Senior Associate jobs at Precision Medicine Group

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Pharma Physician Development Program is a premier two-year rotational program designed to equip high-potential clinicians with critical insights into the pharmaceutical industry while fostering business acumen, leadership skills, and scientific expertise. Through three diverse rotations-Clinical Development (12 months), Medical Affairs (6 months), and Pharmacovigilance (6 months), Participants will gain hands-on exposure to key functions that drive product innovation and patient impact. Throughout the program, participants will receive in-depth training on the Product Development Lifecycle, develop essential leadership abilities, and gain valuable knowledge and experience working with cross functional teams to support Product Life Cycle Management. This experience is supported by mentorship and networking opportunities that create lasting foundations for career success in the pharmaceutical industry. Responsibilities and Accountabilities: Participants will contribute to Astellas programs across three key functional areas and gain a 360 degree view of drug development. This will require participation in 3 specialized rotations: * Clinical Development (12 months) * Collaborate as part of the leadership of the clinical team to support the definition of the clinical hypothesis, the clinical development plan (CDP) including Life Cycle Management (LCM) and execution of clinical programs. * Engage in clinical study design, preparation of essential clinical documents (e.g., Investigator Brochure, Protocols, Clinical Study Reports), and global health authority interactions. * Participate in medical monitoring, clinical safety and efficacy data review, and evidence generation strategy creation based on stage of product development. * Support clinical and program risk assessment and mitigation planning * Work cross-functionally on study-level activities (including operational readiness and execution required to deliver trials within timelines and budgets), stakeholder collaborations within matrix-based Asset Maximization teams to support efficient and timely decision making at governance discussions. * Medical Affairs (6 months) * Support the development and execution of regional growth strategies, planning the MA strategy aligned with LCM nd alignment of Global Brand Strategies. * Identify medical data gaps based on SWOT analyses lead Medical Affairs scientific initiatives, participate in Medical Legal Review (MLR) and support internal training programs for field teams (e.g., MSLs and Sales Reps ). * Drive the design and execution of clinical and Real-World Evidence (RWE) studies, as well as HEOR initiatives for data generation advisory boards and external engagement for strategic insight collection, publication and congress planning, medical communications and medical education programs. * Embed agile ways of working while fostering collaboration across commercial and Medical teams. * Pharmacovigilance (6 months) * Develop hands-on experience in safety monitoring and risk management throughout the drug lifecycle. * Develop an understanding of global pharmacovigilance regulations by engaging in activities such as signal management, aggregate reporting, and causality assessment in individual case safety reporting. * Develop an understanding of optimizing the benefit-risk profile of a product by participating in Safety Management Teams, Benefit Risk Teams and engaging in risk management planning and product label discussions. * Collaborate with teams on inspection readiness, QMS reviews and CAPAs. * Learn the fundamentals of relevant databases (e.g., LSLMV), dictionaries (e.g. MedDRA) and their use in both pre- and post-marketing safety surveillance. Throughout the Program * Participants will benefit from additional developmental opportunities, including: * Business Acumen Training: Gain specialized knowledge of Astellas' business processes, operational frameworks, and market dynamics. * Product Development Lifecycle Training: Develop a comprehensive understanding of the pharmaceutical innovation process, from concept to commercialization. * Leadership Skill Development: Build core leadership capabilities through mentorship, direct industry exposure, and structured training programs. * Cross-Functional Insights: Connect with and learn about relevant functions, including commercial, regulatory, and clinical teams, while engaging in collaborative decision-making processes. Why Join the Program? This program offers: * Mentorship: Receive guidance from experienced leaders across scientific, clinical, and business disciplines. * Leadership Development: Participate in curated experiences designed to build strategic leadership skills for success in the pharmaceutical industry. * Pharmaceutical Insight: Gain immersive exposure to Clinical Development, Medical Affairs, and Pharmacovigilance. * Cross-Functional Networking: Engage with professionals across global and diverse teams, fostering collaboration and networking opportunities. Embark on a transformative journey into the pharmaceutical industry that will position you as a future leader in clinical, medical, and scientific innovation.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Manager, Quality Audits: Position Summary: This position is part of the global GWWO Auditing Department & entails performing routine GMP audits as well as speciality and technical audits in relation to current products and prospective in-license agreements providing compliance guidance and support throughout the Quality organization, training delivery and leading multi-departmental teams and initiatives. To ensure success as a Manager, Quality Audits, the candidate should possess in-depth knowledge of product standards and extensive pharmaceutical experience preferably in manufacturing, quality assurance, and/or GMP auditing and demonstrated project management experience in leading cross-functional teams. The successful candidate will have people reporting in from other locations. Key Responsibilities: * To ensure success as a Manager, Quality Audits, the candidate should possess in-depth knowledge of product standards and extensive