Senior Medical Writer jobs at QuintilesIMS - 252 jobs

Join us as a Research Grant Specialist II (RGS II) as we explore Academic Pathology. At Cedars-Sinai our academic culture and environment creates an extraordinary opportunity for cross-disciplinary thinking and research while enjoying a larger sense of autonomy, with the freedom to choose when, and with whom, you collaborate. Our research is largely collaborative and team-work oriented, helping to unleash your potential and enjoying intellectual freedom with the ability to make an individual impact and receive recognition for your work. We are setting the benchmark for how medicine can be more effectively delivered by supporting our distinguished staff, specialists, and scientists, to advance discovery, be a mentor to the next generation, and set new standards of care. Are you ready to be a part of breakthrough research? The Research Grant Specialist works with principal investigator to complete and submit federal and non- federal grants and serves as the liaison between department or research groups and sponsored research funds administration, accounting, and finance departments. This role generally performs all Pre- and Post- award administrative functions, including, but not limited to, ensuring internal documents are prepared and routed for signature and processing, monitoring grant accounts, tracking all expenses, providing grant and financial reconciliation, and research-related financial reporting. Ensures compliance with all internal policies, federal and local agency requirements including the Food and Drug Administration (FDA) and local Institutional Review Board. Primary Job Duties and Responsibilities: Works with principal investigator to complete and submit federal and non-federal grants. Works as the liaison between department or research group and sponsored research funds administration, accounting, and finance departments. Generally, performs all Pre-and Post- award administrative functions. Ensures internal documents are prepared and routed for signature and processing. Monitors grant accounts, tracks all expenses, provides grant and financial reconciliation, and research-related financial reporting. Monitors Time & Effort for accurate reporting and performs necessary funding corrections via direct cost transfer requests. Responsible for grant close out. Identifies opportunities for research funding opportunities. May negotiate budgets for clinical trials. May assist with research participant billing. Ensures compliance with internal policies and procedures, all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board. Maintains research practices using Good Clinical Practice (GCP) guidelines. Maintains strict patient confidentiality according to HIPAA regulations and applicable law. Participates in required training and education programs. Qualifications Education: High School Diploma is required. Bachelor's Degree is preferred. Experience and Skills: Three (3) years of experience in administration of research grants, or equivalent combination of education and experience. Establishes effective working relationships with cross-functional team(s) Excellent verbal/written communication skills and solid understanding of federal and major funding agency grant submission guidelines. Experience working with multi-PI proposals. Experience with preparation of general grant submission components, including the preparation of progress and financial reports. Experience with preparation of scientific manuscripts and abstracts. Proficiency with eRA commons, grants.gov, NIH RePORTER, Federal Reporter, and other related proposal submission systems. Knowledge of expense tracking software required. Knowledge of general accounting and financial analysis required. Knowledge of PeopleSoft strongly preferred. Proficiency in Microsoft Office (Word, Excel, Outlook) and related applications required. Demonstrated ability to create and utilize Excel spreadsheets for budget and data tracking. Ability to identify problems and resourcefulness to resolve them independently using own initiative. Able to handle multiple tasks with short timelines, to prioritize work, and to complete assignments in a timely, accurate manner. Ability to work independently, set priorities and handle multiple tasks requiring attention to detail. Must be highly organized, patient, persistent, and require minimal supervision in execution of assigned tasks. Req ID : 12838 Working Title : Research Grant Specialist II - Academic Pathology Department : Pathology Group Operations Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Contract & Grant Budget/Fund Overtime Status : EXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $71,219 - $121,076

Our employees make a difference every day by providing world-class healthcare. The Department of Pathology and Laboratory Medicine participates in the care of virtually every Cedars-Sinai Medical Center patient, using the most sophisticated methods for making accurate diagnoses in all areas of anatomic and clinical pathology. In addition, the department provides expert consultation services to the outside community. Our expert pathologists and clinical scientists are committed to improving precision medicine approaches, advancing basic science and translational research, and providing excellent training and education. The Research Grant Specialist I (RGSI) works with the Principal Investigator (PI) and senior-level research administrators to monitor grant accounts and track expenses. Provides reconciliation and research-related financial reporting of federal and non-federal grants. Serves as the liaison between departments or research groups, as well as the Sponsored Research & Funds Administration, Accounting and Finance departments. This role performs all post-award administrative functions including, but not limited to preparing and routing internal documents for signature and processing and maintaining a clear understanding of grant budgets and expenditure restrictions. Ensures compliance with all federal, state,, and local agencies including the National Institute of Health (NIH), the Department of Defense (DOD), the Food and Drug Administration (FDA) and the Institutional Review Board. This position will report to senior-level research administrators for day-to-day supervision of work Primary Job Duties and Responsibilities: Works as the liaison between departments or research groups and Sponsored Research & Funds Administration, Accounting, and Finance departments. Prepares and routes internal documents for signature and processing. Performs all post-award administrative functions. Monitors federal and non-federal grant accounts, tracks expenses, project reconciliation and research-related financial reporting. Performs necessary funding corrections via direct cost transfer requests (DCTRs). Assists in the development of financial projections for project account management. Assists in the development and submission of progress reports. May enter Notice of Awards (NOAs) details into databases. May assist in the preparation and submission of documentation required for research compliance. Participates in required training and education programs. Assists senior-level research administrators and leadership on other activities as assigned. Department-Specific Responsibilities: Keeps track of cost-sharing agreements, prepares interdepartmental invoices, and monitors payments. Performs all Interns and Visitor Program administrative functions, including but not limited to onboarding/termination/renewals of interns/visitor personnel, and processing all necessary documentation. Performs financial management functions for the department's Mini/Microgrants program, duties include, but are not limited to proposal/purchasing lead, keeping track of individual accounts, expiration and extension dates, account reconciliation. Qualifications Education: High School Diploma/GED is required, but a Bachelor's Degree is preferred. Experience and Skills: One (1) year of experience in the administration of research grants, or an equivalent combination of experience and education. Excellent verbal/written communication skills and understanding of Grants, Manuscripts and Abstracts guidelines. Knowledge of general accounting and financial analysis is required. Knowledge of PeopleSoft is strongly preferred. Proficiency in Microsoft Office (Word, Excel, Outlook) and related applications required. Demonstrated ability to create and utilize Excel spreadsheets for budget and data tracking. Able to handle multiple tasks with short timelines, prioritize work, and complete assignments promptly and accurately. Ability to work independently, set priorities, and handle multiple tasks requiring attention to detail. Establishes effective working relationships with cross-functional team(s). Req ID : 13591 Working Title : Research Grant Specialist I -Pathology Group Operations Department : Pathology Group Operations Business Entity : Cedars-Sinai Medical Center Job Category : Academic / Research Job Specialty : Contract & Grant Budget/Fund Overtime Status : EXEMPT Primary Shift : Day Shift Duration : 8 hour Base Pay : $58,864 - $100,068

Pay Range $111,500 - $123,900 Join us! Looking for a quirky editorial and writing position with a wide variety of projects and challenges? Ready to make your mark on a 300-year-old organization? As the Editorial Director for the Masons of California and its entities, you will direct the editorial efforts of the Communications team in a range of industries - from membership organizations (in our award-winning California Freemason magazine: californiafreemason.org), to live events (several a year), to wellness and healthcare (wellness resources and our vibrant retirement communities), and more. Plus, you'll learn a ton about the fascinating world of Freemasonry. Your curiosity, creative flair and ability to write for a wide variety of mediums (long-form publications, digital formats, traditional marketing formats and more) and industries with a collaborative, creative team will make a lasting impact in California and beyond. You will manage our social and video staff, bringing our organization to life through various channels. Your work will inspire and motivate our members, and inspire new prospects to search us out. You love a challenge, work well within and leading teams, and strive for excellence. You will work with long-time members and employees who are passionate and excited about leadership, making true friends, and impacting our society in positive ways. Join our team! JOB PURPOSE To support the Masons of California Communications Department in giving voice to Masonry in California through relevant, vibrant, consistent and integrated messaging that supports the organization's communications goals. Scope of work includes copywriting for print and web materials, writing long-form articles and conducting interviews for California Freemason Magazine, and overseeing freelancers, social media channels, and video channels, and other content producers. You will consult on PR opportunities and storytelling with our PR agency. Excellent attention to detail, creativity and on-time delivery of projects is required. JOB SUMMARY Envision editorial content of internal and external communication materials, vehicles, and media for all Masons of California entities. Scope of work includes developing, writing, and integrating content across all channels, including long-form articles for California Freemason magazine, collateral materials, ad copy, digital communications, video scripts, social media, internal communications, press releases and other materials. ESSENTIAL FUNCTIONS STRATEGIZE Lead the communications team in content development and calendaring, working with internal and external staff and freelancers to write edit, and proofread each issue of the quarterly California Freemason magazine and annual report. Develops magazine themes in tandem with the Creative Director, and presents ideas to Executive Editor and Editor-in-Chief for the magazine, and to the Chief Communications Officer for internal and external communications. Establish contacts and sources to use in future research Ensure a strong brand identity across communications channels PRODUCE Source, develop, and edit content for internal and external initiatives, marketing and fundraising campaigns, and programs for all communications channels Research and source members for magazine, newsletter and social media stories; conduct interviews, write short and long form stories Write, edit and/or proofread a wide variety of written material: email marketing, direct mail, powerpoint presentations, conference books, video scripts, etc. Ensure written content is excellent quality, relevant, strategic, accurate, consistent, on time, and within budget MANAGE Serves as Editorial Director of California Freemason magazine; manages timelines, editing and fact checking processes and works closely with the Creative Director Manage and maintain relationships with freelance writers to ensure high-quality content that is delivered on time. Negotiate fees and manage the work of editorial services vendors Foster and maintain strategic and collaborative internal relationships with all internal entities (California Freemasonry, Masonic retirement communities, California Masonic Foundation, Masonic Center for Youth and Families) Excellent organizational and project management skills; ability to manage workflow and delegate responsibilities to meet multiple demands and deadlines Ability to envision magazine themes and provide creative input to Creative Director. Strong management and customer service skills; ability to collaborate with executives, employees, volunteer leaders, and members Excellent verbal and interpersonal communication skills Excellent attention to detail and accuracy Proactive, curious, self-motivated team player; strong customer service focus; ability to work as part of a collaborative, entrepreneurial team of communications professionals QUALIFICATIONS 7+ years communications management and writing and editing experience in non-profit, member/association, corporate communications/marketing, or communications-focused agency Experience using Wordpress preferred BA/BS in Communications, Journalism, English, or related field Applicants must provide a cover letter explaining your interest in the position, resume, portfolio of published work, which should include samples of a long-form article, marketing copy, and newsletter copy. The Editorial Director reports to the Chief Communications Officer and works in close conjunction with the other creative professionals on the Communications team and with freelancers and agencies. This has been developed to identify some of the duties and responsibilities of this position. It is not intended to limit or encompass all duties and responsibilities of the position. Masons of California at its sole and absolute discretion, expressly reserves the right to modify, supplement, delete or augment the duties and responsibilities specified in this and all job descriptions. At Masons of California, we are looking for team members who would like to combine their passion for helping people, good communication skills, decision-making skills, and great ethical standards with the opportunities to advance your career. In return for your skills, you will be offered: A work environment focused on teamwork and support Excellent health, wage replacement and other benefits for you and your family's well-being A generous contribution to a 401K plan whether or not you participate, and an additional contribution from the company when you participate in the plan Investment in your growth through Tuition Reimbursement #J-18808-Ljbffr

A historical non-profit organization in San Francisco seeks an Editorial Director to oversee communications across various platforms. The successful candidate will lead content development for the California Freemason magazine and manage editorial staff and freelancers. Strong experience in communications management, writing, and editing is essential. This role offers excellent health benefits, a 401K contribution, and opportunities for career growth. #J-18808-Ljbffr

Manages the entire process of scheduling procedures and surgery for the office(s) and is able to make sound decision based on the needs of the office and the patients. Advises patients of surgical and financial pre-operative requirements. Coordinates, schedules appointments, orders supplies needed for surgeries and procedures at the clinic, ambulatory surgery centers, and hospitals. Responsibilities Manages the entire process of scheduling procedures and surgery for the office(s) and is able to make sound decision based on the needs of the office and the patients. Advises patients of surgical and financial pre-operative requirements. Coordinates, schedules appointments, orders supplies needed for surgeries and procedures at the clinic, ambulatory surgery centers, and hospitals. Qualifications Education H.S. Diploma or General Education Degree (GED) Required Work Experience 3 years experience in Healthcare with one (1) year in a specialty office or procedure scheduling Required Experience working in healthcare is Required Licenses and Certifications None Required Business Unit: Company Name: Piedmont Medical Care Corporation #J-18808-Ljbffr

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.

The Company Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health. We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us. Meet the team: Dexcom Medical Affairs is looking for candidates for the role of Senior Medical Writing and Scientific Communications. This role provides an opportunity to not only write and manage publications based on cutting edge scientific and technological data, but to also assist in building strategic publication plans and associated processes. This is a great opportunity to help shape the development of the medical writing/scientific communications function and work with some outstanding colleagues! Where you come in: You will write high-quality scientific publications, including manuscripts, abstracts, posters, and oral presentations, in accordance with company policies and industry guidelines (eg, GPP) You will contribute to the development and execution of strategic publication plans in line with company objectives and strategy You will collaborate with cross-functional teams to align publication activities with the broader strategy and ensure consistency in scientific narratives You will participate in team meetings to provide input on strategic discussions and decisions related to publication planning and execution You will ensure timely feedback, review cycles, and adherence to deadlines for publications You will build productive working relationships with internal and external stakeholders, including key opinion leaders You will assist with tracking for publication-related activities What makes you successful: You have an advanced degree in relevant scientific field You have a minimum of 3 years of experience writing and developing peer-reviewed publications and developing strategic publication plans in the pharma/biotech/device industry or medical communications agency Previous experience in diabetes highly preferred, experience in devices a plus CMPP certification is a plus You bring In-depth knowledge of industry regulations and guidelines governing publications and medical communications You are proficient in publication management software and referencing tools You bring strong project management skills with the ability to manage multiple high-priority projects simultaneously You have excellent written and verbal communication skills. What you'll get: A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community. A full and comprehensive benefits program. Growth opportunities on a global scale. Access to career development through in-house learning programs and/or qualified tuition reimbursement. An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve. Travel Required: 5-15% Experience and Education Requirements: Typically requires a Bachelor's degree and a minimum of 5 - 8 years of related experience. Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km). If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option. Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************. Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications. Salary: $100,700.00 - $167,900.00

What You'll Do: This role will be responsible for producing high-quality clinical and clinical regulatory documentation that will require a strong understanding of medical and regulatory concepts and terminology as well as the ability to translate complex information into clear and concise documentation. Will work closely and collaborate with project teams spanning multiple departments on Glaukos's current and pipeline of products. The Sr. Medical Writer will be responsible for engaging with cross-functional stakeholders to extract key information, and synthesize that into a clear, logical presentation. You will ensure that documentation is accurate, complete, meets editorial and client specifications, and adheres to established guidelines and standards. * Prepares clinical study reports (CSRs) with limited supervisor direction; based on the clinical study protocol and statistical analysis plan, translates clinical result data tables, listings and figures into a report on the study outcomes, completes final check for discrepancies within data, and ensures compliance with relevant regulatory agencies. * Translate clinical study synopsis into full clinical study protocol, ensuring appropriate level of depth and detail, as well as technical accuracy. Works with other members of the project team to obtain input. * Interpret data, analyze results, and apply knowledge of regulatory/compliance/scientific requirements to document preparation. Systematically review reports and clinical data and cross-check information * Ensure consistency in style, tone, and quality across all documents. * Develop and maintain standardized templates and style guides for clinical and regulatory documentation. * Conduct medical and scientific literature database research to support documentation efforts. * Review, edit, and cross-check documents produced by other team members for clarity, accuracy, and compliance. * Stay up-to-date with industry trends, regulatory requirements, and best practices in both technical and medical writing. * Develop and maintain lists of abstract deadlines, key dates, and locations for relevant/major ophthalmology conferences. Coordinate with R&D leadership to prepare conference abstract submissions while ensuring compliance with conference rules and company objectives and strategy. * Prepare and proof presentations (slide decks and posters) as required for physicians and other key internal stakeholders * Develop figures for publications and presentations (peer-reviewed publications, presentations, and posters) to align with company strategy * Support phase I through phase IV studies prior to database lock, identifying any adverse events or protocol deviations and works with cross-functional * Participate in project meetings and provide updates on the status of writing assignments. How You'll Get There: * Bachelor's Degree Required, Master's Degree or PhD Preferred * 5-8 years of relevant work experience in a clinical or scientific space * Deep understanding of therapeutic areas (ophthalmology), clinical research, and regulatory requirements * Fluency in technical and medical terminology * Experience in pharmaceutical regulatory submissions * Experience with scientific publications and presentations * Familiarity with ophthalmic indications and treatments preferred * Excellent writing, editing, and proofreading skills * Proficiency in using documentation tools and software such as Microsoft Office Suite, Adobe Acrobat, and content management systems (CMS) Strong organizational and project management skills * Excellent communication and interpersonal skills #GKOSUS

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

SerenaGroups Medical Writer - Remote Opportunity $75k SerenaGroups is seeking a highly skilled, detail-oriented Medical Writer to join our growing team. In this role, you'll apply your scientific expertise and writing talent to translate complex medical and scientific information into clear, accurate, and genuinely engaging content. You'll craft materials for a wide range of audiences-from healthcare professionals and regulatory authorities to patients and the general public. Your projects might range from technical and scientific documents (regulatory submissions, clinical research reports, journal articles) to marketing and educational content (press releases, patient brochures, training modules). If you're passionate about clear communication and want your work to make a difference, you'll fit right in. Key Responsibilities Work closely with subject matter experts, researchers, and technical teams to gather and organize information on new products, treatments, and procedures. Research and review medical topics; help physicians draft research articles and review papers. Prepare and edit press releases, training materials, and marketing communications. Write concise articles, reports, and summaries on medical and scientific discoveries. Communicate complex medical concepts in accessible, audience-appropriate language. Collaborate with clinical research teams on study protocols and trial documents. Draft, edit, and review clinical research materials (study reports, investigator brochures, regulatory submissions). Prepare annual reports, abstracts, brochures, and presentation materials. Develop training manuals and eLearning content tailored to various audiences. Ensure all work complies with relevant guidelines, regulations, and industry standards. Stay current on evolving medical terminology, research trends, and regulatory requirements. Why Join Us? At SerenaGroups, our values drive everything we do: integrity, putting patients first, service, respect, collaboration, and a proper family environment. We're passionate about making a difference for our partners and patients and always strive to grow and innovate. Here's what you'll find here: The chance to work on diverse and meaningful healthcare and life sciences projects. Collaboration with leading experts and forward-thinking innovators in the field. Competitive pay, benefits, and real opportunities for professional growth. If you're ready for your work to have a real impact-and want to be part of a values-driven team-we'd love to hear from you. To Apply: Send your resume, a brief cover letter, and relevant writing samples to [your email address]. SerenaGroups is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Requirements Education & Experience Requirements Bachelor's degree in English, Journalism, Life Sciences, or a related field (Master's or Ph.D. preferred; equivalent experience considered). Solid grounding in life sciences, medicine, pharmacy, or a related discipline is highly desirable. Previous experience in medical writing-scientific, technical, or marketing-is required. Certification from a recognized medical writing association is a plus, but not required. Core Competencies & Personal Attributes Outstanding written and verbal communication skills. Meticulous attention to detail and scientific accuracy. Mastery of grammar, language usage, and style guidelines. Ability to interpret and communicate statistical results. Strong research and analytical skills. Critical thinking and problem-solving ability. Self-motivated, curious, and committed to continuous learning. Capable of managing multiple projects and meeting deadlines. Collaborative mindset, comfortable working independently or as part of a multidisciplinary team. Technical Skills Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and online research databases (e.g., PubMed, Medline). Familiarity with AMA, APA, or other scientific style guides. Understanding of clinical research processes, regulatory guidelines (FDA, EMA, ICH), pharmacology concepts, and drug safety requirements. Salary Description $70,000-$75,000

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. The Senior Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications. RESPONSIBILITIES List the major responsibilities of the job. Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.) Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries). Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes Represents Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams). Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met. Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments Adheres to departmental procedures and practices and technical and industry standards during all aspects of work. Works effectively with cross-functional groups within BioMarin Other tasks as assigned. SCOPE Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc. This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Global Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications. EDUCATION State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc. Bachelor's or higher degree required; scientific focus desirable. Minimum requirement: Experience in medical writing. Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association. EXPERIENCE State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job. Relevant ExperienceFulfills one of the following:· Up to 6 years of as a medical writer in the pharmaceutical industry· At least 10 years of medical or scientific writing experience as a primary job responsibility Clinical Studies· Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets.· Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.· Intermediate to advanced applied knowledge of:o documentation required for the conduct of clinical studieso protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)o study results reportingo integrated results reporting· Direct experience with documentation in all phases of drug development. Medical Writing· Experience writing, reviewing, or editing protocols and clinical study reports required.· Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred.· Experience writing, reviewing, or editing regulatory briefing books preferred.· Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.· Ability to interpret and create complex tabular and graphical clinical data presentations.· Advanced applied knowledge of basic clinical laboratory tests.· Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Computer/office equipment Skills Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint. Experience using document management software (eg, LiveLink, SharePoint, Veeva) Experienced with scanners, printers, and copiers. Regulatory Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports). Prior familiarity with standard eCTD IND/NDA work, including: o Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format o Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE) Project Management Capable of working on multiple tasks and shifting priorities. Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation. Capable of representing Global Medical Writing at cross-functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross-functional conflicts. Good conflict management skills. Motivated and shows initiative. Detail oriented. Communication Capable of well organized, concise and clear written and verbal communication. Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements. Effective at explaining writing principles to a varied audience both in individual and group settings; intermediate to advanced presentation skills. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position We are seeking an experienced, detail-oriented individual to join our Medical Writing team. In the Senior Medical Writer role, you will be responsible for independently leading document development by authoring and editing of medical and regulatory writing deliverables that support the Eikon clinical portfolio. You will partner with cross functional colleagues within study teams/project teams to prepare high-quality, accurate and fit for use clinical and regulatory documents enabling delivery of Eikon portfolio milestones. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing. What You'll Do Independently write clinical and regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules (Module 2.7.Xs, 2.5, and Module 5 integrated summaries), briefing documents, posters, abstracts, manuscripts and other documents per company and regulatory guidelines. Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation. Independently manage and maintain document lifecycle, including timelines, workflow of writing assignments, review cycle management, and document quality management where appropriate. Help to iteratively improve medical writing processes as appropriate. Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations. Take ownership of a given assignment, proactively consulting other cross-functional project team members to align and build consensus on timelines, document interdependencies, organize and drive kick off meetings, comment resolution meetings, and ad-hoc meetings to mitigate risks and resolve project related issues. Interpret and understand scientific and clinical data, provide input on data, figures, tables, and listings for clear data presentation per the document scope. Qualifications Doctoral-level degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master's degree with 3+ years of relevant experience, or Bachelor's degree with 5+ years of relevant experience in regulatory, scientific, or medical writing. Substantial clinical study protocol writing experience desired. Excellent communication, presentation, and project management skills. Ability to independently prepare clinical and regulatory documents (e.g., protocol, CSR, IB, CTD modules) in compliance with company SOPs and international health agencies/regulatory guidelines with a focus objective data presentation in a clear, concise format in keeping with industry guidelines. Working knowledge of statistical concepts and techniques. Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results. Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus. Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products. Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote). Familiarity with concepts of structured content management preferred. Proven ability to work independently in a dynamic, fast-moving environment while striving for excellence in collaboration and innovation, as part of a cross-functional team. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site The expected salary range for this role is $125,000 to $136,800 depending on skills, competency, and the market demand for your expertise. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

What You'll Do: This role will be responsible for producing high-quality clinical and clinical regulatory documentation that will require a strong understanding of medical and regulatory concepts and terminology as well as the ability to translate complex information into clear and concise documentation. Will work closely and collaborate with project teams spanning multiple departments on Glaukos's current and pipeline of products. The Sr. Medical Writer will be responsible for engaging with cross-functional stakeholders to extract key information, and synthesize that into a clear, logical presentation. You will ensure that documentation is accurate, complete, meets editorial and client specifications, and adheres to established guidelines and standards. Prepares clinical study reports (CSRs) with limited supervisor direction; based on the clinical study protocol and statistical analysis plan, translates clinical result data tables, listings and figures into a report on the study outcomes, completes final check for discrepancies within data, and ensures compliance with relevant regulatory agencies. Translate clinical study synopsis into full clinical study protocol, ensuring appropriate level of depth and detail, as well as technical accuracy. Works with other members of the project team to obtain input. Interpret data, analyze results, and apply knowledge of regulatory/compliance/scientific requirements to document preparation. Systematically review reports and clinical data and cross-check information Ensure consistency in style, tone, and quality across all documents. Develop and maintain standardized templates and style guides for clinical and regulatory documentation. Conduct medical and scientific literature database research to support documentation efforts. Review, edit, and cross-check documents produced by other team members for clarity, accuracy, and compliance. Stay up-to-date with industry trends, regulatory requirements, and best practices in both technical and medical writing. Develop and maintain lists of abstract deadlines, key dates, and locations for relevant/major ophthalmology conferences. Coordinate with R&D leadership to prepare conference abstract submissions while ensuring compliance with conference rules and company objectives and strategy. Prepare and proof presentations (slide decks and posters) as required for physicians and other key internal stakeholders Develop figures for publications and presentations (peer-reviewed publications, presentations, and posters) to align with company strategy Support phase I through phase IV studies prior to database lock, identifying any adverse events or protocol deviations and works with cross-functional Participate in project meetings and provide updates on the status of writing assignments. How You'll Get There: Bachelor's Degree Required, Master's Degree or PhD Preferred 5-8 years of relevant work experience in a clinical or scientific space Deep understanding of therapeutic areas (ophthalmology), clinical research, and regulatory requirements Fluency in technical and medical terminology Experience in pharmaceutical regulatory submissions Experience with scientific publications and presentations Familiarity with ophthalmic indications and treatments preferred Excellent writing, editing, and proofreading skills Proficiency in using documentation tools and software such as Microsoft Office Suite, Adobe Acrobat, and content management systems (CMS) Strong organizational and project management skills Excellent communication and interpersonal skills #GKOSUS

Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets. Position We are seeking an experienced, detail-oriented individual to join our Medical Writing team. In the Senior Medical Writer role, you will be responsible for independently leading document development by authoring and editing of medical and regulatory writing deliverables that support the Eikon clinical portfolio. You will partner with cross functional colleagues within study teams/project teams to prepare high-quality, accurate and fit for use clinical and regulatory documents enabling delivery of Eikon portfolio milestones. This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration. About You You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing. What You'll Do Independently write clinical and regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules (Module 2.7.Xs, 2.5, and Module 5 integrated summaries), briefing documents, posters, abstracts, manuscripts and other documents per company and regulatory guidelines. Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation. Independently manage and maintain document lifecycle, including timelines, workflow of writing assignments, review cycle management, and document quality management where appropriate. Help to iteratively improve medical writing processes as appropriate. Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations. Take ownership of a given assignment, proactively consulting other cross-functional project team members to align and build consensus on timelines, document interdependencies, organize and drive kick off meetings, comment resolution meetings, and ad-hoc meetings to mitigate risks and resolve project related issues. Interpret and understand scientific and clinical data, provide input on data, figures, tables, and listings for clear data presentation per the document scope. Qualifications Doctoral-level degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master's degree with 3+ years of relevant experience, or Bachelor's degree with 5+ years of relevant experience in regulatory, scientific, or medical writing. Substantial clinical study protocol writing experience desired. Excellent communication, presentation, and project management skills. Ability to independently prepare clinical and regulatory documents (e.g., protocol, CSR, IB, CTD modules) in compliance with company SOPs and international health agencies/regulatory guidelines with a focus objective data presentation in a clear, concise format in keeping with industry guidelines. Working knowledge of statistical concepts and techniques. Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results. Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus. Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products. Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote). Familiarity with concepts of structured content management preferred. Proven ability to work independently in a dynamic, fast-moving environment while striving for excellence in collaboration and innovation, as part of a cross-functional team. At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including: 401k plan with company matching Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%) Mental health and wellness benefits Weeklong summer and winter holiday shutdowns Generous paid time off and holiday policies Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies Enhanced parental leave benefit Daily subsidized lunch program when on-site The expected salary range for this role is $125,000 to $136,800 depending on skills, competency, and the market demand for your expertise. Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment. We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.

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

The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to contribute to other regulatory documents may be provided. The SMW tracks his/her own writing projects and is responsible for adhering to regulatory guidelines and department document standards. The SMW may also serve as lead for a compound and may also review the work of junior/outsourced writers as well as review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion. **In this role, a typical day might include:** + Works with the clinical team, to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to write or contribute to other Regulatory documents may be provided + Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development + Manages processes and organizes priorities; solves problems; fosters collaboration to resolves conflict + May review the work of junior and outsourced MWs + May review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion + Writes in plain language style as appropriate (eg, for ICFs) + Explains complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience + May mentor junior staff + Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area + Remains compliant with internal training **This role might be for you if can:** + Drives document development meetings + Articulates document strategy and timelines + Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss + Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly **To be considered for this opportunity, you must have the following:** + Bachelor's degree (advanced degree preferred) + Minimum of 3 years of relevant MW experience including working knowledge of biostatistics. + Strong knowledge of the clinical research process and regulations/guidelines + Clinical document reading, writing, and editing experience + Strong organizational, interpersonal and communication skills + Strong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems + Ability to manage multiple projects + Familiarity with ICH GCP guidelines Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. **Salary Range (annually)** $128,600.00 - $210,000.00

The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to contribute to other regulatory documents may be provided. The SMW tracks his/her own writing projects and is responsible for adhering to regulatory guidelines and department document standards. The SMW may also serve as lead for a compound and may also review the work of junior/outsourced writers as well as review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion. In this role, a typical day might include: Works with the clinical team, to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to write or contribute to other Regulatory documents may be provided Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development Manages processes and organizes priorities; solves problems; fosters collaboration to resolves conflict May review the work of junior and outsourced MWs May review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion Writes in plain language style as appropriate (eg, for ICFs) Explains complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience May mentor junior staff Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area Remains compliant with internal training This role might be for you if can: Drives document development meetings Articulates document strategy and timelines Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly To be considered for this opportunity, you must have the following: Bachelor's degree (advanced degree preferred) Minimum of 3 years of relevant MW experience including working knowledge of biostatistics. Strong knowledge of the clinical research process and regulations/guidelines Clinical document reading, writing, and editing experience Strong organizational, interpersonal and communication skills Strong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems Ability to manage multiple projects Familiarity with ICH GCP guidelines Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $128,600.00 - $210,000.00

The Senior Medical Writer (SMW) works with team members and independently to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to contribute to other regulatory documents may be provided. The SMW tracks his/her own writing projects and is responsible for adhering to regulatory guidelines and department document standards. The SMW may also serve as lead for a compound and may also review the work of junior/outsourced writers as well as review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion. In this role, a typical day might include: * Works with the clinical team, to write the content of clinical documents that may include CSRs, protocols, ICFs, narratives and IBs in a variety of therapeutic areas. Opportunities to write or contribute to other Regulatory documents may be provided * Participates in process improvement initiatives, working groups, etc. within MW and throughout Global Development * Manages processes and organizes priorities; solves problems; fosters collaboration to resolves conflict * May review the work of junior and outsourced MWs * May review CSR-related documents (Statistical Analysis Plans, TFLs) to help ensure appropriate content for inclusion * Writes in plain language style as appropriate (eg, for ICFs) * Explains complex medical/scientific concepts (such as medical procedures, clinical study design, and drug mechanisms) to a lay or patient audience * May mentor junior staff * Ensures adherence to applicable guidelines, templates and SOPs for all MW documents provided for therapeutic area * Remains compliant with internal training This role might be for you if can: * Drives document development meetings * Articulates document strategy and timelines * Identifies the appropriate parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss * Follows discussions to their conclusion, synthesizes the message, and presents clear accurate prose quickly To be considered for this opportunity, you must have the following: * Bachelor's degree (advanced degree preferred) * Minimum of 3 years of relevant MW experience including working knowledge of biostatistics. * Strong knowledge of the clinical research process and regulations/guidelines * Clinical document reading, writing, and editing experience * Strong organizational, interpersonal and communication skills * Strong knowledge of MS WORD, Adobe Acrobat, PowerPoint, and electronic document management systems * Ability to manage multiple projects * Familiarity with ICH GCP guidelines Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit ********************************************************************* For other countries' specific benefits, please speak to your recruiter. Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Salary Range (annually) $128,600.00 - $210,000.00

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. The Medical Writer 1 applies basic to intermediate documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications. RESPONSIBILITIES List the major responsibilities of the job. Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.) Aids in managing study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials Adheres to departmental procedures and practices and technical and industry standards during all aspects of work. Assists in developing and reviewing standard processes and templates within Global Medical Writing Works effectively with cross-functional groups within BioMarin Other tasks as assigned. SCOPE Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc. This position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications. EDUCATION State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc. Bachelor's or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association. EXPERIENCE State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job. Relevant ExperienceFulfills one of the following:· Up to 2 years as a medical writer in the pharmaceutical industry· At least 5 years of medical or scientific writing experience as a primary job responsibility Clinical Studies· Familiar with drug development process (discovery to market).· Basic understanding of biostatistical and clinical research concepts.· Basic applied knowledge of:o documentation required for the conduct of clinical studieso protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)o study results reporting Medical Writing· Writing high-quality documents that support corporate goals and objectives.· Experience writing, reviewing, or editing protocols and clinical study reports preferred.· Basic applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.· Ability to interpret basic tabular and graphical clinical data presentations.· Ability to create basic tables using AMA style (eg, Schedule of Events).· Basic to intermediate applied knowledge of basic clinical laboratory tests.· Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Computer/office equipment Skills Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, and PowerPoint. Familiar with document management software (eg, LiveLink, SharePoint, Veeva) Experienced with scanners, printers, and copiers. Regulatory Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports). Project Management Capable of working on multiple tasks and shifting priorities. Good conflict management skills. Motivated and shows initiative. Detail oriented. Communication Capable of well organized, concise and clear written and verbal communication. Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements. Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.