Manager, Medical Writing jobs at Sumitomo Corporation - 215 jobs

Evolution Health Group is a full-service, integrated healthcare communications agency which has broad strategic capabilities and consists of 4 main divisions, Evolution Medical Communications - thought leaders in promotional medical education, including P2P engagement strategy from pre-launch to LOE Maestro360 - leaders in program execution of meetings, events and conventions blulava - experts with respect to optimizing the customer engagement experience through technology Darwin Academy - dedicated to providing novel, interactive peer to peer education We have been evolving (no pun intended) and growing since 2005. We take pride in our strategic partnerships with our clients and working with transformative therapies. We are proud of our diverse culture that inspires great work. EHG offers comprehensive benefits, cutting edge technology, both hybrid and remote work options, an office center with many amenities, and social action opportunities. Evolve with us (pun intended) and take the next step to boost your career. Job Title: Senior Medical Writer Job Purpose: In this role, you will be primarily responsible for developing and editing scientific materials for promotional and/or educational programs, as well as taking an active role in content development and curation. As a Senior Medical Writer, you will also work closely with Senior Management on other aspects of the content delivery process, from initial scientific and tactical strategy, new business presentations, client communications, faculty identification and outreach, including product and program development, through outcomes assessment and program evaluation. To successfully function as part of the Evolution and broader client teams, it will be necessary to act as a close liaison with all other Evolution departments and to establish in-depth professional relationships with key customers. Responsibilities: Initiate and drive content development from kick-off through final approval of resource, providing ownership of projects through the routing process. Participate in client meetings and CMLR for assigned projects and independently act to incorporate feedback and prepare for submission. Review materials from contributing team members for scientific accuracy and appropriateness. Work collaboratively with internal teams (accounts, operations, creative, shared services), and clients to ensure projects are completed on time and within budget. Attend conferences, trade shows, advisory boards or other venues as necessary. Execute all aspects of administrative responsibilities (weekly timesheets, weekly status updates, maintenance of a calendar in Outlook, etc.) in appropriately detailed and timely manner. Actively participate in all internal meetings, including planning meetings, project kick-off, internal status, client status, and brainstorming meetings. Perform other duties and assignments as directed. Qualifications: An advanced degree in life science is preferred (e.g., PharmD, PhD, or MD). A minimum of 3 years of medical education or relevant experience in a related field is required for the Medical Writer's position. Or, a minimum of three years of medical education or relevant experience in a related field for the Senior Medical Writer's position. Proven content development management experience. Ability to think creatively and identify and work to develop unique customer solutions/service offerings. Excellent oral and written communication skills. Excellent analytical skills. Excellent organizational skills and attention to detail, with absolute commitment to quality. Ability to work independently in a fast-paced environment; self-motivated. Ability to participate and interact effectively with team. Effectively manage time, multi-task, and handle a high volume of work in a fast-paced environment. Advanced proficiency in Microsoft Office Suite (e.g., Word, Excel, PowerPoint, and Outlook). Sample of Therapeutic Areas/Subjects: Cardiovascular (CVD, Lipid Management, Hypertension, Metabolic Syndrome) Endocrinology (Diabetes, Kidney Disease, Metabolic Syndrome) Neuroscience (Major Depressive Disorder, Bipolar Disorder, Schizophrenia, Parkinson's Disease, ADHD) Rare Diseases Respiratory (Asthma, COPD) Infectious Diseases Genetic Disorders (Hereditary Angioedema, Gaucher Disease, Hunter Syndrome and Fabry Disease) Women's Health Immuno-allergy Oncology Managed care Ophthalmology Sample of Service Offerings: Key Opinion Leader Identification Advocacy Development Advisory Boards Scientific Platforms Speaker Training and Development Meetings Strategic Consulting Slide Kit Development Meeting and Logistical Services Local and Regional Consultant Conferences Patient Education Teleconferences and Teleconferences-on-Demand Website Development Webcasts and Webcasts-on-Demand E-based Initiatives Salesforce Communication MSL tools and support Managed Care Initiatives Monographs CD-ROMs Newsletters Convention and Logistical Services Working Environment: Normal office environment. Travel required: estimated up to 30% of the time. May require regular evening and weekend work. EHG is an Equal Opportunity Employer. All applicants will be considered without regard to race, color, religion, sex, age, national origin, citizenship status, sexual orientation, disability, veteran status or any category or class of person protected by law.

**Job Title:** Global Medical Writing Franchise Head - Vaccines **About the Job** The Global Medical Writing Franchise Head is part of the Vaccine Clinical Documentation group and will manage a global group of Medical Writers who are assigned to the different projects/clinical trials part of the Franchise. In this role, you will be accountable for the timely delivery of high-quality clinical content and documentation, within the scope of the assigned franchise, prepared in accordance with regulatory specifications and strategic messaging to support the clinical development, marketing applications and lifecycle management of the Vaccine portfolio. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. **Main Responsibilities:** + Lead, manage, advise, mentor and evaluate a culturally diverse, international team of Medical Writers located at different regional sites, ensuring alignment of objectives, goals, and understanding with the mission of the department and current needs of the changing environment, internal and external. + Represent the Medical Writing function in different strategic meetings (e.g. Clinical and Regulatory Strategic forum (CRSF), CTD advisory board) and with external partners; ensure medical writing support to produce clinical and submission documents that meet the requirements of Health Authorities, as well as internal standards. + Participate in the review of strategic clinical documents (e.g. protocol ID card, Common Technical Document) prepared by the team to ensure appropriate quality and scientific content. + With the support of the Global Head of Vaccines clinical documentation, develop an outsourcing strategy for document production, focused on cost-effective delivery of timely documents of appropriate quality. + Manage and allocate human and financial resources related to medical writing activities for the effective realization of the goals of VCD. + Support changes, training & development, and evaluation of Medical Writers. + Contribute to the development and implementation of process improvement and innovative technologies to bring efficiencies and cost savings. **About You** **Education and Experience** : + Master's degree is the minimum education requirement. Advanced degree in a scientific related field is preferred. + 7+ years of experience in the pharmaceutical industry with some team management experience. + Candidate should have experience preparing regulated documentation for health agencies in support of drug development, or equivalent experience in Regulatory Affairs or Medical Affairs. Knowledge of Vaccine Clinical Development is an asset. **Skills & Capabilities** : + Knowledge of regulatory or other guidelines pertaining to document standards and submission requirements. + Understanding of the functioning and constraints of other functions providing input to clinical documents (biostatistics, pharmacovigilance, clinical development, regulatory, etc.) + Collaborative experience with external partners providing resources or expertise with contract research organizations (CROs), key opinion leaders (KOLs), vendors, etc. + Strong leadership ability, coupled with strategic and innovative thinking. + Proven ability to manage people, budgets and change; negotiate and influence others, and resolve conflict. Understanding of business considerations (basic finance, human resources). + Extensive project and/or clinical experience in a global environment and the ability to lead others to complete projects. + Awareness of electronic document management, content re-use and submission tools, trends and technologies. + Capable of working collaboratively across different cultures and time zones. + Ability to adapt to needs of a changing business environment (e.g., regulatory requirements, corporate structure and processes, customer focus, technological advances). + Willingness to engage in dialogue with management, customers, and colleagues to give and receive feedback. + Diplomacy, negotiation skills, and ability to network. **Why Choose Us?** + Bring the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. + Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. \#GD-SP \#LI-SP \#LI-Onsite \#vhd **Pursue** **_progress_** **, discover** **_extraordinary_** Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video (************************************************** and check out our Diversity Equity and Inclusion actions at sanofi.com (************************************************************************ ! _US and Puerto Rico Residents Only_ Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. _North America Applicants Only_ The salary range for this position is: $172,500.00 - $249,166.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK (********************************************************************************************************* . Global Terms & Conditions and Data Privacy Statement (*************************************************************** Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions. With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting ************** or via our movie We are Sanofi (***************************** As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live. All in for Diversity, Equity and Inclusion at Sanofi - YouTube (************************************************

Job Title: Global Medical Writing Franchise Head - Vaccines About the Job The Global Medical Writing Franchise Head is part of the Vaccine Clinical Documentation group and will manage a global group of Medical Writers who are assigned to the different projects/clinical trials part of the Franchise. In this role, you will be accountable for the timely delivery of high-quality clinical content and documentation, within the scope of the assigned franchise, prepared in accordance with regulatory specifications and strategic messaging to support the clinical development, marketing applications and lifecycle management of the Vaccine portfolio. We are an innovative global healthcare company that helps the world stay ahead of infectious diseases by delivering more than 500 million vaccine doses a year. Across different countries, our talented teams are exploring new technologies to protect people and promote healthy communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world. Main Responsibilities: Lead, manage, advise, mentor and evaluate a culturally diverse, international team of Medical Writers located at different regional sites, ensuring alignment of objectives, goals, and understanding with the mission of the department and current needs of the changing environment, internal and external. Represent the Medical Writing function in different strategic meetings (e.g. Clinical and Regulatory Strategic forum (CRSF), CTD advisory board) and with external partners; ensure medical writing support to produce clinical and submission documents that meet the requirements of Health Authorities, as well as internal standards. Participate in the review of strategic clinical documents (e.g. protocol ID card, Common Technical Document) prepared by the team to ensure appropriate quality and scientific content. With the support of the Global Head of Vaccines clinical documentation, develop an outsourcing strategy for document production, focused on cost-effective delivery of timely documents of appropriate quality. Manage and allocate human and financial resources related to medical writing activities for the effective realization of the goals of VCD. Support changes, training & development, and evaluation of Medical Writers. Contribute to the development and implementation of process improvement and innovative technologies to bring efficiencies and cost savings. About You Education and Experience: Master's degree is the minimum education requirement. Advanced degree in a scientific related field is preferred. 7+ years of experience in the pharmaceutical industry with some team management experience. Candidate should have experience preparing regulated documentation for health agencies in support of drug development, or equivalent experience in Regulatory Affairs or Medical Affairs. Knowledge of Vaccine Clinical Development is an asset. Skills & Capabilities: Knowledge of regulatory or other guidelines pertaining to document standards and submission requirements. Understanding of the functioning and constraints of other functions providing input to clinical documents (biostatistics, pharmacovigilance, clinical development, regulatory, etc.) Collaborative experience with external partners providing resources or expertise with contract research organizations (CROs), key opinion leaders (KOLs), vendors, etc. Strong leadership ability, coupled with strategic and innovative thinking. Proven ability to manage people, budgets and change; negotiate and influence others, and resolve conflict. Understanding of business considerations (basic finance, human resources). Extensive project and/or clinical experience in a global environment and the ability to lead others to complete projects. Awareness of electronic document management, content re-use and submission tools, trends and technologies. Capable of working collaboratively across different cultures and time zones. Ability to adapt to needs of a changing business environment (e.g., regulatory requirements, corporate structure and processes, customer focus, technological advances). Willingness to engage in dialogue with management, customers, and colleagues to give and receive feedback. Diplomacy, negotiation skills, and ability to network. Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave. Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. #GD-SP #LI-SP #LI-Onsite #vhd Pursue progress , discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! US and Puerto Rico Residents Only Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law. North America Applicants Only The salary range for this position is: $172,500.00 - $249,166.66 All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.

Madrigal is a biopharmaceutical company focused on delivering novel therapeutics for metabolic dysfunction-associated steatohepatitis (MASH), a serious liver disease that can progress to cirrhosis, liver failure, need for liver transplantation and premature mortality. Every member of our Madrigal team is connected by our shared purpose: leading the fight against MASH. Madrigal's medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of MASH. Rezdiffra is the first and only medication approved by both the FDA and European Commission for the treatment of MASH with moderate to advanced fibrosis (F2 to F3). An ongoing Phase 3 outcomes trial is evaluating Rezdiffra for the treatment of compensated MASH cirrhosis (F4c). Our success is driven by our people. We are building a dynamic, inclusive, and high-performing culture that values scientific excellence, operational rigor, and collaboration. To support our continued growth, we are strengthening our workforce strategy to ensure we have the right talent, at the right time, in the right way. Overview Madrigal Pharmaceuticals is seeking an Senior Manager of Medical Writing. The successful candidate will play a crucial role in ensuring the accuracy, consistency and quality of clinical documents. This role is critical in supporting the company's mission to develop transformative therapies for patients with liver disease, primarily metabolic dysfunction-associated steatohepatitis (MASH). Responsibilities Write documents supporting Phase 1 though IV clinical trials (primarily clinical study protocols, clinical study reports and investigators brochures) Collaborate closely with cross-functional teams to create documents that support program goals and timelines Ensure that documents are of the highest quality and compliant with global regulatory requirements and industry best practices. This role may also include contributing to updates to standard operating procedures to reflect evolving requirements. Contribute to the development and implementation of processes and systems to optimize Madrigal's efficiency and productivity in document development Stay current with regulatory guidelines, industry trends, and best practices in medical writing Qualifications 6+ years of clinical or regulatory medical writing experience supporting pharmaceutical drug development Able to: Analyze and interpret complex clinical data and scientific information to write clear and concise documents fit for a variety of audiences Ensure accuracy and consistency in the quality control of documents with precise attention to detail Work collaboratively in a fast-paced environment, often while balancing multiple documents of varying complexity Strong understanding of drug development process, including clinical research, regulatory requirements, and publication strategies Experienced in using industry standard technical tools (e.g., use of templates, Microsoft Word macros) and electronic document management systems Committed to adhere to ethical principles and industry standards, including Good Clinical Practice (GCP) and Good Documentation Practices (GDP) Preferred : Familiarity with designing and operationalizing clinical studies Advanced degree in scientific area Experience in liver, cardiovascular or metabolic diseases Madrigal's Total Rewards strategy is based on a biotech industry peer group comparator and is inclusive of base pay, bonus and equity. Our equity offers meaningful opportunity allowing our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. All employees receive equity, which we believe reinforces our ownership culture. Base salary is determined by several factors including the candidate's qualifications, skills, education, experience, business needs and market demands. The base salary range for this position is $155,000 to $189,000 per year. All full-time employees receive equity, which reinforces our ownership culture and offers meaningful opportunity for our employees to share in the success they help create. By aligning individual and company performance, we empower employees to think like owners, giving them a stake in the organization. Full-time employees are also eligible for comprehensive benefits, including flexible paid time off, medical, dental, vision and life/disability insurance, and 401(k) offerings (i.e., traditional, Roth, and employer match) in accordance with applicable plans. We also offer additional voluntary benefits like supplemental life insurance, legal services, and other offerings. In addition, we offer mental health benefits through our Employee Assistance Program for employees and their family. The company also provides other benefits in accordance with applicable federal, state, and local laws. We are committed to providing reasonable accommodations for individuals with disabilities throughout the hiring process. If you need assistance, please contact *********************. Madrigal is an Equal Opportunity Employer. All employment is decided on the basis of qualifications, merit, and business need. Applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex gender identity, sexual orientation, national origin, age, disability, protected veteran or disabled status, or other characteristic protected by applicable federal, state, or local law. Unsolicited resumes from agencies should not be forwarded to Madrigal. Madrigal will not be responsible for any fees arising from the use of resumes through this source. Madrigal will only pay a fee to agencies if a formal agreement between Madrigal and the agency has been established. Applications are being accepted on an ongoing basis and can be submitted through our Madrigal Careers site. Please be aware that we have received reports of individuals misrepresenting themselves as Madrigal Pharmaceuticals' Hiring Managers, seeking to engage with job candidates through fraudulent online advertisements or job posting sites. These unauthorized individuals are using Madrigal's name and logo in an attempt to solicit up-front fees and obtain personal information from interested job candidates. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process. Please also note that any correspondence with regard to employment would come from an authorized madrigalpharma.com email address or from an email address from one of our trusted search firm partners. We are aware that incorrect/fraudulent email addresses, with Madrigal misspelled, have been utilized in these most recent fraud attempts. If you receive unsolicited employment offers from people claiming to work for or on behalf of Madrigal, we recommend that you: do not respond to their questions; do not open any attachments; and do not click on any hyperlinks. Any questions regarding the legitimacy of job-related contacts can be directed to ********************* .