experience as a related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing and demonstrated project management experience in leading cross-functional teams. * Prepare and execute internal self-inspections and supplier audits and issue reports. * Follow up on post audit action tracking & progress. * Assisting in implementing Internal Audit plans for all Grifols manufacturing plants within North America. * Assisting in implementing Supplier Audit plans for all Grifols manufacturing plants within North America. * Trends, analyses, and reports on quality data to improve product and process Quality for all Grifols plants; develop actions for improvement based on data analyses. * Peer Review and approval of Audits Reports. * Provide support prior, during and post inspections for External Regulatory Inspections, Customer Audits and Corporate Internal Audits. * Ensures the corrections of findings, risks and improvements are promptly and thoroughly incorporated into the quality systems. * Keeping abreast of industry standards and regulations. * All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. * Contribution to the continuous improvement of the Quality Management System is required. * Other additional duties may be assigned by the Director Quality Audits from time to time if required. * Ability to travel (up to 30%) Key Competencies Skills: * Strong interpersonal skills. * Excellent written and verbal communication skills. * Effective influence management and conflict resolution abilities. * Highly developed investigative and reporting skills. * Effective organisation and time management skills. * Expected to work and grow in a team-oriented environment and continue to build synergies between the Quality Audits group and internal and external quality and manufacturing groups. Abilities: * Ability to travel. (up to 30%) * Ability to generate and/or maintain reports, databases and presentations using Microsoft Office. * Flexible, able to adapt quickly to change in a fast-paced environment. Qualifications * Minimum Bachelor's degree in a scientific discipline. * Minimum of 5+ years related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing. * ASQ Certification as a Quality Auditor, Manager or Engineer a plus. * Superior knowledge of U.S. cGMPs and FDA guidance. * Superior knowledge of EU GMPs, Annexes and ICH Guidance's and International Standards (Risk Management, ICH 8, 9, 10) * Knowledge of drug product manufacturing, packaging, laboratory, and warehousing operations. Desirable * Experience in SAP * Experience in sterile manufacturing * Previous experience in managing teams Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : NC-Clayton:[[cust_building]]

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at ***************** This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. Purpose and Scope: The Pharma Physician Development Program is a premier two-year rotational program designed to equip high-potential clinicians with critical insights into the pharmaceutical industry while fostering business acumen, leadership skills, and scientific expertise. Through three diverse rotations-Clinical Development (12 months), Medical Affairs (6 months), and Pharmacovigilance (6 months), Participants will gain hands-on exposure to key functions that drive product innovation and patient impact. Throughout the program, participants will receive in-depth training on the Product Development Lifecycle, develop essential leadership abilities, and gain valuable knowledge and experience working with cross functional teams to support Product Life Cycle Management. This experience is supported by mentorship and networking opportunities that create lasting foundations for career success in the pharmaceutical industry. Responsibilities and Accountabilities: Participants will contribute to Astellas programs across three key functional areas and gain a 360 degree view of drug development. This will require participation in 3 specialized rotations: Clinical Development (12 months) Collaborate as part of the leadership of the clinical team to support the definition of the clinical hypothesis, the clinical development plan (CDP) including Life Cycle Management (LCM) and execution of clinical programs. Engage in clinical study design, preparation of essential clinical documents (e.g., Investigator Brochure, Protocols, Clinical Study Reports), and global health authority interactions. Participate in medical monitoring, clinical safety and efficacy data review, and evidence generation strategy creation based on stage of product development. Support clinical and program risk assessment and mitigation planning Work cross-functionally on study-level activities (including operational readiness and execution required to deliver trials within timelines and budgets), stakeholder collaborations within matrix-based Asset Maximization teams to support efficient and timely decision making at governance discussions. Medical Affairs (6 months) Support the development and execution of regional growth strategies, planning the MA strategy aligned with LCM nd alignment of Global Brand Strategies. Identify medical data gaps based on SWOT analyses lead Medical Affairs scientific initiatives, participate in Medical Legal Review (MLR) and support internal training programs for field teams (e.g., MSLs and Sales Reps ). Drive the design and execution of clinical and Real-World Evidence (RWE) studies, as well as HEOR initiatives for data generation advisory boards and external engagement for strategic insight collection, publication and congress planning, medical communications and medical education programs. Embed agile ways of working while fostering collaboration across commercial and Medical teams. Pharmacovigilance (6 months) Develop hands-on experience in safety monitoring and risk management throughout the drug lifecycle. Develop an understanding of global pharmacovigilance regulations by engaging in activities such as signal management, aggregate reporting, and causality assessment in individual case safety reporting. Develop an understanding of optimizing the benefit-risk profile of a product by participating in Safety Management Teams, Benefit Risk Teams and engaging in risk management