• Provides medical oversight of assigned clinical studies in the duty as a medical monitor • Often serves as primary medical contact for customers for assigned clinical studies • Provides medical input and oversight in support of the Drug Safety and Pharmacovigilance department • Responsible for protocol design and development, upon request • Provides input into protocol amendments • Develops and delivers project-specific and therapeutic training to project team members and clinical site staff; provides training to customer staff as needed • Provides medical and therapeutic input to Study Start Up, Feasibility, and Subject Identification efforts • Provides medical input into data collection tools, monitoring plans, and review and analysis plans • Provides oversight to assigned Medical Scientist staff and Medical Director colleagues to review clinical data • Presents identified trends and issues, and mitigation strategies, to customers and project team members to minimize risks to subject safety or integrity of study data • Provides after-hours medical coverage for clinical studies • Adheres to all enterprise policies, work instructions, standard operating procedures, and project plans • Adheres to customer policies and standard operating procedures, as required in project plans • Maintains in-depth knowledge of FDA and worldwide drug development regulations and national and ICH Good Clinical Practice (GCP) guidelines • May support responses to Requests for Proposals (RFPs) or Bid Defense Meetings (BDMs), upon request • May provide input to clinical development or regulatory teams within the Company, upon request • May represent the Company at scientific meetings, upon request

Role Description The Director of Regulatory Affairs position will serve as a key member of the Regulatory team and may provide regulatory support across all disciplines, as needed. This role will be responsible for assisting in all regulatory strategies, writing, and activities for the organization, including all communications with FDA and other regulatory bodies. Additionally, the Director will assist as a steward of the Regulatory Affairs processes, procedures, and compliance to facilitate effective execution by the regulatory function across the organization. Qualifications - Bachelor's degree in a related field; advanced degree or equivalent preferred - 10 years of experience in technical/regulatory roles in the pharmaceutical/biotech industry - 5 years of experience in Regulatory Affairs in pharmaceutical/biotech industry - 3 years of demonstrated success in a regulatory leadership role and proven management by influence - Direct experience with FDA interactions, including written and verbal interactions and negotiations - Direct experience in writing and crafting regulatory submissions - Demonstrated experience managing complex virtual and matrixed organizational structures - Demonstrated experience in developing effective and successful regulatory strategies for all aspects of development programs - Thorough drug development technical expertise across Pre-Clinical and/or Clinical disciplines, and CMC - Ability to interpret, communicate, and present regulatory information in a clear, concise and timely manner - Ability to provide effective project communications, verbal and written, tailored for specific audiences - Ability to translate complex information into a logical and credible plan - Ability to work independently (with minimal supervision) as well as work in a team environment with changing timelines and priorities - Demonstrated organizational skills and attention to detail - Familiarity with eCTD requirements and e-submission formats/processes - Experience in establishing portfolio and program Regulatory strategy from pre-Candidate Selection through Post-Licensure Requirements - Direct experience in leading a monoclonal antibody/protein therapeutic through the drug development process through BLA submission, approval, and launch of the product - Experience in commercialization of monoclonal antibody therapies - Advanced degree or equivalent in a related field - Experience in interacting and negotiating with non-US Regulatory Agencies - Experience with post-approval change management, comparability assessments, post-marketing commitments and overall product life cycle management - Experience with FDA Animal Rule requirements for licensing drugs - Experience with US government acquisition and procurement contracting and Project Management deliverables - Experience in supporting US Government grant or proposal planning and writing - Previous experience establishing effective working relationships in a virtual environment - Previous experience with mentoring and/or development of employees - Previous experience developing drugs for rare diseases/Orphan drugs - Previous experience with FDA's regulations on expanded access and/or emergency use authorization of investigational drugs - Previous experience working with regulatory authorities in developing countries and in resource limited environments - Ability to effectively work remote/virtual using telecons and web conferences Responsibilities - Ensures that all regulatory goals are met and are in compliance with current industry standards and global regulations - Serves as a steward of Regulatory Affairs processes, procedures, and tools - Contributes to coordination, preparation, and timely submission of all regulatory documents - Develops regulatory strategies for the company as well as for product development teams - Facilitates FDA interactions, presentations and negotiations - Interprets and disseminates FDA communications, expectations and decisions to internal and external stakeholders - Advises the Head of Regulatory Affairs, senior management, and program team members on the impact of the changing regulatory environment - Assists in providing direction to regulatory team members related to assignments, timelines, and prioritization of project goals Benefits - Medical, dental, and vision insurance benefits are available to eligible employees and their families - Basic life insurance, short and long term disability, and a 401K plan with Company contributions - 7 days of sick time, 13 paid holidays, and 18 days of vacation throughout the calendar year

