committed to supporting your career development. We embrace diversity! Eurofins network of companies believe in strength and innovation through diversity, being an Equal Opportunity Employer. We prohibit discrimination against employees or applications based on gender identity and/or expression, race, nationality, age, religion, sexual orientation, disability, and everything else that makes employees of Eurofins companies unique. Sustainability matters to us! We are well on our way to achieving our objective of carbon neutrality by 2025, through a combination of emission reduction and compensation initiatives. We encourage our laboratory leaders to make sustainable changes at their local level, and in addition to their initiatives we also count on our dedicated carbon reduction team to help us to achieve this goal! Find out more in our career page: ***************************** Company description: 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 laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in discovery pharmacology, forensics, advanced material sciences and agroscience contract research services. It 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. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products. In over 35 years, Eurofins has grown from one laboratory in Nantes, France to 61,000 staff across a decentralised and entrepreneurial network of ca. 900 laboratories in 61 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products. In 2024, Eurofins generated total revenues of EUR 6.515 billion, and has been among the best performing stocks in Europe over the past 20 years. All your information will be kept confidential according to EEO guidelines. Eurofins USA Environment Testing is a Disabled and Veteran Equal Employment Opportunity employer.

We recognize and reward top talent. If you are looking for a team environment where you can also make an individual contribution and are seeking opportunities for continual learning/advancement, we encourage you to apply today! The Project Manager is responsible for the oversight and taking a lead role in planning, executing, monitoring, controlling, and completing assigned projects including the Workforce Grant as well as any other assigned projects given by the Clinic Senior Directors. The Project Manager works in collaboration with the Clinic leadership team to identify the project goals, objectives, and scope and creates a plan that outlines the tasks, timelines and resources required to complete the project. The Project Manager ensures that all projects are completed on time, within scope and within budget. The Project Manager is an experienced team builder collaborator and leader who can function comfortably in a team environment or independently, and relates well to co-workers, community partners and County representatives. This position requires the ability to multi-task effectively and the ability to manage time with little supervision. The individual in this position must be able to assume a wide range of responsibilities, provide timely responses to requests and deadlines, and work well under pressure. The ideal candidate will take the responsibility to achieve the set goals and has initiative and adapts to change easily. Also is a leader that promotes a culture of safety, empathy, and compassion, encourages staff to be heart centered and authentic. This person is committed to diversity and understands the related issues. Creates and maintains a work environment where differences are valued and encouraged. Requirements: One year of experience managing projects or initiatives on behalf of a program or department. Advanced working knowledge of Microsoft Office Suite (Excel; Word; PowerPoint etc.). Valid California driver's license; current automobile insurance; have and maintain a clean driving record acceptable to the organization's insurance company; have immediate access to his or her vehicle during work hours. Position Location: North Hills, CA Salary Range: $65,000 up to $89,759 per year Penny Lane Centers offers competitive salaries and benefits. Please visit ***************** to see a complete list of perks and benefits. Medical benefits are effective the first of the month upon hire, not to exceed 31 days. Equal Employment Opportunity. Penny Lane is committed to equal employment opportunity. We will not discriminate against employees or applicants for employment on any legally recognized basis (Protected class) including, but not limited to race; religious creed; color; national; origin; ancestry; physical disability; mental disability; medical condition, including genetic characteristics; genetic information; marital status; sex; pregnancy' child birth or related medical conditions; actual or perceived gender; gender identity or expression or sexual orientation. Our management is dedicated to ensuring the fulfillment of this policy with respect to hiring, placement, recruitment advertising, pay and other forms of compensation, training and general treatment during employment.

If you are passionate about regulatory affairs and project management, and are looking for a challenging and rewarding opportunity, we would love to hear from you! Join our dynamic team at Parexel, where we are committed to partnering with our clients to bring new and innovative treatment options to patients. We are currently seeking a dedicated and detail-oriented **Regulatory CMC Project Manager** to join a growing, dedicated client partnership and play a pivotal role in their regulatory affairs department. Key Responsibilities: Collaborative Coordination: Work closely with Regulatory CMC and Technical Development teams to prepare comprehensive tables of contents for CMC/Module 3 submission deliverables. This includes managing start/end timelines, identifying ownership, and tracking deliverables from authorship initiation through to approval, ensuring timely and high-quality submissions. Strategic Planning: Under the guidance of the Regulatory CMC Lead, develop and maintain a high-level global regulatory plan tracker. This tracker will illustrate the timing of key Regulatory CMC activities for the program, ensuring alignment with global regulatory requirements. Project Management: Serve as the project manager for meetings, adhering to best practices for meeting conduct and materials management. Ensure that all meetings are productive and that materials are well-organized and effectively managed. Regulatory Support: Assist in the preparation of materials for health authority engagements, ensuring that all documentation is thorough, accurate, and compliant with regulatory standards. Health Authority Engagement: Support the preparation of materials for health authority engagements Qualifications: + Bachelor's degree in a relevant field (e.g., Life Sciences, Regulatory Affairs, Project Management). + 3+ years proven experience in regulatory affairs, particularly in CMC (Chemistry, Manufacturing, and Controls). + Strong project management skills with a track record of managing complex projects and meeting deadlines. + Excellent organizational and communication skills. + Excellent time management abilities + Proficient in Microsoft Office Suite + Proven experience with project management software ie. Smartsheet + Strong communication and interpersonal skills + Ability to work collaboratively in a fast-paced, dynamic environment. Additional Requirements: + Must be able to work East Coast hours, regardless of physical location in Central or West Coast US time zones \#LI-LB1 \#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.

