Director, Medical Writing jobs at MMS - 778 jobs

The US Medical Director - Neuromuscular and Neurodegenerative Diseases leads medical strategy and thought leader engagement for Sanofi's neurology portfolio, including Riliprubart. This role involves cross-functional collaboration to support clinical development, product strategy, and medical education within the pharmaceutical industry. The position requires an MD, PhD, NP, or PharmD with expertise in neurology and experience in biologics or clinical care. Job Title: US Medical Director - Neuromuscular and Neurodegenerative Diseases Location: Cambridge, MA / Morristown, NJ About the Job Sanofi focuses on developing specialty treatments for debilitating diseases that are often difficult to diagnose and treat, providing hope to patients and their families. Learn This leadership position reports to the Head of North America Neurology Medical, offering an opportunity to work in a patient-centric, high-performance culture. The role combines support for Sanofi's MS portfolio with primary responsibility for medical leadership of Riliprubart and other neurology pipeline assets in neuromuscular and neurodegenerative diseases. We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting 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 Strategic Leadership Lead US Neurology Medical activities related to Riliprubart and other pipeline assets addressing unmet needs in neuromuscular and neurodegenerative diseases Develop and execute the annual US Medical Brand Plan aligned with critical success factors Identify unmet medical needs in neuromuscular and neurodegenerative diseases addressable by Sanofi assets Thought Leader Engagement Cultivate relationships with current and future experts in MS, neuromuscular and neurodegenerative diseases across US academic and clinical medicine Develop and implement KOL management plans with the cross-functional team Gather expert insights to influence Clinical Development and Life Cycle Planning strategies Product Strategy & Support Collaborate with the cross-functional team to define and refine branded product strategy Work with Clinical, Global Medical/Scientific Communications, Pharmacovigilance, and Statistics teams on post-hoc analyses and benefit/risk profile refinement Support communication strategies for company-generated data in collaboration with Global Medical Scientific Communications Cross-Functional Collaboration Provide medical support, education, and guidance to Commercial, Marketing, Sales, and Market Access teams Liaise with Global and US Neurology Medical Directors to ensure alignment across the organization Participate in Medical Affairs, Clinical Sciences & Operations, and cross-functional teams and committees About You Qualifications Education & Experience MD, PhD, NP, or PharmD required 2+ years relevant experience in biologics/pharmaceutical industry OR relevant clinical experience. Expertise in neuromuscular and neurodegenerative diseases, multiple sclerosis, and/or neurology preferred Experience in both clinical development and patient care preferred Professional Skills Outstanding scientific acumen Strong leadership and analytical skills with ability to deliver on project objectives Proven ability to lead and influence teams without direct authority Excellent communication, presentation, and organizational skills Self-directed with ability to work independently with minimal direction Collaborative and transparent leadership capabilities Creative and innovative thinking 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-SG #LI-GZ #LI-Onsite #vhd All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here. Keywords: Medical Director, Neuromuscular Diseases, Neurodegenerative Diseases, Pharmaceutical Industry, Clinical Development, Medical Leadership, Neurology, Product Strategy, Key Opinion Leader, Healthcare Management

Are you ready to make a difference in the world of rare diseases? As the Associate Director, External Scientific Partnerships, US Medical Affairs, you will be at the forefront of strategic initiatives with US-based health professional societies and associations. Collaborating with Director, ESP and TA Leadership teams, you will drive and deliver a comprehensive strategic engagement plan for our rare disease portfolio. Your role will involve professional society collaborations, HCP education, and engagement with Key Opinion Leaders, all aligned with US Medical Affairs' strategic goals. You will analyze and communicate key strategic external landscapes, enabling informed decisions that contribute to Alexion's success. Accountabilities: Maintain strategic relationships with US-based scientific societies and be responsible for execution of plans. Align partnership initiatives with TA strategies and Leadership Teams to ensure evidence-based care and build the HCP talent pipeline. Engage cross-functionally with Alexion leaders to optimize interactions related to scientific associations and identify collaboration opportunities. Contribute to project objectives in line with medical strategy, incorporating new clinical evidence and guidelines. Represent Alexion at key professional organization meetings and events, collaborating with internal collaborators. Strategically fund programs through sponsorships, ensuring effective budget management. Develop communications to ensure visibility of Alexion Professional Society partnerships. Track and evaluate performance metrics to inform future strategy. Undertake other strategic projects as assigned. Essential Skills/Experience: PhD, PharmD or equivalent experience in a scientific field preferred (BS, MS, MD, PhD, PharmD) 3-5 years of experience in the pharmaceutical field or alliance/partnership experience with large ESPOs and External Experts Knowledge in rare disease and enterprise thinking; ability to tap into connections across products Proven leadership and collaboration skills; shown capability in building relationships with diverse groups Ability to foster strong, compliant, productive alliances Proven ability to establish relationships with scientific associations and external experts Ability to work in a highly matrixed environment; lead multiple projects and collaborate cross-functionally Strong interpersonal, communication, and negotiation skills Knowledge of drug development process and commercialization Strong project management skills; track record in working effectively with cross-functional teams Experience working in medical affairs Fluent in English Detailed knowledge of social media space, business channels, and advancing digital health Solid understanding of regulatory environment and industry standards Proven technical, organizational, project management, negotiation, and budgeting capabilities; self-starter 25% Travel anticipated At AstraZeneca's Alexion division, we are driven by a passion for innovation and a commitment to making a meaningful impact. Our unique culture fosters connections that inspire new ideas, profoundly impacting patients' lives. We value diversity and inclusion, ensuring that life-changing ideas can emerge from anywhere. Our dedication to giving back to communities is matched by our ambition to succeed for those in need. Join us in a journey where your career is not just a path but an opportunity to make a difference where it truly counts. The annual base pay for this position ranges from $150,202 - $225,304 USD Annual. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Ready to take the next step in your career? Apply now and be part of a team that is transforming lives every day! Date Posted 21-Nov-2025 Closing Date Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Med First is committed to expanding access to high-quality primary care in underserved communities. We're looking for a Medical Director who can lead with both clinical excellence and operational insight- advancing value-based care and sustainable growth across 25+ clinics. How You'll Make an Impact: Lead clinical strategy, quality, and patient safety across diverse, community-based settings Advance value-based care, care management, and use of innovative AI models Partner with operations/finance on access, growth, and performance (MLR, quality, experience) Develop clinical leaders, recruit/retain talent, and foster a culture of compassion + accountability Provide direct patient care in one of our primary care sites Who you are: Board-certified (FM/IM) with 5+ years of clinical leadership, success in value-based and multi-site environments, and a mission-driven, collaborative mindset. Location: Hybrid: 2 Clinic Days in a Med First Clinic/2 Admin Days remote

Director, Clinical Operations San Francisco Bay Area (Hybrid) $180,000 - $230,000 About the Opportunity A privately held, early‑stage biotechnology company in the San Francisco Bay Area is seeking a Director of Clinical Operations to lead operational strategy and execution across its emerging therapeutic pipeline. The organization is currently in a growth and scaling phase, having recently closed their series A funding. The company is developing next‑generation, extended‑duration therapeutics designed to enable monthly or quarterly dosing, primarily within metabolic and obesity‑related diseases. Their technology centers on proprietary drug‑delivery innovations that enable controlled, predictable, long‑acting release of small molecules, peptides, and proteins. This is an exciting opportunity to help shape clinical operations at a small, dynamic company Key Responsibilities Oversee global clinical trial execution (Phase 1-2), from trial start‑up through close‑out. Build and operationalize clinical development processes as the organization scales. Lead vendor and CRO oversight, including metrics, budgets, and timelines. Drive inspection readiness and ensure compliance with all regulatory and GCP/ICH standards. Partner cross‑functionally with Clinical Development, CMC, Regulatory, and Program Leadership. Develop and mentor a growing clinical operations team. Contribute to long‑range planning, risk mitigation strategies, and portfolio execution. Qualifications Bachelor's degree in a scientific discipline required; advanced degree preferred. 10+ years of clinical operations experience in biotech/pharma, with leadership responsibility, metabolic experience highly favored. Demonstrated success running early‑phase clinical trials. Strong understanding of operationalizing first‑in‑human and dose‑escalation studies. Experience in fast‑paced, resource‑lean, early‑stage environments. Exceptional vendor management, communication, and cross‑functional leadership skills. Ability to thrive in a dynamic, evolving company nearing and entering clinical development. Why Join High‑impact leadership role with strategic influence in a rapidly growing biotech. Mission‑driven culture focusing on transformative medicines that may improve long‑term disease management. Competitive compensation, equity participation, and comprehensive benefits. If you are interested in this role, please apply today and we will be in touch with qualified candidates.

The Physical Therapist Clinical Director is responsible for complete oversight of operations and administration of rehabilitative outpatient clinic providing Physical and Occupational Therapy. Ensures compliance with all regulations and health care requirements. This position is also responsible for patient evaluation and treatment. Who We Are: JAG Physical Therapy's care-first model of rehabilitation may be the change you are looking for! JAG Physical Therapy, a comprehensive outpatient, orthopedic physical therapy company with 100 facilities throughout Pennsylvania, New Jersey, and New York, is seeking compassionate and motivated individuals to join our winning team! JAG has been honored by the area's top publications as the best in the business based on growth and outcomes and is considered the Gold Standard for physical therapy care by the Metro area's largest healthcare systems and insurance providers. What You'll Love About Us: • up to $7,500 sign-on bonus • up to $2,500 relocation bonus • Competitive salary • Yearly Bonus based on the performance of the Clinic • Health, Dental, & Vision Benefits • HSA Options including dependent care, medical, and commuter benefits • $10,000.00 Term Life Insurance benefit at NO cost to employees • up to 4 weeks PTO • 401(k) with company match • Continuing Education reimbursements • MedBridge Membership • Yearly review for growth opportunities • Professional Development Growth Tracks • Tuition discounts for employees and their families • TicketsAtWork and LifeMart company perks • Our workplace fosters a close-knit and supportive environment where individuals genuinely care for and uplift one another, creating a strong sense of unity and camaraderie What You'll Need: • Bachelors or Masters Degree required, Doctorate degree preferred • Professional License/Certification required • Valid CPR license • Minimum of three years' clinical outpatient experience and two years' clinical supervision or clinical program development experience preferred • Knowledge of EMR system • Able to troubleshoot, keen sense for decision making and judgment; action oriented; approachable • Team player and effective at building and fostering teamwork as well as maintain composure when dealing with conflict • Excellent customer service skills, interpersonal and communication skills What You'll Do: • Responsible for meeting census goals of clinic and each clinician (office KPIs, number of patients seen). Scorecard review weekly with RCD • Working with People Operations, ensures compliance with all federal and state employment laws. • Facility maintenance • Review and approve timecards through ADP ensuring adherence to all federal and state regulations with respect to Exempt and Non-Exempt staff • Interview/hiring (clinical, admin, aide) in collaboration with HR- take out admin • Training and onboarding clinical staff, ongoing evaluation of performance • Resolve performance problems on a clinic level and elevating to HR when appropriate • Monitor staff compliance • Follow up with patients on low net promoter scores • Monitor monthly budget of visits, labor, and clinical supplies • Monitor documentation audits, Medicare compliance and patients approaching MMR cap • Prompt EMR schedule review weekly • Monitor staff unsigned notes • Perform new patient eval audit weekly • Manages and approves expenses of staff in clinic • Physician referral management (outreach visits, Direct access review, etc) • Clinical support staff expense management, scheduling, interviewing, hiring/termination • Monitor discharge policy adherence • Monthly clinical supply ordering • Adhere to lost patient log workflow • Weekly call with RCD • Weekly meeting with OM Important Disclaimer Notice: The above statements are only intended to represent the essential job functions and general nature of the work being performed and are not exhaustive of the tasks that an Employee may be required to perform. The employer reserves the right to revise this at any time and to require Employees to perform other tasks as circumstances or conditions of its business, competitive considerations, or the work environment change. This job description is not a guarantee of employment. What you'll love about us section is based on full time employment with the company and is not guaranteed based on employment type. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

A healthcare organization is seeking a Director of Trauma in Tyler, Texas. The ideal candidate is a registered nurse with leadership experience in trauma care, holds a Master's degree, and has strong communication skills. Responsibilities include program oversight, educational opportunities for staff, and liaising with administration for quality trauma care. This full-time position requires active participation in budget processes and performance improvement initiatives. #J-18808-Ljbffr

Company Background: Plus Therapeutics is a U.S. public healthcare company focused on improving survival for patients with brain cancer. Plus brings together novel therapeutics, diagnostics, and data analytics to achieve its goal. Plus is staffed by a talented and diverse team working alongside world experts in brain cancer. We operate principally from 3 facilities in Houston, Texas, San Antonio, Texas, and Charlottesville, Virginia. Role: The Director of Clinical Operations will work across all areas of the company, therapeutics, diagnostics, and data analytics, to support Plus Therapeutics' various preclinical, clinical, and commercial programs. This includes Plus' lead drug REYOBIQ for conditions such as leptomeningeal metastases, recurrent GBM in adults, and pediatric brain cancer. This position will involve helping to design and oversee clinical trials, contributing to scientific manuscripts, abstracts, and presentations, supporting grant applications and management, and reporting to the CEO and President. The Director will work cross-functionally to ensure the successful execution of Plus' programs in line with regulatory and corporate objectives. Responsibilities: Assist in the strategic planning, design, and execution of clinical trials for products, ensuring alignment with regulatory requirements and company goals. Aid in oversight of clinical study operations, including protocol development, site selection, patient recruitment, data analysis, and regulatory submissions. Collaborate with cross-functional teams (regulatory affairs, medical affairs, biostatistics, and CMC) to advance products toward regulatory approval. Contribute to the preparation of scientific manuscripts, abstracts, and presentations for peer-reviewed journals, conferences, and regulatory bodies. Support the identification and application for grant funding opportunities, including drafting proposals and managing grant timelines and deliverables. Monitor clinical trial progress, ensuring adherence to timelines, budgets, and quality standards. Provide scientific and clinical expertise in neuro-oncology and/or radiotherapeutics to guide program strategy and decision-making. Engage with key opinion leaders (KOLs), investigators, and external partners to support clinical development and build strategic relationships. Ensure compliance with FDA, ICH, and other regulatory guidelines throughout the clinical development process. Mentor and guide junior team members, fostering a collaborative and innovative team environment. Qualifications: Advanced degree (PhD, MD, PharmD, or MD/PhD) in a relevant scientific or medical field. 7-10 years of experience in clinical development within the pharmaceutical or biotechnology industry, preferably in a small biotech environment. Expertise in neuro-oncology is strongly preferred; experience in radiotherapeutics or nuclear medicine is highly desirable. Proven track record in designing and managing clinical trials, including Phase I-III studies. Strong understanding of regulatory requirements (FDA) and experience in preparing regulatory submissions (e.g., IND, NDA). Demonstrated ability to author scientific manuscripts, abstracts, and presentations for peer-reviewed journals and conferences. Experience in grant writing and management, with a focus on securing funding and ensuring project milestones are met. Excellent project management skills, with the ability to prioritize and manage multiple tasks in a fast-paced environment. Strong communication and interpersonal skills, with the ability to collaborate effectively with internal teams and external stakeholders. Ability to thrive in a dynamic, entrepreneurial setting with a focus on innovation and patient-centric solutions. Requirements: Familiarity with radiopharmaceutical development and associated regulatory considerations. Experience working with CROs, academic collaborators, and clinical trial sites. Knowledge of pediatric oncology and rare disease clinical development. Proficiency in data analysis and interpretation, with familiarity in clinical trial software and tools. Plus Therapeutics, Inc. and CNSide Diagnostics, LLC are Equal Employment Opportunity employers and consider all qualified applicants without regard to protected status.

Med First Primary and Urgent Care is one of the largest independent family practice groups in the state of North Carolina. Our innovative hybrid model of delivering urgent care, primary care and occupational medicine care delivers exceptional patient care to the communities that we serve. Med First is growing rapidly and expanding into both rural and urban communities throughout North and South Carolina. Our mission is to fill primary care service gaps within underserved communities. As a leader in accountable care organizations (ACOs) and population health management, we're committed to forward thinking programs that emphasize preventive care, chronic disease management and integrated delivery systems. In this pivotal leadership role, you'll drive our value-based care (VBC) strategy, overseeing programs that reward quality outcomes. You'll collaborate with clinical leaders, analytics teams, and external partners to design and implement initiatives that enhance patient experiences, lower costs, and achieve superior performance in risk-based contracts. This is a chance to shape the future of healthcare in a dynamic, mission-driven environment. Key Responsibilities Lead the development and execution of VBC strategies, including ACOs, bundled payments, and shared savings programs Oversee clinical initiatives focused on total cost of care reduction (e.g., chronic care management, readmission prevention, senior care programs) Partner with providers to educate on VBC tools, workflows, and performance metrics; drive adoption of best practices Analyze data to identify opportunities, monitor KPIs (quality metrics, utilization, RAF scores), and implement performance improvement plans Negotiate and manage value-based contracts with payers, ensuring alignment with organizational goals Build cross-functional teams and foster collaborations to support population health and care coordination Stay abreast of regulatory changes (e.g., CMS guidelines, MIPS) and industry trends in VBC Qualifications Bachelor's degree in Healthcare Administration, Business, Nursing, or related field; Master's (MBA, MHA, MPH) or clinical degree strongly preferred 7+ years of progressive experience in healthcare, with at least 5 years in value-based care, population health, or managed care Proven track record in leading VBC programs, contract negotiations, and achieving quality/cost targets Deep knowledge of VBC models (e.g., ACOs, risk adjustment, shared risk), reimbursement methodologies, and healthcare regulations Strong analytical skills with experience in data-driven decision-making and performance metrics Preferred Skills Experience with Medicare/Medicaid programs, chronic care management, or clinically integrated networks Leadership in care transformation initiatives, such as reducing ED visits or managing chronic diseases Excellent communication and stakeholder management abilities, with a focus on provider engagement What We Offer Competitive salary (depending on experience and location) Performance-based bonuses and incentives tied to VBC outcomes Comprehensive benefits: health, dental, vision, 401(k) match, and generous PTO A collaborative, innovative culture committed to health equity and clinician well-being

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. *********************************************

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

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 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

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

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. *********************************************

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.

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 Associate Director 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 synthesize development strategies into study designs Author documents with a precise eye for detail and accuracy and for global regulatory requirements and industry best practices 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 At least 12 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 when authoring documents Work collaboratively in a team-based environment 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: 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 $192,000 - $211,000 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 ********************* .

Overview Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value. The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules. Job Summary (Primary function) The Director, Medical Writing is responsible for the medical writing activity within a portfolio of programs. Ensures oversight of the development of the clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. While partnering with the Head of Medical Writing, ensures the deliverables are resourced, any issues are escalated, and the strategic direction of the clinical documents for submission to regulatory authorities globally is sound. Keeps abreast of the clinical development of each of the compounds within the programs assigned and has functional understanding of global regulatory document standards. May have direct people management responsibilities. Reports to a Director of Medical Writing or above, and, if a people manager, is a member of the Medical Writing Leadership Team contributing to the strategic direction of the department. Essential Functions of the Job (Key responsibilities) Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, as well as Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives. Lead, manage, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for assigned programs/compounds. Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents. Lead or participate in cross-functional process improvement initiatives. Serve as a subject matter expert (eg, document type, process, technology). Lead or participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents. Oversee contract medical writing resources as required to ensure timely completion of assigned projects, which may include defining and reviewing of scopes of work (content and financial) within the assigned programs. May have direct people management responsibility of writers including providing mentoring and facilitating employee professional development. Serve as a member of the Medical Writing Leadership Team, if a people manager, helping to define the strategic direction and process improvements both within MW and cross-functionally. Qualifications (Minimal acceptable level of education, work experience, and competency) Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred. More than 10 years medical writing experience in the biopharmaceutical/CRO industry required. Demonstrated ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages developed by the clinical team. Excellent project management skills including in depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups. Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment. Proficient understanding and knowledge of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development desired. Demonstrated ability to independently lead the clinical portions of a marketing authorization submission including the development, review, and approval of clinical documents and the ability to identify any new or unique document types that may require a different approach. Proficient in MS Word. Working knowledge using an electronic document management system; ability to use document templates; ability to work with multiple document template styles and types. Ability to interact effectively with team members/leaders and senior leaders at Incyte proactively facilitating effective information exchange/communication (including problem solving and issue resolution). If direct people manager, prior management experience preferred. Ability to manage people and provide active support in all aspects of the job. Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required. Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer. We Respect Your Privacy Learn more at: *********** incyte. com/privacy-policy The Incyte hiring organization processes your personal data to manage your job application in order to enter into an employment relationship with you if you are the successful candidate. During the process, you may be asked to respond to questions that will screen out your application if you do not meet certain objective criteria required by the job. You can learn more about this process here. You may have the right to access, delete, restrict, edit, move, or object to the use of your personal data. You may also have a right to report concerns to the authority responsible for data privacy in the country where the position is based or where you live or work. You can learn more about Incyte's data protection practices here. By accessing this link you can learn about the types of personal data we collect, how we use it, whether collection and processing is optional, sources of the personal data we process, how it is shared, where it is stored or transferred to, how long we keep it, and contact information for Incyte, Incyte's data protection officer, and your supervisory authority (if applicable). Please contact privacy@incyte. com if you have any questions or concerns or would like to exercise your rights.

The Associate Medical Director will act as the Medical Monitor for Xeris clinical trials, collaborating with cross-functional study teams on clinical trial strategy, design and execution. In this role, the individual will oversee study conduct and safety monitoring for assigned trials, spanning Phases 1 through 3, and may also contribute to selected projects across multiple clinical development programs. Responsibilities Provides project physician support to clinical study teams during the execution of clinical research studies, including but not limited to protocol development, electronic Case Report Form (eCRF) development, therapeutic area training, protocol queries, patient eligibility determination, clinical/safety data review, and clinical summary report generation. Serves on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution. Contributes to the preparation of regulatory documents in support of regulatory submissions, including but not limited to clinical section of Investigational New Drug's (IND) application and Clinical Trial Agreement (CTA), IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/Institutional Review Boards , and other documents as appropriate. Provides scientific and clinical input to study-related documents and analysis plans [e.g. informed consent forms (ICF), statistical analysis plans (SAP), clinical study reports (CSR)]. Performs other duties as assigned related to other aspects of Clinical Research. Represents Xeris at clinical sites during studies and in external reporting of study results. Up to 30% global travel Qualifications Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD degree with relevant therapeutic specialty in an academic or hospital environment. Board certification/eligibility Internal Medicine, Endocrinology or another relevant medical field, is highly desired Ability to run a clinical research study with minimal supervision Clinical trial experience in the pharmaceutical industry, academia, or equivalent is desired Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials Excellent oral and written communication skills Ability to work collaboratively in a fast moving, team-based matrix environment and to function independently as appropriate This is a hybrid position based in Xeris' Chicago office and a minimum of three days per week on-site is required. On-site requirements 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 $200,000 to $260,000. 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.

The Associate Medical Director will act as the Medical Monitor for Xeris clinical trials, collaborating with cross-functional study teams on clinical trial strategy, design and execution. In this role, the individual will oversee study conduct and safety monitoring for assigned trials, spanning Phases 1 through 3, and may also contribute to selected projects across multiple clinical development programs. **Responsibilities** + Provides project physician support to clinical study teams during the execution of clinical research studies, including but not limited to protocol development, electronic Case Report Form (eCRF) development, therapeutic area training, protocol queries, patient eligibility determination, clinical/safety data review, and clinical summary report generation. + Serves on cross-functional teams for assigned trials, working with other team members to achieve efficient, high-quality study execution. + Contributes to the preparation of regulatory documents in support of regulatory submissions, including but not limited to clinical section of Investigational New Drug's (IND) application and Clinical Trial Agreement (CTA), IND safety reports and annual reports for assigned trials, responses to regulatory authorities and Ethics Committees/Institutional Review Boards , and other documents as appropriate. + Provides scientific and clinical input to study-related documents and analysis plans [e.g. informed consent forms (ICF), statistical analysis plans (SAP), clinical study reports (CSR)]. + Performs other duties as assigned related to other aspects of Clinical Research. + Represents Xeris at clinical sites during studiesand in external reporting of study results. + Up to 30% global travel **Qualifications** + Medical Doctor (MD), Doctor of Osteopathy (DO), or non-US equivalent of MD degree with relevant therapeutic specialty in an academic or hospital environment. + Board certification/eligibility Internal Medicine, Endocrinology or another relevant medical field, is highly desired + Ability to run a clinical research study with minimal supervision + Clinical trial experience in the pharmaceutical industry, academia, or equivalent is desired + Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials + Excellent oral and written communication skills + Ability to work collaboratively in a fast moving, team-based matrix environment and to function independently as appropriate + This is a hybrid position based in Xeris' Chicago office and a minimum of three days per week on-site is required. On-site requirements 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 $200,000 to $260,000. 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** _Associate Medical Director_ **ID** _2025-2297_ **Category** _Medical Affairs_ **Type** _Full-Time_