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 ******************* **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Writing **Job Category:** People Leader **All Job Posting Locations:** Allschwil, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, Netherlands, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, Toronto, Ontario, Canada **Job Description:** **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 *******************/innovative-medicine **We are searching for the best talent for Director, Medical Writing, Oncology.** Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-038874 Belgium & Netherlands- Requisition Number: R-039974 United Kingdom- Requisition Number: R-039973 Switzerland- Requisition Number: R-039972 Canada- Requisition Number: R-039966 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. **Purpose:** The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, RegMW has the authority to oversee projects, identify risks, and implement process improvements, while managing internal teams and contributing to organizational initiatives. Additionally, the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications, leading within a team matrix environment, setting functional tactics, making strategic contributions, and proactively planning for resources. The Director will influence TA-level strategies, lead process working groups, champion internal standards, and improve internal systems and tools. **You will be responsible for:** + Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals. + Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles. + Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions. + Write or provide guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence. + Represent the MW department with decision-making authority in the R&D organization, leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments. + Directly lead or set objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently. + Serve as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration. + Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross-functional team members. + Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed. + Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems. + Participate in industry standards working groups to represent MW and ensure alignment with best practices. + Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team, in close consultation and accordance with the Delivery Unit (DU) + Head and in line with R&D priorities and TA objectives. + Recognized expert medical writer for any document within and across TAs. + Accountable for MW resource management and allocation within their portfolio(s). + Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority. + Can step in for DU Head in case of absence. + Is a major contributor to multiple deliverables for the function, TA, or DU. + Provides leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. + Responsible for creating an environment where employees feel engaged and empowered, and + take pride in their role, responsibilities, and deliverables. + Takes on additional major responsibility with minimal supervision, operating at an expert level with accountability for the highest levels of quality: + o Cross-functional, cross-TA, cross-J&J initiative/collaboration. + o Larger organizational responsibility (eg, manage a subset of functional area/TA organization) with some level of independence to operate within that subset of the organization. + Supervises/manages and is accountable for direct reports. + Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing feedback on performance and development. + Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. + Ensures direct report's adherence to established policies, procedural documents, and templates. + Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning. + If applicable, frequent engagement with staff and leading discussions on employee development and talent management. **Qualifications / Requirements:** + A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. + Minimum of 14 years of relevant pharmaceutical/scientific experience is required. + Minimum of 12 years of relevant clinical/medical writing experience is required. + Minimum of 5 years of people management experience is required. + Expertise in project management and process improvement is required. + Strong decision-making skills, strategic thinking, agility, broad vision is required. **Other:** + Excellent oral and written communication skills. + Attention to detail. + Expert time management for self, direct reports (if applicable), and teams. + Ability to delegate responsibility to other medical writers. + Expert ability to lead and influence by example and stay focused (positive). Demonstrate integrity. + Expert ability to motivate and develop best in class talent pipeline. + Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers. + Creates a positive Credo-based work environment for staff members. + Shows openness to new ideas and fosters organizational learning. The expected pay range for this position is $160,000 to $276,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. + Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance. + 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 For additional general information on company benefits, please go to: ********************************************* This job posting is anticipated to close on October 31, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market 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, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** **The anticipated base pay range for this position is :** $160,000 - $276, 000 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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 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 Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

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 ******************* Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: People Leader All Job Posting Locations: Allschwil, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, Netherlands, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, Toronto, Ontario, Canada Job Description: 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 *******************/innovative-medicine We are searching for the best talent for Director, Medical Writing, Oncology. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-038874 Belgium & Netherlands- Requisition Number: R-039974 United Kingdom- Requisition Number: R-039973 Switzerland- Requisition Number: R-039972 Canada- Requisition Number: R-039966 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Purpose: The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, RegMW has the authority to oversee projects, identify risks, and implement process improvements, while managing internal teams and contributing to organizational initiatives. Additionally, the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications, leading within a team matrix environment, setting functional tactics, making strategic contributions, and proactively planning for resources. The Director will influence TA-level strategies, lead process working groups, champion internal standards, and improve internal systems and tools. You will be responsible for: * Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals. * Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles. * Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions. * Write or provide guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence. * Represent the MW department with decision-making authority in the R&D organization, leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments. * Directly lead or set objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently. * Serve as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration. * Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross-functional team members. * Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed. * Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems. * Participate in industry standards working groups to represent MW and ensure alignment with best practices. * Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team, in close consultation and accordance with the Delivery Unit (DU) * Head and in line with R&D priorities and TA objectives. * Recognized expert medical writer for any document within and across TAs. * Accountable for MW resource management and allocation within their portfolio(s). * Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority. * Can step in for DU Head in case of absence. * Is a major contributor to multiple deliverables for the function, TA, or DU. * Provides leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. * Responsible for creating an environment where employees feel engaged and empowered, and * take pride in their role, responsibilities, and deliverables. * Takes on additional major responsibility with minimal supervision, operating at an expert level with accountability for the highest levels of quality: * o Cross-functional, cross-TA, cross-J&J initiative/collaboration. * o Larger organizational responsibility (eg, manage a subset of functional area/TA organization) with some level of independence to operate within that subset of the organization. * Supervises/manages and is accountable for direct reports. * Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing feedback on performance and development. * Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. * Ensures direct report's adherence to established policies, procedural documents, and templates. * Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning. * If applicable, frequent engagement with staff and leading discussions on employee development and talent management. Qualifications / Requirements: * A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. * Minimum of 14 years of relevant pharmaceutical/scientific experience is required. * Minimum of 12 years of relevant clinical/medical writing experience is required. * Minimum of 5 years of people management experience is required. * Expertise in project management and process improvement is required. * Strong decision-making skills, strategic thinking, agility, broad vision is required. Other: * Excellent oral and written communication skills. * Attention to detail. * Expert time management for self, direct reports (if applicable), and teams. * Ability to delegate responsibility to other medical writers. * Expert ability to lead and influence by example and stay focused (positive). Demonstrate integrity. * Expert ability to motivate and develop best in class talent pipeline. * Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers. * Creates a positive Credo-based work environment for staff members. * Shows openness to new ideas and fosters organizational learning. The expected pay range for this position is $160,000 to $276,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. * Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance. * 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 For additional general information on company benefits, please go to: ********************************************* This job posting is anticipated to close on October 31, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market 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, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $160,000 - $276, 000 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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 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 Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

Job title: Expert Scientific Writer * Hiring Manager: Scientific Writing Team Lead About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Expert Scientific Writer, you will lead the end-to-end development of complex scientific and medical education content, ensure compliance and quality, while maintain therapeutic area expertise, coaching writers, and fostering best practices and stakeholder collaboration. Main responsibilities: * Build and maintain strong relationships with key stakeholders (medical/scientific community) to deliver educational and communication content. * Interact effectively with healthcare professionals on publication content. * Mentor and support both senior and junior writers by sharing expertise and guiding knowledge development. * Deliver high-quality publication and medical education materials (e.g., slide decks, abstracts, posters, manuscripts) within agreed timelines and standards. * Provide strategic support and collaborate with individuals and institutions serving as resources for publications. * Develop complex publication and medical education content with high scientific and compliance standards. * Act as subject matter expert in medical communication for assigned therapeutic areas. * Conduct publication-need analysis and implement annual publication plans for the region. * Coordinate with vendors to ensure timely and compliant delivery of assigned projects. * Work closely with regional scientific communication teams to identify needs and develop deliverables. * Liaise with the medical department to prepare relevant and customized materials. About you * Experience: Solid experience in content creation for the pharmaceutical/healthcare industry, or academia. * Soft and technical skills: * Stakeholder management. * Communication skills * Ability to work independently and within a team environment * Proficient in multiple TAs/domains under one GBU; scientific communications/writing; medical communications/writing; publication planning; and/or project management). * Publication submission * Education: Advanced degree in life sciences/pharmacy/similar discipline or medical degree) * Languages: Spanish and advanced English level (spoken and written) Why choose us? * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * You'll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions. * You'll be part of a truly diverse cross-cultural team and can have real business impact. * Flexible working policies, including up to 50% remote work. * Private medical care, life and health insurance, and gender-neutral paid parental leave * Colombia is one of Sanofi's key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation. * Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants. Pursue Progress. Discover Extraordinary. Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! #LI-LAT #LI-Hybrid Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Job title: Senior Scientific Writer * Hiring Manager: Scientific Writing Team Lead About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Senior Scientific Writer, you will manage end-to-end development of complex scientific content and publications, ensure quality, compliance, and stakeholder collaboration, while maintaining therapeutic area expertise and coaching junior writers. Main responsibilities: * Build and maintain strong relationships with key stakeholders (medical/scientific community) to deliver educational and communication content. * Interact effectively with healthcare professionals regarding publication content. * Mentor and support junior writers by sharing expertise and guiding knowledge development. * Deliver high-quality publication and medical education materials (e.g., slide decks, abstracts, posters, manuscripts) within agreed timelines. * Provide strategic support and collaborate with individuals and institutions serving as resources for publications. * Develop complex publication and medical education content with high scientific standards. * Support medical communication and maintain subject matter expertise in assigned therapeutic areas. * Conduct publication-need analysis and implement annual publication plans for the region. * Coordinate with vendors to ensure timely and compliant delivery of assigned projects. * Work closely with regional scientific communication teams to identify needs and develop deliverables. * Liaise with the medical department to prepare relevant and customized materials. About you * Experience: 4+ years of experience in content creation for the pharmaceutical/healthcare industry, or academia. * Soft and technical skills: * Stakeholder management. * Communication skills * Ability to work independently and within a team environment * Proficient in multiple TAs/domains under one GBU; scientific communications/writing; medical communications/writing; publication planning; and/or project management). * Publication submission * Education: Advanced degree in life sciences/pharmacy/similar discipline or medical degree) * Languages: Spanish and advanced English level (spoken and written) Why choose us? (External) * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * You'll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions. * You'll be part of a truly diverse cross-cultural team and can have real business impact. * Flexible working policies, including up to 50% remote work. * Private medical care, life and health insurance, and gender-neutral paid parental leave * Colombia is one of Sanofi's key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation. * Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants. Pursue Progress. Discover Extraordinary. Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! #LI-LAT #LI-Hybrid Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

Job title: Scientific Writer * Grade: Level 1 * Hiring Manager: Scientific Writing Team Lead About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As a Scientific Writer, you will develop specialized scientific content with limited supervision, manage the end-to-end publication and medical education process (including compliance and approvals), maintain therapeutic area expertise, collaborate on best practices, and engage effectively with stakeholders. Main responsibilities: * Build and maintain strong relationships with key stakeholders (medical/scientific community) to deliver educational and communication content. * Interact effectively with healthcare professionals regarding publication content. * Mentor and support junior writers by sharing expertise and guiding knowledge development. * Deliver high-quality publication and medical education materials (e.g., slide decks, abstracts, posters, manuscripts) within agreed timelines. * Provide strategic support and collaborate with individuals and institutions serving as resources for publications. * Develop complex publication and medical education content with high scientific standards. * Support medical communication and maintain subject matter expertise in assigned therapeutic areas. * Conduct publication-need analysis and implement annual publication plans for the region. * Coordinate with vendors to ensure timely and compliant delivery of assigned projects. * Work closely with regional scientific communication teams to identify needs and develop deliverables. * Liaise with the medical department to prepare relevant and customized materials. About you * Experience: 2+ years of experience in content creation for the pharmaceutical/healthcare industry, or academia. * Soft and technical skills: * Stakeholder management. * Communication skills * Ability to work independently and within a team environment * Proficient in multiple TAs/domains under one GBU; scientific communications/writing; medical communications/writing; publication planning; and/or project management). * Publication submission * Education: Advanced degree in life sciences/pharmacy/similar discipline or medical degree) * Languages: Spanish and advanced English level (spoken and written) Why choose us? * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * You'll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions. * You'll be part of a truly diverse cross-cultural team and can have real business impact. * Flexible working policies, including up to 50% remote work. * Private medical care, life and health insurance, and gender-neutral paid parental leave * Colombia is one of Sanofi's key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation. * Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants. Pursue Progress. Discover Extraordinary. Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! #LI-LAT #LI-Hybrid Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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 ******************* Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: People Leader All Job Posting Locations: Allschwil, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, Netherlands, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, Toronto, Ontario, Canada Job Description: 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 *******************/innovative-medicine We are searching for the best talent for Director, Medical Writing, Oncology. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-038874 Belgium & Netherlands- Requisition Number: R-039974 United Kingdom- Requisition Number: R-039973 Switzerland- Requisition Number: R-039972 Canada- Requisition Number: R-039966 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Purpose: The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, RegMW has the authority to oversee projects, identify risks, and implement process improvements, while managing internal teams and contributing to organizational initiatives. Additionally, the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications, leading within a team matrix environment, setting functional tactics, making strategic contributions, and proactively planning for resources. The Director will influence TA-level strategies, lead process working groups, champion internal standards, and improve internal systems and tools. You will be responsible for: * Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals. * Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles. * Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions. * Write or provide guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence. * Represent the MW department with decision-making authority in the R&D organization, leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments. * Directly lead or set objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently. * Serve as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration. * Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross-functional team members. * Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed. * Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems. * Participate in industry standards working groups to represent MW and ensure alignment with best practices. * Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team, in close consultation and accordance with the Delivery Unit (DU) * Head and in line with R&D priorities and TA objectives. * Recognized expert medical writer for any document within and across TAs. * Accountable for MW resource management and allocation within their portfolio(s). * Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority. * Can step in for DU Head in case of absence. * Is a major contributor to multiple deliverables for the function, TA, or DU. * Provides leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. * Responsible for creating an environment where employees feel engaged and empowered, and * take pride in their role, responsibilities, and deliverables. * Takes on additional major responsibility with minimal supervision, operating at an expert level with accountability for the highest levels of quality: * o Cross-functional, cross-TA, cross-J&J initiative/collaboration. * o Larger organizational responsibility (eg, manage a subset of functional area/TA organization) with some level of independence to operate within that subset of the organization. * Supervises/manages and is accountable for direct reports. * Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing feedback on performance and development. * Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. * Ensures direct report's adherence to established policies, procedural documents, and templates. * Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning. * If applicable, frequent engagement with staff and leading discussions on employee development and talent management. Qualifications / Requirements: * A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. * Minimum of 14 years of relevant pharmaceutical/scientific experience is required. * Minimum of 12 years of relevant clinical/medical writing experience is required. * Minimum of 5 years of people management experience is required. * Expertise in project management and process improvement is required. * Strong decision-making skills, strategic thinking, agility, broad vision is required. Other: * Excellent oral and written communication skills. * Attention to detail. * Expert time management for self, direct reports (if applicable), and teams. * Ability to delegate responsibility to other medical writers. * Expert ability to lead and influence by example and stay focused (positive). Demonstrate integrity. * Expert ability to motivate and develop best in class talent pipeline. * Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers. * Creates a positive Credo-based work environment for staff members. * Shows openness to new ideas and fosters organizational learning. The expected pay range for this position is $160,000 to $276,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. * Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance. * 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 For additional general information on company benefits, please go to: ********************************************* This job posting is anticipated to close on October 31, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market 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, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $160,000 - $276, 000 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. 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 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 Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

