28 jobs found

WHO WE ARE As the nation's largest producer of clean, carbon-free energy, Constellation is focused on our purpose: accelerating the transition to a carbon-free future. We have been the leader in clean energy production for more than a decade, and we are cultivating a workplace where our employees can grow, thrive, and contribute. Our culture and employee experience make it clear: We are powered by passion and purpose. Together, we're creating healthier communities and a cleaner planet, and our people are the driving force behind our success. At Constellation, you can build a fulfilling career with opportunities to learn, grow and make an impact. By doing our best work and meeting new challenges, we can accomplish great things and help fight climate change. Join us to lead the clean energy future. TOTAL REWARDS Constellation offers a wide range of benefits and rewards to help our employees thrive professionally and personally. We provide competitive compensation and benefits that support both employees and their families, helping them prepare for the future. In addition to highly competitive salaries, we offer a bonus program, 401(k) with company match, employee stock purchase program comprehensive medical, dental and vision benefits, including a robust wellness program paid time off for vacation, holidays, and sick days and much more. Expected salary range of $146,700 to $163,000, varies based on experience, along with comprehensive benefits package that includes bonus and 401(k). PRIMARY PURPOSE OF POSITION Performs advanced regulatory/technical problem solving and provides analysis/insights in support of nuclear plant operations. Responsible for regulatory/technical decisions. Possesses superior knowledge in functional discipline and its practical application and has excellent knowledge of applicable industry codes and regulations. Understands interrelations and functions of various organizations (e.g., NRC, INPO, NEI, etc.) related to nuclear power. Functions with recognized level of expertise in the regulatory area. PRIMARY DUTIES AND ACCOUNTABILITIES (means principal, main, major or most important duties / accountabilities that the employee performs) Item Accountability % 1 Perform advanced regulatory and technical tasks, and provide insights in support of nuclear plant operations. 20 2 Perform independent research, reviews, studies and analyses in support of regulatory/technical projects. 15 3 Provide in-depth regulatory/technical expertise to develop, manage and implement regulatory activities related to plant safety, reliability, maintainability, and availability ensuring compliance to customer's needs, regulatory requirements, and corporate policies. 15 4 Accountable for the accuracy, completeness, and timeliness of work ensuring proper licensing basis management and assuring that standard design criteria, practices, procedures, regulations and codes are used in preparation of products. 15 5 Provide regulatory/technical expertise and consultation through direct involvement to identify and resolve regulatory issues. 10 6 Provide initial or complete task management of regulatory issues. 5 7 Recommend new concepts and techniques to improve performance, simplify operation, reduce costs, reduce regulatory burden, correct regulatory non-compliances, or comply with changes in codes or regulations. 5 8 Support resolution of regulatory issues associated with plant design modifications, testing and problem solving. 5 9 Assure all regulatory products prepared or overseen are in accordance with applicable procedures, licensing basis, industry codes, and all regulatory requirements. 5 10 Perform ERO role and maintain qualifications as an active member of the ERO. 5 MINIMUM QUALIFICATIONS Minimum: BS Engineering or equivalent technical degree Minimum 10 years professional experience and exceptional performance (e.g., rated in upper quartile for last 2 years) Superior regulatory/technical expertise in a specific area (e.g., licensing actions, reportability, performance improvement, etc.) and recognized regulatory resource (internal/external) Effective written and oral communication skills Approval of VP Licensing & Regulatory Affairs required to obtain this classification (and recommendation of Licensing Page 1 of 2 L:\Title and Description Alignment\REG & LICENSING\2007 Licensing_NEW\2007 Sit Reg Assur_NEW\XLAH_Prin_Regulatory_Engineer_9107.doc Manager/Director/Regulatory Assurance Manager and Site Vice President, as applicable) PREFERRED QUALIFICATIONS Preferred: Previous SRO license/certification Advanced technical degree or related coursework Page 1 of 2 L:\Title and Description Alignment\REG & LICENSING\2007 Licensing_NEW\2007 Sit Reg Assur_NEW\XLAH_Prin_Regulatory_Engineer_9107.doc Manager/Director/Regulatory Assurance Manager and Site Vice President, as applicable)

Position Title:Adjunct Instructor - Orthotics and ProstheticsJob Description:POSITION: ADJUNCT INSTRUCTOR (Orthotics and/or Prosthetics) STATUS:Part time DEPARTMENT: Health and Public Services DIVISION: Academic Affairs CLASSIFICATION: Exempt UNION: Adjunct Faculty REPORTS TO: Department Chair PLACEMENT: Faculty Hiring Rate Per Contact Hour: Fall 2024 to Summer 2025: $1005.00 if candidate holds a Bachelor's or Master's degree and $1056.00 if candidate holds a Ph.D, Ed.D, or J.D. Hiring Rate Per Contact Hour: Fall 2025 to Summer 2026: $1030.00 if candidate holds a Bachelor's or Master's degree and $1082.00 if candidate holds a Ph.D, Ed.D, or J.D. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The student population at the college is diverse in ethnicity, gender, language, age and background. Joliet Junior College is an AA/EO employer and strongly encourages applications from candidates who would enhance the diversity of its staff. POSITION SUMMARY An adjunct community college instructor is an instructor hired for one week, a few weeks, a month or semester to teach one or more courses for which he/she is qualified to teach. The adjunct instructor reports to the appropriate Instructional Coordinator and/or Director; provides quality instruction for the assigned courses. The instructor works with full-time faculty in assessing students and following all course guidelines. Position is subject to all terms and provisions of the Joliet Junior College adjunct faculty contract. ESSENTIAL DUTIES: 1. Course load of no more than 12 contact hours in appropriate instructional area. 2. Participate in annual student and chair/coordinator evaluations. 3. Comply with departmental curriculum, grading standards, attendance policies, textbook choices, and assessments, and other established processes. 4. Attend classes regularly; return college reports, credentials, and other requested documentation in a timely manner; effectively communicate with appropriate staff and director. 5. Comply with all legal and ethical obligations, including FERPA, ADA, and other regulatory legislations. Communicate discrepancies to appropriate officials. 6. Commit to furthering the mission, goals, and core values of the college at all times. 7. Meet other contractual obligations as spelled out in the Joliet Junior College adjunct faculty contract. MINIMUM QUALIFICATIONS 1. Orthotic and/or Prosthetic Technician with three (3) years of experience. 2. Expertise in appropriate technologies for instruction. 3. Demonstrated commitment to teaching and learning. 4. Ability to establish and maintain cooperative and effective working relationships with other members of the college and community, displaying cultural competence as well as emotional intelligence. 5. Demonstrate commitment to the college's core values of respect and inclusion, sustainability, integrity, collaboration, humor and well-being, innovation and quality PREFERRED QUALIFICATIONS 1. Certified Technician or Clinician by the American Board for Certification in Orthotics and Prosthetics. 2. Experience at the community college level. 3. Experience with traditional and non-traditional students from diverse backgrounds. 4. Experience in teaching online and/or using course management programs. 5. Experience in course development and assessment, planning, quality and accreditation processes, and committee service. 6. Experience with traditional and non-traditional students from diverse backgrounds. 7. English and Spanish verbal and written communication proficiency. 8. Demonstrated multicultural competence. PHYSICAL DEMANDS 1. Standard classroom equipment and software. 2. The ability to work with the equipment and tools necessary for the lab portion of the class. WORKING CONDITIONS 1. Classroom teaching environment. 2. Lab environment for the lab portion of the class. Full Time/Part Time:Part timeUnion (If Applicable):Scheduled Hours:0 Benefits Click on the link below for information about JJC's Benefits: Total Rewards Joliet Junior College

