At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Affairs – Marketed Products **Job Category:** People Leader **All Job Posting Locations:** North Ryde, New South Wales, Australia **Job Description:** + **Great Place to Work® Certified – 2025** + **Johnson & Johnson named a 2025 Fortune World’s Most Admired Company** + **Competitive salary package, flexible work practices** **, award winning benefits** + **Continuous training and development** **ABOUT INNOVATIVE MEDICINE** 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. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine **THE OPPORTUNITY** We are seeking a highly skilled, effective communicator, and knowledgeable Medical Affairs Associate to join our team. This role is focused on our established products and combines both medical and regulatory responsibilities. The ideal candidate will have extensive experience in communicating and working with external and internal stakeholders, scientific knowledge, with ability to work with agility and execute on action plans with diligence, being comfortable to work with strict timelines. This is a critical and strategic role. The successful candidate will make a positive impact on patients and healthcare professionals as well as supporting the business through medical and regulatory leadership activities and expertise. **RESPONSIBILITIES** + Provide expertise and project execution on the medical and regulatory components of established products (EP) -related issues and projects in Australia and New Zealand. This includes Discontinuations, Delistings and Deregistrations, Dear Doctor Letters, and Divestments (transfers of sponsorship) as well as safety issues. This person will work with the cross functional (XF) team. + Orchestrate and lead projects related to safety actions and issues within EP + Leadership of Dear Doctor letters including drafting, coordinating XF reviews, defining distribution plan, audience and timings. Also includes consultation and approvals from the TGA and Medsafe. Close collaboration with cross-functional teams to ensure regulatory and medical compliance and appropriate language on dear doctor letters and distribution plans. + Perform Medical assessments on medicine shortages in line with Health Authority guidelines. + Understanding of patients, healthcare professionals and clinical impact for diversity of issues and projects. + Communicate effectively with the Therapeutic Goods Administration (TGA) and Medsafe to ensure compliance with HA requirements and guidance + Monitor and assess any changes required by the HA or new policies and their potential impact on established products. + Develop and implement strategies to mitigate risks associated with medicine shortages and safety issues. + Maintain good understanding of regulatory environment and guidelines + Ensure all relevant work is undertaken in compliance with local regulation requirements and local and global corporate standards **ABOUT YOU** + Bachelor’s degree in medicine, Pharmacy, Science, Medical Science or a related field. + Advanced degree in Medicine, Pharmacy, Science, Medical Science or a related field preferred. + Familiarity with regulatory processes and documentation is preferred. + Medical Leadership: Leadership and input in cross-functional teams related to medical and regulatory components including Dear Doctor letters and distribution, medical assessments. Preferable previous experience in medical affairs and /or experience in drafting letters to healthcare professionals and other external stakeholders. + Regulatory Leadership: Input and consultation with TGA and Medsafe related to EP issues as appropriate. + Audience Definition: Ability to define target audiences for distribution letters, Dear Doctor letters, and other medical communications as well as communications and discussions with the TGA about communication plans related to shortages and safety issues. + Medical Landscape: Understanding of the medical landscape and needs. + Collaborative Work: Demonstrated ability to work collaboratively with cross-functional teams with agility. + Regulatory Affairs: Preferable previous exposure and /or experience with regulatory affairs. + Medical/Scientific Experience: Background on medical and /or scientific roles/fields. + Minimum 2 years of experience in medical roles and /or regulatory roles within the pharmaceutical industry. + In-depth knowledge of TGA and Medsafe requirements and guidance. + Strong communication and interpersonal skills, ability to negotiate and influence. + Ability to work independently and as part of a team. + Excellent problem-solving, critical thinking and analytical skills. + Positive can-do attitude and are self-motivated with a sense of urgency + Excellent verbal and written communication skills + Strong project management skills including time management, and risk mitigation. + Extremely strong ethical values and patient focus Johnson & Johnson, as a world leader across multiple therapy areas, offers a dynamic environment with opportunities to learn and grow across a broad range of those therapeutic areas. We encourage candidates with a strong desire to learn and a willingness to adapt to new challenges to apply. **COMPANY CULTURE** + Competitive remuneration package. + Continuous training and support. + Award-winning leadership development programs. + Inclusive, flexible, and accessible working arrangements. + Equal opportunity employer supporting diversity and inclusion. **WHY CHOOSE US:** + Competitive remuneration package and continuous training. + Supportive environment with award-winning leadership development programs. + Inclusive, flexible, and accessible working arrangements for all. **OUR BENEFITS:** + Up to 18 weeks of parental leave to support new parents. + 4 days of volunteer leave to give back to the community. + Option to purchase up to 2 weeks of additional annual leave for extra time off. + Enjoy a dedicated Wellbeing Day to prioritize self-care. + Global Wellness Reimbursement of $780 per year for healthy eating, exercise, or mindfulness activities. + Access to an Employee Assistance Program for personal and professional support. + Enhanced leave provisions for compassionate (caregiver) leave, providing up to 30 days of additional support. + Life insurance coverage for added peace of mind. And much more... **Great Place to Work® Certified– 2025** Great Place to Work® Certification recognises employers who create outstanding employee experience. The certification process is recognised worldwide as the global benchmark for identifying outstanding workplaces. Johnson & Johnson - Australia and New Zealand was certified as a Great Place to Work® in ANZ in its first year of participation.