planning and product label discussions. Collaborate with teams on inspection readiness, QMS reviews and CAPAs. Learn the fundamentals of relevant databases (e.g., LSLMV), dictionaries (e.g. MedDRA) and their use in both pre- and post-marketing safety surveillance. Throughout the Program Participants will benefit from additional developmental opportunities, including: Business Acumen Training: Gain specialized knowledge of Astellas' business processes, operational frameworks, and market dynamics. Product Development Lifecycle Training: Develop a comprehensive understanding of the pharmaceutical innovation process, from concept to commercialization. Leadership Skill Development: Build core leadership capabilities through mentorship, direct industry exposure, and structured training programs. Cross-Functional Insights: Connect with and learn about relevant functions, including commercial, regulatory, and clinical teams, while engaging in collaborative decision-making processes. Why Join the Program? This program offers: Mentorship: Receive guidance from experienced leaders across scientific, clinical, and business disciplines. Leadership Development: Participate in curated experiences designed to build strategic leadership skills for success in the pharmaceutical industry. Pharmaceutical Insight: Gain immersive exposure to Clinical Development, Medical Affairs, and Pharmacovigilance. Cross-Functional Networking: Engage with professionals across global and diverse teams, fostering collaboration and networking opportunities. Embark on a transformative journey into the pharmaceutical industry that will position you as a future leader in clinical, medical, and scientific innovation.

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **Manager, Quality Audits:** **Position Summary:** This position is part of the global GWWO Auditing Department & entails performing routine GMP audits as well as speciality and technical audits in relation to current products and prospective in-license agreements providing compliance guidance and support throughout the Quality organization, training delivery and leading multi-departmental teams and initiatives. To ensure success as a Manager, Quality Audits, the candidate should possess in-depth knowledge of product standards and extensive pharmaceutical experience preferably in manufacturing, quality assurance, and/or GMP auditing and demonstrated project management experience in leading cross-functional teams. The successful candidate will have people reporting in from other locations. **Key Responsibilities:** - To ensure success as a Manager, Quality Audits, the candidate should possess in-depth knowledge of product standards and extensive experience as a related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing and demonstrated project management experience in leading cross-functional teams. - Prepare and execute internal self-inspections and supplier audits and issue reports. - Follow up on post audit action tracking & progress. - Assisting in implementing Internal Audit plans for all Grifols manufacturing plants within North America. - Assisting in implementing Supplier Audit plans for all Grifols manufacturing plants within North America. - Trends, analyses, and reports on quality data to improve product and process Quality for all Grifols plants; develop actions for improvement based on data analyses. - Peer Review and approval of Audits Reports. - Provide support prior, during and post inspections for External Regulatory Inspections, Customer Audits and Corporate Internal Audits. - Ensures the corrections of findings, risks and improvements are promptly and thoroughly incorporated into the quality systems. - Keeping abreast of industry standards and regulations. - All listed tasks and responsibilities are deemed as essential functions to this position; however, business conditions may require reasonable accommodations for additional task and responsibilities. - Contribution to the continuous improvement of the Quality Management System is required. - Other additional duties may be assigned by the Director Quality Audits from time to time if required. - Ability to travel (up to 30%) **Key Competencies** Skills: - Strong interpersonal skills. - Excellent written and verbal communication skills. - Effective influence management and conflict resolution abilities. - Highly developed investigative and reporting skills. - Effective organisation and time management skills. - Expected to work and grow in a team-oriented environment and continue to build synergies between the Quality Audits group and internal and external quality and manufacturing groups. Abilities: - Ability to travel. (up to 30%) - Ability to generate and/or maintain reports, databases and presentations using Microsoft Office. - Flexible, able to adapt quickly to change in a fast-paced environment. **Qualifications** - Minimum Bachelor's degree in a scientific discipline. - Minimum of 5+ years related pharmaceutical experience preferably in manufacturing, quality assurance, or GMP auditing. - ASQ Certification as a Quality Auditor, Manager or Engineer a plus. - Superior knowledge of U.S. cGMPs and FDA guidance. - Superior knowledge of EU GMPs, Annexes and ICH Guidance's and International Standards (Risk Management, ICH 8, 9, 10) - Knowledge of drug product manufacturing, packaging, laboratory, and warehousing operations. **Desirable** - Experience in SAP - Experience in sterile manufacturing - Previous experience in managing teams Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** **Location: NORTH AMERICA : USA : NC-Clayton:[[cust_building]]** Learn more about Grifols (************************************** **Req ID:** 537819 **Type:** Regular Full-Time **Job Category:** TECHNICAL

Senior Associate of Regulatory Affairs, Labeling About Us: Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in 2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good. Position Summary: The Senior Associate of Regulatory Affairs, Labeling, is responsible for providing effective support to the Labeling function in Regulatory Affairs, in compliance with the FDA regulations, 21 CFR Part 201 and internal labeling policies and/or procedures. Payrate is determined by considering a person's prior experience and competence. The pay range for this position is $70,000 to $85,000. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. Why Work with Us? · Hybrid Work Schedule: Enjoy the flexibility to work remotely three days a week. · Casual Dress Code: Embrace a relaxed and comfortable dress code that allows you to express your personal style. · Collaborative Culture: Join a team that values open communication, teamwork, and the exchange of ideas. · Professional Growth: We offer ample opportunities for professional development and career advancement. Essential Duties and Responsibilities include the following. Other duties may be assigned. • Performs daily labeling functions in Regulatory Affairs which includes creation of draft labeling, revision of current labels and/or FDA deficiency letters. • Creation and maintenance of all SPL (Structured Product Labeling) and PLR (Physicians Labeling Rule) files to ensure accurate rendering for all products. • Makes strategic and critical decisions regarding patents, carve-outs and labeling content. • Assesses labeling processes and practices for efficiency and continual improvement. • Format/develop labeling annotations and deficiency responses. • Meet deadlines and goals in a timely manner. • Proofreading and annotating label copy to the highest quality standards. • Ability to document changes and justification by developing and creating change controls. Competencies · Planning and Organizing · Teamwork · Problem Solving · Quality · Judgement · Dependability Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Education and/or Experience Bachelor's degree in life sciences from a 4-year college or university; over 4 years related experience and/or training; or equivalent combination of education and experience. Language Skills Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public. Reasoning Ability Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. The ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. Travel N/A Computer skills Adobe Systems (Pro, Acrobat DC and Illustrator), Microsoft Office, DocuProof, Barcode Studio Equal Opportunity Employer: Meitheal Pharmaceuticals is an Equal Opportunity Employer. We welcome and encourage applications from all qualified individuals, including minorities, women, veterans, and individuals with disabilities. Salary Description $70,000 to $85,000

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at **************** . This position is based in Northbrook, Illinois. Remote work from certain states may be permitted in accordance with Astellas' Responsible Flexibility Guidelines. Candidates interested in remote work are encouraged to apply. **Purpose and Scope:** The Pharma Physician Development Program is a premier two-year rotational program designed to equip high-potential clinicians with critical insights into the pharmaceutical industry while fostering business acumen, leadership skills, and scientific expertise. Through three diverse rotations-Clinical Development (12 months), Medical Affairs (6 months), and Pharmacovigilance (6 months), Participants will gain hands-on exposure to key functions that drive product innovation and patient impact. Throughout the program, participants will receive in-depth training on the Product Development Lifecycle, develop essential leadership abilities, and gain valuable knowledge and experience working with cross functional teams to support Product Life Cycle Management. This experience is supported by mentorship and networking opportunities that create lasting foundations for career success in the pharmaceutical industry. **Responsibilities and Accountabilities:** Participants will contribute to Astellas programs across three key functional areas and gain a 360 degree view of drug development. This will require participation in 3 specialized rotations: 1. **Clinical Development (12 months)** + Collaborate as part of the leadership of the clinical team to support the definition of the clinical hypothesis, the clinical development plan (CDP) including Life Cycle Management (LCM) and execution of clinical programs. + Engage in clinical study design, preparation of essential clinical documents (e.g., Investigator Brochure, Protocols, Clinical Study Reports), and global health authority interactions. + Participate in medical monitoring, clinical safety and efficacy data review, and evidence generation strategy creation based on stage of product development. + Support clinical and program risk assessment and mitigation planning + Work cross-functionally on study-level activities (including operational readiness and execution required to deliver trials within timelines and budgets), stakeholder collaborations within matrix-based Asset Maximization teams to support efficient and timely decision making at governance discussions. 1. **Medical Affairs (6 months)** + Support the development and execution of regional growth strategies, planning the MA strategy aligned with LCM nd alignment of Global Brand Strategies. + Identify medical data gaps based on SWOT analyses lead Medical Affairs scientific initiatives, participate in Medical Legal Review (MLR) and support internal training programs for field teams (e.g., MSLs and Sales Reps ). + Drive the design and execution of clinical and Real-World Evidence (RWE) studies, as well as HEOR initiatives for data generation advisory boards and external engagement for strategic insight collection, publication and congress planning, medical communications and medical education programs. + Embed agile ways of working while fostering collaboration across commercial and Medical teams. 1. **Pharmacovigilance (6 months)** + Develop hands-on experience in safety monitoring and risk management throughout the drug lifecycle. + Develop an understanding of global pharmacovigilance regulations by engaging in activities such as signal management, aggregate reporting, and causality assessment in individual case safety reporting. + Develop an understanding of optimizing the benefit-risk profile of a product by participating in Safety Management Teams, Benefit Risk Teams and engaging in risk management planning and product label discussions. + Collaborate with teams on inspection readiness, QMS reviews and CAPAs. + Learn the fundamentals of relevant databases (e.g., LSLMV), dictionaries (e.g. MedDRA) and their use in both pre- and post-marketing safety surveillance. **Throughout the Program** + Participants will benefit from additional developmental opportunities, including: + Business Acumen Training: Gain specialized knowledge of Astellas' business processes, operational frameworks, and market dynamics. + Product Development Lifecycle Training: Develop a comprehensive understanding of the pharmaceutical innovation process, from concept to commercialization. + Leadership Skill Development: Build core leadership capabilities through mentorship, direct industry exposure, and structured training programs. + Cross-Functional Insights: Connect with and learn about relevant functions, including commercial, regulatory, and clinical teams, while engaging in collaborative decision-making processes. **Why Join the Program?** This program offers: + Mentorship: Receive guidance from experienced leaders across scientific, clinical, and business disciplines. + Leadership Development: Participate in curated experiences designed to build strategic leadership skills for success in the pharmaceutical industry. + Pharmaceutical Insight: Gain immersive exposure to Clinical Development, Medical Affairs, and Pharmacovigilance. + Cross-Functional Networking: Engage with professionals across global and diverse teams, fostering collaboration and networking opportunities. Embark on a transformative journey into the pharmaceutical industry that will position you as a future leader in clinical, medical, and scientific innovation. **Qualifications:** **Required** + Medical degree (MD or equivalent). + Clinical: 2 to 5 years of clinical experience, (including clinical fellowships and/or experience as an attending physician in clinical practice) preferably in Oncology. + Scientific Research: Prior experience and interest in scientific (non-clinical or clinical) research would be an asset. + No pharmaceutical experience required **Key Skills:** + Strategic thinking, strong analytical, and problem-solving capabilities. + Excellent verbal and written communication skills, particularly in conveying scientific and clinical concepts to diverse global audiences. + Proven ability to work independently with a results-driven approach, as well as collaboratively within teams. + Professional fluency in English. + Highest level of scientific integrity and impeccable work ethic ( + Demonstrate Astellas Core Values: Commitment to Innovation, Integrity, and Impact. **Preferred:** + Published clinical or nonclinical research **Salary Range** $193,200 - $276,000 (Final compensation will be determined based on a variety of factors, including but not limited to skills, experience and organizational equity considerations) **Benefits:** + Medical, Dental and Vision Insurance + Generous Paid Time Off options, including Vacation and Sick time, plus national holidays including year-end shut down + 401(k) match and annual company contribution + Company paid life insurance + Annual Corporate Bonus and Quarterly Sales Incentive for eligible positions + Long Term Incentive Plan for eligible positions + Company fleet vehicle for eligible positions + Referral bonus program \#LI-SS Category Oncology Development Astellas is committed to equality of opportunity in all aspects of employment. EOE including Disability/Protected Veterans

Who Are We? Founded in 1997 and built upon 25+ years of dermatology-specific experience, we are the only full-service dermatology CRO that takes products from concept to approval. Voted one of San Diego's Top Workplaces, we take pride in maintaining a company culture that values collaboration, diversity of background and thought, and dedicated talent. When you join Therapeutics, you are not a number or a cog in the wheel, you are valued for your unique and important contributions that you bring to our team and our clients. Who Are You? You are a dedicated individual who is passionate about your work and you want to join a team that believes a company is only as successful as its people. You lead with humility and know that your individual contribution is important to the team so you take pride in delivering great work. You believe anything worth doing, is worth doing right. You communicate clearly and have great attention to detail. You love to collaborate with the team but are able to think on your feet to problem-solve independently. What is the Primary Objective of the Sr. Regulatory Associate-Project Management The ideal candidate will have experience leading regulatory project teams for US FDA drug applications, including strategic planning for INDs/NDAs, managing submission timelines and resources, and coordinating cross-functional teams. Also desired is experience in developing and executing regulatory project plans for both internal and external Sponsored projects, managing interactions with FDA and Sponsors, and ensuring project deliverables meet quality and compliance standards Your Main Responsibilities and Duties Include: Leading and managing regulatory submission projects from initiation through completion, including defining project scope, timelines, deliverables, and resource requirements. Developing comprehensive submission content plans for INDs, NDAs, Amendments, FDA meeting packages, and other key regulatory activities. Occasional oversight of BLA, IDE, and PMA projects may be required. Coordinating cross-functional project teams including Medical Writing, Clinical Operations, Biostatistics, Product Development, and external consultants. Preparing regulatory administrative content included as part of a regulatory submission or application. Assisting primary/technical writers to ensure submission compliance with FDA eCTD formatting requirements. Reviewing submission components for quality and completeness. Serving as primary liaison between project teams, sponsors, and regulatory authorities To Succeed in this Position: You should have a Bachelor's-level degree in scientific related field or a combination of education and industry experience. At least six (6) years of prior regulatory experience in the pharmaceutical industry. Must have successfully