The Associate Director, Medical Writing Science manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments. This is a hybrid role which allows for 2 days per week remote work and 3 days per week in the Boston Fan Pier office. We offer a full relocation package. Key Duties and Responsibilities: Independently authors routine and complex clinical and regulatory documents Provides strategic input into program-level plans Deep insight into how different functions contribute to the successes of the team Aligns, coordinates, and builds consistent information and messages across clinical program(s) Provides leadership related to the activities of Medical Writing Science and manages a team Participates in developing and implementing goals and initiatives for Medical Writing Science Facilitates implementation of new technologies and initiatives related to the preparation of clinical documents Proactively anticipates risks, solves complex problems, and seeks out and implements process improvements Knowledge and Skills: Demonstrated aptitude for planning, managing, and optimizing department resources (e.g., staff, technology) to maximize and streamline the advancement of company goals and objectives Record of leadership, independence, and ability to solve non-routine, complex problems involving a broad range of issues Proven track record of anticipating potential problems and preparing contingency plans as needed Understanding of scientific disciplines beyond own specialty area Experience managing direct reports and guiding staff development Experience with marketing authorization application regulatory submissions Education and Experience: Bachelor's degree in relevant discipline Ph.D. (or equivalent degree) Typically requires 8 years of work experience and 2 years of supervisory/management experience, or the equivalent combination of education and experience #LI-AR1 #LI-Hybrid Pay Range: $157,600 - $236,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Ironwood Pharmaceuticals is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. One of the focus areas is on discovering, developing, and commercializing innovative treatments for patients with severe, rare conditions for which there is a significant unmet medical need. These conditions are challenging to diagnose, often devastating, and have limited, if any, treatment options. The lead product candidate, apraglutide, is a next-generation, best-in-class, synthetic peptide analog of glucagon-like peptide-2, or GLP-2, and is in Phase 3 for the treatment of patients with short bowel syndrome, or SBS, a malabsorption disorder caused by the loss of functional small intestine. It is an exciting time to join as Phase 3 is underway and the company is preparing for an initial launch in the coming years for which it is building out a commercial presence. The Senior Director of Medical Writing will have responsibility for executing a fit-for-purpose delivery model to produce a range of high quality clinical and regulatory documents to advance company goals across all investigational and marketed products. To achieve that aim, the Senior Director will collaborate with stakeholders across the Research & Development organization to understand priorities and needs. The Senior Director will initially oversee the selection and operation of external vendors and may eventually build an internal team to resource projects. The Senior Director will lead the development of processes and initiatives to ensure the consistent delivery of high quality, efficient medical writing services that comply with regulatory and internal guidelines. The Senior Director will represent the medical writing function on cross-functional teams for marketed and/or investigational products. The Senior Director will independently deliver clinical and regulatory documents that span the drug development lifecycle. The Senior Director will ensure high quality with regard to compliance with regulatory and internal guidelines, and the accuracy, consistency, and organization of documents. The Senior Director must be a proactive leader, effectively able to organize and collaborate with cross-functional teams to produce on-time, on-target documents that further the program goals. The Senior Director must have a strong understanding of drug development, clinical research concepts and data interpretation and presentation. Responsibilities: Maintain a long-term project forecast and resource plan to deliver all the documents required to advance company goals. Manage the selection of external vendors, from the initial preparation and review of completed Requests for Proposals through to contract negotiation and finalization. Independently author and manage others in creation of clear and concise, submission-ready clinical and regulatory documents. Manage the ongoing operations of high performing external vendors, including resource forecasting, contract change management, of oversight of vendor financials. Drive the ongoing development of processes, initiative, and tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines. Serve as a subject matter expert, advising and collaborating with cross-functional stakeholders on document strategy, authoring and review processes, and best practices. Represent Medical Writing and provide medical writing expertise on cross-functional teams. Develop detailed timelines for document development in line with company goals and SOPs. Write clinical and regulatory documents in accordance with applicable guidelines, regulations, practices, and procedures. Documents include, but are not limited to, clinical study protocols, clinical study reports, Investigator's Brochures [IBs], and Module 2 summaries of registration dossiers. Manage multiple rounds of team review through document finalization (ie, distribute documents for review; consolidate and resolve of reviewer comments; lead efficient cross-functional review roundtables). Ensure the accuracy, consistency, and quality of documents. Coordinate a formal quality control (QC) review of documents, as applicable. Coordinate with the Regulatory Operations team to publish documents that meet eSubmission‑ready standards. Collaborate with Data Sciences to review statistical analysis plans to ensure that the outputs planned meet data reporting needs and document templates. Lead the preparation of public disclosures of study results on national registries such as ClinicalTrials.gov and EU Clinical Trials Information System (CTIS), ie, coordinate with the external vendor to prepare the posting, distribute the posting for review, perform a quality control review [QC], consolidate and resolve reviewer comments, coordinate the redaction of required documents, notify the relevant stakeholders, in accordance with the company SOP and relevant regulations. Collaborate effectively across Ironwood and with Ironwood partner companies and external vendors, as applicable. Participate in the development of department SOPs and process-related tools to improve and enhance operations and to ensure compliance with regulatory standards and ICH/GCP/eCTD guidelines. Support medical writing and other cross-functional colleagues as necessary (eg, document review, format, and QC). Qualifications: BA/BS and 12+years of medical writing experience in the pharmaceutical or biotech industry; advanced degree preferred Success in managing resources (internal, external, or hybrid) Prior direct experience leading medical writing teams responsible for global marketing authorization applications Experience with a broad range of clinical regulatory documents spanning the drug development lifecycle Strong understanding of the drug development process, including regulatory requirements and ICH/GCP/eCTD guidelines. Working knowledge of drug development, clinical research, study design, biostatistics, regulatory, and medical terminology Excellent technical writing and editorial skills; excellent attention to detail Strong ability to understand and interpret medical and scientific data Proficient in Microsoft Word, PowerPoint, Excel, Project, and SharePoint Experience with automated document templates (eg, StartingPoint by Accenture), Adobe Acrobat and EndNote Excellent communication, interpersonal, and organizational skills Experience working on cross-functional teams Well organized; able to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines Ironwood is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. Ironwood currently anticipates that the initial base salary for this position could range from between $239,000 to $278,565. The actual base salary will depend, in part, on the successful candidate's qualifications for the role, including education and experience. Ironwood offers a comprehensive compensation and benefits program to eligible employees, including Restricted Stock Unit awards; eligibility to participate in either a bonus or sales incentive program; company-sponsored 401(k) with matching contributions; eligibility for medical, dental, vision and prescription drug benefits; wellness stipends; and a generous vacation/holiday schedule. #LI-Hybrid

