Medical writer jobs in California

The position will mainly focus supporting the inhouse team with the Clinical Evaluation Reports (CERs), with potential for future additional responsibility for development of other clinical evidence documents. The purpose of this job is to support clinical evaluation reports (CERs) per Medical Device Regulation (MDR), to meet essential requirements in support of submission for CE Mark application to obtain Declaration of Conformity and EU market clearance, recertification and proposed indication/labeling changes, as well as CER updates to maintain EU product conformance. Responsibilities: This position has responsibility and authority for: Authoring sections of Clinical documentation as part of the Clinical Evaluation Reports [CER]. Acquire knowledge of therapeutic areas, literature review processes and the ability to keep abreast of current literature. Participates in and/or performs comprehensive literature searches to develop in-depth knowledge and understanding of current scientific literature required to support identified product lines and related clinical studies. Work with the clinical librarian to help with conducting literature searches on products/product families Review the scientific literature and critically appraise and write clinical summaries for products and surgical procedures Support the internal team members by adhering to CER timelines and providing data in a timely manner to support global Regulatory activities. Interacting with internal teams to understand the plan and strategy for development of the Clinical evaluation reports for new and existing products. Conduct proofreading, editing, document formatting, review comment integration and document completion / approval activities. May assist with creation of clinical content including the preparation of manuscripts, scientific abstracts, conference presentations and posters based on clinical trials. May author Protocols and/or routine Clinical Study Progress Reports. Ensure compliance with corporate (e.g., SOP's) and regulatory requirements (e.g., GCP and US and OUS guidelines). Required experience: Previous experience in the application of therapeutic and device knowledge to support the development of clinical evaluation reports. Must have a minimum of 2-4 years of medical writing experience Minimum of 0-2 years of experience in clinical evaluation report writing in a medical device industry is preferred. Strong experience in conducting literature searches, reviews and appraisal of the scientific data. Demonstrated ability to clearly and effectively communicate verbally and in technical or scientific writing; demonstrated effective scientific writing skills. Excellent critical and analytical thinking skills. MD, PhD or M.S. degree in scientific field is desired. Must have high level of attention to detail and accuracy. Must be able to work effectively with internal team members. Must be able to manage multiple projects across numerous surgical disciplines. Strong communication, presentation and interpersonal skills with high attention to detail and organization Strong experience in protocol development and writing clinical section for regulatory submission. Ability to learn quickly and self-educate on different surgical specialties as applicable to medical products and procedures (Self-starter attitude).

About the Role We're looking for a skilled Proposal Writer who can turn complex scientific and technical ideas into compelling, client-ready stories. In this role, you'll play a key part in helping win new business by creating clear, persuasive proposals that highlight the companys capabilities and innovation. You'll collaborate closely with business development, technical, and scientific teams to craft proposals that truly stand out - especially in the areas of Drug Product development and Sterile Fill-Finish manufacturing. What You'll Do Review RFPs and RFIs to understand client needs, requirements, and evaluation criteria Partner with business development to define winning strategies, core themes, and differentiators Write and edit proposal content that's persuasive, on-brand, and tailored to each opportunity Collaborate with subject matter experts to accurately capture technical and scientific details - particularly in Drug Product and Sterile Fill-Finish areas Translate complex technical processes into clear, accessible language for a wide range of audiences Ensure all proposal materials meet brand, style, and compliance standards Manage multiple projects simultaneously, balancing speed, quality, and accuracy Keep proposal templates and content libraries organized, updated, and easy to use Work with finance and business development teams on costing and pricing inputs Maintain accurate records and activity tracking in CRM systems What You'll Bring A bachelor's degree in English, Communications, Science, Technical Writing, or a related field (or equivalent experience) 3+ years of experience writing proposals in a technical, scientific, or regulated environment - pharmaceutical or biotech experience strongly preferred Expertise in Drug Product development and a strong understanding of Sterile Fill-Finish operations - these are key to success in this role Excellent writing, editing, and research skills with a sharp eye for detail The ability to grasp and communicate complex scientific and technical concepts clearly Strong organizational skills and the ability to manage multiple deadlines A strategic mindset - you know how to align messaging to business goals and client needs Familiarity with CRM tools and collaborative document systems Why You'll Love Working Here You'll join a collaborative, fast-moving team that values creativity, precision, and scientific excellence. If you're passionate about translating complex science into winning proposals - and you bring deep experience in Drug Product and Sterile Fill-Finish - this is your chance to make a real impact on high-stakes projects that matter. ...

The Grant Writer is responsible for writing and submitting proposals and coordinating the grant application process. Apply fast, check the full description by scrolling below to find out the full requirements for this role. This includes researching and identifying grant opportunities managing the proposal submission process, maintaining the grantor/funder database and ensuring program compliance by working closely with department heads, the SPBMI procurement officer, Business Committee and stakeholders including grantors to achieve funding for critical Tribal initiatives projects and programs. The grant writer works under the direction of the Tribal Chief Financial Officer as a member of the Finance staff. The grant writer is proficient in developing project budgets, creating workflow performance milestones, ensuring all deadlines are met and proposals are completed and submitted on time in a professional manner.

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description • Communicate SER's position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed. Ensure assigned documents are produced in accordance with relevant internal SOPs and external regulatory guidance, alerting project teams and line management in a timely manner of any definite or potential deviations. • Drive the document strategies and messages in a collaborative way with relevant project team subject matter experts. • Ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents. • Deliver assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps or potential shortcomings in quality. • If leading a team of other authors (internal or external), be accountable for timely delivery of high-quality, fit-for-purpose documents to the project team. • Produce documents in conjunction with external vendors. • Review documents produced by vendors and help evaluate vendor performance. • Understand relationships and dependencies between documents and analyses produced for regulators including the development RMP, DSUR, PBRER, and ACO. • Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents. • Develop and sustain constructive relationships within other lines including country organizations. • If assigned by manager, serve as the SER ‘point of contact' for all document issues for a given product or set of products. • Identify potential areas for process improvements and possible solutions, and communicate these to line management or appropriate functional line. Writing skills: • Excellent scientific writing skills, including an ability to summarize and interpret complicated data effectively, concisely and persuasively. Analytic skills: • Ability to examine data, formulate reasonable hypotheses, and design and execute analyses to test them. Oral presentation skills: • Strong oral presentation skills, including ability to present, explain and defend data analyses before internal and external (including Regulatory Authority) audiences. Language skills: • High fluency in written English and strong functional fluency in spoken English. Knowledge of additional languages is an asset. Personal skills: • Strong organizational skills and ability to prioritize multiple projects and meet deadlines. Interpersonal skills: • Effective influencing and negotiating skills, including when appropriate an ability to guide decision-making for document content strategy. • Ability to work well with all levels and roles in cross-functional, global teams. • Ability to mentor more junior colleagues and external vendors. • Regulatory knowledge-Familiarity with global regulatory guidance (especially ICH, FDA and EMA) relevant to clinical and safety data. • Software Knowledge- Previous experience with software commonly used to present and analyze data (Word, PowerPoint, Excel) is preferred. • Statistical Knowledge-Proficiency with statistical concepts and ability to carry out statistical analyses is desirable. Epidemiology. • Extensive familiarity with epidemiologic principles and concepts is desirable. Qualifications • Degree or qualification in life sciences (e.g., MD, DVM, PhD in relevant field, BSN, PharmD, Master's or Bachelors' degree in relevant field); alternatively, bachelor's or higher degree in field with transferable skills and pharmaceutical industry experience, ideally in safety, regulatory or clinical areas. • 7+ years of experience in FDA regulations. • Proficiency with M.S Word and M.S Office. Additional Information For more information contact me on 732-429-1925 Ricky Bansal

ImmunityBio, Inc. (NASDAQ: IBRX) is a commercial-stage biotechnology company developing cell and immunotherapy products that are designed to help strengthen each patient's natural immune system, potentially enabling it to outsmart the disease and eliminate cancerous or infected cells. We envision a day when we no longer fear cancer, but can conquer it, thanks to the biological wonder that is the human immune system. Our scientists are working to develop novel therapies that harness that inherent power by amplifying both branches of the immune system, attacking cancerous or infected cells today while building immunological memory for tomorrow. The goal: to reprogram the patient's immune system and treat the host rather than just the disease. Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary The Medical Writer will be responsible for the preparation of high-quality regulatory documents, including clinical study reports, clinical summaries and overviews, study protocols, Investigator's brochures, and informed consent forms. The Medical Writer may also be responsible for planning, managing, and preparing internal and external communications of key scientific and clinical data, including abstracts, poster and oral presentations, manuscripts, congress materials, and educational/training materials. Essential Functions Write, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents. Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents. Write effectively for diverse audiences, including scientists, physicians, payers, regulators, and patients. Work collaboratively with other functional groups (eg, Regulatory Operations, Biometrics, Clinical Operations) to gather source data, and prepare and finalize regulatory documents. Lead document review meetings and discussions. Provide direction and solutions to cross-functional teams on expectations for document content. Perform QC of clinical and nonclinical documents. Provide documents that are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines. Participate in project team meetings. Performs other duties as assigned. Education & Experience A bachelor's degree in science-related fields with 1+ years of experience is required; Or A master's degree in science-related fields with some experience is required. 1+ year of medical writing experience preferred. Experience in NDA submissions and writing CSRs, IBs, clinical study protocols and other documents for regulatory submissions required. Strong scientific background in oncology, immunotherapy, or related field required. Knowledge, Skills, & Abilities Proficient knowledge of AMA writing guidelines. Excellent verbal and written communication skills in English. Knowledge of FDA, EMA, and ICH guidelines. Deep understanding of the drug development process and prior experience in the biopharmaceutical industry. Excellent time- and project-management skills, attention to detail, and ability to balance multiple projects simultaneously. Strong critical and logical thinking with ability to analyze problems, identify alternative solutions, and implement recommendations for resolution. Ability to work collaboratively in a dynamic environment. Highly proficient in MS Project, MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, EndNote, and eCTD authoring templates. Working Environment / Physical Environment This position works onsite. Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer. Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval Lift and carry materials weighing up to 20 pounds. This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location. National Market (all markets unless identified as Premium) $100,000 (entry-level qualifications) to $110,000 (highly experienced) annually Premium Market (Premium markets include Los Angeles, San Diego, San Francisco, New York City, Chicago, & Boston) $103,000 (entry-level qualifications) to $113,000 (highly experienced) annually The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed. ImmunityBio employees are as valuable as the people we serve. We have built a resource of robust benefit offerings to best support the total wellbeing of our team members and their families. Our competitive total rewards benefits package, for eligible employees, include: Medical, Dental and Vision Plan Options • Health and Financial Wellness Programs • Employer Assistance Program (EAP) • Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability • Healthcare and Dependent Care Flexible Spending Accounts • 401(k) Retirement Plan with Company Match • 529 Education Savings Program • Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks • Paid Time Off (PTO) includes: 11 Holidays • Exempt Employees are eligible for Unlimited PTO • Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day • We are committed to providing you with the tools and resources you need to optimize your Health and Wellness. At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.

R&D Partners is seeking to hire a Senior Medical Writer in the San Francisco Bay Area. Your main responsibilities as a Senior Medical Writer: Apply advanced documentation preparation and document project management skills to assist in the development, review, editing and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications. Draft and edit documents used in conducting and reporting the results of clinical studies including protocols, protocol amendments, and informed consent forms Draft and edit documents used in reporting aggregate safety and efficacy information for a molecule including Investigator s brochures and periodic safety reports (PSURs, DSURs, etc.) Manage study team participation in the preparation of documents including running meetings, managing timelines, and overseeing the document review and comment adjudication processes What we are looking for in a Senior Medical Writer: Bachelor s or higher degree; scientific focus preferred 6 plus years of medical writing experience within pharmaceutical industry Experience with drug development process, clinical study protocol design and study conduct and documentation required for the conduct of clinical studies Previous protocol development experience required Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred Why choose R&D Partners? As an employee, you have access to a comprehensive benefits package including: Medical insurance PPO, HMO & HSA Dental & Vision insurance 401k plan Employee Assistance Program Long-term disability Weekly payroll Expense reimbursement Online timecard approval Salary: $130,500 to $147,500 (Dependent on Experience) R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies. R&D Partners is an equal-opportunity employer.

The Medical Writer will primarily work on the development and delivery of high-quality documents such as Clinical protocols, protocol amendments, Investigator's Brochures (IBs), non-clinical and clinical summaries together with integrated summaries (ISS and ISE), and other related clinical/regulatory documents to support Investigational New Drug Applications (IND), New Drug Applications (NDAs) and Biologics License Applications (BLA) within agreed-upon timelines. Education and Credentials Minimum of 5 years of relevant medical writing experience in a pharmaceutical, biotechnology, CRO, or related environment Bachelor's degree in life sciences or related disciplines; advance degree preferred (MD, PhD, PharmD, etc.) Experience in supporting the publication of meeting abstracts or journal manuscripts is a plus. Skills Ability to work independently and collaboratively in a team environment consisting of internal and external contributors Experience in managing multiple projects simultaneously Excellent problem-solving skills with the ability to adapt to changing priorities and deadlines. Excellent interpersonal skills and ability to work with cross-functional teams to meet business objectives. Ability to initiate and generate with limited supervision medical, regulatory, and clinical documents within a reasonable timeframe Ability to develop document templates for ongoing and future submissions depending upon the scope of the project. Ability to pivot from one project to another and multitask Ability to understand client objectives and provide feedback that supports projects and deliverables in multiple therapeutic areas Ability to move efficiently in a dynamic environment Excellent verbal and written communication and listening skills. Highly proficient with Microsoft Office. Effective time management Bilingual in Mandarin and English is not required, but will be a plus Responsibilities Prepares, edits, and finalizes various documents, medical and technical from non-Clinical / pre-clinical to Phase IV studies. Serves as medical writing representative on cross-functional study teams and provides guidance on document strategy and content, timelines, and resource needs Manages the document development process from start to finish which may include generating multiple draft documents and formulating final approved versions, editing, reference retrieval, as well as managing other various processes are undergone (i.e., internal & external reviews, quality checks, audits, formatting, publishing). Collaborates with cross-functional team to ensure results and statistical interpretations are accurately and clearly reflected in documents. Participates in all necessary cross-functional document development meetings (i.e., kick-off meetings, comment resolution meetings) to ensure appropriate alignment from different stakeholders. Responsible for the scientific integrity, quality, accuracy, and regulatory quality assurance of developed content and deliverables. Monitors regulatory, clinical/medical, and scientific findings and conclusions ensuring key messages are clear and consistent within and across documents. Provides editorial or review support for other types of documents as requested. Maintains ongoing familiarity of US and international regulations, requirements and guidance associated with the preparation and submissions of clinical regulatory documents and scientific publications Proponent of Good Publications Practice Guidelines and understand the importance of adhering to the rules and regulations of External Scientific Professional Organizations and scientific journals. Requirements To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. BA, BS, RN, BSN or equivalent Basic knowledge and adherence to GCPs 5+ years of clinical research experience Strong attention to detail Ability to multi-task Unquestionable integrity and highest ethical standards Excellent written and verbal communication skills Self-motivated, assertive, and driven BenefitsContract - $60+/hr.

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.

Our client focuses on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. SCOPE: 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. RESPONSIBILITIES: 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.

We are seeking a highly motivated and qualified contributor to join ADARx Pharmaceuticals as an Sr. Medical Writer to lead medical writing strategies and deliverables aligned with clinical and regulatory goals and execution across clinical development programs. The successful candidate will provide scientific writing support through clinical development, regulatory submissions, and post-marketing activities. This role is ideal for an individual who thrives in a fast-paced, high-growth environment and is passionate about making a meaningful impact in drug development. Essential Responsibilities: Lead the planning, authoring, and on-time delivery of clinical and regulatory documents in accordance with the corporate timeline, including: Clinical trial protocols/amendments Clinical Study Reports (CSRs) Investigator's Brochures (IBs) Regulatory submission documents (IND/CTA, NDA/BLA/MAA, briefing books) Clinical summaries for eCTD modules Conduct version management and tracking of drafts and final document and ensure compliance with global regulatory standards (e.g. FDA, EMA, ICH-GCP). Verify 100% accuracy of data against source documents Coordinating with document management systems and archiving finalized documents for audits and inspections in partnership with Regulatory and Quality function. Develop and maintain templates, style guides, and best practices for medical writing tailored to RNA-based drug development for ADARx portfolio. Collaborate with clinical operations, clinical development, biostatistics, regulatory affairs, safety, and CMC teams to align timelines and messaging complex scientific data into clear and compliant content. Responsible for authoring protocols, IBs, CSRs, and regulatory submissions with scientific accuracy and strategic alignment. Support preparation and delivery of scientific presentations and publications (abstracts/posters), investigator meetings, and advisory boards. Oversee internal and external medical writing teams, as applicable, including CRO partners, ensuring compliance with regulatory standards (e.g., FDA, EMA, ICH). Evaluates and manages CRO for applicable scope, timelines and deliverables. Mentor and develop junior medical writers, while contributing to building medical writing capabilities and infrastructure within the company for exceptional cross-functional collaboration. Stay current with evolving regulatory requirements, industry trends, and methodological innovations relevant to medical writing with special focus on RNA therapeutics. Drive continuous improvement of processes, tools, and workflows to increase efficiency and quality. Creates, maintains, and implements SOPs, processes, standards, and work instructions with respect to medical writing to ensure compliance, accuracy, and efficiency. Act as a scientific and communication bridge between Discovery and Clinical Development teams. Essential Physical Characteristics: Reasonable accommodation(s) may be made to enable qualified individuals with disabilities to perform the essential functions of a job, on a case-by-case basis. On-Site Protocol: Physical presence at the ADARx Pharmaceuticals worksite is preferred, although remote candidates will be considered for this role. The Company deems full critical engagement to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. Qualifications: Advanced degree in life sciences (PhD, PharmD or MSc) with strong background in molecular biology, pharmacology, or related fields preferred. 5+ years of experience in biotech/pharmaceutical industry with medical writing responsibilities. Expertise in regulatory writing and clinical development for RNA therapeutics, oligonucleotides, gene therapies, or biologics (strongly preferred). Proven track record contributing to or leading major regulatory submissions (IND/CTA, NDA/BLA/MAA). Strong understanding of clinical trial design, pharmacology, and RNA-specific therapeutic considerations (delivery, immunogenicity, biodistribution). Exceptional communication, writing, and editing skills with the ability to distill complex science for diverse audiences while incorporating input from cross functional subject matter experts (SMEs). Leadership experience is preferred Strategic thinker with the ability to integrate clinical science and regulatory strategy with SMEs. Passion for advancing RNA-based therapies to address unmet medical needs. Comfortable working in a fast-paced, entrepreneurial biotech environment Required Key Attributes: Must be able to work independently with supervision as needed. Must be collaborative, work well with other Clinical Development team members in a matrix team environment. Excellent written and verbal communication skills are essential for this role. Strong organizational skills with attention to detail and accuracy. Ability to maintain a high level of confidentiality and exercise discretion. Adaptable / Flexible - willing and able to adjust to multiple demands and shifting priorities as well as an ability to meet day-to-day challenges. Understand project timelines and deliverables and plans/coordinate project work accordingly with departmental, functional, and external stakeholders. Compensation: This is a full-time position, Monday-Friday. Pay is commensurate with experience. Equity-based compensation Performance-based bonuses 401(k) with Company Match Medical, Dental, Vision Flexible Spending Account Life Insurance Employee Assistance Program Employee Discounts Gym Membership Paid Vacation Paid Holidays Paid Sick, Jury Duty, Bereavement Work Authorization: United States (Required) Background Check As a condition of employment, you must successfully complete all post-offer, pre-employment requirements, including but not limited to a background check. Company Overview: ADARx Pharmaceuticals, Inc., (the “Company” or “ADARx”) located in San Diego, is a late-clinical stage biotechnology company committed to turning cutting-edge science into life-saving therapeutics. ADARx has developed proprietary RNA targeting platforms and technology for silencing or editing target mRNA. ADARx has a growing pipeline of RNA targeting therapeutics for treating diseases across a range of therapeutic areas including genetic, cardiometabolic, complement-mediated diseases and central nervous system. ADARx currently has multiple active programs in development with the lead candidate in the clinic. We are well-financed by a syndicate of highly regarded investors. ADARx Pharmaceuticals is an EEO employer committed to an exciting, diverse, and enriching work environment. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. Disclosure Statement The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual target bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, type and length of experience within the industry, and other job-related factors permitted by law. Total Compensation includes base salary; benefits: medical, vision, and dental insurance; life insurance; 401(k) matching program; paid time off; paid holidays; Employee Assistance Program; and other employee benefits. This role may also be eligible for short-term or long-term incentive compensation, including but not limited to cash bonuses. Following a conditional offer of employment, satisfactory completion of a background check (including criminal records check) is required prior to beginning employment. Any offer of employment may be rescinded if the background check reveals disqualifying information, and/or it is discovered that the candidate knowingly withheld or falsified information. Failure to satisfactorily complete the background check may affect the continued employment of a current NAI employee who was conditionally offered the position.

Position Overview: We are seeking a highly qualified and experienced Senior Medical Writer to join our team. The ideal candidate will have over 10 years of experience in medical writing, with a proven track record of producing high-quality, scientifically accurate, and regulatory-compliant documents. This role offers the opportunity to work on a variety of projects, collaborate with cross-functional teams, and contribute to the success of our clients and products. Key Responsibilities: Lead the development of clinical and regulatory documents, including clinical study reports, protocols, investigator brochures, and regulatory submission documents. Ensure all documents are scientifically accurate, clear, and adhere to regulatory guidelines and company standards. Collaborate with cross-functional teams, including clinical research, regulatory affairs, biostatistics, and project management, to gather and interpret complex scientific data. Provide strategic input and expertise on clinical development plans, regulatory strategies, and publication plans. Mentor and guide junior medical writers, providing training and feedback to foster professional growth and development. Stay current with industry trends, regulatory requirements, and best practices in medical writing. Qualifications: A minimum of 8-10 years of experience in medical writing within the pharmaceutical, biotechnology, or medical communications industries. Advanced degree in a life science discipline (PhD, PharmD, MD) preferred. Extensive knowledge of clinical development and regulatory processes. Exceptional writing, editing, and communication skills, with a keen attention to detail. Strong organizational skills and the ability to manage multiple projects and deadlines simultaneously. Proficiency in Microsoft Office Suite and familiarity with document management systems. Ability to work independently and as part of a collaborative team.

The Arc Institute is a new scientific institution conducting curiosity-driven basic science and technology development to understand and treat complex human diseases. Headquartered in Palo Alto, California, Arc is an independent research organization founded on the belief that many important research programs will be enabled by new institutional models. Arc operates in partnership with Stanford University, UCSF, and UC Berkeley. While the prevailing university research model has yielded many tremendous successes, we believe in the importance of institutional experimentation as a way to make progress. These include: Funding: Arc fully funds Core Investigators' (PIs') research groups, liberating scientists from the typical constraints of project-based external grants. Technology: Biomedical research has become increasingly dependent on complex tooling. Arc Technology Centers develop, optimize, and deploy rapidly advancing experimental and computational technologies in collaboration with Core Investigators. Support: Arc aims to provide first-class support-operationally, financially, and scientifically-that will enable scientists to pursue long-term high risk, high reward research that can meaningfully advance progress in disease cures, including neurodegeneration, cancer, and immune dysfunction. Culture: We believe that culture matters enormously in science and that excellence is difficult to sustain. We aim to create a culture that is focused on scientific curiosity, a deep commitment to truth, broad ambition, and selfless collaboration. Arc has scaled to nearly 300 people to date. With $650M+ in committed funding and a state of the art new lab facility in Palo Alto, Arc will continue to grow quickly in the coming years. About the position As Arc's Scientific Writer, you'll serve as the bridge between Arc's world-class interdisciplinary research and its diverse audiences. You'll work collaboratively with Arc's Core Investigators, Science Fellows, Innovation Investigators, and Tech Center researchers to ensure their work is accurately and compellingly communicated to other researchers, employees, and other Institute audiences. You'll develop a deep understanding of Arc's science, the Institute's's goals, and where everything fits into the larger research ecosystem to prepare content that resonates with scientific readers. This is a hybrid onsite role, reporting to the Head of Communications. About you Exceptional writer, editor, and presenter with a portfolio of work communicating to researcher and/or technical audiences Thoughtful about translating complex science for target audiences without sacrificing accuracy Detail-oriented professional who asks good questions, takes feedback well, and understands the importance of scientific precision Strong collaborator who can work effectively with diverse research teams and support staff Lifelong learner who is excited to communicate about a range of research happening at the interface of biology, AI, engineering, neuroscience, and immunology In this position you will Write and edit research updates, blog posts, press releases, and web content that accurately represents Arc's diverse research portfolio Assist researchers with journal commentaries and perspective manuscript preparation, particularly in translating technical findings for broader scientific audiences Collaborate with Arc scientists to develop presentations for internal meetings, conferences, and stakeholder presentations Work closely with Arc scientists to understand and communicate emerging research developments while identifying opportunities to participate in broader scientific discussions that could raise Arc's profile Identify opportunities for strategic content that would help Arc tell its story Requirements PhD in biological sciences, computational biology, machine learning, neuroscience, or related field with demonstrated research experience 3+ years conducting original scientific research with a track record of peer-reviewed publications Proven ability to write about complex scientific topics for both technical and general audiences Experience creating presentations and visual materials for scientific audiences Excellent project management skills and ability to work on multiple pieces simultaneously Able to commit to a hybrid onsite schedule. The base salary range for this position is $110,250 - $135,500. These amounts reflect the range of base salary that the Institute reasonably would expect to pay a new hire or internal candidate for this position. The actual base compensation paid to any individual for this position may vary depending on factors such as experience, market conditions, education/training, skill level, and whether the compensation is internally equitable, and does not include bonuses, commissions, differential pay, other forms of compensation, or benefits. This position is also eligible to receive an annual discretionary bonus, with the amount dependent on individual and institute performance factors.

Candidate Required Qualifications MPH or equivalent of education and experience. Minimum of 5 years' experience in public health communication Advanced understanding of public health data and research, and ability to work with researchers and analysts to use data to tell a coherent story for a broad audience. Significant experience with interpreting epidemiologic and scientific information and translation into written and visual messaging that is understandable to a broad audience. Excellent written communication skills. Experience writing talking points and other content for multiple and broad audiences, including the media. Comfortable handling sensitive and confidential information. Proficiency with Microsoft PowerPoint and Microsoft Excel, including creating and formatting multiple types of graphs and charts. Bilingual Spanish is a plus. Competitive salary and benefit package (PTO, medical, dental, vision, life insurance), office perks, dog-friendly office.

Job Description Number of hours per week: 24-40 hours Shift timing/schedule: 9AM-5:30 PM (with 30 min lunch break) Hybrid schedule (how many days onsite/at home): Remote and is available for inperson for weekly brainstorming/white-boarding meetings Library Science Professional: The Periyakoil Lab is seeking a detail-oriented and creative professional with training in library and information science to support the development of high-quality curricular materials for academic research programs. The ideal candidate will have experience in organizing and curating educational content, applying information literacy principles, and working collaboratively with faculty or instructional teams. Strong writing, editing skills are essential, along with a passion for making complex information accessible and engaging for learners. Desired Qualifications: The ideal candidate will hold a degree in Library and Information Science, with demonstrated experience in organizing and curating educational or research materials. A strong understanding of information literacy principles, metadata standards, and digital resource management is essential. Experience collaborating with faculty or instructional teams to develop curricular content is highly desirable, as is familiarity with learning management systems, instructional design tools, or open educational resources (OER). Requirements: Education & Experience (Required): Bachelor\'s degree and three years of related experience, or a combination of education and related experience. Knowledge, Skills And Abilities (Required): Demonstrated knowledge of library and information science principles, including information organization, metadata standards, and digital resource curation Understanding of information literacy frameworks and best practices for supporting learner engagement Proven success in writing for publication in print, web, and other platforms. Excellent writing and communication skills with proven ability to write, edit, and organize thoughts in a clear, concise, and well-organized manner. Ability to understand materials of moderate complexity and synthesize across multiple sources to produce materials for trainees. Ability to manage and prioritize multiple deadlines. Excellent time management skills. Physical Requirements: Constantly perform desk-based computer tasks. Frequently stand/walk, sit, grasp lightly/fine manipulation, and use a telephone, writing by hand. Occasionally reach/work above shoulders, grasp forcefully, and sort/file paperwork or parts, lift/carry/push/pull objects that weigh up to 10 pounds. Visual and auditory acuity, including color vision required.

TEN: The Enthusiast Network is seeking a full-time Editor-in-Chief, HOT ROD for the El Segundo, CA office.

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

A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty aretas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description The Contractor will work in three phases: Phase 1 - Document Initiation • At initiation of a new deliverable, the relevant Therapeutic Area (TA) authoring team will provide the Contractor FTE with all relevant information required to complete the deliverables, including a description of the required activities, names of colleagues who will be providing input, timelines, the names of reviewers and approvers and the final handover customer. • All documents should be prepared according to submission-ready standards. • Each document will be prepared according to the project team specified timelines, and such timelines will be clearly communicated to the Contractor FTE. Phase 2 - Document Development • After agreement of the document strategy between team and the Contractor FTE, the POC will communicate with the Contractor FTE regularly, or as needed, to discuss progress (the Contractor FTE should not wait for a scheduled meeting in order to resolve issues that prevent progress) • More urgent jobs may require daily meetings in order to meet project timelines • The Contractor FTE may coordinate and lead meetings (e.g., regularly scheduled team meetings, immersion meetings to review comments, etc.) • Documents should be prepared and maintained in Global Document Management System (GDMS) at all times to enable real time review of the current draft. • The POC will act as facilitator between the Contractor FTE and customer and/or contributor, as needed, to ensure waiting times are minimized • At the time the draft document is deemed ready for team review, the POC will review an early draft and provide comment and strategic direction as necessary to ensure the document meets needs. • Following this step, the relevant TA authoring member confirms that the draft is ready for full internal team review and either the relevant TA authoring member, or the Contractor FTE, sends the document for team review as per internal SOP(s). Phase 3 - Document Completion • Once comments are received, the Contractor FTE addresses editorial comments and updates the documents. • Technical comments that enhance accuracy and clarity of the document may also be addressed by the Contractor FTE; however, any comment where interpretation is changed, or where there may be uncertainty on how to address the comment, should be raised to the POC. • The POC will then discuss these review comments with the Contractor FTE and they will agree how they should be addressed. • For any review comments not implemented, a reason for not doing so should be communicated to reviewers. • If deemed necessary, a meeting with reviewers may be held to discuss and resolve comments. • The Contractor FTE may coordinate and lead meetings (e.g., regularly scheduled team meetings, immersion meetings to review comments, etc.) • QC will be conducted internally and the Contractor FTE will work with the team to address comments. • Once any QC findings have been addressed, the Contractor FTE sends the document with corrections highlighted to the PCO for final review. • If satisfactory, either the POC or the Contractor FTE sends the document for approval and once having achieved this, ensures that the document is final and approved in GDMS. • Finally, the Contractor FTE notifies the pre-defined handover customer and the POC of completion. • If relevant, the Contractor FTE will participate in activities to complete an Integrated Quality Control Plan (IQCP), which is included in SOP QMS05; the need for undergoing an IQCP will be communicated at initiation of the process by the POC. • In addition, the Contractor FTE will support any additional QC requirements as mandated by the relevant SOPs. Qualifications • A minimum of a BA or BS is required. Advanced degree (MS, PhD, JD, MD, and/or PharmD) preferred. • At least 5 years medical writing experience with a bachelor's degree; 10+ years of experience preferred and advanced degree preferred. • Competent in analyzing and understanding complex datasets and conveying that information in clear and concise written form in support of authoring required document types to support global pharmaceutical submissions; direct experience authoring Module 2 and Module 5 summary documents of the common technical document required for this position. Medical Document Knowledge- • Advanced knowledge of clinical research, drug development process, regulatory requirements, good clinical practices, human patho-physiology and diseases (advanced experience in vaccines development would be an advantage). • Can summarize raw data for submission to the FDA/EMA, internal use, and/or presentations at other venues, as needed. • Ability to express medical/scientific terms in a clear, accurate and succinct way. • Knowledge of regulatory requirements/regulations, guidelines, and standards. Project Scope- • Authoring, updating, and reviewing of summary medical documents to agreed-upon specifications. • Working collaboratively with project team and leading document preparation meetings (e.g., addressing document review comments), as necessary. • Population of the document with relevant input • Sending document on review and updating, and ensuring document is fit for purpose prior to internal QC. • Achieving approval of the document. Additional Information Warm Regards Ricky Bansal 732-429-1925

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. 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.Hybrid (1-2 days in office to align with company policy). Seeking candidates who are regulatory medical writers (not Medical Communication) The Contract 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 Drafts and edits documents used for submissions including CTDs and RtQs Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, and informed consent forms Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PSURs, DSURs, etc.) 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 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. SUPERVISOR RESPONSIBILITY None.CONTACTSClinical Medical Writing, Biostatistics, Clinical Data Management, Statistical Programming, Clinical Operations, Medical Affairs, Medical Directors, Regulatory Affairs, Legal, Commercial, Pharmacology/Toxicology, Corporate Compliance, Project management, Pharmacovigilance. EQUIPMENTAccess to corporate computer network, production computing environment, and MS Windows software. Skills Fulfills one of the following: Medical writer in the pharmaceutical industry Medical or scientific writing experience as a primary job responsibility Skill and Experience: At least 5 years experience required Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies. Familiar with clinical study data collection and results reporting. Previous protocol development experience required. Experience writing, reviewing, or editing protocols and clinical study reports highly preferred. Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred. Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content. Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals. Ability to interpret basic tabular and graphical clinical data presentations. Ability to create basic tables using AMA style (eg, Schedule of Events). Intermediate applied knowledge of basic clinical laboratory tests. Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Basic understanding of biostatistical and clinical research concepts.Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint. Experienced with scanners, printers, and copiers.Basic knowledge of regulatory requirements and guidances associated with ‘standalone' regulatory documents (eg, protocols, investigator brochures, and clinical study reports). 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.Good conflict management skills.Motivated and shows initiative. Detail oriented.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. Education Bachelor's or higher degree; scientific focus desirable. Evidence of medical writing career development desirable, eg, American or European Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

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 Experience Fulfills 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: odocumentation required for the conduct of clinical studies oprotocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs) ostudy 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. The salary range for this position is: $74,100 to $100,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit: