Scientific writer work from home jobs

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately Manage medical writing activities associated with individual studies, coordinating these activities within and across departments with minimal supervision Complete a variety of documents, including clinical study protocols, amendments, reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, and abstracts, posters, and presentations for scientific meetings Adhere to established regulatory standards, including ICH E3 guidelines, company standard operating procedures, client standards, and approved templates, authorship requirements, and style and formatting guides Coordinate quality and editorial reviews, ensuring source documentation is managed appropriately Act as a peer reviewer for the internal team to ensure document scientific content, clarity, overall consistency, and proper format Review statistical analysis plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency, providing feedback to further define statistical output required and document needs Interact and build good working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce writing deliverables Perform online clinical literature searches and comply with copyright requirements Identify and propose solutions to resolve issues, providing technical support, training, and consultation to department and other company staff Mentor and lead less experienced medical writers on complex projects Develop deep expertise on key topics in the industry and regulatory requirements Work within budget specifications for assigned projects Qualifications: Bachelor's degree in a relevant discipline with relevant writing experience; graduate degree preferred 3-5 years of relevant experience in science, technical, or medical writing Experience working in the biopharmaceutical, device, or contract research organization industry required Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices strongly required Experience writing relevant document types required Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style Necessary Skills: Strong presentation, proofreading, collaborative, and interpersonal skills Strong project and time management skills Strong proficiency in MS Office Strong understanding of medical terminology, principles of clinical research, and how to interpret and present clinical data and other complex information At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $80,600.00 - $145,000.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Thank you for your interest in joining Solventum. Solventum is a new healthcare company with a long legacy of solving big challenges that improve lives and help healthcare professionals perform at their best. At Solventum, people are at the heart of every innovation we pursue. Guided by empathy, insight, and clinical intelligence, we collaborate with the best minds in healthcare to address our customers' toughest challenges. While we continue updating the Solventum Careers Page and applicant materials, some documents may still reflect legacy branding. Please note that all listed roles are Solventum positions, and our Privacy Policy: *************************************************************************************** applies to any personal information you submit. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: Medical Writer - Clinical Compliance(Solventum) 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers' toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You'll Make in this Role As a Medical Writer - Clinical Compliance you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Authoring and coordinating Clinical Evaluation Plans and Clinical Evaluation Reports (CEPs/CERs), to support new product introductions and sustaining product activities in the Dental Solutions business unit. Collaborating with cross-functional teams to collect, analyze, and assess clinical data in compliance with EU MDR and other global regulatory requirements. Supporting internal and external audits as a subject matter expert in clinical evaluations. Maintaining up-to-date clinical evaluations across the full lifecycle of medical devices. Contributing to Summary of Safety and Clinical Performance (SSCP) reports and regulatory responses with guidance from manager/supervisor. Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications: Bachelor's degree or higher from an accredited institution, preferably in a scientific or technical discipline (Biology, Chemistry, Biomedical Eng, etc.) AND five (5) years of experience in the medical device industry Minimum of five (5) years of experience in medical writing or technical writing in a regulated industry, preferably aligned to EU MDR requirements Knowledge of relevant regulatory guidelines, including EU MDR, FDA, NMPA, and associated clinical evaluation processes Strong scientific writing and communication skills, with the ability to interpret and present clinical data Additional qualifications that could help you succeed even further in this role include: Dental experience in a private, public, government or military environment Demonstrated experience working on cross-functional teams in a global or regulatory environment Familiarity with SSCP authoring and Class III/implantable medical device regulations in the EU Excellent attention to detail, time management, and organizational skills Ability to manage multiple complex projects simultaneously. Strategic thinking, critical thinking, reasoning, and interpretive skills Proficiency in Microsoft Office applications (Excel, Teams, Word, PowerPoint) with strong analytical skills. Experience utilizing AI technologies to optimize workflows, automate tasks, and enhance operational efficiency. Work location: Remote - United States Travel: May include up to 10% domestic Relocation Assistance: Not authorized Must be legally authorized to work in country of employment without sponsorship for employment visa status (e.g., H1B status). Supporting Your Well-being Solventum offers many programs to help you live your best life - both physically and financially. To ensure competitive pay and benefits, Solventum regularly benchmarks with other companies that are comparable in size and scope. Applicable to US Applicants Only:The expected compensation range for this position is $119,076 - $145,537, which includes base pay plus variable incentive pay, if eligible. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate's relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental & Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences and Retirement Benefits, etc.). Additional information is available at: *************************************************************************************** of this position include that corporate policies, procedures and security standards are complied with while performing assigned duties. Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain *****************. Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Please note, Solventum does not expect candidates in this position to perform work in the unincorporated areas of Los Angeles County.Solventum is an equal opportunity employer. Solventum will not discriminate against any applicant for employment on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. Please access the linked document by clicking here, select the country where you are applying for employment, and review. Before submitting your application you will be asked to confirm your agreement with the terms.

Fishawack Group of Companies is a group of dynamic healthcare communications companies that includes US offices in the San Francisco and Philadelphia areas, as well as offices in the UK and Switzerland. Fishawack has a reputation built on excellence and creativity and bound by a common philosophy as well as a commitment to providing premium medical communications services tailored to meet our clients' individual needs. Our hand-picked team has a unique blend of scientific, marketing, and creative expertise with fresh thinking and enthusiasm. We believe that our clients' endorsement is the best testament to the success of our approach. Job Description Position Summary Fishawack has an immediate need for a Medical Writer or Sr. Medical Writer who will work in our San Francisco office, and a Lead Medical Writer who will be home-based (any US location). Both positions require experience in a medical communications or medical education agency, researching and writing scientific posters, abstracts, manuscripts and presentation materials. These are NOT regulatory medical writer positions. As part of our Medical Writing & Scientific Services Staff, Medical Writers provide research, writing, and editing expertise for customized medical communications initiatives-scientific posters, abstracts, manuscripts and presentation decks/materials for our pharmaceutical clients. Medical Writers are primarily responsible for developing and delivering original, accurate, high-quality scientific content within the project specifications, timeline, and budget. Our customized initiatives include print, video, and web-based programs. Our Lead Medical Writers function as scientific and therapeutic experts for assigned project teams, and provide high-quality content oversight for both project work and business development efforts. Medical Writers interact regularly with clients and Publication Managers, Project Managers, Review Specialists, Editorial Assistants, faculty, and authors to ensure scientific accuracy, quality, and successful completion of projects. Main Responsibilities Research, write, and revise high-quality, original scientific content; develop clear, concise outlines and on-target first drafts, and incorporate data and revisions as needed Interpret and analyze complex datasets to develop comprehensible scientific content for medical communications initiatives and publications Cultivate expertise in assigned therapeutic areas Edit and appropriately reference content written by others; improve the clarity in others' writing and serve as a mentor to junior members of the medical writing team Represent the company at client meetings (eg, advisory boards, speaker-training meetings) in a professional manner; lead client and internal meetings as necessary Attend and participate in relevant meetings-based projects (eg, advisory board meetings, symposia, roundtable meetings, congresses, business development meetings) as needed (travel may be required up to 10 times per year) Effectively and proactively communicate with team members, authors/faculty, clients, and vendors Qualifications Advanced degree in the life sciences or related field is required 1-7 years' experience (depending on position level) as a scientific/medical writer in a medical communications or medical education agency setting is required; knowledge of pharmaceutical healthcare marketing principles is preferred Experience (3-5 years) in developing scientific publications (specifically: posters, abstracts, manuscripts, and presentations) is required; and experience in developing publication plans is preferred Proficiency in the use of MS Office, specifically Word, PowerPoint, and Excel Proficiency in Internet and PubMed searches Demonstrated ability to write scientifically focused medical education materials for healthcare professionals with a high degree of grammatical and scientific accuracy and quality Thorough familiarity with AMA editorial style and medical terminology Ability to understand the evolving regulatory environment Ability to work independently with minimal supervision, and as part of a team Additional Information All your information will be kept confidential according to EEO guidelines. Fishawack offers a comprehensive benefits package, which includes generous PTO time; medical, dental, and life insurance coverage that begins on your first day of employment; and a 401(k) retirement plan. If you are interested in learning more about these full-time opportunities, please submit your cover letter, resume, and writing samples. For more information about Fishawack Group of Companies, visit our website at *************************

Principal Medical Writer At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Our Medical Writing team is growing, and we are looking for a Principal Medical Writer. This role is based in the United States. Discover Impactful Work: Lead ambitious initiatives that craft the future of clinical research. Your expertise will enable us to deliver flawless Regulatory Medical Writing documents, such as protocols, CSR, Investigator Brochures, and Marketing Applications, ensuring outstanding quality and compliance. A Day in the Life: Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. As an essential advisory member of the writing team, may provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development strategy, document types, regulatory requirements, and industry best practices. May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications. Keys to Success: Acts with intensity Strong project management skills Excellent interpersonal skills including problem solving and negotiation Able to perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Education Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred Experience Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). Experience in managing and directing complex Regulatory medical writing projects required Experience working in the pharmaceutical/CRO industry preferred Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous. Knowledge, Skills, Abilities Significant knowledge of global, regional, national and other document development guidelines Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, marketing application submissions, communications, etc Strong project management skills Excellent interpersonal skills including problem solving and decision-making Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook); willingness to utilize technology to support authoring efficiency Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! What We Offer: As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

About Us At Prenuvo, we are on a mission to flip the paradigm from reactive “sick-care” to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience across our domestic and global clinics, have allowed us to lead the change against “we caught it too late again". We are looking for a Medical Writer, you will be the primary author of externally published research content representing Prenuvo's clinical and scientific credibility. You will collaborate closely with Prenuvo's Medical Affairs, Scientific, and Communications teams to craft persuasive, referenced, and accessible white papers for publication on Prenuvo's website and social platforms helping strengthen Prenuvo's leadership position in the preventive imaging landscape such as these recent writings found on Prenuvo's company website: Whole-body and brain changes associated with alcohol intake in adults without alcohol use disorder Exercise is related to distinctly larger brain volumes in depressed versus non-depressed populations Beyond BMI: AI-driven insights on body composition's impact on brain health In addition to ongoing research publications, the Medical Writer will lead a focused Medical Affairs initiative to produce a series of evidence-based white papers addressing key evidence gaps surrounding whole-body MRI (WB MRI) and preventive imaging. This role combines scientific rigor, clarity of communication, and efficiency transforming complex medical and imaging evidence into accessible, authoritative materials that reinforce and further strengthen Prenuvo's scientific credibility and clinical integrity. Your writing will shape how Prenuvo's research influences both clinical practice and public understanding of our preventive imaging services. Please note this is a part-time contract role, with the potential to extend or transition into a full-time position. This contract role requires an average of 25 hours per week, with an expected total of approximately 60 hours for the full scope of work. Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise - join us to make a difference in people's lives! What You'll Do Research, draft, and edit evidence-based white papers addressing evidence gaps about whole-body MRI and preventive imaging. Conduct and document literature reviews; source, verify, and archive all references in accordance with scientific standards. Translate complex medical and imaging data into clear, credible, and engaging narratives for both professional and public audiences. Incorporate feedback efficiently and deliver 1-2 polished white papers per week ready for online publication. Stay current with emerging research and public discourse on preventive imaging, screening, and brain-body health. Partner with Prenuvo's Clinical Research, HEOR, and Medical Affairs teams to extract insights, validate data, and ensure scientific accuracy. Collaborate with design and communications teams to make findings visually compelling and accessible for web and social channels. Maintain consistent scientific tone, accuracy, and integrity aligned with ICMJE, AMA, and GPP best practices. Uphold Prenuvo's voice as a trusted, evidence-based thought leader in early detection and preventive imaging. What You'll Bring Advanced degree (PhD, MD, PharmD, or MS) in life sciences, neuroscience, biomedical engineering, public health or related field. At least 5 years of experience in medical or scientific writing - ideally within diagnostics, imaging, or healthcare research. Strong portfolio of peer-reviewed publications, white papers, or research summaries for scientific and clinical audiences. Proven ability to translate complex data into clear, engaging scientific narratives. Familiarity with research publication processes, reference management, and data visualization. Ability to work independently, with minimal oversight, in a collaborative and fast-paced environment. Our Values First: we are Pioneers Transforming healthcare requires divergent thinking, bias for action, disciplined experimentation, and consistent grit and determination to maintain momentum. This journey is as challenging as it is rewarding. Second: we are Platform-Builders We're always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of what's ahead - in a mindset of ownership and duty to our mission. Above all: we are Patients We could all be the next person who walks through our very doors, seeking clarity or peace of mind. We are proud of our impact on our patients' lives, and we won't stop till everyone can benefit from our work. What We Offer An avenue to make a positive impact on people's lives and their health Growth opportunities are at the heart of our people journey, we're doing big things with bright minds - there is no single path to success, it can be shaped along the way Building strong relationships is at the core of everything we do - our team gets together each week to connect, share, and socialize The hourly rate for this role ranges from $100-$175 in local currency, depending upon experience and geographic location We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. As part of the hiring process, successful candidates will undergo a background check in compliance to applicable federal, provincial, and state rules. Please be advised that official communication from our recruitment team will only come from our authorized domain [prenuvo.com]. If you are contacted by a recruiter, please ensure their email address ends *****************. We do not use third-party recruitment services or any other email domains for hiring purposes. If you receive communication that you believe to be fraudulent, please report it immediately to ****************.

Our Company CMEsquared is dedicated to improving clinical care and patient outcomes by providing the highest quality education in dermatology for dermatologists and other providers who care for patients with skin disorders. CMEsquared develops both live and enduring CME-accredited activities in collaboration with ACCME-accredited joint providers. Areas of experience and expertise include medical, surgical, and cosmetic dermatology, dermatopathology, pediatric dermatology, and important, late-breaking updates in general dermatology. CMEsquared accredited education is developed based on a thorough assessment of identified educational needs, resulting in timely, relevant learning opportunities that convey actionable knowledge, skills, and tools. For more details on our portfolio of conferences and programs please visit cmesquared.org. To view our portfolio of companies, visit HCEsquared.com The Essentials This opportunity is only for those looking for a fast-paced entrepreneurial environment and brings a track record of both consistent results and a way of working admired by their partners. Vision - the ability to zoom out, take a point of view on “What does good look like” and passionately communicate this across and outside the organization Strategic problem solving - the ability to define how to get to the vision by breaking the opportunity or problem down to simple and executable strategies. Be resourceful and solution-oriented Accountability and collaboration - the ability to take ownership and be accountable for the outcome and motivate others to work effectively across the organization and set clear expectations Personal grit - the willingness and ability to dive into executional details Job Description Title: Medical Writer Status: Full time Reporting to: Chief Medical Officer Location: Home office-based (Eastern or Central Time Zone). Some travel required (~15%). Responsibilities include: Overall Agenda development and support for CME: In-Person and Virtual Conferences, Workshops, Summits, VGRs, Breakout Sessions, Hands-on Training, and other new formats that get added Migration of funded and non-funded CME topics for conference agendas Scope, agendas, and structure of new CME Workshops, Immersives, bootcamps, etc. Faculty support on CME content development Identification of potential new faculty for non-funded CME activities Development of learning objectives for non-funded CME activities Development of test questions for non-funded CME activities Review and copy editing on marketing materials for conferences and non-funded CME activities CME Compliance review of non-funded presentations CME Compliance/Conflict of Interest audits for funded and non-funded speakers Review of quiz, survey, and polling questions for non-funded CME activities Support of funded CME activities when time allows Qualifications and Skills The ideal candidate will be highly motivated to work independently as well as part of a team and must be comfortable working in a deadline-driven environment. The candidate also must demonstrate the following: Advanced medical or science degree is preferred or at least 2 years of relevant experience in medical education. Knowledge of the rules and regulations overseeing medical education and familiarity with current trends in the industry Ability to become familiar with new diseases/conditions quickly Familiarity with dermatologic conditions a plus Experience working with faculty experts and writing needs assessments Expertise researching, compiling, and analyzing clinical and scientific evidence quickly Solid editorial (writing and editing) skills and capability to adapt editorial style based on the educational format and/or the target audience (physicians, nurses, physician assistants, and other healthcare professionals). Comfort working in a fast-paced, constantly evolving work environment while maintaining attention to detail and quality Proven ability to effectively set priorities, manage multiple projects/assignments in various stages of development, and meet timelines, all while maintaining high quality standards Positive, upbeat personality who communicates concisely and clearly, both written and verbal Comprehensive understanding of AMA Style Guide Proven success in creating pre and post test questions and completing medical analysis for outcomes reports Strong proficiency Microsoft Office Suite required (Word, Excel, and Power Point) Salary Commensurate with Experience plus Benefits

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix The Medical Writer will contribute to the achievement of Telix's strategic goals by leading and driving the writing process. This role will be responsible for planning and preparing a variety of clinical and regulatory documents necessary for all phases of clinical drug development. This role will provide medical writing support by organizing, analyzing, and interpreting scientific and statistical data. Such documents include all types of regulatory documents, including eCTD summary documents (for INDs/NDAs/BLAs), clinical study reports, clinical study protocol synopses and protocols, Investigator Brochures, patient safety narratives, and briefing books, among others. Key Accountabilities: Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summary documents for IND, NDA, MAA, BLA applications and amendments. Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions, and compose text accordingly. Work with colleagues, physicians, clinical scientists, and statisticians in a professional and organized manner to complete projects in a timely manner. Collaborate with project teams to respond to heath authority questions and requests. Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed. Maintain knowledge to enable ongoing execution of function as medical writing expert. Maintain working knowledge of the Telix clinical development pipeline. Education and Experience: Bachelor of Science a science or related field required; Advance degree preferred 5+ years of experience in regulatory medical writing required Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. Understanding medical terminology and statistical methodology is a must. Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy. The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word are required. Strong command of English language, grammar, style, logical progression. Ability to write in a clear, concise, and persuasive manner, as well as to review and edit on all levels, from copy editing to message strengthening to major rewriting. Experience and proficiency with document templates, document toolbars and proper version control. Demonstrated leadership capability. Good team player characteristics. Excellent communication and interpersonal skills. Strong project management skills. Organized and self-motivated. Strong attention to detail. Key Capabilities: Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE

**INNOVATION STARTS WITH YOU** Are you interested in working for an organization that is making a difference in people's lives every day? We're a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We're a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what **Micro** Vention **TERUMO** has to offer. **Position Overview** The Sr. Medical Writer/Medical Writer will act as primary contact for medical writing projects, cross-functionally working with MicroVention departments and clients to set and meet internal and external deliverables. Some typical job duties include: + Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions, including but not limited to: + Clinical evaluation reports + Interim and final clinical study reports + Briefing documents + Previous human experience summaries + Investigator brochures + Study protocols + Medical literature analysis reports + Research, create, and edit assigned clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical, & Regulatory Affairs Teams, KOLs and physician investigators. + Conducting literature searches, manage the literature database and prepare literature reviews for external and internal clients. + Assisting in the creation of clinical educational materials for the global Sales & Marketing organizations. Salary Range $111,000 - $145,000 Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. **Auto req ID:** 12933BR **Location MV:** Aliso Viejo, California, USA **Department Name:** 650-Clinical Admin-Post Market **Qualifications:** 1. BA/BS degree 2. Three (3) to five (5) years of scientific experience. 3. Demonstrated experience in the development of regulatory/ clinical submissions (preferably as a medical writer for pharmaceutical, CRO, or medical device clients). 4. Excellent writing and editing skills, and attention to detail. **Desired Qualifications** 1. Advanced degree (Ph.D, MD, Sc.D, MA/MS or MPH). Experience as author or contributor of peer-reviewed manuscripts is strongly desired. 2. Strong verbal, written, and interpersonal communication skills. 3. Highly proficient in using Microsoft Office applications (Word, Excel, PowerPoint) and EndNote. 4. Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases. **Additional Information** + The primary work location for this position is Tustin, CA (the company will be relocating to a new facility in Aliso Viejo, CA in Q3 2017). + Relocation may be available for qualified candidates. + Candidates must be eligible to work in the U.S. and not require visa sponsorship. + For more information, visit our web site at ******************** EEO We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law. Fair Chance Ordinance If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance. **External-Facing Title:** Sr. Medical Writer (U.S. Remote & Temp to Hire)) **Posting Country:** US - United States **Salary Range:** $111,000 - $145,000 Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, ethnicity, disability, religion, national origin, gender, gender identity, gender expression, marital status, sexual orientation, age, protected veteran status, or any other characteristic protected by law.

INNOVATION STARTS WITH YOU Are you interested in working for an organization that is making a difference in people's lives every day? We're a medical devices company that develops innovative neuroendovascular technologies for the treatment of vascular disease. We're a high-growth, customer-focused company with an entrepreneurial spirit producing some of the most reliable and technologically advanced products supported by proven clinical data. Take a closer look at what MicroVention TERUMO has to offer. Position Overview The Sr. Medical Writer/Medical Writer will act as primary contact for medical writing projects, cross-functionally working with MicroVention departments and clients to set and meet internal and external deliverables. Some typical job duties include: Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions, including but not limited to: Clinical evaluation reports Interim and final clinical study reports Briefing documents Previous human experience summaries Investigator brochures Study protocols Medical literature analysis reports Research, create, and edit assigned clinical reports, documents and scientific presentations in cooperation with the Clinical, Medical, & Regulatory Affairs Teams, KOLs and physician investigators. Conducting literature searches, manage the literature database and prepare literature reviews for external and internal clients. Assisting in the creation of clinical educational materials for the global Sales & Marketing organizations. Salary Range $111,000 - $145,000 Financial compensation packages may be higher/lower than what is listed, & will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. BA/BS degree Three (3) to five (5) years of scientific experience. Demonstrated experience in the development of regulatory/ clinical submissions (preferably as a medical writer for pharmaceutical, CRO, or medical device clients). Excellent writing and editing skills, and attention to detail. Desired Qualifications Advanced degree (Ph.D, MD, Sc.D, MA/MS or MPH). Experience as author or contributor of peer-reviewed manuscripts is strongly desired. Strong verbal, written, and interpersonal communication skills. Highly proficient in using Microsoft Office applications (Word, Excel, PowerPoint) and EndNote. Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases. Additional Information The primary work location for this position is Tustin, CA (the company will be relocating to a new facility in Aliso Viejo, CA in Q3 2017). Relocation may be available for qualified candidates. Candidates must be eligible to work in the U.S. and not require visa sponsorship. For more information, visit our web site at ******************** EEO We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, veteran status, marital status or any other characteristics protected by law. Fair Chance Ordinance If you are applying to perform work for Terumo Neuro in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Terumo Neuro reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. Terumo Neuro will consider for employment qualified job applicants with arrest or conviction records in accordance with the California Fair Chance Act, Los Angeles County Fair Chance Ordinance for Employers, Fair Chance Initiative for Hiring Ordinance, and San Francisco Fair Chance Ordinance.

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.

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description: • Candidate must be team orientated Work directly with clinical study teams, the Oncology medical writing teams, regulatory affairs personnel, and the publishing group in the preparation of scientifically valid regulatory documents. • Responsibilities include preparation of regulatory documents on behalf of Client in accordance with the ICH guidelines, international regulations, Client standards and processes, and the Client Writing Style Guide as applicable. Documents include but are not limited to: Protocols and protocol amendments, clinical study reports, Investigator brochures, and submission documents. • Participate in project team meetings to provide input regarding deliverables, timelines, and processes. Responsible for managing the document review process. Route documents for approval. The medical writer should be familiar with ICH guidelines and the current AMA Style Manual. The writer will be expected to format and manage long documents with multiple review cycles and tight deadlines Qualifications Qualifications and Experience: Bachelor's degree in life sciences, RN, Master's degree in life sciences, PharmD or PhD preferred. Would prefer full time onsite 5 days a week, however we will accept someone to work remotely but must work 3 days minimum onsite. Excellent regulatory writing skills, meticulous attention to detail, proficiency using an electronic document management system and standard style guide, and strong analytical ability to interpret clinical data. Experience: 5+ years writing experience in the pharmaceutical industry. Please take note this is a FULL time 40 hour work week. We are looking for someone with experience working as a MW for a major Pharma. Prior experience in oncology is a plus. The most important requirement is the ability to independently write regulatory documents in collaboration with the various members of study team. Additional Information Sneha Shrivastava Technical Recruiter (Clinical/Scientific) Artech Information Systems LLC 360 Mt. Kemble Avenue, Suite 2000 | Morristown, NJ 07960 Office: ************ | Fax: ************ Connect with us on - LinkedIn | Facebook | Twitter

Verantos (********************* is the global leader in high-validity real-world evidence (RWE) for life sciences. By incorporating robust clinical narrative data, artificial intelligence (AI) technology, and measured validity, Verantos is the first company to generate research-grade evidence at scale across therapeutic areas. The Verantos Evidence Platform integrates heterogeneous real-world data sources and generates evidence with the accuracy required for market access, health economics and outcomes research (HEOR), medical affairs, and regulatory use. Leveraging data science, AI, and advanced data sources such as electronic health records (EHRs), the platform supports complex clinical studies across multiple therapeutic areas. Today, some of the largest biopharma companies in the world are Verantos customers. As a Senior Clinical Informaticist, you will help shape how clinical data is transformed and made usable for research by leading efforts in knowledge management, semantic normalization, and data quality. You will collaborate with clinicians, scientists, data scientists, product managers, and engineers to define scalable approaches for mapping clinical concepts, identify where and how key concepts can be captured, develop concept lists for cohort creation, and design clinical data quality checks to ensure datasets meet clinical expectations. Your work will directly support high-impact research by ensuring that the right concepts are captured, standardized, and accessible across diverse data sources. This is an opportunity to work at the intersection of clinical insight and technical implementation, transforming complex healthcare data into research-grade evidence that advances decision-making at scale. Responsibilities Knowledge management Create and maintain concept groups. Review customer code lists and recommend updates as needed. List and define critical variables for each pragmatic registry. Semantic normalization Map claims data and health system data to standard concepts in the OMOP Common Data Model (CDM). Semantically normalize CDM-converted data coming from multiple different health systems and map high priority unmapped concepts Data usability Create documentation on how to best use data to generate insights. Collaborate with customers to help them understand how to leverage data to answer research questions. Data Quality Define disease-area-specific data quality testing processes. Concept Identification Determine how to best capture concepts needed to answer customer research questions and analyze prevalence of concepts for feasibility assessments. Specify annotation projects to capture complex clinical ideas. Qualifications Required Clinical degree (MD, DO, PA, NP, or RN) with at least 2 years of clinical experience. Experience working with standard clinical vocabularies such as SNOMED CT, LOINC, RxNorm, ICD-10-CM, CPT, or HCPCS, including an understanding of their structure and use in representing clinical data. Familiarity with EHR systems and common clinical documentation practices. Strong understanding of data captured in structured EHRs, unstructured EHRs (e.g., clinical notes), and claims datasets, including which types of concepts each source best captures. Excellent verbal and written communication skills for cross-functional collaboration. Preferred Advanced training or certification in clinical informatics. Minimum of 2-3 years of experience in clinical informatics or a closely related role. Demonstrated expertise in semantic mapping of source clinical terms to standard vocabularies (e.g., SNOMED CT, LOINC, RxNorm, ICD-10-CM, CPT, HCPCS). Demonstrated analytical and problem-solving skills applied to complex clinical data challenges, such as resolving semantic ambiguity, aligning heterogeneous data sources, or developing scalable mapping solutions. Experience defining and reviewing data quality tests on clinical datasets. Experience with the OMOP Common Data Model. Proficiency with terminology mapping tools. Familiarity or experience with AI-based extraction from unstructured clinical notes. Strong understanding of the hierarchical structure and relationships in standard clinical terminologies. Proficiency in tools for data analysis or transformation (e.g., SQL, Excel, Python, or R). Prior involvement in projects involving phenotyping or computable cohort definitions. Proven ability to collaborate with technical teams to design and implement repeatable, scalable approaches to knowledge-driven workflows. AI-first mindset, with a focus on leveraging automation to develop scalable, repeatable solutions for clinical data normalization, concept identification, and quality assessment.

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Title: Sr. Medical Writer Duration: 2 years Location: Mansfield, MA 02048(100% possibility of relocation) Summary of position: The Medical Writer is responsible for the preparation of documents that support the presentation, publication needs of assigned therapeutic areas and/or products in the Covidien Scientific Communications group. Remote candidates are an option. Local candidate to Mansfield, MA preferred. Essential functions: This role predominantly focuses on writing, editing and reviewing regulatory (e.g. Clinical Evaluation Reports/clinical study reports/summaries) documents and responses to Notified Bodies. Post Market Surveillance activities (monthly literature review of our product) Scientific Writing e.g. abstracts, manuscripts, presentations Requires a strategic understanding of the therapeutic areas, business and study objectives as well as statistical data Independently, critically writes and edits scientifically complex documents for substantial intellectual content Reviews and provides input on the data being considered for publication to ensure alignment with current medical issues and corporate goals Expert knowledge of clinical research, device/drug development processes, regulatory requirements, and good clinical practices Ability to understand and interpret statistical results of clinical studies; ability to summarize complex results and present them in a clear, concise, and scientifically accurate manner to a wide range of audiences Non-essential functions: 1. Other duties as assigned with or without accommodation. Minimum requirements: Clinical, scientific or research background Ph.D./Pharm.D plus 1 to 2 years of related pharmaceutical/medical device industry experience (e.g., medical writing, clinical research) BS, B. Pharm, MS, plus 4 to 6 years of relevant pharmaceutical/medical device industry experience Experience in Medical Writing Communication/Presentation Skills Excellent Interpersonal Relationships Expert understanding of scientific or clinical research and the scientific method Demonstrated scientific writing ability Must be highly proficient in the use of Microsoft Office suite (especially Microsoft Word and PowerPoint); skill in Microsoft Excel, Photoshop, Illustrator, EndNote Reference Software, and other scientific graphics software would be helpful Good understanding of statistical methods Other Skills: Organizational relationships/scope: The Medical Writer will report to the Sr. Director of Scientific Communications. This position will meet and communicate regularly with Clinical Affairs, PACE, R&D, marketing, Sales, KOL's and others as necessary to build and collaborate Qualifications Special Notes: 100% remote work is possible, on site is preferred PHD with 5+ years of experience or Nurses with 10+ years of experience is required The Medical Writer has to review the post market surveillance data, has to create a demonstration of safety reports Extensive experience with Clinical Evaluation Report is required, person has to be able analyze complex scientific information Post Marker Surveillance experience is required Good understanding of risk management and hands on experience with risk management documentation is required Additional Information Kind Regards, Sabanaaz Shaikh Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities * Develop regulatory documents for submission to regulatory agencies globally including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives. * Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations. * Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents. * Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate. * eCTD submission experience preferred. * We don't need for this person to mentor junior writers, manage external vendors, or participate in the standard operational procedures or other department initiatives. And I don't have a preference for the EU versus US. We have writers located on both sides and work globally as a team. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary * The Principal Medical Writer is responsible for the development of clinical documents for submissions to regulatory authorities globally. • Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. • Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. • Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. • Has a broad understanding of clinical research processes and global regulatory document standards. • Mentors less experienced writers.

We are seeking a Senior Clinical Informaticist to join our Clinical Informatics and Data Science team. In this role, you will serve as a key bridge between clinical expertise and data science, applying deep clinical reasoning and informatics knowledge to design, evaluate, and optimize data-driven healthcare solutions. You'll partner closely with clinicians, analysts, data scientists, engineers, and product teams to ensure safe, evidence-based workflows, high-quality datasets, and AI/machine learning model integrity. This is an opportunity to shape next-generation digital health solutions and mentor a growing team of clinical informaticians. What you'll do: Collaborate with clinicians, data scientists, and engineers to design, validate, and optimize digital health and analytics solutions. Translate clinical workflows and hypotheses into structured data, rules, and logic for algorithms and quality measurement. Oversee clinical data labeling, abstraction, and validation to ensure model safety, accuracy, and clinical integrity. Mentor junior informaticians and research specialists on annotation quality, workflow efficiency, and clinical decision-making. Evaluate models, algorithms, and rule logic for clinical soundness, patient safety, and alignment with evidence-based practice. Contribute to product and workflow optimization through user feedback, quality audits, and internal best practices. Participate in the development of informatics methodologies and frameworks to scale annotation, labeling, and clinical review processes. What you'll need: BSN or related clinical degree with active RN license. 4-6+ years of combined experience in clinical informatics, analytics, or digital health. Demonstrated expertise in clinical data interpretation, annotation, and validation. Advanced understanding of EHR systems, data standards, and clinical workflows. Strong skills in clinical reasoning, collaboration, and workflow optimization. Ability to mentor junior staff and lead annotation/data quality initiatives. Pay & Perks: 💻 Fully remote opportunity with about 5% travel 🩺 Medical, dental, vision, life, disability insurance, and Employee Assistance Program 📈 401K retirement plan with company match; flexible spending and health savings account 🏝️ Up to 184 hours (23 days) of PTO per year + company holidays 👶 Up to 14 weeks of paid parental leave 🐶 Pet insurance The salary range for this position is $75,000.00 to $100,000.00 annually; as part of a total benefits package which includes health insurance, 401k and bonus. In accordance with state applicable laws, Cohere is required to provide a reasonable estimate of the compensation range for this role. Individual pay decisions are ultimately based on a number of factors, including but not limited to qualifications for the role, experience level, skillset, and internal alignment. Interview Process*: Connect with Talent Acquisition for a Preliminary Phone Screening Meet your Hiring Manager! Behavioral Interview(s) Case Study *Subject to change About Cohere Health: Cohere Health's clinical intelligence platform delivers AI-powered solutions that streamline access to quality care by improving payer-provider collaboration, cost containment, and healthcare economics. Cohere Health works with over 660,000 providers and handles over 12 million prior authorization requests annually. Its responsible AI auto-approves up to 90% of requests for millions of health plan members. With the acquisition of ZignaAI, we've further enhanced our platform by launching our Payment Integrity Suite, anchored by Cohere Validate™, an AI-driven clinical and coding validation solution that operates in near real-time. By unifying pre-service authorization data with post-service claims validation, we're creating a transparent healthcare ecosystem that reduces waste, improves payer-provider collaboration and patient outcomes, and ensures providers are paid promptly and accurately. Cohere Health's innovations continue to receive industry wide recognition. We've been named to the 2025 Inc. 5000 list and in the Gartner Hype Cycle™ for U.S. Healthcare Payers (2022-2025), and ranked as a Top 5 LinkedIn™ Startup for 2023 & 2024. Backed by leading investors such as Deerfield Management, Define Ventures, Flare Capital Partners, Longitude Capital, and Polaris Partners, Cohere Health drives more transparent, streamlined healthcare processes, helping patients receive faster, more appropriate care and higher-quality outcomes. The Coherenauts, as we call ourselves, who succeed here are empathetic teammates who are candid, kind, caring, and embody our core values and principles. We believe that diverse, inclusive teams make the most impactful work. Cohere is deeply invested in ensuring that we have a supportive, growth-oriented environment that works for everyone. We can't wait to learn more about you and meet you at Cohere Health! Equal Opportunity Statement: Cohere Health is an Equal Opportunity Employer. We are committed to fostering an environment of mutual respect where equal employment opportunities are available to all. To us, it's personal. #LI-Remote #BI-Remote

Are you passionate about making a difference in the medical device industry? Join our dynamic team at CONMED as a Medical Writer! I This is an entry level medical writer role, that will require 5 years experience in a medical background. In this pivotal role, you'll leverage your expertise in global regulations to proactively collect and analyze market and customer feedback on our medical devices. Your work will ensure compliance with Medical Device Regulation (EU 2017/745) and other global standards, driving innovation and excellence in healthcare. ** This is a REMOTE opportunity. ** Key Responsibilities: Develop and refine strategies and processes for market and customer feedback collection. Assist in creating medical device market research protocols and Case Report Forms. Craft and update post-market surveillance plans, Periodic Safety Update Reports, and Post Market Surveillance reports. Collaborate with cross-functional teams and surgeons for Post Market Clinical Follow-up studies. Keep relevant procedures up-to-date. What You'll Do: Utilize your knowledge of medical devices and In-Vitro Diagnostic products to gather proactive customer feedback per Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Medical Device Regulation (EU 2017/746) Create market research protocols, deploy questionnaires, and compile technical reports. Review and provide feedback on (Periodic Safety Update Reports) and PMSRs (Post-Market Surveillance Reports) Author and update post-market surveillance plans for upcoming and existing medical devices. Interface with engineering, medical, safety, regulatory, quality, and manufacturing teams to complete surveillance activities. Ensure timely creation of deliverables to prevent project delays. Develop proactive customer feedback templates and process workflows. Communicate roadblocks and escalate issues promptly to stakeholders. Qualifications: Associate's degree in clinical research, health sciences, or a related field. 5+ years of experience in a medical setting, ideally as a CST, CSFA, or RN. Preferred Skills: Experience with medical device complaint investigation, CAPAs, Recalls, or Post Market Surveillance. Proficiency in creating PMS plans, PMSRs, or PSURs. Strong knowledge of risk management, product design practices, and Good Manufacturing Practices (GMP). Understanding of medical device regulations and adverse event reporting. This position is not eligible for employer-visa sponsorship Disclosure as required by applicable law, the annual salary range for this position is $68,110- $85,000. The actual compensation may vary based on geographic location, work experience, education, and skill level. The salary range is CONMED's good faith belief at the time of this posting. This job posting is anticipated to close on January 23, 2025. We may, however, extend this time period, in which case the posting will remain available on careers.conmed.com. Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them. Benefits: CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information. Competitive compensation Excellent healthcare including medical, dental, vision and prescription coverage Short & long term disability plus life insurance -- cost paid fully by CONMED Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period Employee Stock Purchase Plan -- allows stock purchases at discounted price Tuition assistance for undergraduate and graduate level courses Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives! CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment. Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information. If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at ************ option #5.

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X. About This Role Axsome Therapeutics is seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols and clinical study reports. This is a key position within the Clinical Development Group with ample opportunity to make real impact. This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles. Job Responsibilities and Duties include, but are not limited to, the following: Interpret, analyze, and synthesize complex clinical data and develop high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, and other documents in support of Clinical Development programs Attend strategic meetings as applicable Closely collaborate with, and apply strategic direction from, project leads and biostatisticians to manage and prioritize assignments and ensure deliverables are completed per time and quality goals Develop documents for assigned programs in compliance with company standard operating procedures (SOPs) Participate in developing timelines, managing review/approval workflows, and QC/publication readiness Lead cross-functional teams to ensure team-wide agreement on documents content Oversee outsourced medical writings projects and the associated vendor(s), as applicable Ensure compliance and accountability for all regulatory documents prepared by the company Requirements / Qualifications Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 6 years of relevant experience Previous experience with preparation and QC of clinical regulatory documents: Protocols, IBs, CSRs, Module 2 Summary Documents, Clinical Overviews and Agency Briefing Document A strong working knowledge of pharmaceutical drug development and GxP principles Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles Experience, Knowledge and Skills Highly knowledgeable in psychiatric and/or neurological disease areas is a plus Track record of developing high-quality scientific documents Ability to interpret, analyze, and synthesize complex clinical data into compelling and easily understood documents Familiarity with the preparation of Statistical Analysis Plans and document data mapping Experience with programmed outputs of tables, figures and listings for analysis and communication of clinical data Ability to work collaboratively with and coordinate the efforts of team members to resolve comments and complete deliverables Excellent interpersonal skills and judgement that facilitates working with cross-functional executive leadership and maintaining the security of proprietary information Ability to manage/prioritize multiple projects under general supervision while working in a fast-paced environment Flexibility for adapting to rapidly changing deadlines and priorities Must be extremely detail oriented Able to self-manage effort to maintain alignment with strategy and corporate goals Salary & Benefits The anticipated salary range for this role is $140,000 - $175,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package. Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law. Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.

Requirements Required Knowledge, Skills, and Abilities: Bachelor's degree or equivalent work experience drafting plan documents in a healthcare or benefits TPA setting. 3+ years of experience as a Plan Document Writer role or in a Technical Writer role specific to medical benefits documents. Familiarity with, and an understanding of the differences in, each type of Plan Document: SBC, SPD, BPD, SMM, and SMR. Knowledge of medical procedure terminology preferred. Solid working knowledge of standard computer applications including MS Word, Excel, Outlook and PowerPoint. Ability using a computer which includes expert keyboard and navigation skills and learning new programs. Communicate clearly and professionally with internal and external customers. Work effectively as part of a team to achieve established outcomes. Understand other's roles and empower one another to take responsibility to be successful. Demonstrate a collaborative interaction with peers to reach a common goal as well as be a resource to team members and internal/external customers. High attention to detail, excellent analytical and writing skills. Make decisions using available resources and sound judgment. Maintain confidentiality and discretion. Identify and resolve problems in a timely manner. Share knowledge with associates by effectively communicating and providing follow-up. Open to other's ideas and exhibits a willingness to try new things. Demonstrate accuracy and thoroughness; monitor work to ensure quality. Prioritize and plan work activities to use time efficiently. Adapt to changes in the work environment, manage competing demands; able to deal with frequent change, delays, or unexpected events. Follow instructions, respond to direction, and solicit feedback to improve. Act in such a way to instill trust from management, other associates, as well as customers. Physical and Cognitive Demands: The demands described here are representative of those necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable individuals with disabilities to perform the essential functions. Constant: Talk, hear, speak, and use hands and fingers to operate a computer, telephone, keyboard/mouse; occasionally move about the office Constant: Visual ability such as close vision, distance vision, color and peripheral vision, depth perception and ability to adjust focus Occasional: Lift and/or move up to 30-50 pounds Constant: Regular, predictable attendance is required Constant: While performing the duties of this job, the employee is regularly sitting for the full shift Constant: The cognitive skills needed to complete tasks include abilities such as learning, remembering, focusing, categorizing, and integrating information for decision making, problem-solving, and comprehending. Work Environment: The work environment described is representative of what must be met by an employee successfully perform the essential functions of this job. The physical environment is indoors in a controlled climate, office setting. The noise level may be low to moderate. The duties described are representative, but not restrictive of tasks that may be assigned or of the abilities required to do the job. The description is subject to change at any time. Other related duties may be assigned. This description does not alter the at-will status of employment. Pay may vary based on location. Offers will be adjusted based on an individual's experience, education, and other job-related factors as permitted by law. Pay range is $57,000-$75,000/year

Description Sutro Biopharma, Inc. is looking for a Senior Medical Writer who will provide leadership in development and execution of document deliverables intended to support clinical trial applications including Health Authority interactions and filings, protocols, CSRs, INDs/ CTAs, and marketing applications. This successful candidate will be proficient in the principles of scientific writing and will work cross‑functionally, maintaining compliance with global regulatory expectations for document content and advising the project teams accordingly. Experience in oncology drug development is preferred. This role may be performed remotely or onsite, with flexibility based on business needs. Responsibilities: Independently authors complex documents compliant with relevant internal processes and standards as well as external regulatory guidance. Collaborates cross-functionally with subject matter experts to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents. Collaborates with Medical functions on authoring of documents intended to support clinical trials including (but not limited to) protocols, investigator brochure's, clinical study reports, clinical summaries for marketing applications, and responses to queries from regulatory authorities. Provide guidance for document development for regulatory writing deliverables, including organization, content, and resource requirements. Collaborates with the CMC subject matter experts on generation of CMC-focused sections of briefing documents, DMFs, INDs/CTAs, response documents and technical reports, as necessary. Collaborates with the non-clinical subject matter experts on generation of non-clinical focused sections of INDs/CTAs, and technical reports, as necessary. Works with Project Management and Regulatory Affairs functions to establish appropriate timelines and identify contingencies for delivery of assigned documents in a timely manner. Perform internal document reviews, editing, and QC as needed. Qualifications: 4+ years' experience with PhD, PharmD, or MD; 6+ years with Masters; 8+ years with BS/BA (provided degrees are in relevant fields with 2 years of direct experience in regulatory/clinical writing. Ability to collaborate successfully with all levels and roles in cross-functional, global teams. Experience with independently authoring CSRs, protocols and submission documents, such as IND components and/or NDA components (Integrated Summaries and Clinical Summaries). Collaborative organizational skills; demonstrated ability to prioritize multiple projects and timelines. Strong analytical skills: ability to understand and interpret complex clinical and scientific data from multiple data sources and formulate those data into a well-thought out and reviewer friendly manner. Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members. Knowledge in the publicly available databases (eg, PubMed, DailyMed, FDA, and EMA sources and guidelines) for literature and information mining to support document content and how to cite such information appropriately. Able to consolidate, analyze, interpret, and summarize data from multiple data sources. Track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences. Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel, Adobe Acrobat). Veeva RIM experience preferred. Strong attention to detail; experience with Quality Control and editing of scientific documents. Sound exciting? Apply today and join our team!Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment. As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together. We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies. The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma's California based locations will be $120,000 - $155,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education. About Sutro Biopharma Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro's platform has led to ADCs, bispecific antibodies, cytokine-based immuno-oncology therapies, and vaccines directed at precedented targets in clinical indications where the current standard of care is suboptimal. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit *****************