Be part of something great! Synchrony Group is an independently owned network of companies, headquartered in West Chester, PA. At Synchrony, we are dedicated to providing the highest quality products and services in the medical communications industry. Our vision is to create the highest value for our clients and the most opportunity for our team members, while working together to improve the lives of patients. Collectively, we are leaders in strategic planning, development, and execution of best-in-class programs that address medical needs, maximize strategic objectives, and make significant scientific and clinical contributions. Our passion and commitment to improving outcomes for our clients, healthcare professionals, and patients drives us to exceed expectations in everything we do. Synchrony consists of integrated groups of medical-scientific, clinical, creative, commercial, and industry experts. Synchrony Medical Communications specializes in strategic medical communications, publication planning, and associated scientific content and engagement. Our teams reflect our commitment to excellence-we're smart, enthusiastic, and driven. We align the skills, experiences, and perspectives of diverse individuals to achieve unparalleled results in an environment of respect and mutual support. Above all, we are passionate about changing the world and improving the lives of patients. Our success is built on the foundation of our team, and we're always striving to strengthen our foundation. More than just seeking out the best and brightest to join us, we also create a work environment in which employees are respected and encouraged to grow. Are you looking to be part of something great? We'd like to meet you! Job Description The Senior Medical Writer: 1) writes original content for publications activities, and other materials for healthcare professional (HCP) and internal client audiences; 2) demonstrates a command of relevant therapeutic areas and expertise with assigned products; 3) analyzes, interprets, and applies clinical data to produce high-quality scientific communications; 4) follows all internal processes and procedures with regard to workflow, development of deliverables, and adherence to industry best practices and guidelines. Job Duties Demonstrate a command of assigned therapeutic areas and expertise with assigned products Write original content for publication/communication activities (primary and review manuscripts, abstracts, posters), slide presentations, meeting summaries, and other materials for HCP and internal audiences Prepare materials according to internal writing guidelines and other applicable guidelines (eg, client-specific style guidelines, compliance best practices, journal style guidelines) Follow all internal processes and procedures with regard to workflow, development of deliverables, and adherence to industry best practices, including GPP3 Demonstrate the flexibility/adaptability necessary to function on different therapeutic teams as needed Interpret and apply clinical data Maintain a proactive approach on initiatives for existing and prospective clients Work in conjunction with team members to manage workload and develop and adhere to logical and attainable timelines for project completion Attend team meetings to provide input and aid in troubleshooting/problem-solving Efficiently and accurately collate and incorporate author/client comments Participate in author/client teleconferences and answer content-related questions Lead author teleconferences as necessary Review/revise medical writers and freelance writers' work as necessary Participate in brainstorming sessions and strategic publications planning meetings to aid in strategy/goals Attend advisory boards, roundtables, etc, to record and synthesize meeting into a formal report Assist in development of new business presentations by researching, analyzing, and synthesizing pharmacologic attributes, existing clinical data, and market research into strategic application for capabilities Attend and participate in new business presentations as appropriate Internal and External Relationships Foster and develop collaboration with internal and external stakeholders to produce quality work within established timelines and to ensure innovative and collaborative solutions to client needs Exhibit professional manner and be a positive force for enhancing the team culture, constructive working relationships, consensus building, and internal communications Work as part of a team to ensure that it is meeting company goals and objectives, and adhering to corporate values Represent the organization in an appropriate manner Communicate effectively both verbally and in writing with internal and external stakeholders Keep management apprised of key departmental concerns and issues Key Competencies Excellent attention to detail and high degree of scientific and medical accuracy Ability to manage outcomes to win-win resolution Ability to identify key issues and to creatively and strategically overcome challenges or obstacles High level of integrity, ethics, confidentiality, and accountability Sound analytical thinking, planning, prioritization, and execution skills with an ability to multitask Well-developed professional communication skills, including written and interpersonal Flexibility and adaptability to change; ability to work effectively under time constraints Ability to interact effectively in a fast-paced, team-oriented environment Established track record of high-quality medical communications outputs (eg, manuscripts, posters, physician/patient materials) Expertise in multiple therapeutic areas Proficiency in Microsoft Office (Word, Excel, Outlook) Qualifications Requirements PhD, PharmD, or MD Minimum of 3 years' experience in medical communications Substantial professional medical writing experience in a wide variety of communication formats Ability to work independently on assigned projects Working Conditions Ability to travel as client needs require (e.g., client meetings, congress meetings, sales meetings) Ability to attend and conduct virtual or in-person presentations Ability to commit to extra and/or nontraditional hours as client needs require Additional Information Synchrony places high value on the well-being of its employees; therefore, Synchrony team members are eligible for a comprehensive array of benefits, including competitive salaries, generous paid time off, excellent health insurance, family leave, and a 401(k) plan with employer matching. All your information will be kept confidential according to EEO guidelines. EOE. Synchrony is not able to provide visa sponsorship for this role.

Corcept is leading the way in the research and development of cortisol modulators, molecules that regulate cortisol activity at the glucocorticoid receptor (GR). To date, we have discovered more than 1,000 selective proprietary cortisol modulators. In 2012, we received FDA approval of Korlym (mifepristone), the first approved treatment for hypercortisolism (Cushing's syndrome). Today, our team and collaborators continue to unlock the possibilities of cortisol modulation as a way to treat serious diseases. With more than 30 ongoing studies across a wide range of disease areas, including endocrinology, oncology, metabolism, and neurology, we remain dedicated to advancing the possibilities of cortisol modulation. What began as a ripple of scientific truth is now poised to unleash a sea change of discovery representing a fundamental shift in the way we understand and treat disease. The Associate Director, Medical Writing (Regulatory) will provide strategic and operational medical writing expertise to prepare high-quality clinical regulatory documents for Health Authority submissions. This position will collaborate across the organization to implement and maintain a standardized document development process for regulatory documents. This is a hybrid role typically requiring on-site presence at least 3 days per week. Responsibilities: Develop and execute strategies for organizing and preparing documents for regulatory health authority submissions Plan, prepare, write, edit, format, and finalize regulatory documents including IND, CTA/IMPD, NDA, MAA, clinical and non-clinical summaries, updates to regulatory submissions, meeting requests, briefing books, annual reports/development safety update reports (DSURs) Oversee document preparation activities and track progress against targets; produce timely and accurate status update reports Provide oversight of document quality and consistency for ease of review across multiple documents assembled in a regulatory dossier or briefing package Lead document review and comment resolution processes with cross-functional teams Leverage scientific expertise to write, review, and edit science-based documents such as those included in IND/NDA sections, meeting requests, briefing books and annual reports Coordinate the review and approval of documents Develop templates, style guidelines, and SOPs for regulatory documentation Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements Preferred Education and Experience: JD/Paralegal degree with scientific background or advanced scientific degree (MS, PhD or PharmD) Regulatory medical writing experience in the pharmaceutical industry/CRO environment or equivalent experience writing technical materials for submission to regulatory authorities, legal entities and/or other audiences Able to compile, analyze, and present data clearly, concisely, and effectively Experience participating in submissions to the US FDA (IND, NDA) and EMA (MAA) Strong understanding of drug development and regulations (US, EU and ICH) Broad knowledge of relevant regulatory guidelines (e.g., FDA, EMA) and compliance requirements Proficiency with Electronic Common Technical Document (eCTD) templates Strong verbal and written communication skills to effectively collaborate with cross-functional teams and address regulatory queries The pay range that the Company reasonably expects to pay for this headquarters-based position is $144,800 - $212,900; the pay ultimately offered may vary based on legitimate considerations, including geographic location, job-related knowledge, skills, experience, and education. Applicants must be currently authorized to work in the United States on a full-time basis. For information on how Corcept collects, uses, discloses, protects, and otherwise processes personal information and an explanation of the rights and choices available to you with respect to your personal information, please refer to our Privacy Notice link. Corcept appreciates the commitment and hard work of all our team members as we strive to discover and develop novel treatments for patients with serious unmet medical needs. Please visit our website at: ************************ Corcept is an Equal Opportunity Employer Corcept will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third-party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Corcept.

