Director, Medical Writing jobs at AbbVie

Base Salary: $145K-$215K USD + Bonus | Full-Time | Remote A fast-growing, clinical-stage biotech is redefining treatment paradigms with cutting-edge bispecific antibody therapies for immune and inflammatory disorders. Backed by strong investors and powered by a lean, agile team, this company is on a mission to deliver transformative biologics for patients with complex immune-mediated conditions. Be part of a team where innovation meets purpose-and help shape the next generation of therapies. Key Responsibilities Lead and oversee global Phase I-III clinical trials across immunology and inflammatory indications. Manage CROs and specialty vendors, ensuring adherence to GCP, ICH, and regulatory standards. Own budgets, timelines, and risk mitigation plans for all clinical programs. Collaborate cross-functionally with Clinical Development, Regulatory, Data Management, and Quality teams. Drive inspection readiness and ensure audit preparedness. Qualifications Minimum 8 years of clinical operations experience in biotech/pharma, including 3+ years in a leadership role. Proven track record managing global trials and CROs. Strong knowledge of GCP, ICH, and regulatory requirements. Immunology or inflammatory disorder experience preferred. If you or someone you know fits this experience and shows interest, we'd love to speak with you!

**Compensation Data** This position offers a base salary typically between $220,000.00 and $350,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here (***************************************************************** . **Description** As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Group Lead, Medical Writing ExpMED, is accountable for the organizational set up, development, implementation, and oversight of a high-performing, innovative Medical Writing group for the early phase, and the development and oversight of an ExpMED Medical Writing excellence strategy (i.e., acceleration of clinical development timelines, use of AI, and creation of patient value while maintaining high quality) via strategic planning and execution of early clinical documents across all Therapeutic Areas. The Group Lead, Medical Writing ExpMED, in alignment with Head of ExpMed Clinical Operations (ExpMED CO) and ExpMED Leadership team, contributes to overall ExpMED strategy. The Group Lead provides leadership and guidance to a diverse team, creates an environment that inspires, motivates, and empowers colleagues, fosters a culture of continuous learning, knowledge sharing, improvement, innovation, accountability, and collaboration to accelerate clinical trial delivery and maximize value for investigational sites, patients, and the organization. **Duties & Responsibilities** - Develop and implement a global early phase Medical Writing excellence strategy that simplifies processes, sharpens focus, and accelerates clinical development across all Therapeutic Areas. - As part of the ExpMED Clinical Operations department, you will build and continuously enhance a high-performing and innovative global Medical Writing team. - Accountable for the creation and continuous refinement of a world-class ExpMED Medical Writing (MW) department to effectively deliver in the early phase. - Accountable for talent attraction, development retention, and succession planning within ExpMED (MW), in close alignment with HR. Group Lead MW in close alignment with other members of the ExpMED CO Leadership team, is responsible for functional talent development within ExpMED CO. - Accountable for the creation of an environment that inspires, motivates, and empowers colleagues within ExpMED MW to accelerate clinical development timelines and to create value for patients and the healthcare system. - Accountable that staff is well trained and qualified; supports staff in technical and personal skills development to support career progression. - Leads the communication of scientific programs and holistic evidence to key stakeholders, including investigators, regulators, payers, patients, and caregivers. - Oversees capacity planning, financial management, and the strategic deployment of internal and external (CRO) resources to support clinical program needs. - Provide oversight to constantly improve ExpMED MW processes and standards to prevent and/or remedy quality and/or compliance findings (in-house and/or CRO setting) to ensure early clinical execution excellence, in alignment with other Corporate functions. - Representation of Boehringer Ingelheim at external meetings and conferences to create value for Boehringer Ingelheim and external stakeholders. **Requirements** - Minimum of Bachelor's degree required; advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., Master's), strongly preferred. - 10+ years of professional experience in a scientific, clinical, and/or medical space. - Strong leadership skills with the ability to inspire and motivate to build a high-performing, innovative team. - Comprehensive understanding of drug development and reporting process required for study reports, submission documents, and data transparency deliverables across multiple providers. - Experience in (at least passion for) storytelling. - Knowledge of vendor processes, contracting, and best practices in outsourcing; ability to influence vendor improvements. - Demonstrated experience presenting to scientific and non-scientific audiences. - Experience managing multiple, complex projects, and a strong record of developing successful partnerships and meeting customer expectations in global settings. - Strategic mindset with the ability to drive innovation, digital transformation, and process integration across complex, global environments. - Expertise in globalizing functions to operate in a standardized fashion. - Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with colleagues and vendors. - Proactively identify gaps, emerging risks, and opportunities for improvement through ongoing analysis and benchmarking to maintain industry leading position - Encourages the adoption of new technologies, smart risk-taking, and a unified ExpMED CO identity that empowers teams and accelerates clinical development. - Demonstrated ability to build, lead, develop and maintain a high-performance, medical writing team. - **Remote*:** this position is considered remote based. **Eligibility Requirements:** + Must be legally authorized to work in the United States without restriction. + Must be willing to take a drug test and post-offer physical (if required). + Must be 18 years of age or older. All qualified applicants will receive consideration for employment without regard to a person's actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.

Compensation Data This position offers a base salary typically between $220,000.00 and $350,000.00 USD. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. Description As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. The Group Lead, Medical Writing ExpMED, is accountable for the organizational set up, development, implementation, and oversight of a high-performing, innovative Medical Writing group for the early phase, and the development and oversight of an ExpMED Medical Writing excellence strategy (i.e., acceleration of clinical development timelines, use of AI, and creation of patient value while maintaining high quality) via strategic planning and execution of early clinical documents across all Therapeutic Areas. The Group Lead, Medical Writing ExpMED, in alignment with Head of ExpMed Clinical Operations (ExpMED CO) and ExpMED Leadership team, contributes to overall ExpMED strategy. The Group Lead provides leadership and guidance to a diverse team, creates an environment that inspires, motivates, and empowers colleagues, fosters a culture of continuous learning, knowledge sharing, improvement, innovation, accountability, and collaboration to accelerate clinical trial delivery and maximize value for investigational sites, patients, and the organization. Duties & Responsibilities • Develop and implement a global early phase Medical Writing excellence strategy that simplifies processes, sharpens focus, and accelerates clinical development across all Therapeutic Areas. • As part of the ExpMED Clinical Operations department, you will build and continuously enhance a high-performing and innovative global Medical Writing team. • Accountable for the creation and continuous refinement of a world-class ExpMED Medical Writing (MW) department to effectively deliver in the early phase. • Accountable for talent attraction, development retention, and succession planning within ExpMED (MW), in close alignment with HR. Group Lead MW in close alignment with other members of the ExpMED CO Leadership team, is responsible for functional talent development within ExpMED CO. • Accountable for the creation of an environment that inspires, motivates, and empowers colleagues within ExpMED MW to accelerate clinical development timelines and to create value for patients and the healthcare system. • Accountable that staff is well trained and qualified; supports staff in technical and personal skills development to support career progression. • Leads the communication of scientific programs and holistic evidence to key stakeholders, including investigators, regulators, payers, patients, and caregivers. • Oversees capacity planning, financial management, and the strategic deployment of internal and external (CRO) resources to support clinical program needs. • Provide oversight to constantly improve ExpMED MW processes and standards to prevent and/or remedy quality and/or compliance findings (in-house and/or CRO setting) to ensure early clinical execution excellence, in alignment with other Corporate functions. • Representation of Boehringer Ingelheim at external meetings and conferences to create value for Boehringer Ingelheim and external stakeholders. Requirements • Minimum of Bachelor's degree required; advanced science/clinical degree (PharmD, M.D., DNP, DO, Ph.D., Master's), strongly preferred. • 10+ years of professional experience in a scientific, clinical, and/or medical space. • Strong leadership skills with the ability to inspire and motivate to build a high-performing, innovative team. • Comprehensive understanding of drug development and reporting process required for study reports, submission documents, and data transparency deliverables across multiple providers. • Experience in (at least passion for) storytelling. • Knowledge of vendor processes, contracting, and best practices in outsourcing; ability to influence vendor improvements. • Demonstrated experience presenting to scientific and non-scientific audiences. • Experience managing multiple, complex projects, and a strong record of developing successful partnerships and meeting customer expectations in global settings. • Strategic mindset with the ability to drive innovation, digital transformation, and process integration across complex, global environments. • Expertise in globalizing functions to operate in a standardized fashion. • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with colleagues and vendors. • Proactively identify gaps, emerging risks, and opportunities for improvement through ongoing analysis and benchmarking to maintain industry leading position • Encourages the adoption of new technologies, smart risk-taking, and a unified ExpMED CO identity that empowers teams and accelerates clinical development. • Demonstrated ability to build, lead, develop and maintain a high-performance, medical writing team. • Remote*: this position is considered remote based. Eligibility Requirements: Must be legally authorized to work in the United States without restriction. Must be willing to take a drug test and post-offer physical (if required). Must be 18 years of age or older.

