Role Description The Director Medical Writing is an expert medical writer, responsible for writing and coordinating the writing of various clinical and regulatory documents including: - Protocols/amendments - Investigator brochures - Clinical study reports - NDA/BLA submission documents The Director Medical Writing will work closely with cross-functional teams to manage the preparation of written clinical and regulatory documents, ensuring that they are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines, and company goals. The Director will also manage and mentor more junior writers and will be seen as a key SME for medical writing providing leadership across global teams. Work Model: Remote - Officially documented as working full-time from home, with travel to Ultragenyx's offices or other locations on occasion as needed. Responsibilities - Development and implementation of document strategy for clinical and regulatory documents including writing, editing and/or reviewing of protocols, investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, and briefing books. - Develop and maintain a strong network of internal relationships to actively support cross-functional project team(s) representing Clinical Regulatory Writing. - Provides strategic insight for timely and accurate deliverables, negotiating timelines as necessary. - Drives and executes writing strategies across clinical development program(s) ensuring effective collaborations with other functional areas. - Review, edit, and ensure quality of documents or sections of documents prepared by functional area representatives and/or contract writers as required and ensure adherence to standards. - Effectively manages vendor/contract writers and forecasts external resources as needed to support internal deliverables. - Proactively implements clinical transparency and disclosure practices in document development (e.g. Policy 70, Clintrials.gov, etc.). - Provides coaching, training, and supervision of medical writing staff as applicable. - Provides department leadership by proposing and overseeing new initiatives and capabilities. - Work across departments to help set priorities and establish best practices for document preparation and review. - Manages resource planning including program and team forecasting. Qualifications - BS, MS, or doctorate in a scientific or medical field with 10 years working as a medical writer in the biotechnology/pharmaceutical industry (advanced degree preferred). - Demonstrated experience in medical writing, editing, and clinical development; has written protocols, IBs, CSRs; worked on at least one eCTD/NDA submission. - Deep understanding of the key requirements for regulatory submissions as stipulated in FDA and ICH guidelines for preparation of INDs, NDAs/BLAs and MAAs. - Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support. - Proven ability to develop and implement medical writing processes and standards. - Exceptional oral and written communication skills. - Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues. - Flexible; adapts work style to meet organization needs. - Strong organizational abilities and experience in a multitasking environment. - Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals. - Dedication to quality and reliability. - Excellent computer skills (Microsoft Office Suite, Power Point, Adobe Illustrator, figures and graphic design; Project and Visio a plus). - Ability to build and maintain effective partnerships, both internally and externally, and experience working successfully on matrixed teams. - Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels. - Rare disease experience and a strong understanding of metabolic genetics or metabolic bone disease a plus. Requirements - The typical annual salary range for this full-time position is $207,600 — $256,400 USD. - This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment. Benefits - Generous vacation time and public holidays observed by the company. - Volunteer days. - Long term incentive and Employee stock purchase plans or equivalent offerings. - Employee wellbeing benefits. - Fitness reimbursement. - Tuition sponsoring. - Professional development plans. - Benefits vary by region and country.

Role Description You'll write the in-product copy that shapes how users experience the app — button labels, onboarding flows, error messages, tooltips, and push notifications. You'll work embedded in the product design team, contributing to features from early concept through to shipped. - Write clear, concise copy for UI components, flows, and empty states - Collaborate with product designers and PMs from brief to launch - Conduct content audits and rewrite copy that isn't working - Maintain and evolve the product voice and tone guidelines - Review designs for copy consistency and UX writing best practices Qualifications - Strong written English with a natural, human voice - Understanding of UX principles — you think in user flows, not just words - Confident working in Figma or similar design tools - Collaborative — you work well with designers, PMs, and engineers Requirements - Portfolio of UX writing work from apps or web products (nice to have) - Experience with content strategy or information architecture (nice to have) - Background in copywriting, journalism, or a related writing discipline (nice to have) Benefits - $700–$1,100 USD/month based on experience - Fully remote with flexible hours - Embedded in product design — high visibility and impact - Paid leave - Path to Content Design Lead or Product Strategy roles

• Provide consultation services to students in the dissertation process, as well as doctoral and master’s-level assignments. • Provide overflow support to the Writing Center as needed, providing personalized guidance to students on a wide range of assignments including, but not limited to, essays, research papers, and dissertations. • Ensure feedback is delivered promptly, meeting established deadlines and service standards. • Maintain regular communication with the Writing Center leadership to align with best practices and improve student outcomes. • Facilitate workshops and writing boot camps, including curation and delivery of related materials, virtually as needed. • Create and curate content for dissertation support resources, such as handouts, explanations, and tutorials. • Provide copyediting services for the University’s research journal prior to publication. • Attend Writing Center team meetings and participate in professional development activities. • Effectively use relevant software and platforms, including Learning Management Systems (Moodle), video conferencing tools (Zoom), and document editing tools (Microsoft Word, Google Workspace). • Adapt teaching methods to support second-language learners and students from diverse linguistic and cultural backgrounds. • Assist in Writing Center projects, such as piloting new programs or developing advanced resources. • Track and report student progress and engagement to Writing Center leadership. • Apply knowledge from certifications (e.g., TESOL or advanced academic editing) as applicable.

Title: Senior Medical Writer Location: Warsaw, Indiana, United States of America time type Full time job requisition id R-070211 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.  As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Operations Job Sub Function: Clinical/Medical Operations Job Category: Professional All Job Posting Locations: Warsaw, Indiana, United States of America Job Description: 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/ We are searching for the best talent for a Senior Medical Writer, Scientific Operations, to join our MedTech Team. Remote work options may be considered on a case-by-case basis and if approved by the Company. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech Purpose: The Senior Medical Writer, Scientific Operations provides oversite and execution of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance Reports (SSCP), State of the Art Reviews (SOA) and Systematic Literature Reviews (LRR) for their assigned therapeutic area within Orthopedics. They also support broader initiatives and general Scientific Operations activities to support the continuous process improvement activities of the Scientific Operations Team. Key Responsibilities: - Planning and writing CERs, SSCPs, SOAs, and LRRs as well as mentoring other writers. - Conducting technical reviews to ensure document accuracy and compliance with local procedures, J&J guidelines and regulatory requirements. - Managing daily activities to ensure timelines are met. - Participating in workshops and other initiatives to help define and continuously improve process efficiency. - Participating in continuous education activities to improve understanding of associated regulatory requirements and industry trends/practices. - Supports interactions with respective Notified Bodies and regulatory agencies - Supports audits and inspections pertaining to SciOps processes and deliverables. - Actively partners with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs - Responsible for communicating business related issues or opportunities to next management level - Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable. - Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures - Performs other duties assigned as needed Qualifications: Education: - Minimum of a Bachelor’s degree and/or University degree is required. Advanced degree is preferred Experience: Required: - A minimum of four (4) years of experience in a related, professional environment - Strong oral communication, presentation, project management and prioritization skills - Excellent interpersonal relationships Preferred: - Experience within the medical device industry and knowledge of Clinical Evaluation Report regulatory requirements, evidence generation, literature reviews, and/or Clinical Evaluation Report (CER) document creation - Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting - Previous experience in orthopedics, specifically joint reconstruction and/or spine Other: - May require up to 10% domestic and/or international travel to other locations and sites - This is a remote position 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. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $109,000.00 - $174,800.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year Holiday pay, including Floating Holidays –13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52-week rolling period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year About Us 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.