Freelance medical writer jobs near me - 256 jobs

, candidate must be located within the USA About This Role The Principal Medical Writer serves as a scientific communication and innovation leader within Biogen's Medical Writing department, focusing on leveraging Generative AI (GenAI) technologies to transform regulatory writing. In this role, you will combine your expertise in regulatory document strategy with forward-looking approaches to content generation, automation, and AI-enabled writing support. You will author and oversee preparation of high-quality clinical regulatory documents (e.g., clinical summaries, CTAs, INDs, and briefing packages) and collaborate closely with cross-functional teams to ensure clarity, accuracy, and consistency. Additionally, you will work on collaborative initiatives with internal and external partners to develop and pilot GenAI tools that enhance efficiency, quality, and compliance in medical writing workflows. Coding experience is not required, but a strong curiosity and comfort with GenAI tools (e.g., ChatGPT, Claude, Gemini, Copilot, etc.)-and an ability to apply them in daily work-will be key to success. What You'll Do Provide medical writing leadership and authoring expertise for assigned program(s), ensuring timely delivery of regulatory and clinical documents of the highest quality. Lead or contribute to innovation projects applying GenAI to automate and optimize regulatory writing processes in collaboration with internal stakeholders (e.g., Data Science, Regulatory, and Clinical teams) and external partners. Serve as a GenAI champion within the Medical Writing function-sharing best practices, identifying use cases, and promoting responsible adoption of AI-enabled tools. Provide strategic input and writing support for major submission documents such as Clinical Overviews, Summaries, and regulatory briefing packages. Mentor and guide junior writers, providing oversight and feedback on content, timelines, and quality expectations. Support the development of GenAI training materials and process enhancements to upskill the medical writing team. Contribute to departmental initiatives that foster innovation, efficiency, and continuous improvement. Ensure consistency of scientific messaging and alignment with therapeutic area strategy across documents. Who You Are You are an experienced regulatory writer who combines deep scientific and communication expertise with an innovative mindset. You are eager to explore how AI can transform regulatory writing and are comfortable experimenting with new technologies to improve workflows. You excel in cross-functional collaboration, balance strategic thinking with hands-on writing, and are passionate about quality, compliance, and innovation. Required Skills Bachelor's degree in Life Sciences or a health-related discipline required; advanced degree (MS, PhD, PharmD, MD) preferred. At least 7 years of experience in the biopharmaceutical industry (advanced degree or academic research may substitute for some experience). Minimum 5 years of hands-on medical writing experience supporting clinical regulatory submissions (e.g., CTD, IND, NDA/BLA components). Demonstrated expertise in therapeutic area document requirements and global regulatory standards. Familiarity with large language models (LLMs) and GenAI applications for writing, summarization, or data interpretation. Proven ability to manage multiple complex deliverables, work effectively in a matrixed team, and mentor others. Excellent written and verbal communication skills, with meticulous attention to scientific and regulatory accuracy. Preferred Skills Experience or strong interest in applying GenAI tools for writing, document review, or data summarization. Ability to translate AI capabilities into practical solutions within regulated environments. Understanding of ethical and compliance considerations for AI use in scientific communication. Job Level: Management Additional Information The base compensation range for this role is: $132,000.00-$176,000.00 Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity. Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance. In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being ; including, but not limited to: Medical, Dental, Vision, & Life insurances Fitness & Wellness programs including a fitness reimbursement Short- and Long-Term Disability insurance A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31) Up to 12 company paid holidays + 3 paid days off for Personal Significance 80 hours of sick time per calendar year Paid Maternity and Parental Leave benefit 401(k) program participation with company matched contributions Employee stock purchase plan Tuition reimbursement of up to $10,000 per calendar year Employee Resource Groups participation Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Senior Medical Writer and Medical Writer, Market Access Craft Compelling, Data-Driven Content That Shapes Market Access Strategy Remote Position (EST Hours) Join a fast-growing, high-impact division within an established, financially stable agency. As a Medical Writer, Market Access, you will play a critical role in developing strategic, scientifically accurate content that drives brand differentiation and maximizes access goals. Working closely with internal teams and clients, youll translate complex clinical data into clear, compelling narratives that support payer engagement and brand success. Note: This is a remote position. Candidates may be based in PST or CST but must be available to work EST hours (with some flexibility). Key Responsibilities Content Strategy & Development Develop a deep understanding of assigned products, therapeutic areas, and competitor landscapes. Lead content creation efforts, crafting engaging, high-quality materials that support market access strategies with minimal oversight. Translate complex clinical and health economics data into clear, compelling, and strategically relevant content for a variety of digital and print assets. Ensure all resources are scientifically accurate, well-referenced, and compliant with regulatory guidelines. Guide medical/regulatory approval submissions, incorporating client and compliance feedback efficiently. Identify credible sources and ensure adherence to the agencys standards for referencing and citations. Proactively explore new, innovative ways to present data, enhancing impact and readability. Collaboration & Client Engagement Work closely with Account, Creative, and Market Access Strategy teams to develop content that aligns with client objectives. Act as a trusted medical resource, supporting internal teams and client discussions with scientific expertise. Defend content choices and perspectives in client interactions, ensuring strategic alignment and accuracy. Partner with creative teams to develop accurate and effective visuals that support medical messaging. Research, Thought Leadership & Operations Support research and development efforts for new business pitches, contributing to strategic recommendations and the medical portion of proposals. Educate internal teams on clinical and market access topics, strengthening agency-wide expertise. Stay informed on industry trends, FDA regulations, and best practices to maintain high standards in content development. Qualifications 3+ years of experience in medical writing or scientific content development, with a strong focus on market access. Advanced degree (PhD, PharmD, MD, or equivalent) preferred; strong scientific or clinical background required. Experience across multiple therapeutic areas; prior launch experience is a plus. Proven ability to distill complex scientific and economic data into engaging, strategic content. Strong understanding of FDA marketing regulations, AMA style, and compliance best practices. Ability to prioritize multiple projects, meet deadlines, and adapt in a fast-paced, collaborative environment. Excellent communication and stakeholder engagement skills. Willingness to travel periodically for client meetings or industry events. Salary & Benefits Base Salary: $100K - $160K (dependent on experience) Performance-Based Bonus Unlimited PTO Comprehensive Benefits Package Career growth opportunities in a high-impact, innovative team environment This is a fully remote opportunity to contribute to a growing, forward-thinking agency where your scientific expertise and writing skills will make a tangible impact. Candidates must be able to work EST hours, flexible for those in PST or CST. We'd love to hear from you if you're passionate about creating high-quality, strategic medical content!