led (or played key supportive role) in at least one IND (or NDA) application from initial planning through submission. Strong project management skills, including good communication and interpersonal skills, with demonstrated ability to manage multiple projects simultaneously. You must have a good understanding of FDA regulations relating to investigational drug/biologic/device development, submission requirements, and regulatory strategy development. Technical knowledge in eCTD compliant submissions and experience with off-the-shelf publishing software is highly desirable. The most likely starting base pay range for this position is $100,000 to $125,000 per year. Several factors, such as experience, tenure, skills, geographic location and business needs will determine an individual's exact level of compensation. Consideration will be given to experience that exceeds the listed requirements. **Please note the candidate must be either currently residing in San Diego, CA or willing to relocate. We at Therapeutics, Inc. are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants and team members without regard to race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law. If you are smart and good at what you do, we welcome you to apply!

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Senior Associate, Global Talent Development This role, in partnership with the rest of the Global Talent Development Team, turns Elanco's talent priorities into real, usable learning-facilitating live sessions, creating practical resources, and executing the delivery of key development initiatives. It equips leaders and employees with the skills they need to perform and grow by building clear curriculum, blended learning experiences, and dependable execution across a global, matrixed organization. The role reflects Elanco's leadership behaviors-Innovate Boldly, Deliver Outcomes, Involve Purposefully, and Own It-through hands-on creation, thoughtful facilitation, and reliable partnership with teams across the business. Your Responsibilities: Enabling Leaders at all Levels Facilitate development experiences for leaders at all levels by delivering core learning sessions and supporting nominated programs through strong facilitation practices. Write and develop content and blended learning materials - including curriculum for live sessions, playbooks, videos, podcasts, microlearning, and digital assets-that build leadership and team capabilities. Create practical, application-focused tools for leaders-such as how-to guides, conversation templates, coaching resources, and activity-based tools that support day-to-day leadership moments. Deliver accessible, self-service development tools to leaders that help them navigate key moments-such as performance conversations, onboarding, coaching, and team development. Equip global and local partners to localize learning through train-the-trainer guides, facilitation resources, translation support, region-ready content, and by incorporating feedback and usage insights to enhance the learner experience. Executing Priorities & Creating Strategic Enablers Develop and deliver support materials-playbooks, job aids, guides, checklists, and toolkits-that enable GTD priority initiatives across the enterprise. Partner with GTD project leader and teammates to execute major initiatives through dependable preparation, accurate resource creation, and coordinated delivery of assigned components. Consult on talent development requests by partnering with stakeholders to adapt content, prepare materials, or deliver targeted learning solutions that address capability needs. What You Need to Succeed (minimum qualifications): Education: Bachelor's Degree in Business Administration, Organizational Development, Human Resources, or a related field. Experience: 3-8 years of progressive experience in talent development, leadership development, or a related field. Demonstrated excellence in leadership development program design and facilitation (including familiarity with adult learning principles and various learning methodologies) and program management and stakeholder collaboration What will give you a competitive edge (preferred qualifications): Experience with Situational Leadership, Insights Discovery, Gallup StrengthsFinder, SuccessFactors, and Workday. Proven ability to work in a fast paced environment with numerous competing projects. Proven ability to manage large-scale programs with multiple stakeholders. Strong project management skills with the ability to prioritize and manage multiple projects simultaneously. Additional Information: Travel: Minimal, less than 10% Location: Global Elanco Headquarters - Indianapolis, IN Don't meet every single requirement? Studies have shown underrecognized groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles! Elanco Benefits and Perks: We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: · Multiple relocation packages · Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO) · 8-week parental leave · 9 Employee Resource Groups · Annual bonus offering · Flexible work arrangements · Up to 6% 401K matching Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

At Elanco (NYSE: ELAN) - it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose - all to Go Beyond for Animals, Customers, Society and Our People. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you'll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals' lives better makes life better - join our team today! Your Role: Clinical Research Associate (CRA) As a Clinical Research Associate, you will play a direct role in advancing Elanco's global product pipeline by monitoring clinical and laboratory studies across companion animal and farm animal programs. You'll ensure every study is conducted with integrity, accuracy, and regulatory compliance. Your work supports pivotal and pilot registration studies and connects closely with our R&D teams to help secure global approvals. Your Responsibilities: • Proactively identify solutions and remove barriers to study progress. • Work effectively across Elanco R&D teams and external partners to support shared deliverables. • Foster a positive work environment aligned with company objectives and values. • Promote innovation by challenging yourself and others to deliver strong technical outcomes. • Demonstrate Elanco values of integrity, respect, and excellence while modeling the behavioral pillars of involve, deliver, innovate, and own. • Organize work to deliver high-quality, timely, and cost-effective outcomes. • Provide information to support accurate project and budget forecasting. Key Technical Responsibilities • Independently oversee clinical studies in companion and farm animals, ensuring all work is conducted, recorded, and reported in compliance with protocols, SOPs, VICH GCP, and regulatory standards. • Prepare and ship study site documentation, regulatory materials, and correspondence. • Verify drug accountability during initiation and closeout visits. • Interact with investigator sites and third-party contract facilities. • Verify study data using approved Data Management tools and monitoring processes to ensure data integrity. • Manage query communication with study sites. • Support QA audits as needed. • Facilitate site recruitment, site training, study initiation, in-life monitoring, and close-out activities. • Collaborate across R&D and commercial teams based on project phase and needs. • Assist in preparing submissions and dossiers for global regulatory agencies. What You Need to Succeed (minimum qualifications): • Education: Bachelor's degree in a scientific, veterinary, or related field, or equivalent experience. • Experience: Experience in clinical research, veterinary/animal health, laboratory science, or related regulated study environments. • Top Skills: Study monitoring, regulatory compliance, data verification and documentation quality. What Will Give You a Competitive Edge (preferred qualifications): • Experience with VICH GCP or similar regulated environments. • Prior work with companion animal or food animal clinical studies. • Familiarity with QA audits and regulatory submissions. • Experience interacting with CROs, clinical investigators, or farm operations. • Strong organizational, communication, and collaboration skills. Additional Information: • Travel: Approximately 35-50% annually, including multi-day travel blocks to study sites. • Location: Global Elanco Headquarters - Indianapolis, IN, Hybrid Work Environment. Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status

Who we are We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way. Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit. Why Worldwide We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us! What Pharmacovigilance department does at Worldwide Pharmacovigilance is the gateway to ensuring drug safety! Our Pharmacovigilance team comprises a dynamic group of individuals with extensive experience within the Drug Safety world. Watching drugs progress from First in Human Administration to global regulatory approval, we can be a part of the entire lifecycle of a compound making it to the market. We review safety events from all over the world and work with our clients to review, analyze, and submit to Investigators, Ethics Committees/IRBs, and Regulatory Agencies furthering clinical drug development! What you will do Author Safety Management Plan for assigned studies Attend internal and client meetings as appropriate Attend and present at Investigator Meetings Review incoming SAE data for completeness and accuracy Perform data entry in the Safety Database and/or complete applicable tracking of incoming safety information Generate queries for missing or unclear information and follow-up with sites for resolution Perform QC of SAEs processed by other PV Associates Generate regulatory reports and perform safety submissions as needed Prepare and submit periodic safety reports as needed Maintain knowledge and understanding of safety related regulations and guidelines Maintain basic understanding of budget and scope of work for assigned projects, ensuring compliance and escalation of any potential changes in scope May assist with bid defences or other presentations May mentor or train new PV staff Perform other duties as assigned What you will bring to the role Excellent understanding of medical and scientific terminology, of the principles of clinical assessment of adverse drug events, of international regulations and of reporting requirements Excellent understanding of computer technology, and management of relational database systems, including extraction of data Positive attitude and ability to interact diplomatically and professionally with internal and external customers in a global environment Excellent organization skills and ability to handle multiple competing priorities within tight timelines Ability to anticipate needs and follow through on all assigned tasks Able to effectively receive and provide constructive feedback without becoming defensive Makes sound decisions within the scope of responsibility. Focuses on solutions and problem resolution verses complaining or placing blame. Good understanding of computer technology, and management of relational database systems, including extraction of data Your experience Bachelor's degree in a science-related field, or nursing, or equivalent Minimum of 5 years of pharmacovigilance experience (pre-approval clinical trials) Equivalent combination of relevant education and experience. Computer literacy and strong working knowledge of MS Office applications (Excel, PowerPoint, Word). Excellent written and verbal communication skills Ability to work independently, prioritize work effectively and work successfully in matrix team environment Ability and willingness for potential limited travel (domestic and international) as needed (attend Investigator Meeting, project kick-off meeting and/or bid defense meeting) Fluent in written and verbal English We love knowing that someone is going to have a better life because of the work we do. To view our other roles, check out our careers page at Discover a world of difference at Worldwide! For more information on Worldwide, visit ***************** or connect with us on LinkedIn. Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative, innovative, and successful. We're on a mission to hire the very best and are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law.

About Meitheal Founded in 2017 and based in Chicago, Meitheal is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and brand products. Meitheal currently markets over 60 U.S. Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytic, intensive care, and fertility. As of January 2025, Meitheal, directly or through its partners, has 19 products in the research and development phase, 22 additional products planned for launch in 2025, and 24 products under review by the FDA. Meitheal's mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers' needs. Ranked #2 in2024 on Crain's Fast 50 in Chicago, and in the top 100 of Crain's Best Places to Work in Chicago from 2022 to 2024, Meitheal emulates the traditional Irish guiding principle we are named for - working together toward a common goal, for the greater good. Position Summary The Regulatory Affairs Senior Associate is responsible for providing effective support to the Publishing Operations function in Regulatory Affairs. The responsibilities for this position include utilizing publishing systems and processes for the preparation of high-quality submission dossiers, ensuring compliance with the FDA regulations and internal policies/procedures. Pharmaceutical experience required. The estimated salary range reflects an anticipated range for this position of $70,000 to $85,000. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location. Essential Duties and Responsibilities Prepare, compile, publish, validate, and submit electronic regulatory submissions (eCTD) for ANDA, NDA, BLA, IND, and DMF applications. Manage pre-approval, post-approval, and lifecycle management submissions, including Annual Reports, PADERs, PAS, CBE-0, CBE-30, Amendments, Supplements, and Safety Reports. Publish and submit Promotional and Advertising materials in compliance with FDA OPDP/2253 requirements. Perform advanced quality control (QC) reviews of submission components, including XML backbone, metadata, hyperlinks, bookmarks, file naming conventions, and validation reports. Submit eCTD submissions through the ESG FDA gateway, ensuring all components meet eCTD format requirements in collaboration with the publishing operations lead. Handle ANDA, NDA, and BLA submissions for pre-approval, post-approval, and promotional materials, supporting full product lifecycle management. Develop and maintain an in-depth understanding of relevant US and EU regulatory requirements for submissions. Troubleshoot and resolve complex technical issues related to publishing systems, validation errors, gateway rejections, large file handling, and system performance. Perform administrative tasks related to submissions, including transferring files via FTP servers. Input submission information into internal databases and systems per company procedures. Perform other duties as assigned to support Regulatory Affairs publishing operations. Competencies Planning and Organizing Teamwork Problem Solving Quality Judgement Dependability Qualifications To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Assimilate to changing environments. Ability to prioritize and multitask. Organized and detailed orientated. Have a sense of urgency to meet all required deadlines. Education and/or Experience Required Bachelor's degree from a 4-year college or university; over 3-4 years pharma experience and/or training; or equivalent combination of education and experience. Computer Skills Excellent dexterity: Microsoft Office (Word, Excel, Power Point and Outlook), Adobe Systems (Pro, Acrobat DC), and Practice Database system (DocuBridge, Veeva Systems, eCTD Manager, Liquent Insight publisher, etc). Physical Demands While performing the duties of this Job, the employee is frequently required to stand; walk; sit and talk or hear. The employee must occasionally lift and/or move up to 10 pounds. AAP/EEO Statement Equal Opportunity Employer Minorities/Women/Veterans/Disabled. Salary Description $70,000 to $85,000