Job Description: Primary Responsibility The Program Director is responsible for the administration and leadership of the CLETA program and oversees faculty and all aspects of the program. Under the supervision of the Dean of Allied Health, Public Safety, Wellness and Outdoor Studies, the Program Director for CLETA is responsible for providing general oversight of program offerings at multiple campuses, to include responsibility for structured guidance around consistency of practices in risk management in the Training Academy across the college. The Program Director provides instructional and administrative leadership and support to the program and all related areas of the College. This position reports directly to the Dean of Allied Health, Public Safety, Wellness and Outdoor Studies, and works directly with faculty and collaboratively with the campus academic and student affairs supervisors. Responsibilities include but are not limited to: ensuring that offerings of the program articulate with CMC's mission, vision, strategic plan and institutional learning outcomes as well as state and national standards; handling budget, hiring and support of faculty, coordination of program accreditation applications/renewals and program activity reporting, leading program advisory committee meetings, outreach, marketing, & recruiting activities, and program assessment. The program director provides instructional and administrative leadership and support to the assigned program areas college wide. This position assists (as needed) with recruiting, contracting, orientations, and evaluations of instructors; facilitates with the instructional design of schedules for courses; curriculum and catalog updates; works with faculty across the college to ensure consistency of curricular and learning outcomes for students; manages all aspects of the program budgets to comply with CMC standards; attends program advisory committee meetings for the disciplines, and coordinates program and discipline assessment. In conjunction with college leadership and designated campus VPs, the program coordinator also serves as a liaison with relevant external agencies in the CMC service area to ensure compliance with regulatory matters and ensures the programs meet the needs of the communities served. With regard to instructional risk management practices, this position will be responsible for developing, evaluating, and maintaining consistent risk management policies and procedures, in conjunction with the Risk Management office, faculty, and instructional leadership across the college. Risk Management duties for CLETA courses will include identifying, measuring, and making decisions on operational risks. They will also be responsible for analyzing, developing, and maintaining contingency plans to deal with emergencies in the instructional spaces across the CLETA programming. This program director is a year-round administrative, non-faculty, staff position. The incumbent must be qualified to be credentialed to teach in the assigned areas, however, is not assigned a faculty rank. This position will have teaching assignments, as well as oversight during guest lecturers, community member presentations, and some adjunct lead instruction times. Pre-requisites for Position (Qualifications Standards) Education and experience sufficient for the rigors of the position required. Qualified candidates must be credentialed to teach in the program, or eligible to be credentialed to teach in the program. Examples of idea qualifications include a minimum of a Bachelor's degree or equivalent in Public Safety, Public Administration, Law Enforcement or related fields from an accredited college or university and two years' experience 4,000 hours verifiable work experience within the last 7 years) in one of the above listed fields; or equivalent combination of education and experience. Experience with, and demonstrated sensitivity to an understanding of, the diverse academic, social, economic, cultural, ability, and ethnic backgrounds of community college students. Teaching Experience: One-year full-time teaching experience or equivalent as part time instructor. Preferred Qualifications: Master's Degree in Criminal Justice, Police Science, Public Safety, Public Administration, Law Enforcement related fields from an accredited college or university Experience in teaching, training, and leadership in the field of law enforcement. Experience as a community college instructor in one or more law enforcement related disciplines. Management experience in public safety/law enforcement Higher education teaching and administration experience is preferred. A candidate with full-time higher education teaching experience is preferred. Special Skills or Attributes: Colorado Peace Officer Standards and Training (P.O.S.T) certified or completion of P.O.S.T. certification within the first 6 months of employment required; P.O.S.T. supervisory experience in law enforcement and instructor certification in one or more of the three P.O.S.T. skill areas preferred. Valid Colorado driver's license required. Welcoming. Innovative. Focused on Student Success. These principles reflect the soul of CMC. They guide us in building our teams, cultivating leaders, and expanding our approaches and mindset. They guide us to be an institution of higher education that's the right fit for every faculty member, staff, student, and community member in its trust. Applicants must demonstrate a commitment to working effectively with students, employees, and community members of all backgrounds. Bilingual (English/Spanish) or conversational language abilities preferred. Hiring range = $106,670.61 - $118,522.89 annual salary depending upon a combination of education and experience. Benefits include Medical, Dental, Vision, Life Insurance, Pet insurance, retirement contribution, tuition reimbursement, annual & sick time, mental health resources, healthy lifestyle benefits, affordable transitional housing may be available to the successful candidate based on eligibility and availability, relocation if applicable. CMC utilizes a wage progression compensation model that accounts for a candidate's skill and experience. Although a salary range is listed, salary will be set commensurate with the successful candidate's qualifications and in compliance with the Equal Pay for Equal Work Act. Position anticipated to close on March 3, 2025 or until filled. Minimum Qualifications: Essential Duties The percentages noted below represent anticipated averages. Program oversight and administration (60%): Leadership of the CLETA program along with general administration/oversight of assigned areas and functions. 1. Oversee department and program in compliance with college, state and national expectations. 2 Ensure consistency and integrity of the program curriculum across all locations offered, and that program contracts are current across all campuses. 3. Support all instructors in establishing an effective classroom instructional environment that accommodates diverse learning styles and promote inclusion from culturally diverse groups. Maintains accurate up-to-date instructor files to ensure an adequate pool of instructors and for state inspection. Teaches academy classes as needed, to include required academic and skills related training. 4. Manage program review process including curriculum, contracts, accreditation standards, applications, renewals, annual reporting, and assessment (e.g., syllabus course review). 5. Coordinate department budget including grants, course and program fees with campus and school leadership. 6. Program Administration Ensure quality and consistency or program delivery, college-wide, by sharing exemplar course plans with adjunct and full time faculty and managing the curriculum library for the discipline. Supervise the process for faculty recruiting, hiring, credentialing, evaluation and support/mentoring. Coordinate scheduling of curriculum, including lectures, labs, and clinical/internships for the program college-wide, and in conjunction with the school dean and campus leadership. Ensure all programs, services, and functions comply with federal, state, and local codes, legal mandates, contracts, rules, regulations, ordinances, and required procedures of POST and other regulatory agencies, and CMC policies and procedures. Prepares the academy training schedule each semester and submits the schedule to Colorado P.O.S.T. for approval. Monitors both academy academic and skill testing procedures. Seeks P.O.S.T. approval of any new or proposed training sites and maintains previous site approvals. Assesses equipment in the program and organizes maintenance and replacement as needed in accordance with college policies and procedures. Develop, implement, and adhere to the CMC police academy budgets and manage all financial resources consistent with CMC policy. Establish and maintain records that includes enrollment rosters, POST form 11-Es, trainee files, trainee manuals, attendance records, lesson plans, source material, instructor files, instructor course evaluations, and site safety plans. Attend professional conferences, meetings, and workshops to stay current on public safety issues and curricula. Prepare all necessary internal and external reports to maintain accreditation and meet standards of program operation. . click apply for full job details

