• Provides pharmacovigilance and medical leadership of clinical programs to ensure timely delivery of clinical deliverables. • Ensures clinical programs support patient safety and provides oversight of patient safety in clinical studies. • Serves as the primary safety expert for assigned projects and as the first point of contact internally and externally for questions regarding patient safety. • Contributes to the analysis and interpretation of data generated internally or externally and presents study updates, interim results, and final headline data to senior management as required. • Provides medical input and contributes to the safety sections of regulatory documents such as CIOMS, DSUR, IND and NDA Dossiers, and contributes to responses to regulatory agencies regarding questions about complex safety issues. • Participates in the cross-functional development of safety monitoring plans that integrate pre-clinical, early clinical findings and pharmacovigilance approaches. • Identifies and engages with external medical experts to address scientific and medical questions relevant to the program. • Manages drug safety and pharmacovigilance vendors. • Ensures that Serious Adverse Events (SAEs) are properly reported. • Engages in signal detection and aggregate safety review and benefit-risk assessment. • Contributes to reference safety information and investigator brochure safety sections. • Interacts with health authorities, including Food and Drug Administration (FDA). • Creates Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS). • Interacts and liaises with Data Monitoring Committees (DMCs).

• Provide strategic medical safety leadership and hands-on support for assigned product(s) within a cross-functional environment • Develop safety strategies and deliver accurate, timely, and high-quality safety input for global regulatory submission documents (e.g. ISS, SCS, narratives) for assigned product(s) • Conduct safety signal detection and benefit-risk assessment activities, along with routine and ad-hoc aggregate safety data reviews for assigned product(s) • Lead cross-functional discussions and reviews of existing and emerging aggregate safety data for assigned product(s) • Contribute to the advancement of the overall safety governance framework and related activities • Draft and/or review safety sections of clinical and regulatory documents (including study protocols, IBs, Clinical Study Reports, and ICFs) • Provide medical safety expertise in responses to regulatory authority questions and ensure safety information is complete, accurate, and submitted in a timely manner • Lead the preparation of periodic safety reports (e.g. PSUR, DSUR), ensuring consistency, quality, and appropriate medical safety content • Oversee the medical review and assessment of individual case safety reports (ICSRs) • Confirm reporting criteria and content for expedited reporting and unblinding activities (e.g. SUSARs or urgent safety matters) • Lead or contribute to the preparation and presentation of safety data for Data Safety Monitoring Board (DSMB) meetings • Provide medical safety support during internal audits and regulatory inspections • Assist with the development and maintenance of GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates) • Support adverse event reporting training and cross-functional pharmacovigilance awareness initiatives • Support the preparation and review of pharmacovigilance agreements with clinical development and commercial partners • Participate in cross-functional initiatives and project teams • Perform additional responsibilities as needed to support departmental objectives

Role Description The Senior Medical Director, Contraception, USMA, WHC is responsible for developing and leading medical strategy for pre-commercial and marketed programs. The Senior Medical Director will lead the development of strategy and tactical execution of activities across the portfolio, while engaging and aligning with US and global cross-functional teams. YOUR TASKS AND RESPONSIBILITIES - Lead the execution of associated tactical activities specifically related to all current and future LCM activities. - Participate in the planning and administration of activities concerned with the clinical evaluation of drugs in development for the purpose of obtaining an approved IND or NDA. - Participate as a medical and clinical expert in BD and L activities as appropriate. - Review and evaluation of products relative to current standard of care and alternative treatments. - Support completion of annual NDA reports for respective brands through evaluation of clinical data and literature and provide USMA input in the preparation of key medical documents for INDs and NDAs. - Ensure appropriate USMA input in interactions with the FDA and provide appropriate medical leadership for any interactions. - Plan, lead and execute advisory meetings to gather feedback on relevant questions identified for assigned products. - Active participation and effective interaction with global teams to ensure and support appropriate US direction of LCM strategy. - Interface with both internal and external (KOLs, advisors, consultants) experts and medical organizations to develop and maintain productive contacts, develop collaborative research projects, and publish scientific papers with high clinical impact. - Engage members of USMA WHC team to assist with completion of assigned responsibilities, as needed. - Contribute directly to the generation and disclosure of scientific and clinical data on pipeline and marketed products to appropriate health care stakeholders. - Collaborate with internal and external partners/customers including: - US and Global Cross-Functional Partners - Key Opinion Leaders - Clinical Trial Investigators - Medical Affairs and Commercial Senior Management - MSL’s and Field Senior Directors Qualifications - M.D. Degree or equivalent (DO or MBBS) is required. - Previous experience in data generation, management, and publications. - Clinically relevant or independent research experience or equivalent or experience in the pharmaceutical or related industry or of extensive collaboration with the industry (e.g., lead PI and consultant, FDA employee or advisor). - A solid understanding of clinical study design, analysis and interpretation as well as the principles of observational studies and health economics. - Proven ability to identify and resolve complex problems. - Ability to collaborate with a variety of teams and personnel as well as a proven ability to interact effectively with key opinion leaders. - Highly developed ethics and integrity, with demonstrated ethical medical decision-making skills. - Ability to work well within teams as well as ability to assume leadership of a team. - Strong negotiation and influencing skills. - Proven ability to implement successful clinical strategies and programs. - Effective communicator with strong oral and written communications skills. - Demonstrated success in leading both internal and cross functional project teams including contractors and consultants as well as performing successfully under stringent timelines and with competing priorities. - Proven ability to achieve timely approval of dossiers and regulatory submissions and to be able to develop highly successful clinical strategies and programs. Requirements - US Board certification and licensure (active) highly preferred. - 5+ years of clinically relevant or independent research experience or equivalent OR 5+ years’ experience in the pharmaceutical or related industry or of extensive collaboration with the industry (e.g., lead PI and consultant, FDA employee or advisor). Benefits - Employees can expect to be paid a salary of between $248,000 to $372,000. - Additional benefits include health care, vision, dental, retirement, PTO, sick leave, etc.