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Director, Medical Writing Resourcing Group Lead? The job is in our King of Prussia, PA, Waltham MA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. Position Description Summary: You will be responsible for the provision of medical writing services to support clinical development by way of managing the Medical Writing budget project and functional budget, as well as ensuring the medical writing team is resourced appropriately to meet the demands of the portfolio. You are the key leadership role in the Clinical Development group, supporting professional development of 5-10 Medical Writing direct reports including providing strategic and tactical leadership and guidance for clinical development activities in projects as assigned across all Therapeutic Areas (TAs). The Medical Writing Group Lead helps to drive quality scientific and operational clinical development execution, by forming, building and developing a group of talented and committed Medical Writers, collectively delivering timely, scientifically rigorous and high-quality work to meet the needs of Portfolio Development. Additionally, The Medical Writing Group Lead may provide project related medical writing support as needed. Main Responsibilities: Line Management: • Provides strategic and tactical leadership/guidance to 5-10 TA Medical Writing direct reports as they drive the development of Clinical Development Medical Writing Deliverables, including Investigators Brochure (IB), the Clinical Study Outline, The Clinical Study Protocol (CSP), The Clinical Study Report (CSR) Regulatory Briefing Books, and Submission Documents. • Drives in the hiring, on-boarding, training and mentoring processes for TA Medical Writers to ensure CSL hires and retains top talent • Accountable for direct reports performance management, long term career growth, and supports direct reports in the creation of their professional development plan • Supports creation of effective delivery teams (DTs) in alignment with the portfolio requirements focusing on ensuring that the scientific/medical/technical knowledge as well as industry experience to provide high functioning teams • Supports direct reports navigate the Project Operating Model to deliver projects in alignment with the PST Strategy Resource and Budget Management: • Collaborates with Head of Clinical Sciences and Medical Writing, Director Medical Writing Processes & Standards Group Lead, Clinical Scientist Leads, Global Clinical Leads (GCL)s, and Clinical Development Team (CDT) Leads to ensure adequate resourcing across the portfolio • Accountable for the Medical Writing group budget and is responsible for providing adequate oversight in accordance with CSL processes and policies • Accountable for resource allocation management and oversight in Clarity for the Medical Wiring group • Collaborates with the preferred CRO partners to provide Medical Writing Services across all Tas as needed Program Deliverables: • Accountable for the efficient preparation and delivery of high-quality, strategically aligned medical writing deliverables including but not limited to the development and maintenance of the IB, the Clinical Study Outline, Regulatory Briefing Books, Module 2 submission Documents for IND, MAAs and BLAs across all therapeutic areas. • Ensures the establishment of a messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analyzing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency. Qualifications and Experience Requirements: Bachelors degree in pharmacy, biological sciences or related disciplines is essential. • 10+ years of medical writing experience within the biopharmaceutical industry or contract research organization. • At least 3 years' experience in supervisory role. • Comprehensive understanding of medical writing for clinical development, including the documents required at each stage and their associated regulatory requirements. • Comprehensive understanding of medical writing processes, standards and issues. • Extensive experience setting up contracts and collaborating with CRO partners to provide medical writing services in an FSP and FSO environment required #LI-HYBRID Our Benefits CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what's available to you as a CSL employee. About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. We want CSL to reflect the world around us At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL. Do work that matters at CSL Behring!

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Your role The incumbent will be responsible for the quality and delivery of clinical studies and clinical and regualtory documents across the portfolio in collaboration with strategic CRO partners. Responsible for overseeing the recruiting, staffing and development of the clinical scientists and medical writing specialists in the group. Your responsibilities will include Oversight of Individuals Recruiting, staffing, training and development of clinical scientists and medical writing specialists in the group, to maintain a dynamic and cutting-edge level of medical scientific expertise and advanced drug development approaches Ensuring delivery of high-quality clinical development content including: Clinical development plans, protocols, study reports, common technical document modules and publications in academic journals Regulatory submissions and meetings Stage-gate and benefit -risk evaluations and assessments Presentations at scientific and technical review committees Implementation of clinical recommendations from all advisory and governance committees Internal interfaces and collaboration Member of the Clinical Development Leadership Team Will be responsible for managing a team of approximately 50 Scientists . Oversight of and collaboration with partnering functions, e.g. Clinical Operations, Research, GRA & Safety to assure an effective project related deliveries Participate and/or lead enterprise initiatives Maintaining effective oversight of quality in conjunction with appropriate Quality functions External-scientific Enhancing the reputation of the Company through a culture of scientific integration of the department with the scientific community and other partners through visible publication record, KOL interactions, presence at scientific conferences, membership of consortia and similar medico-scientific groups, builds networks with scientific experts Ensures that the patient and health-care provider voice is integrated into CSL's development mindset Building a culture of risk taking, innovation and peer review across the clinical function Providing clinical scientific and medical writing leadership throughout CSL Providing support and insight into business development opportunities as required Your skills & experience Graduate level degree (M.Sc, PhD, MD etc) preferred. 10 years+ of Pharma experience in clinical development Clinical Scientist experience across all phases of development, FIH, POC, late-stage development and life cycle management. Medical writing experience. Strong track record of leadership skills. Enhanced organizational awareness and the ability to interact and influence from the team level to senior management Extensive experience of leading teams and/or line managing a group(s) #LI-Hybrid About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at *************************** Our Benefits For more information on CSL benefits visit How CSL Supports Your Well-being | CSL. You Belong at CSL At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Writing **Job Category:** People Leader **All Job Posting Locations:** Allschwil, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, Netherlands, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, Toronto, Ontario, Canada **Job Description:** **About Innovative Medicine** Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine **We are searching for the best talent for Director, Medical Writing, Oncology.** Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-038874 Belgium & Netherlands- Requisition Number: R-039974 United Kingdom- Requisition Number: R-039973 Switzerland- Requisition Number: R-039972 Canada- Requisition Number: R-039966 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. **Purpose:** The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, RegMW has the authority to oversee projects, identify risks, and implement process improvements, while managing internal teams and contributing to organizational initiatives. Additionally, the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications, leading within a team matrix environment, setting functional tactics, making strategic contributions, and proactively planning for resources. The Director will influence TA-level strategies, lead process working groups, champion internal standards, and improve internal systems and tools. **You will be responsible for:** + Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals. + Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles. + Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions. + Write or provide guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence. + Represent the MW department with decision-making authority in the R&D organization, leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments. + Directly lead or set objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently. + Serve as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration. + Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross-functional team members. + Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed. + Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems. + Participate in industry standards working groups to represent MW and ensure alignment with best practices. + Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team, in close consultation and accordance with the Delivery Unit (DU) + Head and in line with R&D priorities and TA objectives. + Recognized expert medical writer for any document within and across TAs. + Accountable for MW resource management and allocation within their portfolio(s). + Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority. + Can step in for DU Head in case of absence. + Is a major contributor to multiple deliverables for the function, TA, or DU. + Provides leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. + Responsible for creating an environment where employees feel engaged and empowered, and + take pride in their role, responsibilities, and deliverables. + Takes on additional major responsibility with minimal supervision, operating at an expert level with accountability for the highest levels of quality: + o Cross-functional, cross-TA, cross-J&J initiative/collaboration. + o Larger organizational responsibility (eg, manage a subset of functional area/TA organization) with some level of independence to operate within that subset of the organization. + Supervises/manages and is accountable for direct reports. + Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing feedback on performance and development. + Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. + Ensures direct report's adherence to established policies, procedural documents, and templates. + Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning. + If applicable, frequent engagement with staff and leading discussions on employee development and talent management. **Qualifications / Requirements:** + A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. + Minimum of 14 years of relevant pharmaceutical/scientific experience is required. + Minimum of 12 years of relevant clinical/medical writing experience is required. + Minimum of 5 years of people management experience is required. + Expertise in project management and process improvement is required. + Strong decision-making skills, strategic thinking, agility, broad vision is required. **Other:** + Excellent oral and written communication skills. + Attention to detail. + Expert time management for self, direct reports (if applicable), and teams. + Ability to delegate responsibility to other medical writers. + Expert ability to lead and influence by example and stay focused (positive). Demonstrate integrity. + Expert ability to motivate and develop best in class talent pipeline. + Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers. + Creates a positive Credo-based work environment for staff members. + Shows openness to new ideas and fosters organizational learning. The expected pay range for this position is $160,000 to $276,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. + Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance. + Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). + This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: + Vacation -120 hours per calendar year + Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year + Holiday pay, including Floating Holidays -13 days per calendar year + Work, Personal and Family Time - up to 40 hours per calendar year + Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child + Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year + Caregiver Leave - 80 hours in a 52-week rolling period10 days + Volunteer Leave - 32 hours per calendar year + Military Spouse Time-Off - 80 hours per calendar year For additional general information on company benefits, please go to: ********************************************* This job posting is anticipated to close on October 31, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. **Required Skills:** **Preferred Skills:** **The anticipated base pay range for this position is :** $160,000 - $276, 000 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: People Leader All Job Posting Locations: Allschwil, Switzerland, Beerse, Antwerp, Belgium, High Wycombe, Buckinghamshire, United Kingdom, Leiden, Netherlands, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States of America, Toronto, Ontario, Canada Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at *******************/innovative-medicine We are searching for the best talent for Director, Medical Writing, Oncology. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-038874 Belgium & Netherlands- Requisition Number: R-039974 United Kingdom- Requisition Number: R-039973 Switzerland- Requisition Number: R-039972 Canada- Requisition Number: R-039966 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Purpose: The Director of Regulatory Medical Writing (RegMW) is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas (TAs). This role is a primary liaison with cross-functional teams, driving strategic discussions, developing internal medical writers, and ensuring adherence to best practices and regulatory guidelines. The Director, RegMW has the authority to oversee projects, identify risks, and implement process improvements, while managing internal teams and contributing to organizational initiatives. Additionally, the role requires the ability to guide lead medical writers on one or several compounds with the same or different indications, leading within a team matrix environment, setting functional tactics, making strategic contributions, and proactively planning for resources. The Director will influence TA-level strategies, lead process working groups, champion internal standards, and improve internal systems and tools. You will be responsible for: * Assume overall accountability for decision-making within the organization or TA, ensuring alignment with strategic goals. * Proactively identify potential risks and develop strategies to mitigate them, enhancing project outcomes and minimizing obstacles. * Recognize and resolve complex problems related to the development and implementation of new service offerings and deliverables, working independently to find effective solutions. * Write or provide guidance to other writers on all types of clinical, regulatory, and safety documents, taking a proactive lead in content and scientific strategy with complete independence. * Represent the MW department with decision-making authority in the R&D organization, leading discussions with senior cross-functional colleagues and external partners to enhance coordination between departments. * Directly lead or set objectives for team projects and tasks, including leading program-level, submission, indication, and disease area writing teams independently. * Serve as a liaison between team members and senior leadership within a TA or sub-function, facilitating effective communication and collaboration. * Develop, implement, and drive the institutionalization of departmental process improvements and best practices in collaboration with relevant Communities of Practice and Business Process Owners, championing these initiatives to cross-functional team members. * Mentor, support, and coach staff at all levels on document planning, processes, and content, providing peer review as needed. * Maintain and disseminate knowledge of industry, company, and regulatory guidelines within relevant company systems. * Participate in industry standards working groups to represent MW and ensure alignment with best practices. * Accountable for setting the strategy and operational execution for their portfolio(s) within the Medical Writing (MW) team, in close consultation and accordance with the Delivery Unit (DU) * Head and in line with R&D priorities and TA objectives. * Recognized expert medical writer for any document within and across TAs. * Accountable for MW resource management and allocation within their portfolio(s). * Can represent MW DU Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority. * Can step in for DU Head in case of absence. * Is a major contributor to multiple deliverables for the function, TA, or DU. * Provides leadership to their writing teams by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication. * Responsible for creating an environment where employees feel engaged and empowered, and * take pride in their role, responsibilities, and deliverables. * Takes on additional major responsibility with minimal supervision, operating at an expert level with accountability for the highest levels of quality: * o Cross-functional, cross-TA, cross-J&J initiative/collaboration. * o Larger organizational responsibility (eg, manage a subset of functional area/TA organization) with some level of independence to operate within that subset of the organization. * Supervises/manages and is accountable for direct reports. * Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing feedback on performance and development. * Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved. * Ensures direct report's adherence to established policies, procedural documents, and templates. * Participates in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning. * If applicable, frequent engagement with staff and leading discussions on employee development and talent management. Qualifications / Requirements: * A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred. * Minimum of 14 years of relevant pharmaceutical/scientific experience is required. * Minimum of 12 years of relevant clinical/medical writing experience is required. * Minimum of 5 years of people management experience is required. * Expertise in project management and process improvement is required. * Strong decision-making skills, strategic thinking, agility, broad vision is required. Other: * Excellent oral and written communication skills. * Attention to detail. * Expert time management for self, direct reports (if applicable), and teams. * Ability to delegate responsibility to other medical writers. * Expert ability to lead and influence by example and stay focused (positive). Demonstrate integrity. * Expert ability to motivate and develop best in class talent pipeline. * Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers. * Creates a positive Credo-based work environment for staff members. * Shows openness to new ideas and fosters organizational learning. The expected pay range for this position is $160,000 to $276,000. The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/ performance year. Bonuses are awarded at the Company's discretion on an individual basis. * Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short and long-term disability, business accident insurance, and group legal insurance. * Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). * This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: * Vacation -120 hours per calendar year * Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year * Holiday pay, including Floating Holidays -13 days per calendar year * Work, Personal and Family Time - up to 40 hours per calendar year * Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child * Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year * Caregiver Leave - 80 hours in a 52-week rolling period10 days * Volunteer Leave - 32 hours per calendar year * Military Spouse Time-Off - 80 hours per calendar year For additional general information on company benefits, please go to: ********************************************* This job posting is anticipated to close on October 31, 2025. The Company may however extend this time-period, in which case the posting will remain available on *************************** to accept additional applications. The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. Required Skills: Preferred Skills: The anticipated base pay range for this position is : $160,000 - $276, 000 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program. Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member Caregiver Leave - 10 days Volunteer Leave - 4 days Military Spouse Time-Off - 80 hours Additional information can be found through the link below. *********************************************

Job Description Senior Director, Medical Writing The Senior Director, Medical Writing, will work with cross-functional teams to develop, write, and review clinical and regulatory documents, ensuring the documents are of high quality and comply with internal and external standards. This position reports to the SVP Regulatory Affairs & Quality, and is an onsite position based in San Diego. Key Responsibilities: Lead the Medical Writing function to plan, prepare, write, edit, format, and finalize non-clinical, clinical, and regulatory documents. Documents will include, but are not limited to: IND, CTA, non-clinical summaries, clinical protocols, clinical study reports, Investigator brochures, updates to regulatory submissions, briefing books, annual reports/development safety update reports (DSURs), manuscripts and posters. Manage external writing vendors in the delivery of the Medical Writing book of work. Partner with regulatory affairs and cross-functional SMEs in developing and executing strategies for organizing and preparing documents for regulatory health authority submissions. Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (eg, timelines and review/revision responsibilities) with the project teams. Lead the development of templates, style guidelines, and SOPs for clinical documentation. Ensure final documents adhere to standard operating procedures (SOP), good clinical practice (GCP), and International Council on Harmonization (ICH) requirements. Effectively collaborate with Research & Development colleagues, including, but not limited to, clinical research, regulatory, safety, biostatistics, clinical operations, translational medicine, and discovery. Contribute to the future growth and development of the BlossomHill's Medical Writing function, providing insights, experience and counsel to the SVP on strategic planning initiatives. Qualifications: Ph.D. in Life Science related discipline or related field. 10+ years of applicable regulatory affairs experience in a pharmaceutical or biotechnology industry role. Experience in oncology therapeutic areas required (solid tumor and/or hematology) Ability to interpret and present clinical and non-clinical data objectively in a clear, concise format. Excellent organizational and project management skills. Ability to work effectively with other team members and departments at various levels, as well as with CROs and external consultants. Technical system skills (e.g. word processing, spreadsheets, databases, online research) including submission-ready formatting.

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. Could you be our next Director, Medical Writing Resourcing Group Lead? The job is in our King of Prussia, PA, Waltham MA, Maidenhead UK or Zurich Switzerland office. This is a hybrid position and is onsite three days a week. **Position Description Summary:** You will be responsible for the provision of medical writing services to support clinical development by way of managing the Medical Writing budget project and functional budget, as well as ensuring the medical writing team is resourced appropriately to meet the demands of the portfolio. You are the key leadership role in the Clinical Development group, supporting professional development of 5-10 Medical Writing direct reports including providing strategic and tactical leadership and guidance for clinical development activities in projects as assigned across all Therapeutic Areas (TAs). The Medical Writing Group Lead helps to drive quality scientific and operational clinical development execution, by forming, building and developing a group of talented and committed Medical Writers, collectively delivering timely, scientifically rigorous and high-quality work to meet the needs of Portfolio Development. Additionally, The Medical Writing Group Lead may provide project related medical writing support as needed. **Main Responsibilities:** Line Management: - Provides strategic and tactical leadership/guidance to 5-10 TA Medical Writing direct reports as they drive the development of Clinical Development Medical Writing Deliverables, including Investigators Brochure (IB), the Clinical Study Outline, The Clinical Study Protocol (CSP), The Clinical Study Report (CSR) Regulatory Briefing Books, and Submission Documents. - Drives in the hiring, on-boarding, training and mentoring processes for TA Medical Writers to ensure CSL hires and retains top talent - Accountable for direct reports performance management, long term career growth, and supports direct reports in the creation of their professional development plan - Supports creation of effective delivery teams (DTs) in alignment with the portfolio requirements focusing on ensuring that the scientific/medical/technical knowledge as well as industry experience to provide high functioning teams - Supports direct reports navigate the Project Operating Model to deliver projects in alignment with the PST Strategy Resource and Budget Management: - Collaborates with Head of Clinical Sciences and Medical Writing, Director Medical Writing Processes & Standards Group Lead, Clinical Scientist Leads, Global Clinical Leads (GCL)s, and Clinical Development Team (CDT) Leads to ensure adequate resourcing across the portfolio - Accountable for the Medical Writing group budget and is responsible for providing adequate oversight in accordance with CSL processes and policies - Accountable for resource allocation management and oversight in Clarity for the Medical Wiring group - Collaborates with the preferred CRO partners to provide Medical Writing Services across all Tas as needed Program Deliverables: - Accountable for the efficient preparation and delivery of high-quality, strategically aligned medical writing deliverables including but not limited to the development and maintenance of the IB, the Clinical Study Outline, Regulatory Briefing Books, Module 2 submission Documents for IND, MAAs and BLAs across all therapeutic areas. - Ensures the establishment of a messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analyzing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency. **Qualifications and Experience Requirements:** Bachelors degree in pharmacy, biological sciences or related disciplines is essential. - 10+ years of medical writing experience within the biopharmaceutical industry or contract research organization. - At least 3 years' experience in supervisory role. - Comprehensive understanding of medical writing for clinical development, including the documents required at each stage and their associated regulatory requirements. - Comprehensive understanding of medical writing processes, standards and issues. - Extensive experience setting up contracts and collaborating with CRO partners to provide medical writing services in an FSP and FSO environment required \#LI-HYBRID **Our Benefits** CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site (******************************************* to see what's available to you as a CSL employee. **About CSL Behring** CSL Behring (*********************** is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma (************************* . Our parent company, CSL (********************* , headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. **We want CSL to reflect the world around us** At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL (**************************************************** . **Do work that matters at CSL Behring!** R-263490 CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. ************************************************

CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we're building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide. **Your role** The incumbent will be responsible for the quality and delivery of clinical studies and clinical and regualtory documents across the portfolio in collaboration with strategic CRO partners. Responsible for overseeing the recruiting, staffing and development of the clinical scientists and medical writing specialists in the group. **Your responsibilities will include** Oversight of Individuals + Recruiting, staffing, training and development of clinical scientists and medical writing specialists in the group, to maintain a dynamic and cutting-edge level of medical scientific expertise and advanced drug development approaches Ensuring delivery of high-quality clinical development content including: + Clinical development plans, protocols, study reports, common technical document modules and publications in academic journals + Regulatory submissions and meetings + Stage-gate and benefit -risk evaluations and assessments + Presentations at scientific and technical review committees + Implementation of clinical recommendations from all advisory and governance committees Internal interfaces and collaboration + Member of the Clinical Development Leadership Team + Will be responsible for managing a team of approximately 50 Scientists . + Oversight of and collaboration with partnering functions, e.g. Clinical Operations, Research, GRA & Safety to assure an effective project related deliveries + Participate and/or lead enterprise initiatives + Maintaining effective oversight of quality in conjunction with appropriate Quality functions External-scientific + Enhancing the reputation of the Company through a culture of scientific integration of the department with the scientific community and other partners through visible publication record, KOL interactions, presence at scientific conferences, membership of consortia and similar medico-scientific groups, builds networks with scientific experts + Ensures that the patient and health-care provider voice is integrated into CSL's development mindset Building a culture of risk taking, innovation and peer review across the clinical function Providing clinical scientific and medical writing leadership throughout CSL Providing support and insight into business development opportunities as required **Your skills & experience** + Graduate level degree (M.Sc, PhD, MD etc) preferred. + 10 years+ of Pharma experience in clinical development + Clinical Scientist experience across all phases of development, FIH, POC, late-stage development and life cycle management. + Medical writing experience. + Strong track record of leadership skills. + Enhanced organizational awareness and the ability to interact and influence from the team level to senior management + Extensive experience of leading teams and/or line managing a group(s) \#LI-Hybrid **About CSL Behring** CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives. CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit ******************** and CSL Plasma at ************************** . **Our Benefits** For more information on CSL benefits visit How CSL Supports Your Well-being | CSL (********************careers/your-well-being) . **You Belong at CSL** At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. To learn more about inclusion and belonging visit ********************careers/inclusion-and-belonging **Equal Opportunity Employer** CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit ********************accessibility-statement . R-260569 CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. ************************************************

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

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 Director, Medical Writing will collaborate with colleagues to write and/or oversee the development of high-quality, strategically aligned medical-writing deliverables supporting the regulatory requirements of a clinical development program, ensuring completeness, accuracy, and compliance with US and ex-US regulatory requirements. Responsibilities: Provide Medical Writing leadership in strategic project teams as the medical writing subject matter expert, including advising such teams on content, format, and style requirements for documents Manage in-house medical writing staff, vendors and contractors, providing guidance on prioritization, content, timeline development, and process management Mentor and support direct reports in the development of their skills and careers Author, co-author, critically edit, and format clinical/regulatory documents, including New Drug Applications (NDAs), protocols/protocol amendments, clinical study reports (CSRs), Investigator's Brochures, and other regulatory submissions as needed Collaborate with document authors, contributors, and reviewers to deliver on clinical documents, including effective communication to manage expectations, resolve issues, and ensure alignment on document timelines and content Lead the development/refinement of medical writing processes, SOPs, work instructions, templates, style and content guides, and document quality control to ensure efficient preparation of high-quality medical writing deliverables Maintain subject area expertise related to the company's investigational products, disease indications, and regulatory and publication guidelines Perform miscellaneous job-related duties and additional duties and responsibilities as needed Preferred Skills, Qualifications and Technical Proficiencies: Excellent writing skills coupled with good understanding of the drug development process and relevant regulatory guidelines Ability to write and edit complex material to ensure accuracy, clarity, consistency, and effectiveness Successful track record of working on complex clinical/regulatory writing projects across multiple therapeutic areas Excellent attention to detail, multitasking, prioritization, and flexibility Excellent communication skills with proven ability to interact in a cross-functional environment Understanding of the drug-development process, including research and development processes and objectives and the required documents Familiarity with US and European regulatory requirements and guidelines for documents; general knowledge of electronic Common Technical Document (e-CTD) requirements with respect to structure, format, and content Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas Proficiency in use of MS Office applications (Word, Outlook, Excel, Powerpoint), Adobe Acrobat, electronic document management systems (eg, Veeva Vault, Box, SharePoint), and templates (eg, StartingPoint) Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on changing priorities Demonstrated initiative and the ability to manage a variety of projects simultaneously with minimal supervision Ability to think strategically, be resourceful, and lead without formal authority Preferred Education and Experience: BA/BS degree in a scientific field required; advanced scientific degree (PhD, PharmD, or MS) preferred 10+ years (Director) of regulatory medical writing experience in the pharmaceutical industry (or an organization serving them), including experience managing a team and writing clinical study protocols, clinical study reports, investigator's brochures, clinical sections of Investigational New Drug (IND) submissions and New Drug Applications (NDAs); and understanding of the content of higher-level summary documents Knowledge of endocrinology, oncology, neurology and/or metabolic disease areas preferred The pay range that the Company reasonably expects to pay for this headquarters-based position is $172,300 - $253,300; 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.

