Scientific Writer remote jobs

Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research. We are looking for a Scientific Writer for preparing high quality written materials for inclusion in grant applications and publications. You will also prepare data tables, figures, study schematics, model overviews, conference posters, podium presentations, and reference libraries. In addition, you will draft SOPs, IRB & IACUC applications, study calendars & protocols, and other research-related documents. You will also serve a project manager, navigating the regulatory review process for each research study, ushering manuscripts thru the submission & revision process, and ensuring the supervisor or faculty members are apprised of the status of their ongoing projects. You will collaborate with investigators and research staff, serve as a liaison with institutional offices to support research submissions, and help identify new funding opportunities relevant to departmental research. The role will report to the Director of Scientific Affairs with priorities set by the Department Chair, Dr. Randy Taplitz, funding the position and the Vice Chair of Research, Dr. Greg Idos. This will be a hybrid position requiring onsite work at our main campus in Duarte, CA. This role is subject to irregular hours, changing priorities, and unpredictable situations. You must be able to handle stressful conditions while maintaining a high quality of workmanship. As a successful candidate, you will: * Write original content, edit and proofread research documents, such as federal grant proposals, original research manuscripts, clinical study protocols, and IRB/IACUC study applications for faculty and trainees. * Review research data to prepare informative and visually appealing data tables and figures. Prepare schematics and model overview images summarizing data. * Conduct literature reviews, write clear and concise synopsis, maintaining reference libraries. * Perform administrative tasks related to grant proposals, IRB/IACUC applications, progress reports, and productivity reports. * Assist investigators and research team with responses to IRB, IACUC, IND, MTA, FDA and other committees that require careful wording; participate in critical meetings with NIH/DOD program officers, COH philanthropy partners, etc. * Remain current on literature in the field and cutting-edge tools/resources relevant to writing and graphical design, video editing, plagiarism detection, journal selection, etc. Your qualifications should include: * Requires a PhD in biology, biochemistry, or other life science or a Master's degree with 3+ years of scientific writing experience in a healthcare, research, or academic environment. * Strong written and verbal communication skills in English are required. City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location. City of Hope is an equal opportunity employer. To learn more about our Comprehensive Benefits, please CLICK HERE.

Scientific Writer - Department of Medicine - Hybrid - (10032630) Description Join the forefront of groundbreaking research at the Beckman Research Institute of City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research. We are looking for a Scientific Writer for preparing high quality written materials for inclusion in grant applications and publications. You will also prepare data tables, figures, study schematics, model overviews, conference posters, podium presentations, and reference libraries. In addition, you will draft SOPs, IRB & IACUC applications, study calendars & protocols, and other research-related documents. You will also serve a project manager, navigating the regulatory review process for each research study, ushering manuscripts thru the submission & revision process, and ensuring the supervisor or faculty members are apprised of the status of their ongoing projects. You will collaborate with investigators and research staff, serve as a liaison with institutional offices to support research submissions, and help identify new funding opportunities relevant to departmental research. The role will report to the Director of Scientific Affairs with priorities set by the Department Chair, Dr. Randy Taplitz, funding the position and the Vice Chair of Research, Dr. Greg Idos. This will be a hybrid position requiring onsite work at our main campus in Duarte, CA. This role is subject to irregular hours, changing priorities, and unpredictable situations. You must be able to handle stressful conditions while maintaining a high quality of workmanship. As a successful candidate, you will:· Write original content, edit and proofread research documents, such as federal grant proposals, original research manuscripts, clinical study protocols, and IRB/IACUC study applications for faculty and trainees. · Review research data to prepare informative and visually appealing data tables and figures. Prepare schematics and model overview images summarizing data. · Conduct literature reviews, write clear and concise synopsis, maintaining reference libraries. · Perform administrative tasks related to grant proposals, IRB/IACUC applications, progress reports, and productivity reports. · Assist investigators and research team with responses to IRB, IACUC, IND, MTA, FDA and other committees that require careful wording; participate in critical meetings with NIH/DOD program officers, COH philanthropy partners, etc. · Remain current on literature in the field and cutting-edge tools/resources relevant to writing and graphical design, video editing, plagiarism detection, journal selection, etc. Qualifications Your qualifications should include:· Requires a PhD in biology, biochemistry, or other life science or a Master's degree with 3+ years of scientific writing experience in a healthcare, research, or academic environment. · Strong written and verbal communication skills in English are required. City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location. City of Hope is an equal opportunity employer. To learn more about our Comprehensive Benefits, please CLICK HERE. Primary Location: United States-California-DuarteJob: Clinical ResearchWork Force Type: HybridShift: DaysJob Posting: Nov 11, 2025Minimum Hourly Rate ($): 39. 250700Maximum Hourly Rate ($): 60. 838500

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.

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.

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.

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.

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

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

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.

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position The Senior Medical Writer will collaborate with lead medical writers and cross-functional team members to provide authoring support to numerous regulatory documents. The Senior Medical Writer will also lead key supportive documents. The Senior Medical Writer will author with accuracy and technical competency to ensure delivery of high quality regulatory clinical documents in a timely manner. The Senior Medical Writer will demonstrate a high level of flexibility, collaboration skills, and eagerness to learn. Responsibilities Contributing author to regulatory documents such as, but not limited to, clinical study protocols and protocol amendments, investigator's brochures (IBs), clinical study reports (CSRs), components of NDA/MAA documents, and briefing books Lead author of numerous supporting documents such as summary of changes, patient narratives, and IB updates Assists in planning and content creation for kick off meetings (ie, slide deck authoring) Collaborates with nonclinical, clinical safety, biometrics, and clinical development personnel to obtain status updates and plan documents Assists in the review of statistical analysis plans, and mock and draft statistical tables, listings and figures (TLFs) Participates in regulatory and clinical team strategy meetings to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources Assists in resolving team and quality control comments to ensure all comments are appropriately addressed Assists with team training for document processes and software Supports key pilot programs in medical writing such as new process development Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in document management system(s). Requirements: Bachelor's degree in medically-related field or life science, with a minimum of 3 years of relevant medical writing experience in the pharmaceutical industry Master's or doctoral degree with 2 years of relevant medical writing experience in the pharmaceutical industry Familiarity with basic statistical analysis concepts and techniques is helpful Knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards; and demonstrated ability to interpret and apply these guidelines to document writing. A demonstrated track record of contribution to successful clinical documents such as IBs, CSRs, protocols, and protocol amendments Prior experience in interacting with cross-functional study team members is desirable Proficient in the use of MS Word, Excel, EndNote, Adobe Acrobat, and PowerPoint California pay range $100,000-$150,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

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 *************************

EBSCO Information Services (EBSCO) delivers a fully optimized research experience, seamlessly integrated with a powerful discovery platform to support the information needs and maximize the research experience of our end-users. Headquartered in Ipswich, MA, EBSCO employs more than 2,700 people worldwide, with most embracing hybrid or remote work models. As an AI-enabled service leader, we thrive on innovation, forward-thinking strategies, and the dedication of our exceptional team. At EBSCO, we're driven to inspire, empower and support research. Our mission is to transform lives by providing reliable and relevant information - when, where and how people need it. We're seeking dynamic, creative individuals whose diverse perspectives will help us achieve this global, inclusive mission. Join us to help make an impact. **Your Opportunity** As a Medical Writer, you will be responsible for supporting the Section Editors and Clinical Editors in developing high-quality content within specific content domains. You will write/update content based on your understanding of evidence-based practices and ability to analyze and critically appraise medical, nursing, and health professions research/literature and translate findings into point-of-care content. **What You'll Do** + Write and update nursing and health professions content in several formats for point-of-care. + Perform structured literature searches and research analyses to ensure inclusion of recent relevant evidence across all content areas. + Collaborate with editorial team and medical librarians to systematize literature surveillance for and management of standard and reusable content. + Support guideline currency work by evaluating clinical guideline changes, completing a comprehensive report, communicating findings to appropriate publication groups, and maintaining an archive to evaluate guideline impacts + Adhere to style guides (EBSCO and AMA), templates, and content structures. + Maintain quality and currency of content and participate in quality initiatives, such as promoting consistency across content areas and ensuring inclusion of content from global sources. + Participate in editorial improvement projects and other duties assigned by supervisor. + Use authoring tools, such as Oxygen XML Author. + Use pre-approved artificial intelligence (AI) tools such as Microsoft CoPilot to facilitate workflow. **Your Team** You will be welcomed as a member of the Dynamic Health Nursing & Health Professions team, an editorial team supporting six point-of-care products. Our team enjoys the flexibility and greater work life balance working remotely offers. You will be provided with ample resources, tools, training, and support to ensure your success as a Medical Writer and your continued development and career growth at EBSCO. **About You** + Bachelor's degree in nursing, or healthcare-related field. Advanced degree strongly preferred (e.g., MSN, MSW, DPT) + 2 years writing experience involving medical or scientific content and proficiency in working with MS Office Suite, including Word and Excel + Demonstrated understanding of evidence-based practice and use of health information technology to support clinical decision making + Proficiency in systematic literature searching and critical appraisal of medical, nursing, and health professions literature + Demonstrated ability to extract relevant clinical information from the literature and write clinical content concisely and accurately for point-of-care + Demonstrated ability to locate, synthesize, and translate relevant guidelines for inclusion to support evidence-based practice + Willingness to learn content management systems and project tracking programs + Motivated self-learner and ability to self-manage multiple priorities with focus on team success + Excellent interpersonal skills such that feedback is effectively and constructively given and received **What sets you apart** + Clinical experience in nursing + Extensive experience in writing and research + Certification in medical writing + Initiative and a strong work ethic + Experience with content management systems and project tracking programs (i.e., Oxygen, Rally, Distiller) **Pay Range** USD $71,245.00 - USD $101,775.00 /Yr. The actual salary offer will carefully consider a wide range of factors including your skills, qualifications, education, training, and experience, as well as the position's work location. EBSCO provides a generous benefits program including: -Medical, Dental, Vision, Life and Disability Insurance and Flexible spending accounts -Retirement Savings Plan -Paid Parental Leave -Holidays and Paid Time Off (PTO) -Mentoring program And much more! Check it out here: ************************************ We are an equal opportunity employer and comply with all applicable federal, state, and local fair employment practices laws. We strictly prohibit and do not tolerate discrimination against employees, applicants, or any other covered persons because of race, color, sex, pregnancy status, age, national origin or ancestry, ethnicity, religion, creed, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, training, promotion, discipline, compensation, benefits, and termination of employment. We comply with the Americans with Disabilities Act (ADA), as amended by the ADA Amendments Act, and all applicable state or local law. **Not seeing the perfect job?** Join the EBSCO talent community to receive updates on new opportunities that align with your skills and interests - register using the links below: Experienced Talent Community (************************************************** Early Career/Intern Talent Community **Location** _US-MA-Remote_ **ID** _2025-1864_ **Category** _Medical Products and Services_ **Position Type** _Full-Time Regular_ **Remote** _Yes_

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals. At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees. With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive. We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career! PRINCIPAL MEDICAL WRITER - REGULATORY AND MEDICAL WRITING SUMMARY: The Senior Medical Writer will collaborate with internal teams to lead, write, and manage completion of clinical regulatory documents. This role is for an individual contributor, reporting to the Executive Director (Head) of Regulatory and Medical Writing. This role includes responsibilities throughout the lifecycle of a document including working cross-functionally to interpret source information (including leading data interpretation meetings), leading key messaging meetings, writing content following US and international regulations (including Marketing Application Module 2 summary documents), conducting quality control (QC) reviews, resolving Quality Assurance (QA) audit findings, and working with Regulatory Operations for publishing and submission. The Principal Medical Writer will be assigned to projects that require advanced regulatory writing expertise compared with a Senior Medical Writer. This position may be fully remote; however, preference will be given to San Diego-based applicants. RESPONSIBILITIES: Working with the Executive Director, Regulatory and Medical Writing, collaborate with internal teams (e.g., Clinical Development and Biostatistics) to lead, write, and manage complex clinical regulatory documents (e.g., clinical study reports, Investigator Brochures, clinical study protocols, briefing documents, marketing application summary documents [Module 2], etc.). Serve as Medical Writing department lead on multiple project/core teams. Function as subject matter expert within the department for assigned therapeutic/product areas. Responsible for planning (in collaboration with Global Project Management) and leading cross-functional teams to meet timelines for deliverables. Lead complex scientific key messaging/storyboarding cross-functional meetings, ensuring the messages are clear and consistent within and across documents. Understand, assimilate, and interpret sources of information with appropriate guidance. Ensure compliance with appropriate conventions, proper grammar usage, and correct format requirements, as needed (e.g., formatting, hyperlinking). Manage review cycles for documents; schedule and lead data interpretation meetings, comment resolution meetings, and other document-related meetings. Perform quality control (QC) reviews as necessary. Interact with Quality Assurance (QA) to resolve audit findings for specific documents. Maintain expert knowledge of US and international regulations, requirements, and guidance associated with preparation of regulatory documentation. Effectively coordinate with Regulatory Operations to ensure on-time preparation and publication of regulatory submission documents. Support Global Regulatory Lead with preparing information/responses requested by regulatory agencies. Mentor junior writers as needed. Other duties as assigned. REQUIREMENTS: Bachelor's Degree required, advanced degree in a relevant scientific/clinical/regulatory field a plus. A minimum of 8 years of direct experience as a medical writer preparing regulated documents in the pharmaceutical industry. Marketing application experience (e.g., lead writer of Module 2.5, 2.7.3, or 2.7.4) required. Rare disease experience is a plus. Experience as lead writer of key documents included in major US and/or international regulatory submissions comprising, but not limited to, clinical study reports (all sections including safety narratives), Investigator Brochures, clinical study protocols, marketing application summary documents, Investigational New Drug applications, clinical sections of New Drug Applications, and other regulatory documents (e.g., Briefing Documents). In depth experience writing Safety sections of regulatory documents preferred. Ability to independently write and complete documents to completion. Extensive working knowledge of relevant FDA, EMA, and ICH guidelines, particularly ICH E3 and ICH E6. Experience mentoring junior writers a plus. Deep understanding of the drug development process. Strong ability to assimilate and analytically interpret scientific data. Experience preparing data tables and basic figures required. Proficient knowledge of American Medical Association (AMA) style guidelines. Advanced abilities to find and correct errors in spelling, punctuation, grammar, consistency, clarity, and accuracy. Excellent attention to detail and time-management skills. Ability to balance multiple projects simultaneously. Technical expertise in typical Office applications (Microsoft Office, Adobe Acrobat). Experience working in Veeva and with StartingPoint templates is a plus. Ability to follow style guides, lexicons, and eCTD templates etc. Excellent written and oral communication skills with an ability to clearly present technical information within and across functional areas. Energetic, self-motivated, and a hands-on professional with a strong work ethic. Ability to work collaboratively in a dynamic environment. Strong desire and ability to be a team player, working and leading towards common goals. An ability to be productive and successful in an intense work environment. Personable and outgoing. Please visit our website, ******************** for more information about Ionis and to apply for this position; reference requisition #IONIS003825 Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits Full Benefits Link: ************************************************************************************************************************ The pay scale for this position is $126,339 to $160,340 NO PHONE CALLS PLEASE. PRINCIPALS ONLY. Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.

Responsibilities: You will work on projects that involve the detailed analysis and presentation of clinical data, which are instrumental to the successful uptake of novel therapies Salary: $70,000 to $73,000 per annum depending on previous experience (please note this is a standardized, non-negotiable salary) Benefits: Hybrid working options that allow you to work from home up to 50% of your time, generous holiday allowance, flexible working hours, private medical and dental insurance, 401K plan, life insurance, full funding for external training, comprehensive travel insurance and more Role Type: Full-time, permanent Start Date: We are currently recruiting for start dates in 2026 Location: This role is available in our Boston office About the Role The Analyst and Medical Writer positions are ideal for recent graduates in the sciences, and those with experience in scientific research, who are seeking the opportunity to apply their knowledge to real-world projects. Analysts and Medical Writers work on projects involving the detailed analysis of data from clinical trials and the assimilation and creative presentation of this analysis in different formats including posters, slide sets, value dossiers, reports and peer-reviewed publications. These deliverables are used directly by our clients in communication with external stakeholders, which are instrumental to the successful uptake of novel therapies. The work is structured on a project-by-project basis and you will be working on three or four projects at any one time across a range of high-profile disease areas and products, presenting variety of work and the opportunity to develop a wide skill set. You will work in project teams alongside experienced colleagues who will provide training on the technical aspects of the role as well as project management and effective client communication. Delivering project work requires close collaboration with clients, and following a successful induction period you will increasingly participate in teleconferences and face-to-face client meetings. The latter may present opportunities for travel within the US and internationally. You will be based in our office in Boston, which was established in 2020. This presents opportunities to shape and drive our US company; an endeavor supported by the success of our existing operations in the UK and Asia. You will work closely with our Scientific Director, who is based in Boston and has more than 10 years of experience in the industry, and other senior colleagues in the US and globally. Costello Medical is structured into teams focusing on distinct services within the healthcare industry. Our Boston office is structured around three teams who focus on Medical Communications, Evidence Development and Market Access. Upon joining Costello Medical, you will join one of these teams but will also have the opportunity to work on projects in other areas. Please note that you will be asked to specify which team you are applying for in your application form. Please click here to learn more about our service offerings: ******************************************* Hybrid Working Policy: We recognize that home-working can improve work life balance, reduce commuting times and costs, and provide the opportunity to juggle personal commitments. At the same time, we believe that having face-to-face time in the office holds many benefits and is central to ensuring that the community we have created, where people have a workplace they belong to and feel part of, is never lost. Therefore, we offer flexible working arrangements that allow our colleagues to work from home for up to half of the time, measured across a 2-week rolling period. Please note that as part of our wider flexible working policy, employees may work outside of Massachusetts for up to 4 weeks annually. Medical Communications - Medical Writer Medical Communications at Costello Medical encompasses both publications and medical affairs projects, with Medical Writers having the opportunity to work across these types of projects or specialize in one area. Publications projects require you to work closely with clients and world-renowned opinion leaders to produce publications that communicate key scientific and clinical data to a wide audience. This includes the development of abstracts and manuscripts, as well as posters and oral presentations for large international congresses, with the opportunity to provide on-site support at such events. In addition, you may have the chance to work on regulatory documents, lay summaries and policy-related publications. This role is for those looking to apply their scientific writing and creative skills to deliver high-impact publication projects to a wide range of clients. Medical affairs projects provide the scientific bridge between clinical development and commercial functions in pharmaceutical and device companies. Most activities have a strong patient and/or healthcare professional focus, and act to educate and inform clinical decision making and patient care, or to gather insights that inform a product's clinical development. You will work closely with our clients to present the ‘science behind the product' through a wide range of projects including medical education events, advisory boards and medical information materials. You will collaborate with and support expert advisors and event speakers, and the requirement for on-site support at certain events provides opportunities for international travel. You will develop a complementary set of strong scientific, creative and writing skills, as well as the opportunity to become extremely knowledgeable about the therapy areas in which you work. The ability to creatively present scientific information is central to this role. Market Access - Analyst Within the healthcare sector, the market access process is essential to ensuring that novel pharmaceuticals and medical devices are reimbursed and rapidly made available to patients who need them. Our Market Access team supports a wide range of clients in producing materials to demonstrate both the clinical and economic value of some of the newest, most innovative technologies in development. Our work is multidisciplinary, often beginning with evidence generation in the form of literature reviews, advisory boards with clinicians and payers, or economic modelling, to inform the development of global materials that present an evidence-based account of the product's value in a compelling and accessible manner. As a result, our work has a direct impact on patient access to medicines worldwide. A role in the Market Access team suits those who are passionate about patient access to healthcare, are fast-learners and have a strategic, problem solving mindset. Exceptional writing skills are also essential, especially the ability to summarize complex data in a clear and creative way with an excellent attention to detail. Evidence Development - Analyst The work of our Evidence Development team encompasses literature reviews and synthesis projects as well as real-world evidence projects. Literature reviews and synthesis projects involve the identification of clinical, economic and real-world evidence to support the value of a pharmaceutical product or medical device. Our work includes rigorous systematic literature reviews that can be used to inform meta-analyses and network meta-analyses, as well as more creative and pragmatic evidence reviews to inform clients' strategic decisions with regard to clinical development or market access. You will gain a thorough understanding of how to conduct various kinds of evidence review from searching to interpretation of results, ensuring that the reviews conform to industry guidelines where applicable. You will also be involved in transforming the methods and results of the reviews into engaging reports and slide sets. Real-world evidence projects include the design, execution and subsequent reporting of prospective, retrospective or cross-sectional real-world studies. We develop protocols and statistical analysis plans (in collaboration with our Statisticians, Epidemiologists, clients and external experts), acquire and analyze data, and communicate the methodologies and results in both written and oral formats. A role in the Evidence Development team particularly suits those who are passionate about synthesizing and generating evidence, have excellent attention to detail and organizational skills, and a talent for communication. Rare Diseases - Analyst To date, over seven thousand rare diseases have been identified but only four hundred have an approved treatment; our specialized Rare Diseases team supports this sector in overcoming the unique challenges they face, such as an urgent need to bring treatments to patients, little clinical or health economic evidence and limited understanding of the condition across the clinical community and society as a whole. By joining this team, you will develop the appropriate skills and deliver projects that require a broad range of technical expertise and knowledge across all of our service offerings, including literature reviews, the development of global economic models and publications, and the organization of medical education events. You will also have the opportunity to work on some of the most cutting-edge treatments, such as gene therapies, supporting patients in accessing potentially lifechanging treatments. This is an exciting time to join our growing Rare Diseases team and to apply your exceptional written and technical skills to the rare diseases field, leading to a measurable impact on access to novel, often life-extending, treatments for rare disease patients. Career Profile We offer many opportunities for personal and professional development at Costello Medical. Please click below to read firsthand accounts from our colleagues about their time with the company: ***************************************************** A Day in the Life of an Analyst or Medical Writer Our colleagues in the Analyst and Medical Writer roles have shared their experiences of their day to day lives at Costello Medical. Please click here to learn more: ***************************************************** Requirements About You We are looking for individuals who are collaborative, self-motivated and enthusiastic, with a passion for scientific writing and an interest in providing a great service to clients. Positions are available for those looking for an entry-level role in the field as well as those with some prior experience. Essential requirements for the role include: A bachelor's degree in a scientific discipline (minimum GPA 3.3). We welcome applications from candidates with a diverse range of educational backgrounds, but particularly those with coursework in the life sciences An excellent written and spoken fluency in English An ability to communicate scientific materials clearly in both written and oral form An excellent understanding of and ability to apply scientific concepts A close attention to detail An aptitude for and experience with scientific writing which could include dissertations, research summaries, lab reports, poster or oral presentations, peer-reviewed scientific publications, book chapters, literature reviews, grant applications, regulatory documents, and articles for websites or student magazines A competency in Microsoft Word, Excel and PowerPoint An exceptional level of organizational skills and the ability to effectively manage your time and meet deadlines No previous experience in this sector is necessary, but you should display a genuine interest in healthcare and an eagerness to learn about new areas of clinical science. Applicants with higher-level qualifications in a scientific discipline are welcomed but this is not a requirement. Benefits About Costello Medical Costello Medical is a rapidly growing global healthcare agency specialising in medical communications, market access, and health economic and outcomes research. We work with a wide range of clients, including the industry's most successful pharmaceutical and medical technology companies, patient and public health bodies, and charitable organisations. We have been listed in the Top 100 Best Companies to Work For list since 2017, the Boston Globe's Top Places to Work list in 2025, and were proud to receive B Corporation accreditation in 2022. Learn more about us, our work, and our mission on our website: ******************************** The Recruitment Process Our recruitment process includes a short assessment, involving two tasks, for you to complete remotely. If successful, you will be invited to an interview. Our standard recruitment process lasts around 1 month, however, this can be adapted if necessary. As an equal opportunity employer, we are committed to fostering a diverse and inclusive workforce and, throughout the recruitment process, there are a number of reasonable adjustments we can provide. Please click here to read more about this and contact the People Team via ******************************* should you require reasonable adjustments at any stage. We are currently recruiting for start dates throughout 2025, which occur on a monthly basis. Available start dates will be discussed with you ahead of your interview. You will be asked to state your availability on your application form. Please note that this role is available in our Boston office. We accept applications for our Analyst and Medical Writer roles on a rolling basis and, therefore, there are no set application deadlines. However, we would encourage you to submit your application as soon as possible so that we can begin processing your application. What We Offer A starting salary of $70,000 per annum. This increases to $72,000 for successful candidates who hold a master's qualification and $73,000 for those with a PhD. Please note that this salary is standardized and non-negotiable Private medical insurance with a company contribution Dental and vision cover 23 days' vacation leave increasing by 1 day to a maximum of 27 days. 6 public holidays plus 1 floating holiday The chance to work from home for up to half of your working time Retirement savings via a 401k plan with up to a 5% employer match Paid funding for external education and study leave Life insurance Comprehensive travel insurance Flexible and reasonable working hours Regular company-funded social activities Please click here to learn about our reward package and the other benefits of working for Costello Medical: ********************************careers/benefits-package-in-the-us/ How to Apply You are required to submit your resume and a cover letter via our online application form. In your cover letter, you must explain why you think you would be suited to the role and why you would like to join Costello Medical, with examples to support both. Your resume should clearly state the dates of all qualifications and grades achieved where applicable. While we embrace Artificial Intelligence (AI) technologies to innovate and improve processes, we want to understand your unique skills and experiences throughout the recruitment process. Therefore, if you use AI to assist with your application, we recommend that you do not rely solely on this technology to generate your application materials. As your role may involve developing new written content from scratch and handling confidential data that cannot be uploaded to AI technology, it is important for us to assess your own skills and abilities. Please contact the Talent Acquisition team at ******************************* if you have any questions about the role or application process. Visa Sponsorship We welcome applications from international candidates, but we are unfortunately unable to provide visa sponsorship for working visas. Therefore, you must have the right to work in the US independently from the company. However, we are able to consider those on a temporary visa, such as an OPT visa.

We are currently seeking writers to contribute regular and consistent articles (500-700 words), more in-depth articles (700-2,000 words) and ebooks (5,000-30,000 words) on an ongoing basis. The successful candidates should be proficient and have experience in researching and writing the articles in a conversational style, which engages readers that focus in on virtual business-related topics, such as online marketing, virtual branding, social media, networking, etc. Starting Rate: $0.03 per word ** THIS IS A REMOTE POSITION **

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 *****************