Role Description Are you passionate about positively changing the lives of others? California Institute of Applied Technology (CIAT) is growing and seeking educators and professionals with a passion for mentoring others. CIAT prepares students for professional success by offering practical training in today’s most competitive technology fields to make sure students are job-ready. With a large selection of courses, flexible schedules, and an online campus, we aim to empower the working student. We are laser-focused on student success, whether just starting out, making a career change, or transitioning into civilian life, CIAT prepares students for success! Essential Duties and Responsibilities - Teaching: - Available to teach synchronous online courses via Microsoft Teams - Flexibility to teach during the day, or evenings and/or weekends, based on the course schedule - Plan and organize instruction in ways that maximize student learning and engagement - Ensure alignment of instructional strategies with CIAT’s adult learner framework, emphasizing certification readiness - Modify, where appropriate, instructional methods and strategies to meet diverse student’s needs - Employ appropriate teaching and learning strategies to communicate subject matter to students via a synchronous online format (Microsoft Teams) - Current certifications in subjects taught - Mastery of Subject Matter: - Actively maintain certification(s) in the subject area(s) taught through renewal - Demonstrate a thorough and accurate knowledge of their field or discipline - Connect their subject matter with related fields - Stay current in their subject matter through professional development, through involvement in professional organizations, and attending professional meetings, conferences, or workshops - Curriculum Development: - Design, update, and align course materials with college standards for adult learners - Select the instructional materials that align with course objectives - Keep the curriculum up to date - Review course material for accuracy and relevance, providing recommendations for improvements - Ensure compliance with accreditation standards for instructional quality and education - Adhering to College Policies and Procedures: - Ensure Student Database is fully updated and accurate at all times regarding student attendance and grade record information - Maintain compliance with accreditation related to instructional and the quality of education, scheduled class hours requirements and CIAT policies and procedures - Promote collaboration with other staff members and participate in the implementation of new projects, ideas, etc. - Adhere to the CIAT business casual attire. Please refer to the CIAT Employee Handbook for the complete policy. Clothing should be neat, clean, and without rips and holes. We can accommodate polo shirts - Maintain FERPA compliance and handle student data securely in accordance with institutional policy Qualifications - Appropriate certification in National Center for Competency Testing (NCCT) Medical Office Assistant - One year of verifiable full-time experience as a Medical Office Assistant within the past five years OR completion of medical office assistant training program or its equivalent during U.S. Military service within the past five (5) years - Minimum of one year of experience in a training setting, ideally delivering healthcare certification bootcamps - Advanced subject matter expertise preferred - Synchronous online teaching preferred - Prior experience in curriculum development and instructional design for healthcare certification bootcamps - Effective presentation skills - High level of flexibility, creativity, and dependability - Good working knowledge of MS Office applications including Microsoft Teams Word, Excel, and PowerPoint as well as learning technologies such as Canvas - Work independently with minimal supervision - Ability to multitask - Problem solves rapidly and effectively, in a timely manner - Works with a sense of urgency, while engaging and listening to coworkers from other departments - Ability to work collaboratively with colleagues, academic departments, and administration to support student success, achieve institutional goals and contribute to a positive and inclusive culture - Commitment to fostering an inclusive and supportive learning environment that respects the diversity of students' backgrounds, experiences, and perspectives - Knowledge of current trends, best practices, and didactic approaches in higher education - Demonstrated ability to deliver engaging and effective lesson plans that meet the diverse needs of students - Strong communication skills, both verbal and written, with the ability to effectively convey information and interact with students, colleagues, and others - Compliance with all college policies, procedures, and regulations, including those related to academic integrity, student conduct, and instructional delivery - Adhere to CIAT’s compliance requirements to ensure all Federal, State, accreditation, and institutional policies and procedures are being met - Follow communication guidelines to ensure high levels of customer satisfaction and professionalism - Must be able to embody CIAT’s mission, vision, purpose and values Requirements - This is a variable hour position. Days and hours of work are usually Monday through Friday, but weekend hours may be required. Live bootcamp classes will be scheduled Monday through Friday for 8 hours per day PST. Class times are to be determined. - This position has no supervisory responsibilities. - This is a remote position. Work must be conducted in locations that have been approved by the company. Company authorization is necessary for relocation or work from other locations, even if temporarily. Benefits - The starting salary range for the NCCT Medical Office Assistant Bootcamp Instructor position for Florida is $1,600-$1,800 per 40-hour bootcamp + $400 for new hire orientation. Values - We are passionate about education and student success - We value integrity and excellence in our employees and students - We treat ourselves and our students with dignity and respect - We believe in and encourage innovation at our school to better help our students succeed - We have a customer centric focus and we want people highly committed to achieving goals, where our success equals student’s success - We are accountable for our actions and focus on improvements moving forward - We have a growth mindset with a sincere belief that every student can do better and achieve their goals - We expect every employee to be an example of conduct and professionalism, being a role model to students and colleagues - We commit to fostering an inclusive and supportive learning environment that respects the diversity of students' backgrounds, experiences, and perspectives - We foster lifelong learning and professional development