Senior Medical Writer jobs at MMS - 153 jobs

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating. Our mission is to deliver high-quality service and technology solutions - rooted in strong science and decades of regulatory experience - that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide. MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit ******************* or follow MMS on LinkedIn. Responsibilities Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias Write and edit clinical development documents, including but not limited to, clinical protocols, investigator's brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals Complete writing assignments in a timely manner Maintain timelines and workflow of writing assignments Practice good internal and external customer service Highly proficient with styles of writing for various regulatory documents Expert proficiency with client templates & style guides Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects Contribute substantially to, or manages, production of interpretive guides Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary Mentor medical writers and other members of the project team who are involved in the writing process Requirements At least 3 years of previous experience in the pharmaceutical industry Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline Substantial clinical study protocol experience, as lead author, required Experience leading and managing teams while authoring regulatory documents with aggressive timelines Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus Understanding of clinical data Exceptional writing skills are a must Excellent organizational skills and the ability to multi-task are essential prerequisites Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools Experience being a project lead, or managing a project team Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus Not required, but experience with orphan drug designations and PSP/PIPs a plus

The Proposal Writer/Analyst/Strategist will manage, develop, and lead a request for proposal project by working through the (a) development of strategic and client-focused proposal content, (b) written proposals, and (c) other sales-related documents for a variety of client audiences. The Proposal Writer/Analyst/Strategist is a key contributor on the Proposal team, accountable for analyzing assigned opportunities, creating competitively positioned content, and conveying a powerful corporate image to result in significant market share and profitability. This position strives to ensure timely and quality completion of assigned projects in accordance with company standards. This occurs, through a collaborative effort with the Proposal, Sales, Business Informatics, Underwriting, Pricing teams and cross-functionally with internal and external customers. This position is required on-site 5 days a week. Roles and Responsibilities Ensure a proactive and strategic approach in support of client acquisition and retention efforts, including Requests for Proposals (RFPs), Requests for Information (RFIs), Best and Final Offers (BAFOs), client retention bids, and other support and sales-related documents. Develop strategic activities, such as the creation of compelling content to position defined strategies for high-profile opportunities; process execution associated with timely completion; volume planning; and ongoing process enhancements. Provide the Sales team with consultative support on the development and execution of targeted and opportunity-specific strategies to enhance the company's competitive advantage. Utilize expert-level editorial, grammatical, and writing skills to ensure all written deliverables follow and demonstrate tactical, strategic, financial, and sales-capture decisions. Ensure project coordination (e.g., planning, scheduling, organizing, and coordination), follow-up correspondence, and reporting. Contribute to a collaborative environment where knowledge and experience is shared to build expertise and support other members to achieve aligned results. Strive toward an expert-level understanding of internal processes and nuances of subject matter expert departments to unite these deliverables and create a cohesive and competitively positioned proposal. Maintain a deep understanding and continuously develop knowledge of the company's sales strategies, target markets, and trends in those markets and how the company's products and services are/or may be utilized in the target markets. Demonstrate flexibility and ability to work independently and in a team/collaborative environment. Support and/or lead other duties as assigned. Essential Background Requirements Education: A minimum of a bachelor's degree or equivalent of years of experience. Qualifications: Minimum of five years related, professional experience, preferably in pharmacy benefit management, healthcare sales, and/or strategic proposal-related work. Proven support of client acquisition and retention efforts, including Requests for Proposals (RFPs), Requests for Information (RFIs), Best and Final Offers (BAFOs), client retention bids, and other support and sales-related documents. Effective verbal communication skills and advanced writing and editing expertise Advanced expertise in strategic marketing message development, conceptual thinking, problem solving, and ability to interact with and present information to all levels of internal and external audiences. Demonstrated project management proficiency, including managing and leading multiple tasks/projects in a high-pressure environment with competing priorities, within tight time frames. Advanced experience with Microsoft Office products (e.g., Word, Excel, PowerPoint, Project). Customer Relationship Management software experience a plus. Excellent math and organizational skills with a well-developed eye for detail. The ability to consistently interact cooperatively and respectfully with other employees Participate in, adhere to, and support compliance program objectives

**Company: Parexel is hiring an FSP - Senior Medical Writer with Structured Content Authoring experience to work Remotely.** **Employment Type:** Full-time At Parexel, we are dedicated to improving patient lives through innovative clinical research and regulatory solutions. As a leading global clinical research organization (CRO), we partner with the world's most prominent biopharmaceutical companies to bring life-changing therapies to market. Our culture is built on collaboration, integrity, and a shared commitment to excellence-where your expertise can make a real impact on global health. **Role Summary** Parexel is seeking an experienced Senior Medical Writer to support the Structured Content Authoring (SCA) initiative. This position focuses exclusively on SCA and involves configuring the platform for medical writing and regulatory documentation workflows. The role combines technical configuration expertise with a strong understanding of structured content authoring and regulatory standards. The ideal candidate will ensure seamless configuration, integration, and optimization of SCA to meet project and compliance requirements. This position also offers the opportunity to provide end-user support as the user base grows-making it a great learning experience and a chance to deliver impactful solutions. **Key Responsibilities** + Configure and maintain SCA platform settings to support medical writing and regulatory workflows. + Customize templates, metadata fields, and document structures for compliance and efficiency. + Implement and validate workflow configurations for review, approval, and version control. + Ensure integration of SCA with other enterprise systems (e.g., PleaseReview, Veeva RIM). + Conduct functional testing and troubleshoot configuration issues. + Maintain detailed documentation of configuration changes for audit readiness. + Collaborate with internal teams to gather requirements and translate them into technical solutions. + Provide user training and support on SCA features and best practices. + Offer end-user support (as availability allows) to assist with onboarding and troubleshooting, helping new users adapt to the platform. + Ensure all configurations comply with regulatory standards and company SOPs. **Required Qualifications** + Proven experience with SCA platforms. + Background in medical writing or strong familiarity with regulatory documentation processes. + Hands-on experience in content creation, review, standardization, and management within a structured content platform. + Demonstrated ability to collaborate with cross-functional teams to support regulatory consistency and harmonization of content across multiple documents. + Familiarity with core content reuse strategies, metadata management, and troubleshooting within the platform. + Strong problem-solving skills and attention to detail. + Familiarity with compliance and audit requirements in a GxP environment. + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. **Preferred Qualifications** + Experience training users or driving adoption of structured content methods. + Hands-on experience with automation of regulatory medical writing documents and (SCA) Structured Content Authoring platforms. + Experience working in a CRO or pharmaceutical environment. + Knowledge of electronic submission standards (e.g., eCTD). + Strong communication skills for cross-functional collaboration. + Ability to work independently and manage multiple priorities. **Education** Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. **Why Join Parexel?** + **Impactful Work:** Contribute to projects that accelerate the delivery of life-saving therapies to patients worldwide. + **Global Collaboration:** Work with diverse teams across the globe in a dynamic, innovative environment. + **Career Growth:** Access to professional development programs, mentorship, and opportunities for advancement. + **Flexibility:** Enjoy the benefits of a fully remote role with a healthy work-life balance. + **Inclusive Culture:** Be part of a company that values diversity, integrity, and collaboration. **Ready to Make an Impact?** If you are passionate about medical writing, regulatory excellence, and leveraging technology to drive innovation, we want to hear from you! **Apply today and join Parexel in shaping the future of clinical research.** \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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

**Company: Parexel is hiring an FSP - Senior Medical Writer with Structured Content Authoring experience to work Remotely.** **Employment Type:** Full-time At Parexel, we are dedicated to improving patient lives through innovative clinical research and regulatory solutions. As a leading global clinical research organization (CRO), we partner with the world's most prominent biopharmaceutical companies to bring life-changing therapies to market. Our culture is built on collaboration, integrity, and a shared commitment to excellence-where your expertise can make a real impact on global health. **Role Summary** Parexel is seeking an experienced Senior Medical Writer to support the Structured Content Authoring (SCA) initiative. This position focuses exclusively on SCA and involves configuring the platform for medical writing and regulatory documentation workflows. The role combines technical configuration expertise with a strong understanding of structured content authoring and regulatory standards. The ideal candidate will ensure seamless configuration, integration, and optimization of SCA to meet project and compliance requirements. This position also offers the opportunity to provide end-user support as the user base grows-making it a great learning experience and a chance to deliver impactful solutions. **Key Responsibilities** + Configure and maintain SCA platform settings to support medical writing and regulatory workflows. + Customize templates, metadata fields, and document structures for compliance and efficiency. + Implement and validate workflow configurations for review, approval, and version control. + Ensure integration of SCA with other enterprise systems (e.g., PleaseReview, Veeva RIM). + Conduct functional testing and troubleshoot configuration issues. + Maintain detailed documentation of configuration changes for audit readiness. + Collaborate with internal teams to gather requirements and translate them into technical solutions. + Provide user training and support on SCA features and best practices. + Offer end-user support (as availability allows) to assist with onboarding and troubleshooting, helping new users adapt to the platform. + Ensure all configurations comply with regulatory standards and company SOPs. **Required Qualifications** + Proven experience with SCA platforms. + Background in medical writing or strong familiarity with regulatory documentation processes. + Hands-on experience in content creation, review, standardization, and management within a structured content platform. + Demonstrated ability to collaborate with cross-functional teams to support regulatory consistency and harmonization of content across multiple documents. + Familiarity with core content reuse strategies, metadata management, and troubleshooting within the platform. + Strong problem-solving skills and attention to detail. + Familiarity with compliance and audit requirements in a GxP environment. + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. **Preferred Qualifications** + Experience training users or driving adoption of structured content methods. + Hands-on experience with automation of regulatory medical writing documents and (SCA) Structured Content Authoring platforms. + Experience working in a CRO or pharmaceutical environment. + Knowledge of electronic submission standards (e.g., eCTD). + Strong communication skills for cross-functional collaboration. + Ability to work independently and manage multiple priorities. **Education** Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. **Why Join Parexel?** + **Impactful Work:** Contribute to projects that accelerate the delivery of life-saving therapies to patients worldwide. + **Global Collaboration:** Work with diverse teams across the globe in a dynamic, innovative environment. + **Career Growth:** Access to professional development programs, mentorship, and opportunities for advancement. + **Flexibility:** Enjoy the benefits of a fully remote role with a healthy work-life balance. + **Inclusive Culture:** Be part of a company that values diversity, integrity, and collaboration. **Ready to Make an Impact?** If you are passionate about medical writing, regulatory excellence, and leveraging technology to drive innovation, we want to hear from you! **Apply today and join Parexel in shaping the future of clinical research.** \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Company: Parexel is hiring an FSP - Senior Medical Writer with Structured Content Authoring experience to work Remotely. Location: Remote (anywhere in US or Canada) Employment Type: Full-time About Parexel At Parexel, we are dedicated to improving patient lives through innovative clinical research and regulatory solutions. As a leading global clinical research organization (CRO), we partner with the world's most prominent biopharmaceutical companies to bring life-changing therapies to market. Our culture is built on collaboration, integrity, and a shared commitment to excellence-where your expertise can make a real impact on global health. Role Summary Parexel is seeking an experienced Senior Medical Writer to support the Structured Content Authoring (SCA) initiative. This position focuses exclusively on SCA and involves configuring the platform for medical writing and regulatory documentation workflows. The role combines technical configuration expertise with a strong understanding of structured content authoring and regulatory standards. The ideal candidate will ensure seamless configuration, integration, and optimization of SCA to meet project and compliance requirements. This position also offers the opportunity to provide end-user support as the user base grows-making it a great learning experience and a chance to deliver impactful solutions. Key Responsibilities Configure and maintain SCA platform settings to support medical writing and regulatory workflows. Customize templates, metadata fields, and document structures for compliance and efficiency. Implement and validate workflow configurations for review, approval, and version control. Ensure integration of SCA with other enterprise systems (e.g., PleaseReview, Veeva RIM). Conduct functional testing and troubleshoot configuration issues. Maintain detailed documentation of configuration changes for audit readiness. Collaborate with internal teams to gather requirements and translate them into technical solutions. Provide user training and support on SCA features and best practices. Offer end-user support (as availability allows) to assist with onboarding and troubleshooting, helping new users adapt to the platform. Ensure all configurations comply with regulatory standards and company SOPs. Required Qualifications Proven experience with SCA platforms. Background in medical writing or strong familiarity with regulatory documentation processes. Hands-on experience in content creation, review, standardization, and management within a structured content platform. Demonstrated ability to collaborate with cross-functional teams to support regulatory consistency and harmonization of content across multiple documents. Familiarity with core content reuse strategies, metadata management, and troubleshooting within the platform. Strong problem-solving skills and attention to detail. Familiarity with compliance and audit requirements in a GxP environment. Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. Preferred Qualifications Experience training users or driving adoption of structured content methods. Hands-on experience with automation of regulatory medical writing documents and (SCA) Structured Content Authoring platforms. Experience working in a CRO or pharmaceutical environment. Knowledge of electronic submission standards (e.g., eCTD). Strong communication skills for cross-functional collaboration. Ability to work independently and manage multiple priorities. Education Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. Why Join Parexel? Impactful Work: Contribute to projects that accelerate the delivery of life-saving therapies to patients worldwide. Global Collaboration: Work with diverse teams across the globe in a dynamic, innovative environment. Career Growth: Access to professional development programs, mentorship, and opportunities for advancement. Flexibility: Enjoy the benefits of a fully remote role with a healthy work-life balance. Inclusive Culture: Be part of a company that values diversity, integrity, and collaboration. Ready to Make an Impact? If you are passionate about medical writing, regulatory excellence, and leveraging technology to drive innovation, we want to hear from you! Apply today and join Parexel in shaping the future of clinical research. #LI-CF1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Job Summary: The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. Key Accountabilities: Author Clinical Documents Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. Perform literature searches/reviews as necessary to obtain background information and training for development of documents. Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. Quality Control Ensure that all work is complete and of high quality prior to team distribution or shipment to client. Confirm data consistency and integrity across the document. Prepare documents for publishing readiness, when applicable. Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. Provide suggested alternative content when contributors provide content that does not meet document needs. Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. Document Project Management Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. Training/ Compliance Attend and complete mandatory, corporate, project-specific, and departmental training as required. Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. Assist in the training/mentoring of new staff as well as less experienced departmental members. General Attend departmental and company meetings as necessary. Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. Skills: Excellent interpersonal, verbal, and written communication skills. Ability to consistently produce documents of high quality. Demonstrates attention to details and proactivity. Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. A flexible attitude with respect to work assignments and new learning; readily adapts to changes. Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. Understands and satisfies client needs. Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. Knowledge and Experience: Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. Extensive clinical/scientific writing skills. Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite Education: Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. #LI-LO1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

**Company: Parexel is hiring an FSP - Senior Medical Writer with Structured Content Authoring experience to work Remotely.** **Employment Type:** Full-time At Parexel, we are dedicated to improving patient lives through innovative clinical research and regulatory solutions. As a leading global clinical research organization (CRO), we partner with the world's most prominent biopharmaceutical companies to bring life-changing therapies to market. Our culture is built on collaboration, integrity, and a shared commitment to excellence-where your expertise can make a real impact on global health. **Role Summary** Parexel is seeking an experienced Senior Medical Writer to support the Structured Content Authoring (SCA) initiative. This position focuses exclusively on SCA and involves configuring the platform for medical writing and regulatory documentation workflows. The role combines technical configuration expertise with a strong understanding of structured content authoring and regulatory standards. The ideal candidate will ensure seamless configuration, integration, and optimization of SCA to meet project and compliance requirements. This position also offers the opportunity to provide end-user support as the user base grows-making it a great learning experience and a chance to deliver impactful solutions. **Key Responsibilities** + Configure and maintain SCA platform settings to support medical writing and regulatory workflows. + Customize templates, metadata fields, and document structures for compliance and efficiency. + Implement and validate workflow configurations for review, approval, and version control. + Ensure integration of SCA with other enterprise systems (e.g., PleaseReview, Veeva RIM). + Conduct functional testing and troubleshoot configuration issues. + Maintain detailed documentation of configuration changes for audit readiness. + Collaborate with internal teams to gather requirements and translate them into technical solutions. + Provide user training and support on SCA features and best practices. + Offer end-user support (as availability allows) to assist with onboarding and troubleshooting, helping new users adapt to the platform. + Ensure all configurations comply with regulatory standards and company SOPs. **Required Qualifications** + Proven experience with SCA platforms. + Background in medical writing or strong familiarity with regulatory documentation processes. + Hands-on experience in content creation, review, standardization, and management within a structured content platform. + Demonstrated ability to collaborate with cross-functional teams to support regulatory consistency and harmonization of content across multiple documents. + Familiarity with core content reuse strategies, metadata management, and troubleshooting within the platform. + Strong problem-solving skills and attention to detail. + Familiarity with compliance and audit requirements in a GxP environment. + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. **Preferred Qualifications** + Experience training users or driving adoption of structured content methods. + Hands-on experience with automation of regulatory medical writing documents and (SCA) Structured Content Authoring platforms. + Experience working in a CRO or pharmaceutical environment. + Knowledge of electronic submission standards (e.g., eCTD). + Strong communication skills for cross-functional collaboration. + Ability to work independently and manage multiple priorities. **Education** Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. **Why Join Parexel?** + **Impactful Work:** Contribute to projects that accelerate the delivery of life-saving therapies to patients worldwide. + **Global Collaboration:** Work with diverse teams across the globe in a dynamic, innovative environment. + **Career Growth:** Access to professional development programs, mentorship, and opportunities for advancement. + **Flexibility:** Enjoy the benefits of a fully remote role with a healthy work-life balance. + **Inclusive Culture:** Be part of a company that values diversity, integrity, and collaboration. **Ready to Make an Impact?** If you are passionate about medical writing, regulatory excellence, and leveraging technology to drive innovation, we want to hear from you! **Apply today and join Parexel in shaping the future of clinical research.** \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Manage ongoing and/or revised project documentation and correspondence. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. **Project Management** + Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project. + Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives. + Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program. + Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents. + Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget. + Keep client and team informed of project status. + Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences. + Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence. + Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management. + Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements. + Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line manager with input regarding team member's performance for employees' periodic performance review, and as needed. **Client** **Liaison/Service** + Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management. + Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon. + Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in the proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management. + Input to development of client proposals generated by Medical Writing Services and letters of agreement/intent based on existing templates. May function as the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management. + If requested, suggest appropriate resourcing, based on existing templates and standards, for full-service and stand-alone projects. **Training/Compliance** + Keep abreast of new advances in medical writing and regulatory issues. + Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management. + Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate. + Develop and present external training courses. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform + Analyze efficiency of work and discuss improvement ideas with Medical Writing + Services management and colleagues, e.g., evaluation of software to increase productivity and document quality. **Skills:** + Excellent interpersonal, negotiation, verbal, and written communication skills. + A flexible attitude with respect to work assignments and new learning. + Motivation to work consistently in a fast-paced, rapidly changing environment. + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects. + Knowledge of resource management and productivity metric management. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Ability to travel. + Fluent in written and spoken English. **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-KW1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Manage ongoing and/or revised project documentation and correspondence. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. **Project Management** + Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project. + Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives. + Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program. + Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents. + Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget. + Keep client and team informed of project status. + Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences. + Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence. + Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management. + Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements. + Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line manager with input regarding team member's performance for employees' periodic performance review, and as needed. **Client** **Liaison/Service** + Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management. + Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon. + Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in the proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management. + Input to development of client proposals generated by Medical Writing Services and letters of agreement/intent based on existing templates. May function as the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management. + If requested, suggest appropriate resourcing, based on existing templates and standards, for full-service and stand-alone projects. **Training/Compliance** + Keep abreast of new advances in medical writing and regulatory issues. + Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management. + Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate. + Develop and present external training courses. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform + Analyze efficiency of work and discuss improvement ideas with Medical Writing + Services management and colleagues, e.g., evaluation of software to increase productivity and document quality. **Skills:** + Excellent interpersonal, negotiation, verbal, and written communication skills. + A flexible attitude with respect to work assignments and new learning. + Motivation to work consistently in a fast-paced, rapidly changing environment. + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects. + Knowledge of resource management and productivity metric management. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Ability to travel. + Fluent in written and spoken English. **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-KW1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-CF1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. The Senior Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Senior Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Manage ongoing and/or revised project documentation and correspondence. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. **Project Management** + Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project. + Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives. + Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program. + Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents. + Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget. + Keep client and team informed of project status. + Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences. + Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence. + Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management. + Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements. + Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line manager with input regarding team member's performance for employees' periodic performance review, and as needed. **Client** **Liaison/Service** + Be aware of client expectations for self and team members. Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management. + Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon. + Provide strategic and project planning intelligence to Medical Writing Services management for medical writing activities in the proposal generation process, including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management. + Input to development of client proposals generated by Medical Writing Services and letters of agreement/intent based on existing templates. May function as the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management. + If requested, suggest appropriate resourcing, based on existing templates and standards, for full-service and stand-alone projects. **Training/Compliance** + Keep abreast of new advances in medical writing and regulatory issues. + Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management. + Implement and monitor departmental compliance to SOPs. Input to development or revision of departmental SOPs, as appropriate. + Develop and present external training courses. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform + Analyze efficiency of work and discuss improvement ideas with Medical Writing + Services management and colleagues, e.g., evaluation of software to increase productivity and document quality. **Skills:** + Excellent interpersonal, negotiation, verbal, and written communication skills. + A flexible attitude with respect to work assignments and new learning. + Motivation to work consistently in a fast-paced, rapidly changing environment. + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations. + Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects. + Knowledge of resource management and productivity metric management. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Ability to travel. + Fluent in written and spoken English. **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-KW1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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

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

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