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. Summary of Objective: The Project Manager I is responsible for project management tasks for custom Drug Product (DP) projects that support key clients & internal objectives. Under minimal supervision, this position drives planning, decision-making, develops implementation strategies and leads efforts for projects. This position works with team members to create and maintain project plans and timelines, which may include budget, definition, scope, supply chain management, financial resources allocation, dependencies, and target dates. This position does not have direct supervisory responsibilities but will lead cross functional internal/external project team activities. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Responsible for development of project timelines and tracking of contract deliverables. Hosts project meetings to provide status update to clients and internal cross-functional team members. Communicates effectively with client and across all functional groups so that schedules and scope of the project is clear. Identifies project issues such as resource, technical or scheduling constraints and assists to resolve these issues internally and with external stakeholders by development of risk assessments, summarized options and proposed solutions with impact statements. Responsible for hosting client visits. Responsible for evaluating unexpected deviations that may impact project deliverables or timelines and taking steps to resolve these issues. Ensures that projects are completed on time, within budget and scope, and conforms to predetermined quality standards. Manages customer project according to agreed Project Management methodologies (processes, tools, templates, meetings, etc.). Proactively facilitates the communication and cooperation between the customer and project team members. Tracks and forecasts revenue generating activities of assigned projects. Identifies and actively participates in business improvement programs. Support in establishment of common customer experience across global accounts Collaborates with Sales in building long-term relationships with customers. Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]. Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. At ease and comfortable dealing with ambiguity. Proven ability to manage multiple projects simultaneously. Employee will work with moderate noise level. Employee will perform tasks while experiencing numerous interruptions. Able to work in a highly complex environment with competing demands and priorities. Responsible for communication internally and externally on aspects of assigned tasks or customer projects. This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. Off-shift, weekend and overtime duties may be required. TRAVEL - < 10% Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Bachelor's degree in a life sciences or business discipline required. Master's degree preferred. Minimum of 3 years in Biotech/Pharma or CMO. 0-2 years of experience in Project Management. Strong computer skills, MS Office, MS Word, MS PowerPoint. MS-Project and/or Smartsheet is preferred. Excellent organizational and interpersonal skills. Strong verbal and written communication skills. Highly developed interpersonal skills with the proven ability to function effectively and tactfully with multiple departments and personnel, able to gain consensus and commitment Demonstrated leadership, interpersonal, matrix management, problem solving, and conflict resolution skills. Understanding of biotech or drug product development and of multi-project planning and coordination is required. The base salary hiring range for this position is ($76,000 - $85,500) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). #LI-AK2 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ:For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: **********************************

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients. **We are PCI.** Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI. **Summary of Objective:** The Project Manager I is responsible for project management tasks for custom Drug Product (DP) projects that support key clients & internal objectives. Under minimal supervision, this position drives planning, decision-making, develops implementation strategies and leads efforts for projects. This position works with team members to create and maintain project plans and timelines, which may include budget, definition, scope, supply chain management, financial resources allocation, dependencies, and target dates. This position does not have direct supervisory responsibilities but will lead cross functional internal/external project team activities. **Essential Duties and Responsibilities:** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. + Responsible for development of project timelines and tracking of contract deliverables. + Hosts project meetings to provide status update to clients and internal cross-functional team members. + Communicates effectively with client and across all functional groups so that schedules and scope of the project is clear. + Identifies project issues such as resource, technical or scheduling constraints and assists to resolve these issues internally and with external stakeholders by development of risk assessments, summarized options and proposed solutions with impact statements. + Responsible for hosting client visits. + Responsible for evaluating unexpected deviations that may impact project deliverables or timelines and taking steps to resolve these issues. + Ensures that projects are completed on time, within budget and scope, and conforms to predetermined quality standards. + Manages customer project according to agreed Project Management methodologies (processes, tools, templates, meetings, etc.). + Proactively facilitates the communication and cooperation between the customer and project team members. + Tracks and forecasts revenue generating activities of assigned projects. + Identifies and actively participates in business improvement programs. + Support in establishment of common customer experience across global accounts + Collaborates with Sales in building long-term relationships with customers. + Regular and reliable attendance on a full-time basis [or in accordance with posted schedule]. + Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices. **Work Environment:** The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + At ease and comfortable dealing with ambiguity. + Proven ability to manage multiple projects simultaneously. + Employee will work with moderate noise level. + Employee will perform tasks while experiencing numerous interruptions. + Able to work in a highly complex environment with competing demands and priorities. + Responsible for communication internally and externally on aspects of assigned tasks or customer projects. + This position has the utmost responsibility for compliance with the rules and regulations regarding a safe and healthy work environment relative to their actions and conduct. + Off-shift, weekend and overtime duties may be required. + **_TRAVEL -_** < 10% **Qualifications:** The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. + Bachelor's degree in a life sciences or business discipline required. Master's degree preferred. + Minimum of 3 years in Biotech/Pharma or CMO. 0-2 years of experience in Project Management. + Strong computer skills, MS Office, MS Word, MS PowerPoint. MS-Project and/or Smartsheet is preferred. + Excellent organizational and interpersonal skills. Strong verbal and written communication skills. + Highly developed interpersonal skills with the proven ability to function effectively and tactfully with multiple departments and personnel, able to gain consensus and commitment + Demonstrated leadership, interpersonal, matrix management, problem solving, and conflict resolution skills. + Understanding of biotech or drug product development and of multi-project planning and coordination is required. The base salary hiring range for this position is ($76,000 - $85,500) plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), flexible spending account, and 401(k). \#LI-AK2 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (***************** **Equal Employment Opportunity (EEO) Statement:** _PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._ _At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture._ IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ: For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: ********************************** Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled