Medical Editor jobs at Pharmaceutical Product Development - 18 jobs

Company Navitus About Us Navitus - Putting People First in Pharmacy - Navitus was founded as an alternative to traditional pharmacy benefit manager (PBM) models. We are committed to removing cost from the drug supply chain to make medications more affordable for the people who need them. At Navitus, our team members work in an environment that celebrates diversity, fosters creativity and encourages growth. We welcome new ideas and share a passion for excellent service to our customers and each other._____________________________________________________________________________________________________________________________________________________________________________________________________________. Current associates must use SSO login option at ************************************ to be considered for internal opportunities. Pay Range USD $69,627.00 - USD $83,888.00 /Yr. STAR Bonus % (At Risk Maximum) 5.00 - Salaried Non-Management except pharmacists Work Schedule Description (e.g. M-F 8am to 5pm) M-F 8am to 5pm Remote Work Notification ATTENTION: Navitus is unable to offer remote work to residents of Alaska, Hawaii, Maine, Mississippi, New Hampshire, New Mexico, North Dakota, Rhode Island, South Carolina, South Dakota, West Virginia, and Wyoming. Overview Due to growth, we are adding a Senior Content Editor to join our team! The Senior Content Editor role designs and owns the architecture for the overall proposal content knowledgebase used to support the client acquisition and retention efforts of Navitus Health Solutions (Navitus). This position works cross-functionally at a variety of levels to craft, maintain and expand digital content while improving proposal quality and team productivity. The Senior Content Editor ensures regular reviews of the knowledgebase and data integrity. Requires the ability to take complex concepts and translate them into a defined style that clearly and accurately articulates Navitus' value proposition. This position requires strong communication skills and a high proficiency with content data libraries and document automation software. Is this you? Find out more below! Responsibilities How do I make an impact on my team? Seek and build best-in-class content that easily integrates into proposals and other sales related documents for various markets (e.g. health plans, government, national accounts, mid-market employers). Oversee the accuracy, organization and formatting of library content to keep the proposal knowledgebase current, competitive and usable by the proposal team. Collaborate with Subject Matter Experts (SMEs) to convert complex and varying explanations into concise and compelling value propositions and proof points consistent with Navitus' brand/style guide and sales strategy. Identify gaps in the knowledgebase and ensure timely updates of all content positioning and related exhibits through regular content audit reviews. Work collaboratively with those contributing to and/or drawing from the knowledgebase, such as proposal team members, executives, management teams, business units, partners, and SMEs. Serve as a proposal content knowledgebase expert by communicating important updates related to processes, messaging and content management, including SME list management, training and alignment. Serve as a proposal automation software expert to all users in the company. This includes adding new users to the system, providing new user training materials and providing subsequent navigation assistance as needed. Maintain a high level of proficiency with the knowledgebase system and apply new functionality to improve how content is organized, updated and accessed. Contribute to the department goal of improved efficiency and effectiveness by implementing processes to streamline proactive creation. Consult system reporting and analytics to gain insights into content preparation and usage to inform training opportunities and improvement efforts. Other duties as assigned Qualifications What our team expects from you? A minimum of a bachelor's degree, preferably in English, Journalism or a Communications-related field, or equivalent related experience required. Minimum of four years of experience writing and managing content. Experience with proposals in the pharmacy benefit management or health insurance industry is preferred. Demonstrated experience supporting a proposal knowledgebase and related processes. Participate in, adhere to, and support compliance program objectives The ability to consistently interact cooperatively and respectfully with other employees What can you expect from Navitus? Top of the industry benefits for Health, Dental, and Vision insurance 20 days paid time off 4 weeks paid parental leave 9 paid holidays 401K company match of up to 5% - No vesting requirement Adoption Assistance Program Flexible Spending Account Educational Assistance Plan and Professional Membership assistance Referral Bonus Program - up to $750! #LI-Remote Location : Address Remote Location : Country US

The Medical Writing and Disclosure (MWD) department within Global Clinical Trial Operations creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials. In partnership with the medical writing project lead, the Senior Medical Writer leads the preparation and execution of clinical regulatory documents and public-facing documents across multiple programs and therapeutic areas in support of the company portfolio. In this role, the Senior Medical Writer: Demonstrates independence in preparing clinical regulatory (e.g., protocols, clinical study reports, participant narratives, investigator's brochures) and/or public-facing (e.g., informed consent forms, clinical trial registration and results postings, plain language summaries) documents per company and evolving regulatory requirements. Applies an in-depth knowledge and understanding of design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy). Is a scientific contributor and collaborator on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities. Applies emerging critical thinking, problem solving, and negotiation skills to implement solutions to challenges across the medical writing scope of work (e.g., documents, content, processes, timelines, tools) while navigating project team dynamics. Keeps medical writing project lead and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance. Applies knowledge of medical writing-specific tools and technology platforms. Participates in or leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally, as appropriate. Applies knowledge of clinical development, relevant regulations, disease areas, and company products. May help with other departmental needs, such as orientation of new team members or mentoring less experienced writers. May manage direct reports, including workload, professional development, and performance management. Qualifications Bachelor's degree or higher in a scientific discipline (e.g., life sciences, pharmacy, medicine). At least 3 years of plain language medical writing or relevant industry experience. Required skills & experience Experience managing multiple writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members. Ability to interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines, with minimal supervision. Demonstrated critical thinking and problem-solving capabilities. Experience with conflict resolution and negotiation in cross-functional teams. Ability to adapt to changing project needs and unexpected workload demands to help team succeed. Strong oral and written communication and presentation skills. Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology. Experience and proficiency in independent plain language authoring such as patient- or public-facing materials, informed consents, plain language summaries, or other health-literate clinical research materials. Experience independently applying health literacy principles and best practices, such as translating scientific content into easy-to-understand text using health literacy and numeracy principles and sensitivity to the needs of audiences across cultures and communities. Demonstrated leadership in enhancing health literacy best practices and processes Preferred skills and experience: Background in medical writing, authoring clinical regulatory documents (e.g., clinical study reports, protocols). clinicaltrialjobs EligibleforER Required Skills: Adaptability, Clinical Data, Clinical Operations, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Communication, Data Analysis, Ethical Standards, ICH GCP Guidelines, Medical Writing, Microsoft Office, Motivation Management, Regulatory Compliance, Regulatory Documents, Scientific Publications, Team Management Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No Job Posting End Date: 01/30/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record. Are you interested in joining our team? Job Summary A Proposal Writer (Technical Evaluations Specialist) drives results in a fast-paced environment by assessing requests for proposals (RFPs) received from our Sales and Business Development team or customers. Technical Evaluations Specialists demonstrate technical and scientific expertise for assigned business units (Lab Services & Drug Product) to develop proposals, including associated costs. Technical Evaluations Specialists collaborate with Sales and Business Development, Project Management, Finance, Legal, and Operations to provide technical guidance to customers. This includes direct customer interface. Technical Evaluations Specialists demonstrate a high level of independence. On-Site Expectations 100% remote position. 1st Shift: Monday - Friday, 8:00am - 5:00pm Eastern Time. Responsibilities Performs technical evaluations of incoming RFPs and existing program extensions across Alcami capabilities for assigned business units (Lab Services & Drug Product) including proposed scope of work, costing, and budgets with limited guidance from Management. Compilates technical evaluation into appropriate templates and proposal generation. Assesses with Operations and recommends Alcami capabilities to meet customer requirements as part of technical evaluations. Represents technical operations in front of customers in support of project acquisition with Sales & Business Development and Project Management. Attends customer site visits and presentations for new opportunities. Performs data entry into the applicable CRM system. Performs assigned tasks carefully and on schedule per supervisor instructions. Adheres to all company SOPs and policies. Identifies opportunities for process improvements. Ensures timely completion and compliance with cGMP and all other relevant company training requirements. Other duties as assigned. Qualifications Bachelor's degree in a scientific or engineering field with 4+ years of industry experience. Master's degree or doctorate degree in scientific or engineering field with 2+ years of industry experience. CDMO experience preferred. Knowledge, Skills, and Abilities Knowledge of FDA regulations/ICH guidelines. Knowledge of U.S. Drug Development process regulatory requirements for pharmaceutical industry. Knowledge of activity costing, margins, and budgets. Knowledge of scientific terminology and testing procedure requirements as related to area focus. Excellent communication, interpersonal, presentation and organizational skills. Excellent customer service orientation. Excellent organizational skills, detail orientation and ability to effectively manage competing priorities. Proficiency with Microsoft Office including Excel and Word. Ability to gain proficiency working with a CRM. Prior CRM experience such as Salesforce.com preferred. Demonstrated ability to understand the interdependencies of process chemistry, analytical development and manufacturing necessary to support specific assigned area(s). Travel Expectations Up to 5% travel required. Physical Demands and Work Environment The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to sit.

About MMS 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

Job Summary We are currently seeking a full-time, office-based Experienced Proposal Writer to join our Proposal and Feasibility team. This position will work closely with the operations and business development teams to prepare proposals for new business in the pharmaceutical industry with the opportunity to develop strategical content at the intersection of science, operations and financewhile developing your career. If you want an exciting career where using your previous expertise and while developing and growing your career even further, this is the opportunity for you! Responsibilities * Lead proposal planning meetings to: * Identify issues and client requirements * Recommend proposal and overall study strategies, based on experience * Encourage multi-disciplinary discussions among subject matter experts to facilitate full and high-quality contributions to the text * Establish timelines and deliverables and hold internal stakeholders accountable to those plans and timelines * Extract relevant content from Subject-Matter Experts and consolidate this expertise into a meaningful proposal narrative * Include relevant data visualization materials into documents. * Review and analyze Request for Proposal (RFP) and Request for Information (RFI) documents to gain understanding of client requirements and assist in identifying missing information. * Identify information to be addressed in proposal text * Collate follow-up questions for additional information as requested• Draft standard documents in accordance with agreed strategy and Sponsor requirements within often expedited timelines * Contribute to assigned process improvement initiatives and support implementation * Define action plans and timelines; manage and determine modifications needed to ensure proposal alignment with client requirements and business strategies * Perform quality control/peer review and participate in the finalization of documents and distribution to the customer and internal departments Qualifications * Bachelor's degree in life science field required, Master's degree in life science field preferred * 2-3 years of CRO experince or Proposal Writing experience within industry * Strong initiative to learn * Strong written and oral communication skills * Project management skills and the ability to prioritize multiple projects and tasks 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.

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.

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.

We are currently seeking a full-time, office-based Proposal Writer to join our Proposal and Feasibility team. This position will work closely with the operations and business development teams to prepare proposals for new business in the pharmaceutical industry with the opportunity to develop strategical content at the intersection of science, operations and financewhile developing your career. If you want an exciting career where using your previous expertise and while developing and growing your career even further, this is the opportunity for you! Responsibilities * May lead proposal planning meetings to: * Identify issues and client requirements * Recommend proposal and overall study strategies, based on experience * Encourage multi-disciplinary discussions among subject matter experts to facilitate full and high-quality contributions to the text * Establish timelines and deliverables and hold internal stakeholders accountable to those plans and timeline * Extract relevant content from Subject-Matter Experts and consolidate this expertise into a meaningful proposal narrative. * Include relevant data visualization materials into documents. * Review and analyze Request for Proposal (RFP) and Request for Information (RFI) documents to gain understanding of client requirements and assist in identifying missing information Review * Identify information to be addressed in proposal text * Collate follow-up questions for additional information as requested * Draft standard documents in accordance with agreed strategy and Sponsor requirements within often expedited timelines * Contribute to assigned process improvement initiatives and support implementation * Define action plans and timelines; manage and determine modifications needed to ensure proposal alignment with client requirements and business strategies * Perform quality control/peer review and participate in the finalization of documents and distribution to the customer and internal departments Qualifications * Bachelor's degree in life science field required, Master's degree in life science field preferred * Strong initiative to learn * Strong written and oral communication skills * Project management skills and the ability to prioritize multiple projects and tasks 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.

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

The Medical Writing and Disclosure (MWD) department within Global Clinical Trial Operations creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials. In partnership with the medical writing project lead, the Senior Medical Writer leads the preparation and execution of clinical regulatory documents and public-facing documents across multiple programs and therapeutic areas in support of the company portfolio. In this role, the Senior Medical Writer: Demonstrates independence in preparing clinical regulatory (e.g., protocols, clinical study reports, participant narratives, investigator's brochures) and/or public-facing (e.g., informed consent forms, clinical trial registration and results postings, plain language summaries) documents per company and evolving regulatory requirements. Applies an in-depth knowledge and understanding of design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy). Is a scientific contributor and collaborator on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities. Applies emerging critical thinking, problem solving, and negotiation skills to implement solutions to challenges across the medical writing scope of work (e.g., documents, content, processes, timelines, tools) while navigating project team dynamics. Keeps medical writing project lead and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance. Applies knowledge of medical writing-specific tools and technology platforms. Participates in or leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally, as appropriate. Applies knowledge of clinical development, relevant regulations, disease areas, and company products. May help with other departmental needs, such as orientation of new team members or mentoring less experienced writers. May manage direct reports, including workload, professional development, and performance management. Qualifications Bachelor's degree or higher in a scientific discipline (e.g., life sciences, pharmacy, medicine). At least 3 years of plain language medical writing or relevant industry experience. Required skills & experience Experience managing multiple writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members. Ability to interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines, with minimal supervision. Demonstrated critical thinking and problem-solving capabilities. Experience with conflict resolution and negotiation in cross-functional teams. Ability to adapt to changing project needs and unexpected workload demands to help team succeed. Strong oral and written communication and presentation skills. Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology. Experience and proficiency in independent plain language authoring such as patient- or public-facing materials, informed consents, plain language summaries, or other health-literate clinical research materials. Experience independently applying health literacy principles and best practices, such as translating scientific content into easy-to-understand text using health literacy and numeracy principles and sensitivity to the needs of audiences across cultures and communities. Demonstrated leadership in enhancing health literacy best practices and processes Preferred skills and experience: Background in medical writing, authoring clinical regulatory documents (e.g., clinical study reports, protocols). clinicaltrialjobs EligibleforER Required Skills: Adaptability, Clinical Data, Clinical Operations, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Communication, Data Analysis, Ethical Standards, ICH GCP Guidelines, Medical Writing, Microsoft Office, Motivation Management, Regulatory Compliance, Regulatory Documents, Scientific Publications, Team Management Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”. The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ******************************************************* You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: No relocation VISA Sponsorship: No Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: 1st - Day Valid Driving License: No Hazardous Material(s): No Job Posting End Date: 01/30/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

About the job Our Hubs are a crucial part of how we innovate, improving performance across every Sanofi department and providing a springboard for the amazing work we do. Build a career and you can be part of transforming our business while helping to change millions of lives. Ready? As Senior Medical Regulatory Writer within our Global Medical Services Team, you'll be responsible for delivering high‑quality medical documents on time and in compliance with internal and external standards and guidelines. Main responsibilities: * Deliver high‑quality medical and regulatory documents (PBRER, ACO, CSR, ID Cards, clinical evaluation reports, product alerts, trial transparency documents, etc.) on time and in full compliance with all standards and timelines. * Participate independently in planning analyses and data presentations, ensuring high scientific and regulatory accuracy. * Develop and maintain deep Therapeutic Area (TA) expertise to support content quality and scientific rigor. * Review and provide constructive feedback on documents prepared by peer writers, ensuring consistency and excellence. * Collaborate effectively with global and local partners across Scientific Communications, Medical/Regulatory Writing, Pharmacovigilance, Regulatory Affairs and Corporate Affairs. * Build strong relationships with medical and pharmacovigilance stakeholders and mentor junior writers by sharing knowledge and expertise. * Ensure process excellence by authoring, reviewing, and maintaining regulatory‑compliant content, managing product alert documentation, tracking postings, and ensuring audit/inspection readiness. About you * Experience: Previous experience in regulatory writing for the pharmaceuticals/healthcare industry * Soft skills: Stakeholder management, communication skills and ability to work independently/within a team environment * Technical skills: Excellent writing and editing skills, with experience in data retrieval, scientific data interpretation, medical literature screening, and a strong understanding of ICH and GCP/GVP standards * Education: Degree in life sciences * Languages: Advanced English level Why choose us? * Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally. * You'll be part of leading the first experiences a job seeker has with Sanofi and ensuring it is best-in-class and driving conversions. * You'll be part of a truly diverse cross-cultural team and can have real business impact. * Flexible working policies, including up to 50% remote work. * Private medical care, life and health insurance, and gender-neutral paid parental leave * Colombia is one of Sanofi's key locations for new talents, having a big footprint with the Bogota HUB and its best-in-class operation. * Mexico and Argentina Play an instrumental part in creating best practice and innovation within our 3 vaccines production plants. Pursue Progress. Discover Extraordinary. Progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. You can be one of those people. Chasing change, embracing new ideas and exploring all the opportunities we have to offer. Let's pursue progress. And let's discover extraordinary together. At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com! #LI-LAT #LI-Hybrid Pursue progress, discover extraordinary Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people. At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity. Watch our ALL IN video and check out our Diversity Equity and Inclusion actions at sanofi.com!

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 Medical Writing and Disclosure (MWD) department within Global Clinical Trial Operations creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public-facing materials. In partnership with the medical writing project lead, the Senior Medical Writer leads the preparation and execution of clinical regulatory documents and public-facing documents across multiple programs and therapeutic areas in support of the company portfolio. **In this role, the Senior Medical Writer:** + Demonstrates independence in preparing clinical regulatory (e.g., protocols, clinical study reports, participant narratives, investigator's brochures) and/or public-facing (e.g., informed consent forms, clinical trial registration and results postings, plain language summaries) documents per company and evolving regulatory requirements. + Applies an in-depth knowledge and understanding of design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy). + Is a scientific contributor and collaborator on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities. + Applies emerging critical thinking, problem solving, and negotiation skills to implement solutions to challenges across the medical writing scope of work (e.g., documents, content, processes, timelines, tools) while navigating project team dynamics. Keeps medical writing project lead and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance. + Applies knowledge of medical writing-specific tools and technology platforms. + Participates in or leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally, as appropriate. + Applies knowledge of clinical development, relevant regulations, disease areas, and company products. + May help with other departmental needs, such as orientation of new team members or mentoring less experienced writers. + May manage direct reports, including workload, professional development, and performance management. **Qualifications** + Bachelor's degree or higher in a scientific discipline (e.g., life sciences, pharmacy, medicine). + At least 3 years of plain language medical writing or relevant industry experience. **Required skills & experience** + Experience managing multiple writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members. + Ability to interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines, with minimal supervision. + Demonstrated critical thinking and problem-solving capabilities. + Experience with conflict resolution and negotiation in cross-functional teams. + Ability to adapt to changing project needs and unexpected workload demands to help team succeed. + Strong oral and written communication and presentation skills. + Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology. + Experience and proficiency in independent plain language authoring such as patient- or public-facing materials, informed consents, plain language summaries, or other health-literate clinical research materials. + Experience independently applying health literacy principles and best practices, such as translating scientific content into easy-to-understand text using health literacy and numeracy principles and sensitivity to the needs of audiences across cultures and communities. + Demonstrated leadership in enhancing health literacy best practices and processes **Preferred skills and experience:** + Background in medical writing, authoring clinical regulatory documents (e.g., clinical study reports, protocols). clinicaltrialjobs EligibleforER **Required Skills:** Adaptability, Clinical Data, Clinical Operations, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Communication, Data Analysis, Ethical Standards, ICH GCP Guidelines, Medical Writing, Microsoft Office, Motivation Management, Regulatory Compliance, Regulatory Documents, Scientific Publications, Team Management **Preferred Skills:** Current Employees apply HERE (***************************************************** Current Contingent Workers apply HERE (***************************************************** **US and Puerto Rico Residents Only:** Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here (*************************************** if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights (****************************************************************************************** EEOC GINA Supplement We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts (********************************************** **U.S. Hybrid Work Model** Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at ****************************************************** . You can apply for this role through **************************** (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. **San Francisco Residents Only:** We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance **Los Angeles Residents Only:** We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance **Search Firm Representatives Please Read Carefully** Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. **Employee Status:** Regular **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Not Applicable **Shift:** 1st - Day **Valid Driving License:** No **Hazardous Material(s):** No **Job Posting End Date:** 01/30/2026 ***A job posting is effective until 11:59:59PM on the day** **BEFORE** **the listed job posting end date. Please ensure you apply to a job posting no later than the day** **BEFORE** **the job posting end date.** **Requisition ID:** R382720

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.

About MMS 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

Are you a passionate individual that thrives when building scientific content designed to improve patient outcomes? Do you get excited when reviewing the most current research and can you interpret the science into action? We are proud to say that this is our core purpose. Are you a team player - eager to partner with clients, editors, and scientific directors to get the job done? Then this dynamic role in medical communications is for you. Our interactive and dedicated team is committed to excellence and success. We translate the science of medicine into high-level strategy, tactical communication, and flawless execution. With a track record of long-tenured relationships with major pharmaceutical companies and leading biotech firms, we hold a leadership position in the delivery of strategic scientific and medical communication and training solutions for our clients. About you: You have domain knowledge - knowledge of multiple therapeutic areas, regulatory/scientific guidelines, and key statistical concepts. You know your audience and excel at maintaining data integrity. You have excellent writing skills - logical and succinct with accurate data interpretation and representation. You establish clear objectives, organize ideas and embrace creativity. You conduct outstanding literature searches - using appropriate search strategy, keywords, and a variety of sources when researching journal articles, and medical research papers. You're able to perform content reviews, correctly interprets results, identify potential limitations, and discusses unexpected findings. Your interpersonal skills are well-honed verbal, nonverbal and listening skills for problem solving, negotiation and decision-making. You are sought out by others - highly organized, dedicated, respects metrics driven timelines and accountability for quality. What You Can Expect Day-to-Day: You will generate content outlines that contain a clearly highlighted story arc and a complete reference list. We will rely on you to develop client-ready drafts of content in various forms (slide decks, executive and comprehensive summaries, and other meeting materials). We look forward to you organizing and annotating references in accordance with client's directives or house style. We anticipate you will confer with the teams in the medical/legal/regulatory (MLR) review process, answering all queries from the MLR review committee, and understand and implement the required changes. Qualifications Advanced Science Degree (PharmD, MD, PhD) and 0-3 years of relevant experience Proficiency in using Microsoft Word , PowerPoint , Excel , Adobe Acrobat , and reference-management software (e.g. EndNote ) #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$69,600-$104,400 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

The Medical Writer is responsible for developing and writing content for their assigned account(s) and works in conjunction with all internal teams to ensure that the client vision is achieved and content is accurate. The medical writer is responsible for development of a variety of resources, including, but not limited to, flashcards, leave-behinds, and internal training resources. Essential functions of the job include but are not limited to: (This is NOT meant to be an exhaustive task list) Under direct supervision, develop high quality, medically accurate content in print or digital format for a wide range of medical communication resources Deliver requested projects per established timelines Conduct literature reviews and develop annotations to support promotional claims in a variety of promotional medical education and marketing resources Ensure professional, proactive, and collaborative communication with internal and external stakeholders Ensure a constant high quality of work in line with science, good publication practice, and company rules and policies Work closely with account teams to refine content in keeping with strategic imperatives Communicate medical content with internal team and pharmaceutical clients, as necessary Attend medical, legal, regulatory review meetings, as necessary Participate in all internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings Contribute ideas for tactical planning within assigned accounts Promote and adhere to Precision Value and Health's workplace values known as PRECISION Principles (Client Service, Purpose, Accountability, Mutual Respect and Collaboration) Required Education: BA/BS in life sciences BA/BS in English combined with 2 years of experience in a pharmaceutical agency, medical communications company or healthcare advertising. Required Experience: Minimum 1 year of medical writing experience in a pharmaceutical agency, medical communications company or healthcare advertising Required Skills: Knowledge of American Medical Association (AMA) style Proficiency in Microsoft Word, Microsoft PowerPoint, and Adobe Acrobat Familiarity with scientific search engines including PubMed and Google Scholar Required Competencies: Strong written and verbal communication High analytical ability Ability to prioritize deadline-sensitive projects and juggle competing client priorities Team- and detail-oriented Preferred Qualifications: Expertise in gathering, evaluating, and summarizing healthcare business and scientific literature and insights data for a variety of managed care audiences Working knowledge of managed markets, healthcare, and the healthcare delivery system; health reform legislation; and/or managed care experience (HMO, MCO, PBM, etc.) Experience supporting pharmaceutical patient support programs - such as patient hubs and financial assistance offerings - tailored towards both healthcare professional and patient audiences Managed care experience #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$62,500-$93,750 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.