Reporting directly to the Vice President of Clinical Development, the Medical Writer will be responsible for leading and executing all medical writing activities supporting Xeris' clinical programs. The individual will have a strong scientific background, exceptional writing skills, and a proven ability to translate complex clinical and scientific data into clear, accurate, and regulatory-compliant documents tailored to diverse audiences. **Responsibilities** + Develop and authora broad range of clinical and regulatory documents, including but not limited to: clinical study protocols, investigator brochures (IBs), clinical study reports (CSRs), and sections of regulatory submissions (e.g., IND, NDA, etc.). + Ensure accuracy, clarity, consistency, and compliancewith internal standards, applicable regulatory guidelines (e.g., ICH, FDA, EMA), and company SOPs. + Collaborate cross-functionallywith colleagues in Clinical, Regulatory Affairs, Medical Affairs, and other internal stakeholders to gather relevant data and ensure consistency of messaging across documents. + Translate highly technical and statistical informationinto clear, concise content suitable for a wide variety of audiences including regulators, healthcare professionals, and non-scientific business leaders, as required. + Contribute to the development of communication materials, including slide decks, manuscripts, abstracts, and presentations, to support internal and external scientific communications. + Maintain document quality controlthrough proofreading, editing, and adherence to templates, style guides, and version control procedures. + Manage timelines and priorities for multiple projects simultaneously, ensuring timely and accurate delivery of high-quality documents. + Provides detailed medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review. + Ensures document content and style adheres to FDA/EMA or other appropriate regulatory guidelines and complies with departmental SOPs and style guidelines. + Performs literature searches and reviews as necessary to obtain background information and provide literature references. + Provide input on processes, templates, and other business needs within the medical writing function. + Coordinate and/or manage review cycles to triage, incorporate, and resolve team comments, and lead discussion on document revision and finalization for both internally written and outsourced documents. + Serve as a point person for medical writing guidance and document-related problem resolution. **Qualifications** + Bachelor's degree in Life Sciences or a related field is required; advanced degree (PhD, PharmD, or MS) strongly preferred. + Minimum of 5 years of medical writing experience in the pharmaceutical, biotechnology, or clinical research industry, with a focus on late-stage clinical development (Phase 3). + Demonstrated experience in writing regulatory submission documents in compliance with regulatory agency guidelines. + Proficiency in Microsoft Office Suite and familiarity with document management systems and version control tools. + Competencies: Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Independent Judgement, Cross-Team Collaboration, Critical Thinking, Problem Solving + Working Conditions:Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. _This is a hybrid position located in Xeris' Chicago office and requires three days per week on-site. On-site requirement may change at management's discretion._ _The level of the position will be determined based on the selected candidate's qualifications and experience._ \#LI-HYBRID _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary range for this position is $75,000 to $150,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ **Job Locations** _US-IL-Chicago_ **Title** _Medical Writer_ **ID** _2025-2296_ **Category** _Clinical Development_ **Type** _Full-Time_

Reporting directly to the Vice President of Clinical Development, the Medical Writer will be responsible for leading and executing all medical writing activities supporting Xeris' clinical programs. The individual will have a strong scientific background, exceptional writing skills, and a proven ability to translate complex clinical and scientific data into clear, accurate, and regulatory-compliant documents tailored to diverse audiences. Responsibilities Develop and author a broad range of clinical and regulatory documents, including but not limited to: clinical study protocols, investigator brochures (IBs), clinical study reports (CSRs), and sections of regulatory submissions (e.g., IND, NDA, etc.). Ensure accuracy, clarity, consistency, and compliance with internal standards, applicable regulatory guidelines (e.g., ICH, FDA, EMA), and company SOPs. Collaborate cross-functionally with colleagues in Clinical, Regulatory Affairs, Medical Affairs, and other internal stakeholders to gather relevant data and ensure consistency of messaging across documents. Translate highly technical and statistical information into clear, concise content suitable for a wide variety of audiences including regulators, healthcare professionals, and non-scientific business leaders, as required. Contribute to the development of communication materials, including slide decks, manuscripts, abstracts, and presentations, to support internal and external scientific communications. Maintain document quality control through proofreading, editing, and adherence to templates, style guides, and version control procedures. Manage timelines and priorities for multiple projects simultaneously, ensuring timely and accurate delivery of high-quality documents. Provides detailed medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copy editing and content review. Ensures document content and style adheres to FDA/EMA or other appropriate regulatory guidelines and complies with departmental SOPs and style guidelines. Performs literature searches and reviews as necessary to obtain background information and provide literature references. Provide input on processes, templates, and other business needs within the medical writing function. Coordinate and/or manage review cycles to triage, incorporate, and resolve team comments, and lead discussion on document revision and finalization for both internally written and outsourced documents. Serve as a point person for medical writing guidance and document-related problem resolution. Qualifications Bachelor's degree in Life Sciences or a related field is required; advanced degree (PhD, PharmD, or MS) strongly preferred. Minimum of 5 years of medical writing experience in the pharmaceutical, biotechnology, or clinical research industry, with a focus on late-stage clinical development (Phase 3). Demonstrated experience in writing regulatory submission documents in compliance with regulatory agency guidelines. Proficiency in Microsoft Office Suite and familiarity with document management systems and version control tools. Competencies: Attention to Detail, Organizational skills, Adaptability, Multi-Tasking, Strong Written & Verbal Communication skills, Independent Judgement, Cross-Team Collaboration, Critical Thinking, Problem Solving Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel. This is a hybrid position located in Xeris' Chicago office and requires three days per week on-site. On-site requirement may change at management's discretion. The level of the position will be determined based on the selected candidate's qualifications and experience. #LI-HYBRID As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors. The anticipated base salary range for this position is $75,000 to $150,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process. NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Entrepreneurial Spirit, Rooted in Tradition . At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. As a key member of our Clinical Development Team, the Medical Writer will provide regulatory documents support to the clinical teams, ensuring successful preparation of high quality, submission-ready documents and effective implementation of the clinical writing process. Incumbent will provide expertise in the medical writing for multiple compounds and/or projects within the therapeutic area(s). Typical duties would include substantive editing and review, researching and obtaining published reports on studies in a variety of different indications, writing executive summaries, and coordinating the publication of key preclinical and clinical scientific data through peer-reviewed journals and forums. Job Description Researches, writes and edits pre-clinical and clinical reports, summarizing data from pre-clinical and clinical studies. Prepares clinical reports, summary documents, investigator's brochures, package inserts, protocols and protocol amendments, and other documents that may be submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for publication and/or presentation. Works collaboratively, contributing to cross-functional teams and projects. Develops and drives detailed project timelines according to team-specified deadlines. Assists in the development of formats and guidelines for clinical documentation. May prepare scientific manuscripts, abstracts and posters. May also support clinical research associates and medical doctors in clinical protocol development. Proactively keeps abreast of professional information, trends and technology through conferences, networking and other information sources and brings forward innovative ideas for consideration. Perform other duties as assigned. Qualifications BA/BS required; preferably in a related scientific discipline. Advanced scientific degree (MS, Pharm D, PhD) is preferred. 2-8 years of well-documented, proven medical writing experience in a pharmaceutical or clinical/contract research organization including preparation of full and abbreviated clinical study reports, clinical study protocols, integrated summary documentation (ISS/ISE), and other IND/NDA-required regulatory documentation (e.g., pharmacokinetic and toxicology summaries and investigator brochures). Ability to conceptually organize and analyze data, interpret and synthesize complex clinical and non-clinical statistical reports to derive key outcomes and messages coupled with an ability to translate scientific and technical issues for diverse audiences. Expertise in clinical research documentation, related regulations and guidelines (FDA, EMEA, ICH) and GCP. Ability to quickly develop an understanding of company SOPs. Outstanding interpersonal skills and the ability to work within a team, in a collaborative and supportive role, yet taking the lead on key projects as needed. Strong project management skills; ability to multitask while driving towards critical deadlines on all projects. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy. Excellent written/oral communication skills. Good interpersonal skills; able to establish rapport with all functional leaders, experts and colleagues . Superior computer skills. Experienced with MS Office (Word, Excel, PowerPoint, Outlook), MS Project and database applications. Preferably familiar with current electronic authoring, document management and electronic regulatory submissions. Willingness to travel, though travel is likely infrequent. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

Entrepreneurial Spirit, Rooted in Tradition. At Mitsubishi Tanabe Pharma Development America (MTDA), we can tout a storied reputation more than 300 years in the making. Our parent company, Mitsubishi Tanabe Pharma Corporation (MTPC), is a research-driven pharmaceutical company with global reach - and one of Japan's oldest and most respected companies. Relatively new to the U.S. market, the innovative compounds of the Mitsubishi Tanabe Pharma Group have already enjoyed commercial success under the brand labels of our U.S. partners. In this next phase of development, we plan to bring exciting new compounds to market under our own MT Pharma America label. We're currently building a new commercial organization and expanding our other functions to support this strategy. As a key member of our Clinical Development Team, the Medical Writer will provide regulatory documents support to the clinical teams, ensuring successful preparation of high quality, submission-ready documents and effective implementation of the clinical writing process. Incumbent will provide expertise in the medical writing for multiple compounds and/or projects within the therapeutic area(s). Typical duties would include substantive editing and review, researching and obtaining published reports on studies in a variety of different indications, writing executive summaries, and coordinating the publication of key preclinical and clinical scientific data through peer-reviewed journals and forums. Job Description Researches, writes and edits pre-clinical and clinical reports, summarizing data from pre-clinical and clinical studies. Prepares clinical reports, summary documents, investigator's brochures, package inserts, protocols and protocol amendments, and other documents that may be submitted to the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) for publication and/or presentation. Works collaboratively, contributing to cross-functional teams and projects. Develops and drives detailed project timelines according to team-specified deadlines. Assists in the development of formats and guidelines for clinical documentation. May prepare scientific manuscripts, abstracts and posters. May also support clinical research associates and medical doctors in clinical protocol development. Proactively keeps abreast of professional information, trends and technology through conferences, networking and other information sources and brings forward innovative ideas for consideration. Perform other duties as assigned. Qualifications BA/BS required; preferably in a related scientific discipline. Advanced scientific degree (MS, Pharm D, PhD) is preferred. 2-8 years of well-documented, proven medical writing experience in a pharmaceutical or clinical/contract research organization including preparation of full and abbreviated clinical study reports, clinical study protocols, integrated summary documentation (ISS/ISE), and other IND/NDA-required regulatory documentation (e.g., pharmacokinetic and toxicology summaries and investigator brochures). Ability to conceptually organize and analyze data, interpret and synthesize complex clinical and non-clinical statistical reports to derive key outcomes and messages coupled with an ability to translate scientific and technical issues for diverse audiences. Expertise in clinical research documentation, related regulations and guidelines (FDA, EMEA, ICH) and GCP. Ability to quickly develop an understanding of company SOPs. Outstanding interpersonal skills and the ability to work within a team, in a collaborative and supportive role, yet taking the lead on key projects as needed. Strong project management skills; ability to multitask while driving towards critical deadlines on all projects. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy. Excellent written/oral communication skills. Good interpersonal skills; able to establish rapport with all functional leaders, experts and colleagues. Superior computer skills. Experienced with MS Office (Word, Excel, PowerPoint, Outlook), MS Project and database applications. Preferably familiar with current electronic authoring, document management and electronic regulatory submissions. Willingness to travel, though travel is likely infrequent. Additional Information Our Value Proposition: Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate. At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits: Medical/Dental Life Insurance | Supplemental Life Insurance/Dependent Life Insurance |Accidental Death & Dismemberment Insurance | Business Travel Accident Insurance | Short-Term Disability | Long-Term Disability | Flexible Spending Accounts | Employee's Savings Plan (401K Plan) | Competitive Paid Time Off

The Medical Writer position at Medpace offers the unique opportunity to have an exciting career in the research of drug and medical device development while making a difference in the lives of those around them. For those with a PhD in a life science field who want to explore the research field and be part of a team bringing pharmaceutical and medical devices to market - this could be the right opportunity for you! Responsibilities * Write IND modules, NDA modules and other related regulatory documents * Write clinical study reports, protocols, and protocol amendments * Coordinate quality control reviews of those documents and maintain audit trails of changes * Interact closely with the sponsor, and other Medpace subject matter experts Qualifications * PhD degree in a life science; * Strong computer skills, project management skills, and a high attention to detail; and * Strong communication skills (both written and oral). Medpace Overview Medpace is a full-service clinical contract research organization (CRO). We provide Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Our mission is to accelerate the global development of safe and effective medical therapeutics through its scientific and disciplined approach. We leverage local regulatory and therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system, anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, employing more than 5,000 people across 40+ countries. Why Medpace? People. Purpose. Passion. Make a Difference Tomorrow. Join Us Today. The work we've done over the past 30+ years has positively impacted the lives of countless patients and families who face hundreds of diseases across all key therapeutic areas. The work we do today will improve the lives of people living with illness and disease in the future. Cincinnati Perks * Cincinnati Campus Overview * Flexible work environment * Competitive PTO packages, starting at 20+ days * Competitive compensation and benefits package * Company-sponsored employee appreciation events * Employee health and wellness initiatives * Community involvement with local nonprofit organizations * Discounts on local sports games, fitness gyms and attractions * Modern, ecofriendly campus with an on-site fitness center * Structured career paths with opportunities for professional growth * Discounted tuition for UC online programs Awards * Named a Top Workplace in 2024 by The Cincinnati Enquirer * Recognized by Forbes as one of America's Most Successful Midsize Companies in 2021, 2022, 2023 and 2024 * Continually recognized with CRO Leadership Awards from Life Science Leader magazine based on expertise, quality, capabilities, reliability, and compatibility What to Expect Next A Medpace team member will review your qualifications and, if interested, you will be contacted with details for next steps.