• Develop, implement, educate and monitor clinical programs • Advise and support facilities in compliance with State and Federal regulations • Assist during disease outbreaks and prepare plan of corrections • Conduct training and oversee Regional DON meetings • Monitor facilities compliance with nursing standards and metrics

Role Description Johnson & Johnson Innovative Medicine is searching for the best talent for the Medical Science Liaison-Neuroimmunology for the South Central region. The territory covers Texas, Louisiana, and Oklahoma. About Immunology: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Immunology team leads in the development of transformational medicines for immunological disorders and illnesses. You can influence where medicine is going by restoring health to millions of people living with immune diseases. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. The Medical Science Liaison (MSL) is responsible for providing fair balanced, objective, scientific information and education to opinion leaders (OLs), health care professionals, and to internal partners as required by scientific and business needs. The MSL is considered an established scientific and clinical knowledge lead on current and future J&J Innovative Medicine products per Therapeutic Area (TA) alignment. The MSL is responsible for staying abreast of current scientific and treatment trends in their therapeutic areas of interest. MSL provides research support for company and investigator-initiated research. MSL will function with high integrity and follow credo values. The MSL will be responsible for: - Building external relationships with identified KOLs and health care providers (MD, PA, NP, RN, Pharm.D., bio coordinators) and developing and managing geographical territory. These relationships and engagements can include both virtual & in-person, with a prioritization of in-person engagements when appropriate. - Developing and maintaining a territory strategic plan, which includes educational activities with identified OLs, HCPs, institutions, and community practices. - Having a level of competency and experience in the disease state. The MSL is expected to possess foundational competencies in the areas of Influence & Results Focused, Communication, Stakeholder Engagement, Product & Therapeutic Area Knowledge, and Data Insights & Dissemination. - Rapidly identify and compliantly collaborate with field-based partners to ensure support of the Healthcare Providers which will positively impact the patients that they care for. - To enhance their skills in agility, applying the competencies of Change Management, Time Management and Innovation. - Conducting all activities in accordance with current regulatory and health care compliance guidelines. - Ability to travel, primarily throughout assigned geography, with infrequent meeting travel outside of assigned geography. Travel for this role is estimated at 60%. - Consistently demonstrating strategic territory planning and ability to build strong relationships within the territory. - Consistently demonstrating strong scientific acumen. - Continuously supporting Department Operations and Internal Partners. Qualifications - A PharmD, PhD, MD, NP or PA w/ 2+ years relevant neurology, immunology and/or neuromuscular experience. - 0-2 years MSL experience, and/or 2 years relevant work exp (clinical or research experience) and/or related pharma work. - Requires travel of approximately 60% depending on geography includes overnight and weekends as needed. - A valid driver’s license. Requirements - Launch experience in rare disease. - Significant experience giving presentations. Company Description Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource. Required Skills - Clinical Experience - Clinical Research and Regulations - Competitive Landscape Analysis - Cross-Functional Collaboration - Customer Centricity - Data-Driven Decision Making - Data Gathering and Analysis - Developing Others - Inclusive Leadership - Interpersonal Influence - Leadership - Medical Affairs - Medical Communications - Medical Compliance - Mentorship - Performance Measurement - Problem Solving - Relationship Building - Research and Development - Scientific Communications - Strategic Thinking Preferred Skills