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

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

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.

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

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

We are the company that cares - for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 3000 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them. Job Description Writes, edits, and reviews documents, including informed consent forms, patient information, and other project-specific clinical documentation. Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives. Collects and tracks documents for CSR appendices, in support of the Quality Control Associates. Performs quality control (QC) reviews of PSI-developed documents, in support of the Quality Control Associates. Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks. Collaborates with the Process Improvement narrative automation team to develop patient safety narratives. Qualifications College or university degree, preferably a Bachelor's or Master's degree in biomedical or life sciences fields, or an equivalent combination of education, training, and experience that presents the required knowledge, skills, and abilities. Equivalency is defined as a minimum of 2 years of experience in medical and/or regulatory writing and related tasks. Minimum 2 years of corresponding industry experience working with clinical documentation and data Prior pharmaceutical, biotechnology, or contract research organization experience Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of documents Basic knowledge of electronic Common Technical Document (eCTD) requirement Additional Information If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you.

FSP Senior Regulatory Medical Writer (Remote; US) At Thermo Fisher Scientific, you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development, and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Summarized Purpose: We are excited to expand our Medical Writing Functional Service Partnership (FSP) Team and are seeking candidates based in the US! As a remote-based Senior Medical Writer within the FSP team, you will provide high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. You will collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence. Our ideal candidate will possess the versatility to author both clinical and preclinical regulatory documents, with therapeutic area expertise in infectious diseases and/or oncology. Essential Functions: Serves as a primary author who writes and provides input on routine clinical documents such as clinical study reports and study protocols and summarizes data from clinical studies. Serves as a primary author who writes complex clinical and scientific and program level documents, including IBs, bioassay reports, INDs, and MAAs. Reviews routine documents prepared by early career team members. May provide training and mentorship for writers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge. Ensures compliance with quality processes and requirements for assigned documents. Provides input on and independently develops best practices, methods, and techniques for achieving optimal results, including various client-specific processes. May assist in program management activities. Identifies and resolves out of scope activities. Duties could include developing timelines, budgets, forecasts, and contract modifications. Represents the department at project launch meetings, review meetings, and project team meetings. Education and Experience: Bachelor's degree in a scientific field or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred. Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years). Experience working in the pharmaceutical/CRO industry preferred. If CRO experience: experience working in a client-dedicated role or with 1-2 clients over multiple projects is preferred. Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous. In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role. Knowledge, Skills, and Abilities: Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills Strong project management skills Excellent interpersonal skills including problem solving. Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Significant knowledge of global, regional, national, and other document development guidelines In-depth knowledge in a specialty area such as preclinical or regulatory submissions, etc. Great judgment and decision-making skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g., Excel, Outlook). What We Offer: At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development program, ensuring you reach your potential. As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.

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 The position works either onsite in El Segundo, CA; Torrey Pines, CA; or remotely depending on the candidate's geographic location. 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.

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

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

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

at Vaniam Group Medical Writer, Scientific Communications What You'll Do The Medical Writer, Scientific Communications is responsible for writing strategically aligned and accurate materials that meet the high-quality standards of Vaniam Group. You will play a supporting role in managing client satisfaction and relationships. In addition, you are responsible for supporting business improvement by meeting personal and departmental goals and objectives effectively and on time. A Day in the Life Deliverables Develop high-quality content for an array of projects, including publications (eg, abstracts, presentations, and manuscripts), advisory boards, scientific platforms, gap analyses, literature summaries, slide sets, and training materials Develop materials that are grammatically accurate and audience appropriate Client Responsibility Gain an understanding of the treatment landscape and strategic positioning of client products to help produce strategically aligned materials Assess project needs and challenges; identify and implement solutions to meet productivity, quality, and client goals while maintaining compliance standards Participate in client meetings and answer questions about projects when necessary Internal Responsibility Build strong partnerships with and understand the importance of meeting the needs of internal teams Demonstrated ability to effectively utilize time to manage duties, communicating proactively when unable to meet timelines Work on multiple projects concurrently, prioritizing appropriately Collaborate with team to execute project and meet deadlines Emerging ability to assess areas for opportunity and improvement Business Development Ensures that work is of the highest quality and instills confidence for clients Begin to think strategically about work and develop an awareness of the work's impact on business strategy Other duties may be assigned to help drive deliverables within this role. What You Must Have Education and Experience PhD in life sciences, MD, or PharmD At least 1 year of work experience in an agency, the pharmaceutical industry, or a related scientific or medical writing position. Preference will be given for experience in hematologic or solid tumor oncology Working knowledge of digital marketing Skills and Competencies Commitment to ethical and transparent data dissemination standards Demonstrated ability to work collaboratively in a dynamic team environment Excellent interpersonal, organization, verbal, and written communication skills Excellent quantitative and analytical skills and ability to synthesize complex or diverse information Excellent problem-solving skills, including the ability to analyze information skillfully, develop alternative solutions, and work well in group problem-solving solutions Strong attention to detail and listening skills Ability to meet tight deadlines and have excellent time management skills Highly proficient with the following: MS Office (Word, Excel, PowerPoint, Outlook), Adobe, Google or similar calendar system, familiarity with EndNote, and Zoom (or other similar systems) preferred What You Might Have, but Isn't Required At least 1 year of experience as an oncology (solid tumors and/or hematologic malignancies) medical writer Familiarity with EndNote or other reference management software and publication database (ie, DataVision) Proficient in PubMed or other scientific/medical search websites Travel Requirements Travel within the US and internationally as necessary, based on project, sponsor, and organizational needs ( The Team You'll Work Closest With You will work closely with the Scientific Communications team and partner with the Client Services, Editorial, and Creative departments depending on the project need. Why You'll Love Us: 100% remote environment with opportunities for local meet-ups Positive, diverse, and supportive culture Passionate about serving clients focused on Cancer and Blood diseases Investment in you with opportunities for professional growth and personal development through Vaniam Group University Health benefits - medical, dental, vision Generous parental leave benefit Focused on your financial future with a 401(k) Plan and company match Work-Life Balance and Flexibility Flexible Time Off policy for rest and relaxation Volunteer Time Off for community involvement Emphasis on Personal Wellness Virtual workout classes Discounts on tickets, events, hotels, child care, groceries, etc. Employee Assistance Programs Salary offers are based upon several factors including experience, education, skills, training, demonstrated qualifications, location, and organizational need. The range for this role is $70,000 - $85,000. Salary is one component of the total earnings and rewards package offered. About Us: Vaniam Group is a people-first, purpose-driven, independent network of healthcare and scientific communications agencies committed to helping biopharmaceutical companies realize the full potential of their compounds in the oncology and hematology marketplace. Founded in 2007 as a virtual-by-design organization, Vaniam Group harnesses the talents and expertise of team members around the world. For more information, visit ******************** Applicants have rights under Federal Employment Laws to the following resources: Family & Medical Leave Act (FMLA) poster - ********************************************* EEOC Know Your Rights poster - *************************** Employee Polygraph Protection Act (EPPA) poster - **************************************************************************

At Real Chemistry, making the world a healthier place isn't just an aspiration-it's our everyday reality. Our drive to transform healthcare is informed by our blend of deep scientific expertise, human-centred creativity, and AI-driven insights, fostering a unique environment where innovation thrives and our people are impact-obsessed. As a global agency, we provide a full suite of services across healthcare communications and marketing to our clients, including top players in the pharmaceutical and biotech industries. Our #LifeatRealChem culture is rooted in our people-we believe we are best together and are committed to excellence for both our clients and colleagues. Whether you're a seasoned professional or just starting your career, if you share our passion for healthcare and connection, we invite you to explore our opportunities. Discover your purpose. Embrace innovation. Experience #LifeatRealChem. Real Chemistry is looking for a Medical Writer to join our growing team! This is a hybrid role, based in any of our US offices-including New York City, Boston, Chicago, Carmel, or San Francisco-or remotely within the US, depending on team and business needs. What you'll do: Develop scientific copy for various deliverables on assigned brands and products Work independently and collaboratively with medical writers and directors to develop scientifically accurate copy Understand medical strategy and content objectives for assigned projects and accounts Proactively check-in with senior medical leads on project deliverables and raise questions as needed Review current literature for assigned therapeutics areas, including competitor products Understand and adhere to AMA/client style guidelines as directed Ensure references are accurate and research additional references or source materials as necessary Annotate and highlight references for medical review Manage workflow for assigned projects and meet associated deadlines Communicate with clients and/or KOLs to present scientific projects for review and feedback Incorporate and discuss edits requested by clients, KOLs, and/or internal reviewers Attend and participate in kickoff, status, and other job-related meetings Collaborate with creative and illustrative team members to make scientific data visually compelling and scientifically accurate Provide medical guidance to team by maintaining up to date scientific knowledge for assigned brands and products This position is a perfect fit for you if: Our Company values - Best Together, Impact-Obsessed, Excellence Expected, Evolve Always and Accountability with an “I” - really speak to you. You are adaptable, resilient, and OK with adjusting your scope, responsibilities, and focus as we grow. When things change, so do we. We're always evolving. You are proactive, driven, and resourceful with strong prioritization skills and a desire to dive into the data. You are highly organized self-starter, able to work independently and under tight deadlines. What you should have: Advanced degree (eg, MD, PhD, PharmD) required Up to 1 year of previous medical writing experience in a medical communications agency preferred, but not essential Familiarity with FDA, AMA and other relevant guidelines Strong scientific foundation with capability to rapidly become familiar with therapeutic areas and therapies Ability to communicate complex scientific concepts clearly to a wide range of audiences Ability to work under pressure; meeting deadlines on-time and on-budget Ability to work in a team and take initiative to provide input to cross-functional team members Excellent organizational skills and strong attention to detail Computer literacy (Word, PowerPoint, Excel, reference managers) Pay Range: $75,000 - $85,000 This is the pay range the Company believes it will pay for this position at the time of this posting. Consistent with applicable law, compensation will be determined based on job-related, non-discriminatory factors including but not limited to work experience, skills, certifications, and geographical location. The Company reserves the right to modify this pay range at any time. #LI-Remote Real Chemistry is proud to be Great Place to Work certified; check out what our people shared about our culture and workplace on our Great Places to Work Profile here. We believe we can do our best when feeling our best, which is why we've put together a benefits program designed to give you the support you and your family need at every stage of life. Real Chemistry offers a comprehensive benefit program and perks, tailored to your region. Globally, this includes offices in our key markets with free snacks to keep you running all day long, generous holiday and paid time off, options for private medical, dental, and vison plans, and support in saving for the future. Other perks include mental wellness coaching and support and access to more than 13,000 online classes with LinkedIn Learning. Learn more about our great benefits and perks and search specific offerings in your region at: ****************************** Working with Real HART: Since the pandemic, we have adapted to how our people told us they want to work. We have office locations in cities in the US, UK, and Europe with many employees and clients that serve as hubs where and when they need us. For employees who are within an hour of one of our offices, we expect attendance in the office two days per week, either at a Real Chemistry office or onsite with clients. We are also actively opening new office locations, so if one opens near you, our Real HART policy will apply. We are not looking for attendance for the sake of attendance but believe that the opportunity to coordinate in-office team meetings, 1:1 meetings with managers, taking advantage of on-site learning, and connecting with client partners is a critical to delivering on our purpose of making healthcare what it should be. Outside of these offices, we have regions, where people work remotely but come together quarterly for collaboration, culture and learning opportunities. We call this our Real Hybrid and Regional Teams (Real HART) approach. Real Chemistry believes we are best together - and our workplace strategy fosters connection and collaboration in person - but also supports flexibility for our people. Real Chemistry is an Equal Opportunity employer. We continually strive to build and sustain an inclusive and equitable work environment where our employees feel empowered to leverage all they bring from their personal lived experience and professional expertise, to make our team the best in the industry. We encourage motivated and qualified applicants to apply without regard to race, color, religion, sex (including pregnancy), sexual orientation, gender identity/expression, ethnic or national origin, age, physical or mental disability, genetic information, marital information, or any other characteristic protected by federal, state, or local employment discrimination laws where Real Chemistry operates. Should you require accommodations throughout the interview process please let your recruiter know. *Notice: Real Chemistry and its affiliates' names are being misused by scammers through messaging services, fake websites, and apps. Do not share personal or financial information or make payments to any unverified sources claiming to be connected to Real Chemistry. We are working to stop these unauthorized activities and protect our community. Read more here.

The Associate Medical Writer will aid and support to the Clinical Services team on aspects of writing, revising, and annotating promotional medical content. This role will also assist with identifying supporting documentation, organizing references, checking accuracy of cited information, and evaluating literature for appropriate references. The Associate Medical Writer may also be responsible for development of writing projects under direct supervision. Essential functions of the job include but are not limited to: (This is NOT meant to be an exhaustive task list) Support the development of high quality, medically accurate derivative content in print or digital format for a limited range of medical communication resources Deliver requested projects per established time lines Assist with literature review to support promotional claims in a variety of promotional medical education and marketing resources Annotate resources and provide appropriate references for Clinical Services team Search, organize, and prepare references and referencing materials for projects to prepare for medical, regulatory, and legal submissions Ensure professional, proactive, and collaborative communication with internal stakeholders Ensure a constant high quality of work in line with science, good publication practice, and company rules and policies Participate in all internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings Develop working knowledge of AMA-style and brand guidelines Promote and adhere to Precision Value and Health's workplace values known as PRECISION Principles (Client Service, Purpose, Accountability, Mutual Respect and Collaboration) Required Education: BA/BS in life sciences BA/BS in English combined with 1 year of experience in a pharmaceutical agency, medical communications company or healthcare advertising. Required Experience: 0 - 1 year of experience in the medical communication, pharmaceutical and/or healthcare industry. Required Skills: Knowledge of American Medical Association (AMA) style Proficiency in Microsoft Word, Microsoft PowerPoint, and Adobe Acrobat Familiarity with scientific search engines including PubMed and Google Scholar Required Competencies: Strong written and verbal communication Analytical ability Ability to prioritize deadline-sensitive projects and juggle competing client priorities Team- and detail-oriented Preferred Qualifications: Expertise in gathering, evaluating, and summarizing healthcare business and scientific literature and insights data for a variety of managed care audiences Working knowledge of managed markets, healthcare, and the healthcare delivery system; health reform legislation; and/or managed care experience (HMO, MCO, PBM, etc.) #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$52,000-$72,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities * Maintains strong familiarity with FDA, EU, and other relevant guidelines and industry standards to ensure that documents meet or exceed sponsor and regulatory requirements and guidance. * Represents the editorial group in medical writing, on study teams, and in cross-departmental project teams as needed. * Monitors timelines and budgets for assigned projects and updates the lead medical writer, project manager, and/or direct supervisor (as appropriate) if deliverables are at risk. * Provides technical support and expertise as appropriate. Conducts training of medical editing staff and functions as a mentor. Advises medical writers, medical editors, and study teams on quality review, compilation, and editorial standards. Provides training to members of the global medical writing team in aspects relative to their roles. * Serves as project lead for deliverables of assigned complex and/or large medical writing projects, including, but not limited to, scheduling and leading internal project-specific team meetings, organizing project-specific requirements, and ensuring all information is distributed to the editorial team and implemented within the deliverable. * Serves as a member of the medical writing team for projects with medical writing deliverables. Provides feedback to the lead medical writer on progress of editorial process. * Copyedits assigned documents, applying correct grammar, punctuation, spelling, and style following AMA Manual of Style or various custom style guidelines as well as established medical writing internal checklists and best practices. * Performs quality review of assigned documents to ensure accuracy. * Contributes to the development of process improvement tools and the development or revision of internal policies and procedures affecting editorial work. * Manages assigned projects according to medical writing standard operating procedures and client standards, on time and on budget. * May compile medical writing deliverables. At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements. Salary Range: $62,000.00 - $108,600.00 The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary Improves and ensures the quality of compliance of written deliverables through copyediting, quality review, and document management. Provides advanced editorial guidance and technical expertise in the writing, production, and/or review of regulatory and other scientific/clinical documents. Independently performs advanced quality review or compilation tasks for medical writing deliverables to ensure content integrity and consistency with customer and/or regulatory submission standards. Leads editorial team for large deliverables requiring multiple editors. Interacts with medical writing leadership and staff regarding assigned deliverables as appropriate. Provides training and mentoring to other medical editing staff members.

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.

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