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.

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_

Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future. Esperion is a fully remote based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance-based bonus program and stock-based compensation, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays. Position Title: Associate Director/Director of Medical Engagement The Associate Director/Director of Medical Engagement will represent Esperion's commitment to advancing patient care and scientific innovation by engaging with healthcare professionals, researchers, and key stakeholders to deliver scientific information, identify insights, and establish long-term partnerships. These roles reflect a progression of responsibilities, with the Associate Director role focusing on functional area leadership and the Director role encompassing strategic leadership, cross-functional collaboration, and direct field team management. Ideal candidate will be based in the Boston, MA area. Territory: Upstate NY, CT, RI, MA, VT, NH, and ME Essential Duties and Responsibilities* Engage with Thought Leaders (TLs): Build and maintain trusted relationships with healthcare professionals, academic centers, and researchers aligned with Esperion's mission. Scientific Exchange: Deliver and discuss current and emerging scientific data on hypercholesterolemia, ensuring high-quality educational interactions with external stakeholders. Clinical and Scientific Expertise: Develop expertise in cardiometabolic and lipid-related science, Esperion's product portfolio, and emerging clinical trends. Strategic Insight Capture: Gather field insights on unmet needs, treatment landscapes, and competitive intelligence to refine Esperion's strategies. Congress and Event Participation: Represent Esperion at medical congresses, roundtable discussions, advisory boards, and educational programs. Cross-Functional Collaboration: Partner with internal teams as appropriate, including Market Access, Marketing, Clinical Development, Regulatory, to align scientific and commercial strategies. Compliance: Ensure adherence to all corporate policies, U.S. healthcare laws, and industry regulations in all scientific engagements. *Additional duties and responsibilities based on level as assigned such as: Associate Director: Lead scientific initiatives within the functional area, including internal and external projects. Mentor and guide MSLs as appropriate, fostering professional development within the team. Contribute to Medical Affairs strategy development for congress planning, scientific publications, and real-world evidence initiatives. Collaborate on the development of health system quality improvement initiatives. Serve as a subject matter expert in cardiometabolic care, providing advanced scientific guidance to internal and external stakeholders. Ensure compliance with corporate policies, U.S. healthcare laws, and industry regulations in all scientific engagements. Director: Lead strategic external engagement with Integrated Delivery Networks (IDNs), health systems, and high-level stakeholders to establish long-term partnerships. Develop and execute long-term strategies for partnerships and scientific initiatives that align with Esperion's mission. Lead and coordinate cross-functional teams to ensure alignment of scientific, clinical, and commercial objectives in an appropriate and compliant manner. Champion high standards of compliance, ethics, and patient safety across all scientific and medical activities. Field Team Management: Provide leadership, mentorship, and performance oversight for field-based medical engagement teams, including MSLs and ADs, ensuring a positive and collaborative culture. Qualifications (Education & Experience) Advanced degree required (MD, PhD, PharmD, or equivalent); NP or PA with relevant experience may be considered. Associate Director: At least 5+ years of relevant experience, including leadership or mentoring responsibilities. Director: At least 8+ years of pharmaceutical or clinical experience, including leadership roles managing teams and external stakeholder engagement. Director: Proven ability to develop and execute long-term strategic initiatives Director: Strategic vision with cross-functional leadership and team management capabilities. Demonstrated ability to lead functional area projects and initiatives. Expertise in cardiovascular, cardiometabolic, or lipidology required. Strong scientific knowledge and ability to communicate complex medical concepts to diverse audiences. Exceptional communication and interpersonal skills to build trust and credibility with stakeholders. Analytical mindset with attention to detail and problem-solving capabilities. Adaptability to thrive in a fast-paced, dynamic environment with competing priorities. Demonstrated leadership and ability to manage functional area initiatives while mentoring others. Outstanding organizational, planning, and project management skills. Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word) and CRM software. Valid U.S. driver's license with the ability to travel >50% (including overnight travel).