Position Title:Adjunct Instructor, Architecture and ConstructionJob Description:POSITION: ADJUNCT INSTRUCTOR (AEC: Architecture and Construction) STATUS: Part-time DEPARTMENT: Technical DIVISION: Academic Affairs CLASSIFICATION: Exempt UNION: Adjunct Faculty REPORTS TO: Department Chair PLACEMENT: Faculty Hiring Rate Per Contact Hour: Fall 2024 to Summer 2025: $1005.00 if candidate holds a Bachelor's or Master's degree and $1056.00 if candidate holds a Ph.D, Ed.D, or J.D. Hiring Rate Per Contact Hour: Fall 2025 to Summer 2026: $1030.00 if candidate holds a Bachelor's or Master's degree and $1082.00 if candidate holds a Ph.D, Ed.D, or J.D. Competitive starting pay is dependent on education and experience. JJC offers regular full-time positions a variety of fringe benefits including health insurance, retirement benefits, holidays, personal time, and other discounts/reimbursement for classes Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The student population at the college is diverse in ethnicity, gender, language, age, and background. Joliet Junior College is an AA/EO employer and strongly encourages applications from candidates who would enhance the diversity of its staff. POSITION SUMMARY An adjunct community college instructor is an instructor hired for one semester to teach one or more courses for which he/she is qualified to teach. The adjunct instructor reports to the appropriate Instructional Coordinator and/or Director; provides quality instruction for the assigned courses. The instructor works with full-time faculty in assessing students and following all course guidelines. Willingness to teach at other campus sites is required. Adjunct instructors may submit preferences for locations and loads. Position is subject to all terms and provisions of the Joliet Junior College adjunct faculty contract. Opportunities for daytime courses, to meet immediate needs, are available. ESSENTIAL JOB DUTIES AND KEY RESPONSIBILITIES: 1. Course load of no more than 12 contact hours in appropriate instructional area. 2. Participate in annual student and chair/coordinator evaluations. 3. Comply with departmental curriculum, grading standards, attendance policies, textbook choices, assessments, and other established processes. 4. Attend classes regularly; return college reports, credentials, and other requested documentation in a timely manner; effectively communicate with appropriate staff and director. 5. Comply with all legal and ethical obligations, including FERPA, ADA, and other regulatory legislations. 6. Communicate discrepancies to appropriate officials. 7. Meet other contractual obligations as spelled out in the Joliet Junior College adjunct faculty contract. 8. Ability to establish and maintain cooperative and effective working relationships with other members of the college and community, displaying cultural competence as well as emotional intelligence. 9. Demonstrated commitment to the college's core values of respect and inclusion, sustainability, integrity, collaboration, humor and well-being, innovation, and quality. MINIMUM QUALIFICATIONS 1. Bachelor's Degree in Architecture, Engineering, Construction, or related discipline. Will consider Associates degree with additional work related experience. 2. A minimum of 3 (three) years of related industry work experience. 3. Architectural license required for some ARCH courses. 4. Experience in appropriate technologies for instruction. 5. Knowledge of industry software relevant to the specific course and curriculum. 6. Preferred AutoCAD and Revit to meet immediate course needs. 7. Demonstrated commitment to teaching and learning. PREFERRED QUALIFICATIONS 1. Teaching experience at the collegiate level. 2. Experience at the community college level. 3. Experience with traditional and non-traditional students from diverse backgrounds. 4. Experience in teaching online and/or using course management programs. 5. Experience in course development and assessment, planning, quality and accreditation processes, and committee service. PHYSICAL DEMANDS 1. Standard classroom equipment and software. 2. The ability to work with the equipment and tools necessary for the lab portion of the class. WORKING CONDITIONS 1. Classroom teaching environment. Lab environment for the lab portion of the class. Full Time/Part Time:Part timeUnion (If Applicable):Scheduled Hours:28 Benefits Click on the link below for information about JJC's Benefits: Total Rewards Joliet Junior College

Mammoth BioSciences OPPORTUNITY Mammoth is hiring a(n) (Associate) Director/Sr. Director, Regulatory Affairs, Therapeutics, to lead the regulatory activities of our growing CRISPR-based therapeutic programs as we bring them from concept to market. This role will be responsible for coordinating all aspects of regulatory strategy, interactions, and filings. The (Associate) Director/Sr. Director will oversee and partner with several external consultants in the short term. In the longer term, they will be responsible for building out the regulatory function for the company. This is a leadership position that will play a critical role in the successful development of the Mammoth therapeutic candidates. The role will report into the SVP of Translational Science. KEY RESPONSIBILITIES Lead, define and manage the strategic regulatory direction for Mammoth's pipeline Establish the regulatory pathway to IND filing in complex programs using a novel gene editing technology Collaborate with various regulatory consultants, clinical advisory board members, and board members to maintain regulatory knowledge of US and EU Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities Serve as a liaison between the company and regulatory agencies Maintain real time understanding of Mammoth's target patient population Develop and coordinate high quality submissions for global clinical trials REQUIRED QUALIFICATIONS Bachelor's degree in life sciences Minimum of 10+ years of experience in the biotechnology and/or biopharmaceutical industry (Master's degree with 8+ years of experience or PhD with 6+ years of experience); Sr. Director: Minimum of 12+ years of experience in the biotechnology and/or biopharmaceutical industry (Master's degree with 10+ years of experience or PhD with 8+ years of experience). Minimum of 7 years in a Regulatory capacity with experience in drug development Experience with US and clinical trial submissions through with CBER/OTAT or ex-US equivalent Proven track record with regulatory agencies Strong project management skills and drive for excellence Experience with gene therapy products regulatory requirements Proven success interacting efficiently with Preclinical Research, CMC, and Clinical Ability to be onsite a minimum of 2-3x/ per week from a reasonable commuting distance within the Bay Area PREFERRED QUALIFICATIONS Advanced degree in life sciences Creative problem solver BENEFITS Company-paid health/vision/dental benefits Unlimited vacation and generous sick time Company-sponsored meals and snacks Wellness, caregiver and ergonomics benefits 401(k) with company matching Base Salary Range: $ 205,000 - $260,000 Actual base salary will be determined by relevant professional experience, applicable skills, and internal equity. COMPANY Mammoth Biosciences is a biotechnology company focused on leveraging its proprietary ultracompact CRISPR systems to develop long-term curative therapies, as well as other applications such as decentralized precision diagnostics. Founded by CRISPR pioneer and Nobel laureate Jennifer Doudna and Trevor Martin, Janice Chen, and Lucas Harrington, the company's ultracompact proteins are designed to enable in vivo gene editing in difficult to reach tissues utilizing both nuclease applications and new editing modalities beyond double stranded breaks, including base editing, gene writing, and epigenetic editing. The company is building out its pipeline of potential in vivo gene editing therapeutics and capabilities and has partnerships with leading pharmaceutical and biotechnology companies to broaden the reach of its innovative and proprietary technology. Mammoth's deep science and industry experience, along with a robust and differentiated intellectual property portfolio, have enabled the company to further its mission to transform the lives of patients and deliver on the full promise of CRISPR technologies. It is our policy and intent to provide equal opportunity to all persons without regard to race, color, religion, political affiliation, sex/gender (including gender expression/identity, pregnancy, childbirth and related medical conditions), marital status, registered domestic partner status, sexual orientation, age, ancestry, national origin, veteran status, disability, medical condition, genetic characteristics, and/or any other basis protected by law. This policy covers all facets of employment including, but not limited to: recruitment, selection, placement, promotions, transfers, demotions, terminations, training, and compensation. Mammoth Biosciences requires that all employees be vaccinated against COVID as a condition of at-will employment, with exceptions for medical or religious reasons in compliance with local, state, and federal law. PIbd4f0cf964fb-0164

#RPM Teaching faculty at Guilford Technical Community College are responsible for supporting student success by creating an optimum learning environment, responding to student needs, managing effective instructional activities, developing Emergency Medical Science (EMS) courses, modeling employability skills, demonstrating professionalism, developing cooperative work relationships with other faculty and staff, supporting college administrative requirements, and maintaining competency in their instructional field. He/she will be responsible for quality instruction and for effective participation and interest in the total affairs of the college. The EMS OE Instructor will prepare and teach the non-credit In-Service Training, pre-service EMT training as well as American Heart Association courses and the training in accordance with the requirements of the North Carolina Office of Emergency Medical Science (NCOEMS). This position will support program functions by providing customer service, data support and documentation services. It will also work to maintain program compliance with accreditation standards according to Guilford Technical Community College (GTCC), American Heart Association (AHA), Committee on Accreditation of Educational Programs for the Emergency Medical Services Professions (CoAEMSP), Commission on Accreditation of Allied Health Education Programs (CAHEEP) and Commission on Accreditation for Pre-Hospital Continuing Education (CAPSE). This position reports directly to the Program Director of EMS, with oversight by the Dean of Human Services and Public Safety. Duties/Functions Teaching Prepare & teach departmental courses to include: developing learner centered lesson plans employing teaching strategies & instructional materials for different learning styles incorporating, as pedagogically appropriate, current technology in classroom, distance learning and laboratory environments creating and modeling a quality learning environment that supports a diverse student population preparing, distributing and utilizing instructional support materials, including course syllabi, supplementary materials, instructional media and other devices as appropriate updating and revising curriculum to maintain currency developing new courses as needed to support the instructional mission participating in the development and review of course and program/general education outcomes as appropriate developing, conducting and documenting appropriate assessment of student learning in outcomes courses and programs/general education as appropriate Professional Development Maintain a professional status that supports the instructional mission by: participating in professional development activities to maintain currency in field; maintaining current credentials or licensures as required by program or accreditation participating in professional development opportunities to advance teaching skills and strategies Administration Provide daily & ongoing oversight of facilities, equipment and student records to include: maintaining classroom and laboratory spaces including upkeep of assigned equipment providing for the security of facilities, equipment and instructional materials and maintaining safe working conditions maintaining student records (e.g., grades and attendance) in accordance with established deadlines using a variety of technology-based programs (e.g., Colleague, WebAdvisor, Moodle) complying with all applicable college, state and federal rules and regulations Student Support Provide an environment conducive to student success to include: conducting recruiting activities providing academic advising promoting retention/persistence by assisting students to develop strategies for success assisting students with the registration and graduation process referring students to campus and community resources when appropriate maintain student records College Service Support college-wide endeavors to include: collaboration with faculty and staff from other divisions/departments to promote communication, coordinate schedules and support student success serving on department, division and college committees participating in GTCC institutional initiatives collaborating with educational partners, business/industry and/or external agencies as appropriate to promote the instructional mission of GTCC supporting collegiality and teaching excellence by actively participating in the professional development of new and veteran faculty (e.g., mentoring and peer observation) participating in extracurricular student activities/clubs attending college professional development sessions, college/division/department meetings, graduation and convocation, as required demonstrate and model the Colleges employability skills: adaptability, communication, information processing, problem solving, responsibility and teamwork. perform all duties as assigned by supervisor Difficult Challenges Contacts Education Required Associates degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution North Carolina Paramedic Credential North Carolina Level I Emergency Medical Technician (EMT) Instructor Certification or the ability to obtain it within one year of hire. Valid North Carolina Drivers License Education Preferred Bachelors degree in Emergency Medical Science (EMS) or closely related field from a regionally accredited post-secondary institution American Heart Association Basic Life Support (BLS), Advanced Cardiac Life Support (ACLS) and/ or Pediatric Advanced Life Support (PALS) Instructor Certification North Carolina Level I Paramedic Instructor Certification Experience Required Three years of relevant or closely related field experience in Emergency Medical Science (EMS) One year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Experience Preferred Greater than three years of relevant field experience in Emergency Medical Science (EMS) or closely related career field Greater than one year of Emergency Medical Science (EMS) training/teaching experience based on regulatory training standards in any of the following formats: teaching courses, training sessions, conducting professional development workshops, and/or other continuing education seminars. Post-secondary teaching experience Experience with assessment of student learning outcomes KSA Required The Instructor shall possess an understanding of and commitment to the nature and role of the Community College, particularly its open door policy. He/she shall have demonstrated personal and professional competence for the responsibilities assigned. The Instructor must be able to: 1. Multi-task 2. Respect Diversity 3. Adapt to changing procedures, protocols or assignments. 4. Create and maintain a learner centered environment 5. Communicate effectively 6. Ability to effectively implement and apply technology solutions KSA Preferred Department/Job Specific Requirements Physical Requirements Hear and see Stand extended periods of time (up to 4 hours) Lift up to 50 pounds unassisted. Stoop, bend, squat, lift, reach overhead Use and manipulate EMS equipment according to industry standards Participate in and demonstrate physical aspects of EMS work and physical training The following (compliance) training is required and must be completed within the first 30 days of hire with annual refresher training thereafter: (additional training may be added as needed) Reporting Requirements Anti-Discrimination/Harassment & Title IX Safety/Shooter on Campus Personal Information Protection Training (PIP) Ethics and Social Responsibility eLearning Level One (before the first day of the first semester teaching) eLearning Levels Two and Three for instructors who teach online or hybrid delivery methods (before the first day of the first semester teaching) Physical Demands Physical Activity:Long periods of standing and or walking Environmental Hazard(s):30-70% Lifting:=>50lbs. Criminal history checks with acceptable results, are required. Posting Type Faculty recblid wlec6xqxkvpoxrp5yduinyt3ga15sc

SPIRIT OF AMERICA FEDERAL CREDIT UNION General Summary: Responsible for Credit Union Accounting Records; Reporting to Government Agencies and Vendors; Liaison to Data Processor; Security; Regulatory Compliance. Credit Union experience (or financial institution) Required for Experience. Responsible for assisting the Credit Union President/C.E.O. in the overall "management" of the Credit Union assets. Essential Functions 1. Assist the President with projects, new services, obtaining bids, and so forth. 2. Ensure that the President is kept fully informed on the conditions and operations of the Credit Union, and of all important factors influencing them. 3. Assist in the development, implementation and maintenance of operational procedures to maximize efficiency and quality of work, and to provide consistent quality service to members. 4. Assume all responsibilities of the Credit Union President/CEO in his/her absence. 5. Prepare or responsible for overseeing the preparation of monthly, quarterly and annual financial and statistical reports for the President and Board of Directors. 6. Prepare for review by President and approval by the Board of Directors the Budget for the Credit Union which is consistent with the overall strategic plan. To implement and oversee the Budget after approval. 7. Security Officer of the Credit Union. 8. Serve as Bank Secrecy Act Compliance Officer, NMLS (National Mortgage Licensing System), responsible for Truth in Savings and other Regulatory compliance. Annual Federal Reserve Report - Reg D - Form 2910a. NMLS (Nationwide Mortgage Licensing System) - Registration for new and renewal of staff and so forth. 9. Ensure that the Credit Union is in compliance with state and federal laws and regulations as established by the National Credit Union Administration (NCUA), the Nebraska Department of Banking and Finance, FFIEC, and other regulatory agencies. 10. Act on Credit Union investments as a member of the Investment Committee. Obtain together information from the various Board approved investment vendors and also direct investments to include the investment maturity ladder for decision making. 11. Assist President in preparing weekly staff meetings. 12. Assist the President with the replenishment and verifying cash for MSR and MSR/Clerk cash drawers. Replenish and verify safe totals with the President or PAR with Supervisory Authority. 13. Balance previous day's business cash to GL balance; Review daily reports - Large Member Checks clearing; Cash transaction register; Override; Undo and Dormant Account reports; Loan maintenance; Make daily cash flow projection; Post Hold files and so forth. 14. Balance Millennium Corporate statements on a weekly basis. 15. Prepare Employee Retirement Plan reporting for 401(k) and Defined Benefit. 16. Responsible for insurance paperwork to include: Maintaining records for life insurance, long term disability, health and dental. Make insurance disbursements and premium collections for health, life and long-term disability including wrap and summary of benefits for employees. 17. Responsible for the Credit Union's Bond and Casualty Insurance to include: questionnaires, reporting and bond claims. Completes CUNA Mutual Group bond renewal with President. 18. Take action on returned NSF checks deposited to member accounts. 19. Prepare quarterly reports for federal withholding, unemployment compensation, etc. 20. Prepare the quarterly Call Report for NCUA. 21. Prepare Annual 945 Report. 22. Attend Board of Director's monthly meetings and take minutes for the Board secretary. 23. Prepare and/or verify employee and vendor annual W-2's, 1099 MISC and so forth for year-end reporting. 24. Seek legal counsel in processing member POA, Trusts, Guardianship and Conservative accounts. In charge of deceased member accounts. Get appropriate documents, contact joint owners, seek legal counsel as needed and so forth. 25. File the unclaimed property report with the State by November 1 each year. 26. Create and maintain employee payroll records including their semi-monthly paystubs. 27. Staff Liaison for the IST Committee - prepares the agenda, research as needed and takes the Committee minutes. 28. Staff Liaison to the Supervisory Committee - prepares the agenda, research as needed and takes the Committee minutes. 29. Staff Liaison to the Delinquency Committee - prepares the agenda, research as needed and takes the Committee minutes. 30. Maintaining vendor contracts and due diligence to include recordkeeping, mailing notices in advance of potential non-renewal (typically six months), sending contracts to legal counsel for review and for opinion to submit to the Board of Directors, etc. 31. Participate in community and business affairs, as necessary, to contribute to the image of the Credit Union. 32. Other duties as assigned by the President. NOTE: The list of essential functions is not exhaustive. It may be supplemented as necessary from time to time. Vice President- Lincoln, NE #Hiring #Lincoln #Nebraska

Job Summary Amgen is seeking a Director Quality reporting directly to the Vice President, Final Product Quality and Surveillance. This team leads and manages the global Response to Questions (RTQ) process and ensures consistency in approach and deliverables globally. This may include facilitation, escalation and advice on critical issues. The team delivers ongoing monitoring of post market regulatory environment and identification of opportunities and improvements. The Director leads a global team of quality professionals, maintaining accountability for day to day operations of the team. Maintains a state of compliance across Final Product Quality in alignment with GxP (GMP, MDR, PMSR). Sets requirements and procedures to formalize global communication with Competent Authorities driven by Post- Market Surveillance programs. Ensures that there is an adequate number of qualified personnel who possess a combination of education, experience and training to perform the work in accordance with requirements and specifications. Key Responsibilities: Drives a global and consistent process for Responses to Questions (RTQ) as it relates to Final Product Brings together the necessary subject matter experts to ensure appropriate strategy for Responses to Questions (RTQ), Involved in the evaluation, impact assessment, and implementation of outcomes associated with Regulatory Trends and Risks Facilitate global support of Final Product Technology and Quality during internal audits and inspections relevant to Final Product & Surveillance (Complaints). Provides oversight of process for tracking, communicating and, managing CAPAs associated with internal and external audit/inspection commitments Drives insights generation through ongoing, active monitoring Identifies opportunities for improvement to regulatory communications and reporting (i.e., RTQ, BPDR, FAR, EuMDR) Leverages deep knowledge of Quality Management Systems to inform recommendations and improvement opportunities Facilitates inspection continuous improvement (e.g., summarizing lessons learned, takeaways from Management Review, etc.) to identify areas of greatest opportunity Ensures team's collaboration with Corporate Quality Compliance, Site Compliance, and Quality Leadership Teams to identify themes across the network Designs and provides oversight for management of the internal self-audit Final Product Quality program, leveraging the work of Corporate Quality Compliance Provides input into changes or improvements to the Quality Management System (QMS) Outlines infrastructure, strategy, and best practices for audit preparations to ensure consistency across Final Product Quality and Surveillance Participates in and coordinates inspectional preparation activities to prepare for domestic and foreign regulatory agency inspections Ensures a pool of subject matter experts are prepared to support audit and inspection activities Maintains responsibility as document custodian (e.g., playbooks etc.) Provides oversight to ensure compliance to SOPs, and teams are applying a consistent approach Identifies, interprets, and disseminates new regulatory trends, expectations and compliance documents Serves as an active member in the development of regulatory documents that provide guidance for the oversight of final product. Assesses the state of compliance with appropriate regulations and participates in the development of action plans to correct deficiencies Serves as Final Product Quality Compliance representative in group meetings and interacts with other departments in order to achieve goals Participates in the coordination, execution and closure of internal and for-cause audits and regulatory inspections for Final Product Evaluates and provides feedback to Final Product Quality team on potential compliance vulnerabilities Provides compliance-based recommendations and coordinates mitigation activities Oversees generation of compliance performance metrics and their presentation to key stakeholders and management as requested Provides compliance assessments as needed (examples: for validation philosophies, operational problem-solving exercises, SOP changes, technical reports etc.) Partners with Regulatory Affairs to draft and review regulatory submissions (INDs, BLAs, NDAs, other applications and supplements/amendments) Supports and identifies continual improvement initiatives, programs and projects Leads cross-functional initiatives Ensures execution of regulatory and SOP requirements Provides guidance and technical advice Basic Qualifications Doctorate degree and 4 years of Quality experience OR Masters degree and 8 years of Quality experience OR Bachelors degree and 10 years of Quality experience AND 4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources Preferred Qualifications 10+ years of quality and manufacturing experience in biotech or pharmaceutical industry Advanced Degree in a Science Field Knowledge of current Global regulations for final drug product, combination product, and devices and their application In depth understanding of Investigations and Root Cause Analysis Understands criticality of connectivity between product complaints and adverse events Significant experience hosting or participating in regulatory inspections Detail-oriented with experience in QA/QC functions across a broad range of manufacturing, QC and/or supply chain processes Ability to work in a team matrix environment and independently interact with various levels of management Excellent communication skills, both written and oral Ability to effectively present information to all levels of the organization with appropriate messaging and effective focus on desired outcomes Proven ability to create cross-functional networks/partnerships Ability to plan, monitor, and control a set of activities, ensuring efficient utilization of resources to achieve program objectives Leadership skills and the ability to oversee multiple projects simultaneously, including cross-functionally Able to successfully manage workload, timelines, and priorities Able to respond and provide astute advice quickly to difficult scenarios or in response to tough questions Ability to negotiate a strategic position after taking feedback from multiple sources Ability to operate in a matrixed or team environment with site, functional, and executive leadership Experience driving effective decision making Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device Manufacturing, Design Controls) Ability to succinctly communicate level of risk, urgency, or impact to the business Ability to travel +/- 20% of time to domestic and international Amgen sites Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve peoples lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the worlds leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. Join UsIf you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Role Summary "Pfizer Rare Disease has a robust pipeline with 4 potential launches within the next 3 years. This pipeline includes a new transformative and breakthrough Gene therapy for Duchenne Muscular Dystrophy (DMD) which is expected to be our 1st launch within this franchise as well as 3 transformative, breakthrough hemophilia agents - Hemophilia A Gene Therapy (GTx), Hemophilia B Gene Therapy, and a subcutaneously delivered monoclonal antibody to treat hemophilia A & B (marstacimab). All of these products represent significant therapeutic benefits to patients offering breakthrough innovations that address today's high burden of treatment. The hemophilia launches will continue to reinforce Pfizer's legacy and leadership in the hemophilia space while the DMD launch will potentially create the anchor brand for us in the Rare Neurology space. Beyond these launches, there are several programs in development including for Sickle Cell Disease (SCD) in the hematology space and ITP/CIDP in the neurology space. Given the multiple gene therapy launches occurring with the same time frame as well as other products in development, there is a need to develop an integrated approach to launching these products as well as ensure that there is a robust future pipeline of products to complement the growth in these two franchises. The Commercial Development & Strategy Lead, is a unique role with an opportunity to both unlock new sources of value for the franchises while also delivering on key initiatives to maximize the upcoming launches. The role will report to the Global Franchise Lead - Rare Hematology and Neurology and sit on the leadership team. She/he will be responsible for both a) strategic aspects driving commercial development and business development initiatives for the franchise and b) operational aspects supporting key pan-franchise deliverables. The selected leader will have demonstrated not only success/thriving in ambiguous situations, but also a desire to lead in this emerging field for Pfizer and the Pfizer Rare Disease portfolio. This person will need to exercise both strategic and commercial development skills - e.g. define commercial opportunity for the development programs and what is required for a successful launch as well as operational skills in leading pan franchise initiatives such as integrated Operating plan etc. In addition, collaboration within the LT as well as in engagement with cross-functional partners will be another key attribute for this role. It is expected that the person will spend approximately 50% of the time driving Comm Dev/BD activities with the other 50% towards franchise operational initiatives , but could change depending on progress of programs. Roles and Responsibilities Overall Franchise Strategy: Lead development of overall Rare Hematology and Neurology franchise strategy and prioritization Develop and maintain an integrated franchise strategy for the heme and neurology portfolio including preparing and maintaining strategy walking decks for the team. Monitor overall external landscape and partner with the Hematology and Neurology leads to maintain competitive overview of our programs. Shape external narrative, in partnership with the LT and the corporate affairs function, around Rare Hem/Neuro franchise and Pfizer's growing footprint in this space. Drive Operational excellence across Rare Heme/Neuro franchise Lead the preparation and execution of the integrated Operating plan process for the Rare Hem/Neuro franchise including continuous improvements working with the OP captains. Act as the point of contact with the Finance Lead to manage and lead the budgetary process through the year including LE submissions and buy-ups as needed. Act as the primary interface for input on and maintaining progress against RD strategy initiatives, and earnings call coordination for the heme/neuro franchise. Drive overall team culture in collaboration with the LT and also lead integrated approach for key initiatives (e.g. ways of working, townhalls/offsites etc. as needed). Commercial Development and BD Interface: Serve as Commercial Lead on Rare Neuro/Rare Heme Disease Area Working Group (DAWG) Assess current Rare Hem/Neuro landscape for potential assets and/or in-license/partnership opportunities in support of expanding the portfolio. Partner with Glocal Product Development, Global Clinical Development, Medical and Customer Analytics & Insights to develop product concepts to support the key disease state areas of interest Serve as the Commercial voice for BDPC presentation of product concepts. Serve as Commercial lead for the SCD and ITP programs for DP-3 Partner with the Early Commercial Development team (ECD) to prepare for assets prior to DP-3 to ensure seamless transition. Lead DP-3 preparation including development of market understanding, align on key assumptions for forecast modeling on a global scale. Collaborate with Chief Business Office on assessment of business development opportunities. Accountable for implementation of identified business development opportunities, incl elements of commercial assessments, forecasts and research, evaluations, and selection of opportunities and investments that have the potential to deliver the greatest value to Pfizer. Ensure valuations for medicine reflect emerging insights from development program, competitive programs, and emerging environment for pricing, reimbursement and access. Qualifications 15 years of pharmaceutical industry experience in marketing, strategy, new product launch, strategy consulting, business development in pharmaceutical or biotechnology companies. BA/BS - degree required. Advance degree preferred Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. The candidate must be a self-starter who is able to multitask in a fast-paced and dynamic environment. He/ she must be have strong learning agility and a high degree of comfort with ambiguity. Global commercial development experience or participating in pipeline/Global Medicine team helpful. Ability to rapidly comprehend scientific and clinical data; connects understanding of relationship between scientific data and unmet needs in market; translates scientific value proposition into commercial opportunity with value to the business Experience developing, representing and defending commercial opportunities, brand plans, and operating plans to senior leadership required Experience building strategic narrative incorporating internal and external variables. Financial and business planning acumen; strategic, analytical and problem solving skills. Self-motivated colleague with the ability to work independently to drive change in a dynamic environment Strong verbal and written communication skills including ability to distill messages and craft a persuasive story, communicate with clarity to partners and senior stakeholders. Ability to challenge and force a level of rigor and robustness in analyses and decision making in a consistent and thorough manner Other Job Details: Last Date to Apply for Job: September 24, 2021 Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Marketing and Market Research #LI-PFE

In this role, you will have the opportunity to work independently and collaboratively in an exciting young but growing company. Overall Description: The Associate Director/Sr. Manager in Regulatory Affairs is responsible for developing and managing regulatory strategies to remain compliant with U.S. FDA and global regulatory bodies. This position is responsible for planning, drafting, managing global regulatory submissions with personnel within and external to the company. This individual will work closely with clinical development, non-clinical, manufacturing, technical operations, and external stakeholders to ensure regulatory success. Job Duties and Responsibilities: Responsibilities may include, but are not limited to: Manage the preparation and submission of briefing packages and coordinate the sections of INDs, IMPDs, CTAs, and NDAs/BLAs. Responsible for preparing and coordinating company responses to queries from health authorities. Extensive knowledge of regulatory requirements, including ICH and regional requirements and an understanding of current global and regional trends in regulatory affairs. Provide expert guidance roll-out and implementation of new and ongoing regulatory activities to support company goals. Responsible for timely compilation of all necessary documents to support regulatory submissions. Ensure cross-functional alignment on regulatory strategies. Qualifications: Bachelor's degree in science or health field required; advance degree is a plus 5+ years experience in regulatory affairs, clinical drug development, manufacturing, or clinical related function in the pharmaceutical or biopharmaceutical industry Broad and strong understanding of international regulations and guidelines, as well as industry practices in clinical development of drug or biologic drugs. Experience with CTD/eCTD and life cycle management. In-depth knowledge of ICH requirements and US/EU regional requirements. Excellent attention to detail and accuracy. Excellent verbal, written, negotiation, and interpersonal communication skills are required.

Radius Health Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the EEO is the Law poster. Click here to navigate Radius Health's Pay Transparency Policy. Associate Director, Regulatory Affairs US-PA-Wayne Job ID: 2 Type: Regular Full-Time # of Openings: 1 Category: Regulatory Aff - Dept Overview The Associate Director, Regulatory Affairs liaises with Sr. regulatory staff to develop and implement effective regulatory and related strategies for the development and commercialization of Radius products. The individual will ensure adequate planning and accurate data for the earliest possible approvals of products, taking into account both U.S. and international regulatory requirements, and provides regulatory expertise and guidance to Clinical, Pharmacovigilance, Legal, Scientific, Commercial, and other internal stakeholders. The Associate Director, Regulatory Affairs also ensures that there is regulatory input into clinical development plans and clinical trials consistent with the global regulatory strategy for assigned products. Responsibilities Provides regulatory expertise and guidance within a collaborative cross-functional team that includes Clinical, Pharmacovigilance, Legal, Scientific, Commercial colleagues. Assists sr. regulatory staff in the development and implementation of regulatory strategy through cross-functional collaboration with non-clinical, clinical, manufacturing, and other departments. Support the preparation of, and participate in (as appropriate), key Health Authority interactions. Assure consistent positions on common issues are presented to global Health Authorities. Drive the development and on time completion of Health Authority background documents and responses to queries from Health Authorities. Provide regulatory expertise to support Clinical Study teams. Provide strategic input on all key development documents, clinical protocols, study reports, IBs, INDs, and CTAs. Develops content and format for regulatory submissions, such as Investigational New Drugs (INDs), Market Authorization Applications (MAAs), New Drug Applications (NDAs), and related supplements and amendments, Annual Reports, DSURs and PADERs. Sustains excellent relationships with regulatory agency personnel. Responds to requests for additional data, organizes and manages participation in meetings. Negotiates directly with regulatory authorities regarding company's filings. Works cross-functionally to develop and implement revised/new labeling strategies. Works together with Regulatory AdPromo and Labeling, Operations and CMC to ensure an integrated approach to regulatory strategy. Maintains global regulatory strategy documentation for assigned projects. Interprets scientific and clinical data and leads development of labeling to optimize product potential and patient benefit-risk ratio. Mentors and trains junior regulatory staff. Qualifications Requires a BS degree or equivalent with a Master's degree or PhD preferred. Required 10 years related experience within the biotechnology/pharmaceutical industry along with 8 years of clinical regulatory experience or equivalent combination of education and experience. Successful completion of an NDA and MAA application(s). Strong knowledge of US and EU regulations with regard to labeling requirements. Other country/regional experience a plus. Strong understanding of the drug development process and global regulatory requirements for drugs in development, including labeling development process. Working knowledge of eCTD submissions and supportive technologies. Work Environment: The work is performed in a typical office environment with heavy computer duties. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually quiet. Frequent travel required. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision peripheral vision, depth perception and ability to adjust focus. PM18 PI

Position Overview Nektar has an exciting opportunity for a Sr. Director, Drug Safety to join their team. Overall responsibility for leading the Drug Safety Team and directing the safety surveillance of all company investigational drug products in development and for managing patient safety and meeting regulatory reporting requirements.. Actively participates in the oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Analyses changing risk/benefit profile of company drugs in clinical trials to identify potential safety signals and implements appropriate safety updates and risk mitigation plans. Manages compliance with SOPs and FDA and global regulations for the reporting of adverse events to regulatory authorities. Serves as medical safety expert for all products in various stages of development. Lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance servicses. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development and preparation of periodic and annual safety reports , investigator communications,product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Provides medical expert safety review input into all critical documents for clinical development of products. Helps select, develop,train, and evaluate personnel to ensure the efficient operation of the drug safety function. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs. Consistently works on abstract problems across functional areas of clinical development and medical affairs. Identifies and evaluates fundamental issues, providing strategy and direction for major functional areas involved with clinical development of pharmaceutical/biotech products. Interacts internally and externally with executive level management requiring negotiation of extremely difficult matters to influence policymaking bodies. Leads and directs the Drug Safety Team and all aspects of drug safety related to all company sponsored clinical development activities to manage patient safety and compliance with regulatory reporting requirements. Actively participates in oversight of patient safety in all on-going clinical trials. Directs and conducts ongoing safety surveillance of company drug products. Manages internal staff and external resources to ensure delivery of quality pharmacovigilance services. Negotiates contracts, interacts and supervises the activities of contract organizations and consultants for pharmacovigilance services. Provides ongoing advice to senior management on the changing risk-benefit profile of company drug products in clinical trials, based on analyses/evaluation of potential safety signals and implements appropriate safety updates and risk mitigation plans. Provides oversight of all clinical safety services including review of medical coding of adverse event data and management of SAEs through the entire lifecycle including preparation of similar-event analyses for unexpected and related serious adverse events (SAEs) from clinical trials. Manages compliance with SOPs, and FDA and global regulations for the reporting of adverse events to regulatory agencies, IRB/Ethics committees and Investigators. Serves as the medical safety expert for all products at all stages of clinical development (Phase 1, 2 and 3 and post-approval). Plays lead role to help respond to and resolve safety questions from regulatory authorities, as well as regulatory agency audits and corrective action plans. Supports drug safety function and effectively interfaces with all relevant cross functional departments and personnel to ensure safety training and compliance, and readiness level to pass internal/external audits. Directs the development and preparation of reports for company management, as well as for external regulatory agencies. Directs the development, preparation and compliance of periodic and annual safety reports (eg. US IND annual progress reports, EU annual safety reports, periodic line listings, NDA safety updates, etc.), investigator communications, product labeling/package inserts and other reports as necessary. Provides strategic planning, implementation, and management of drug safey operations to support clinical development of company products. Participates with other senior managers to establish strategic plans for the clinical development plan of investigational products. Provides medical expert safety review input into all critical documents for clinical development of products (eg. protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, , INDs, CTAs, etc). Establishes and manages independent Data Safety Monitoring Boards (DSMBs) for clinical studies, if required. Performs research on safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, for clinical development of company drug products. Helps recruit and select personnel, and provides training, development, coaching and regular performance review feedback to direct reports. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures departmental budgets and schedules meet corporate requirements. An MD degree is required. A minimum of 9 years of relevant drug safety experience is required. A minimum of 7 years previous management experience may be required. An in-depth knowledge and thorough understanding of FDA, EU, and global regulations, ICH guidelines, and GCPs that govern drug safety and pharmacovigilance are required. Experience with safety databases, and expertise in clinical safety assessments, safety signal detection and risk management, including interactions with regulatory authorities are required. Must be able to demonstrate extensive experience in the design of clinical studies and have a strong working knowledge of safety reviews for input into critical documents for drug development. Strong oral and written communication skills are required. Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required. Previous experience working with senior management is required. Experience in conducting formal presentations to Sr. Management and key opinion leaders is required. Ability to research and understand the safety profiles of competitor products within therapeutic areas of interest to help develop effective competitive strategies, as well as an in-depth understanding of clinical product development in the pharmaceutical industry. Strong analytical skills, especially with regard to understanding and interpreting scientific research and literature are essential. Knowledge of GMP and GLP is preferred. Must be a demonstrated self-starter and team player with strong interpersonal skills. Must have strong computer skills with a proficiency in various software applications (eg. Microsoft Project, Word, Excel, Visio, PowerPoint). We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.

About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . on Twitter , Facebook , Instagram , YouTube and LinkedIn . • Provides support for tracking and forecasting RQS Ops budget forecasting. • Provides support to the Vendor Management process including management of the end to end invoice process, Administrative Check Requests (ACRs), Vendor Master system, and related activities in financial systems such as Supplier Relationship Management System (SRM) and SalesForce. • Maintains daily support of RQS's financial payments (invoices). Supports and/or facilitates payment solutions for/from RQS staff and external business partners. Receives invoice/payment requests, determines the appropriate compliant solution and facilitates and/or executes payment. Partners with RQS staff, vendors, Finance, Corporate Disbursement Operations (CDO), Iron Mountain, Office of Ethics and Compliance (OEC). • Responsible for suggesting process efficiencies for financial payments process and other team activities to build continuous improvement culture and optimize organization performance • Follows the ARC-Administrative Check Requests process and ensures accuracy. • Monitors and facilitates PO-Purchase Orders progress in Supplier Relationship Management System (SRM) for release of PO number. Submits invoices against PO, Monitors spend on open POs to ensure adequate funds for payment of future invoices. Troubleshoots financial PO challenges elevated by RQS staff and/or vendors. Liaise with Finance on regular basis with focus on process improvement and increased transparency related to payment. • Manages year end accrual process; identifies year-end charges that have not been submitted for payment and accrues against specific budgets as identified. Tracks accruals to ensure completion of payment using accrued funds. • Provides general administrative and transactional activity support to help support RQS Director, Business Services. • Uses multiple systems/software tools (SRM, GEMS/SalesForce, Vendor Master, Magellan, SharePoint) to capture, read analyze and report pertinent data. • Provides back-up support for other business operations roles for coverage during vacations or other circumstances. Qualifications Microsoft Office Proficient, Detail Oriented, Good Written and Verbal Communication, Presentation Skills, Analytical and project management skills, Sharepoint experience preferred. Capability to provide strong customer service preferred. 3.0 minimum GPA Returning to university for at least one semester and graduating within one-year post internship Currently enrolled in university, pursuing a bachelor's degree Demonstrated leadership skills (i.e., extracurricular activities or projects) Authorized to work in the U.S. on a permanent basis without requiring sponsorship (students on an F1 visa with CPT may be accommodated if the department can sponsor in a full-time employee capacity) Preferred Majors: Business Administration Communications Computer Science Design Management Operations Management Statistics Significant Work Activities Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Travel No Job Type Internship Schedule Full-time Job Level Code IC Equal Employment Opportunity At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

For almost 50 years, Lighthouse Professional Services has worked to provide full-service consulting and staffing partnerships to clients in Connecticut, Massachusetts, Rhode Island, New Hampshire, and the Carolinas. Our innovative solutions can reach all areas within your firm including: Administrative, Information Technology, Engineering, Finance, Clerical and Light Industrial. Lighthouse Professional Services committed to the success of the companies, candidates, and employees we serve. We invest in excellent working partnerships, powered by people. We are currently seeking a Regulatory Affairs Associate in Trumbull, CT. to work a contract for a client. Position Summary and Special Duties: As a (an) your day-to-day duties will consist of and may not be limited to: The Regulatory Affairs Associate will provide the internal regulatory affairs support for post-marketing of Class I, II and III medical devices. The incumbent will support the registrations and technical files projects for existing and acquired product lines. At the direction of the Sr. Director of Regulatory Affairs & Compliance, the Regulatory Affairs Associate monitors the regulatory environment and provides assessments of the impact of new and changing regulations. Key Functions: Identifies, completes, and files all necessary documentation as required with applicable Regulatory bodies, both domestic and international for product registrations. Identifies, completes, and files all necessary documentation as required for site registrations both domestic and international locations. Assembles, Reviews and updates "Technical Files" for existing and acquired products. Prepares and updates "Declarations of Conformity" as per MDD. Processes and updates CFGs. Supports International Standards Organization implementation and maintenance. Reviews Medical Device Regulatory standards and updates to ensure compliance. Notifies Supervision and Management of Product safety issues. Assists with maintaining and updating Order Entry Restrictions database. Provides liaison with FDA, Notified Body, and Authorized European Reps. Maintains collaborative relationship with R & D, Marketing and Operations is required. Maintains collaborative relationships with external partners including regulators and external OEM suppliers. Performs additional duties as required by management. Qualifications: Bachelor's Degree in Sciences, Engineering, Technical or equivalent. Minimum 3-5 years quality, regulatory, compliance manufacturing, operations and/or engineering is required. Command of Medical Device QSRs, ISO 13485, MDD 93/42/EEC, Canadian Regulations. Three - Five years QA/RA experience in the medical device or related industry Additional MDD to EU MDR Transfer Class 1 requirements Tech documentation DETAILS : Duration: 3 months contract Location: Trumbull, CT. Salary: contract role open to hourly rate based on experience Can work remotely. Some people come in 2 days a week as well. Qualified candidates are encouraged to apply immediately! Please include a clean copy of your resume and salary expectations and any references. Job Requirements: Support regulatory compliance and submissions Filing documents related to regulatory submissions Ensure compliance to existing regulatory submissions Preparing regulatory documents and/or submissions Submit regulatory applications and internal regulatory file documentation Verify compliance with regulatory requirements Ensure compliance with regulatory requirements Assure compliance of regulatory files Providing regulatory and compliance guidance Prepare submissions and reports for regulatory agencies Ensure compliance to regulatory standards Support and ensure regulatory compliance Discuss regulatory issues and submission requirements Formulate or implement regulatory affairs policies and procedures to ensure regulatory compliance Assisting regulatory team in developing regulatory strategy to ensure high quality and on-time regulatory submissions Maintain regulatory records for regulatory activities and applications Prepare regulatory document submissions and timely submit Review of regulatory quality documents Compile and maintain appropriate technical documents for regulatory submissions Assure global regulatory compliance of company products

Overview Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases. The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do. We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality. The Sr. Director, Geneconomics Cost Modeler, is responsible for developing and implementing (hands on) global strategic economic research and cost models for managing the planning, implementation and publishing of health economics and cost models in disease areas of interest to Novartis Gene Therapies and through the product life cycle. This role oversees cost models conducted for company products and shares that research with other Novartis Gene Therapies stakeholders and regions. Responsibilities Provides insights to Early Development, Clinical R&D Commercial/Marketing/Translational Access, Medical Affairs regarding the development of Novartis Gene Therapies products. Designs cost modeling studies to quantify product value including clinical and/or economic impacts of gene therapy products. Conducts, develops, and validates health economic cost models and analysis, including but not limited to cost effectiveness, cost utility, cost minimization, cost benefit, and budget impact models, using published literature, clinical trial data and/or real world data inputs. Adapts economic models in accordance with local requirements / guidelines. Contributes to HTA submission documentation and tactics, and to pricing and reimbursement (pricing corridor, economically justifiable price, launch sequence/timing, negotiation argumentation). Leads the development of cost models project deliverables: models, reports, abstracts, manuscripts, and slide decks. Reviews and critiques medical and evidence-based health economic literature & statistical analyses in geneconomics. Presents and interprets findings to cross functional teams, including global patient access, clinical development, medical affairs, marketing team, and publication teams. Leverages EHR databases to support model development and reimbursement activities. Obtains value evidence scientific advice from HTAs / Payers and regulatory regarding cost models evidence package. Responds to external reviews and needs such as ICER, local HTAs (NICE, HAS, etc.) and engage external HEOR KOLs. Researches and performs critical economic analyses of medical and scientific evidence including systematic reviews and economic evaluations as the basis for HTA assessments and formulary evaluations. Contributes to the development of high quality global value and AMCP dossiers. Collaborates on the development of Quality of Life measures to generate utilities to be used in cost models. Attends HEOR, medical/scientific, and pharmacy professional meetings to keep up with changing trends and remain current within the field relating to modeling and new research trends affecting each product area. Oversees operation, resourcing and management of the modeling activities. Other related job duties as assigned. Qualifications MD, PhD or Master's degree in economics, health economics, public health, health policy and management, statistics, operational research or related field and 10 years relevant experience. 7 years demonstrated experience in economic modeling. Working knowledge of health economic modeling techniques, including decision analysis. Hand-on experience of using Markov model and discrete event simulation. Experience of using Tableau is preferred. Expert-level proficiency in Microsoft Excel (including Visual Basic), Treeage, and/or R. Possesses excellent HTA, Payer and reimbursement knowledge. Experience working in a global organization highly desirable. Experience working in a matrixed environment highly desirable. Record of publications in health economics, health services research, or clinical journals. Hand-on experience of cost-effectiveness analysis and/or budget impact analysis Proven ability to write and publish for medical or scientific audiences. Extensive working knowledge of ICER and HTAs needs and processes. Strong skills in data analytics and graphic interfaces. Strong organizational skills and proven ability to manage personal responsibilities on multiple priorities and/or projects at once. Ability to work independently and collaboratively. Outstanding ability to communicate technical and complex information to both technical and non-technical audiences. Possess strong business acumen in understanding the needs from ICER, HTAs and payers. Possesses excellent communication and interpersonal skills especially over departmental and geographical boundaries. The level of this position will be based on the final candidate's qualifications. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status. #LI-SN1

SENIOR MANAGER, REGULATORY AFFAIRS CMC Position Summary: The Senior Manager, Regulatory Affairs CMC will provide regulatory guidance on global Chemistry, Manufacturing and Controls (CMC) regulatory activities for Global Blood Therapeutics (GBT) compounds (small molecule) for the treatment of sickle cell disease (SCD) and other disorders. Responsibility will focus mainly on CMC regulatory filings, and providing strategic as well as operational management of the project teams in this area. In addition, responsibilities may include support to on-going clinical activities. The candidate will develop regulatory strategies and manage US and ex-US clinical applications and marketing applications, FDA and other regulatory interactions (responses to requests for information), for the product candidates. This will be an individual contributor and will report to Sr. Director, RA CMC. Essential Duties and Responsibilities: Manage internal review / approval process for CMC related submissions and regulatory questions; manage internal stakeholder meetings, adjudications meetings, and maintain internal trackers and databases, as appropriate Provide interpretation of regulatory authorities' feedback, policies and guidelines to GBT personnel. Support GBT during regulatory authority inspections on designated programs Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of CMC submissions required for regulatory approval Work with project teams to resolve complex project issues. Utilize regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure regulatory agency approvals are obtained Responsible for supporting the filing of IND/CTA/NDA/MAA submissions. Support strategy developed for submissions of product registration documents to health authorities worldwide. Interact with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions Support the planning and preparation of formal meetings with regulatory agencies. Assure compliance with project team timelines and milestones Contribute to the preparation of regulatory impact assessments for change control management and deviation reports Accrue regulatory intelligence on the regions of interest for GBT products and educate the department of RA at large on the evolution of the regulatory landscape Qualifications: Bachelor degree in a Chemistry, Life Sciences or equivalent, advanced degree preferred. 6-9+years of relevant experience (at least 3 years of Regulator Affairs CMC experience) and has earned a BS or equivalent degree Experience providing guidance to team members Experience in eCTD format and structure Balance strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills Strong project management skills. Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule guidelines and regulations a plus Demonstrated excellence in regulatory liaison/strategy Strategic thinking, leadership skills, assertiveness, strong technical background, and excellent negotiation and project management skills as evidenced by past performance on drug development project teams Can prioritize deadlines, projects, and adapt to quickly changing environment Can maintain excellent relationships with peers, despite workoad pressure and tight timelines Fit with GBT culture: Ability to build strong relationships with co-workers of various backgrounds and expertise Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor Excitement about the vision and mission of GBT Integrity Values-based leadership Flexibility NOTE: This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization. Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status, or any other characteristic protected by law.