Manager, Medical Writing jobs at Gilead Sciences - 124 jobs

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager, Medical Writing oversees medical writing projects and team operations in compliance with regulations, GCP, and SOPs. This role leads cross-functional collaboration, manages team performance and hiring, resolves operational issues, and builds strong relationships to drive change and share best practices while ensuring high-quality deliverables and exceptional client service. How you'll make an impact: Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may indirectly manage cross-functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams Review and interpret study data analyses Contribute to the generation of product life cycle plans (e.g., post-market surveillance). What you'll need (Required): Bachelor's Degree in in related field in related experience in medical writing and clinical data analysis or equivalent work experience based on Edwards criteria Demonstrated track record in people management or equivalent work experience based on Edwards criteria What else we look for (Preferred): Master's Degree Experience working in a regulated industry or equivalent work experience based on Edwards criteria Medical writing or regulatory certification or equivalent work experience based on Edwards criteria Experience with Class III devices and CER development under MEDDEV rev. 4 and/or MDR preferred or equivalent work experience based on Edwards criteria Experience working in a regulated industry or equivalent work experience based on Edwards criteria Certification in related fields Strong leadership in project and team management, including coaching and performance oversight. Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), GCP, and ICH guidelines. Advanced knowledge of biomedical statistics, clinical literature review, and therapeutic/product operations. Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). Exceptional problem-solving, analytical, and communication skills; ability to influence and negotiate. Familiarity with coronary interventional and structural heart environments. Proven ability to develop metrics demonstrating medical writing value to the business. Ability to thrive in a fast-paced, dynamic environment with strict attention to detail. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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: 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 will make in this role: Principle Responsibilities: (essential job duties and responsibilities) Utilizes scientific and clinical expertise, along with advanced writing and analytical skills, to research, develop, edit, format, and proofread medical and scientific publications in English. Produces a variety of medical/scientific documents-including abstracts, posters, and manuscripts-in compliance with relevant journal and conference requirements. Reports to the Medical Information and Publications Manager and may provide training or supervision to junior writers or contractors as needed. Participates or leads publication panel planning meetings, contributing expertise and insights. Works independently or collaboratively as part of a project team to accomplish assigned writing projects. Demonstrates initiative in identifying and resolving challenges throughout the publication process. Maintains comprehensive understanding of all Solventum product literature. Effectively manages and prioritizes multiple projects to ensure timely completion of tasks. Assists with special writing projects as assigned. 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, with 7-10 years of experience in medical and scientific publications research and authorship. Proficient in Microsoft Office applications, including Word, Excel, Access, and PowerPoint, or equivalent PC programs. Experience in the design, development, and authorship of publication panels. Demonstrated expertise in medical and scientific writing principles and practices. Additional qualifications that could help you succeed even further in this role include: Master's or PhD degree in Science or related field Knowledge of Solventum products Advanced writing, critical thinking, and analytical abilities. Exceptional communication and presentation skills. Strong organizational skills and attention to detail, with the ability to work independently and collaboratively within a team environment. Proven ability to interact effectively with employees and external business partners while maintaining a positive, service-oriented approach. Demonstrated capacity to handle confidential information with discretion and exercise sound business judgment. Work location: Remote Travel: May include some [domestic/international] travel Relocation Assistance: May be 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 $137,439 - $167,981, 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. 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.

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: This position is responsible for the development of patient safety narratives for Phase 1-4 clinical trials in accordance with the client's controlled processes based on data listings and/or safety reports (eg, CIOMS). Essential Functions of the job: Narrative Writing: Writes, edits, reviews, finalizes, and tracks patient safety narratives based on data listings and/or safety reports (eg, CIOMS) provided by the client. Prepares clear and accurate narratives based on Clinical Database and Safety Database outputs and ensures their appropriate medical cohesiveness. Identifies crucial discrepancies between the clinical and safety databases, investigates discrepancies and provides recommendations regarding relevance and resolution Be able to handle multiple narratives at the same time to provide finalized documents which incorporate client/vendor medical review as well as any Quality Control (QC) findings. Ensures the work is complete and of high quality, including final quality control checks, compilation and formatting. Participates in or leads process improvement activities to develop patient safety narrative capabilities Ensure adherence to regulatory requirements and internal quality standards. Project oversight: Ability to manage timelines and quality of work using strong organizational, communication, and facilitation skills. Builds connection with study team(s) and other related departments to develop safety narrative scope, provide and maintain narrative tracker for each project/study, ensure Responsible for leading and coordinating external vendors to ensure successful delivery of projects within defined timelines, budgets, and quality standards Involved in strategic planning, financial oversight, and proactive risk management to support organizational goals Support for medical review and accuracy of narratives, as appropriate Other Qualifications & Experience Prior pharmaceutical, biotechnology, or contract research organization experience Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process Basic knowledge of electronic Common Technical Document (eCTD) requirements Demonstrated capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write concise unambiguous medical text in English Working knowledge of an electronic document management system and PDF annotation tools to facilitate document reviews. Effective interpersonal skills to work well in a matrix team environment and with colleagues at all levels in the organization. Experience with automation tools for the development of narratives Supervisory Responsibilities: Manages and supervises staffing and performance management, including, but not limited to, hiring, training, coaching, and performance reviews for direct reports, if applicable. Experience/Education Required: Advanced degree (MS/PhD/PharmD/MD) in life science/pharmacy/medical/health-related science is preferred. MS with a minimum of 5+ years of narrative writing (or equivalent) experience. PhD/PharmD/MD with a minimum of 3+ years of clinical safety narrative (or equivalent) experience. Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters Teamwork Provides and Solicits Honest and Actionable Feedback Self-Awareness Acts Inclusively Demonstrates Initiative Entrepreneurial Mindset Continuous Learning Embraces Change Results-Oriented Analytical Thinking/Data Analysis Financial Excellence Communicates with Clarity Salary Range: $137,100.00 - $182,100.00 annually BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness. We are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.

Imagine how your ideas and expertise can change a patient's life. We generate extensive clinical evidence to demonstrate the effectiveness and safety of our innovations and how our products transform patients' lives. As part of our Clinical Affairs team, you'll hone your scientific curiosity and passion for evaluating data to increase access to pioneering technologies for patients in need. In close partnership with principal investigators, dedicated medical professionals, patient advocacy groups, and regulatory authorities, you will drive the evidence needed to optimize patient outcomes. Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and undertreated. Edwards' groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey. The Senior Manager, Medical Writing oversees medical writing projects and team operations in compliance with regulations, GCP, and SOPs. This role leads cross-functional collaboration, manages team performance and hiring, resolves operational issues, and builds strong relationships to drive change and share best practices while ensuring high-quality deliverables and exceptional client service. How you'll make an impact: Manage and oversee the work of small medical writing team to support clinical and regulatory submissions (e.g., clinical study reports, clinical evaluation reports) and may indirectly manage cross-functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department Identify risk, develop and lead in the implementation of strategies which may include negotiations with internal and external parties Provide medical writing expertise and collaborate with cross functional teams including Regulatory Affairs, Biostatistics, R&D, QA and Marketing on clinical data reports and plans throughout product lifecycle Manage activities with the accountability for successful completion of all deliverables. Identify risk, develop mitigation strategies, alternative solutions, resolve issues, action item follow up, etc. in collaboration with cross functional and/or matrix teams Review and interpret study data analyses Contribute to the generation of product life cycle plans (e.g., post-market surveillance). What you'll need (Required): Bachelor's Degree in in related field in related experience in medical writing and clinical data analysis or equivalent work experience based on Edwards criteria Demonstrated track record in people management or equivalent work experience based on Edwards criteria What else we look for (Preferred): Master's Degree Experience working in a regulated industry or equivalent work experience based on Edwards criteria Medical writing or regulatory certification or equivalent work experience based on Edwards criteria Experience with Class III devices and CER development under MEDDEV rev. 4 and/or MDR preferred or equivalent work experience based on Edwards criteria Experience working in a regulated industry or equivalent work experience based on Edwards criteria Certification in related fields Strong leadership in project and team management, including coaching and performance oversight. Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), GCP, and ICH guidelines. Advanced knowledge of biomedical statistics, clinical literature review, and therapeutic/product operations. Skilled in Microsoft Office Suite and publication/database tools (EndNote, Medline, PubMed). Exceptional problem-solving, analytical, and communication skills; ability to influence and negotiate. Familiarity with coronary interventional and structural heart environments. Proven ability to develop metrics demonstrating medical writing value to the business. Ability to thrive in a fast-paced, dynamic environment with strict attention to detail. Aligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families. For California, the base pay range for this position is $142,000 to $201,000 (highly experienced). The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website. Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. COVID Vaccination Requirement Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such, all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role, as a condition of employment, you will be required to submit proof that you have been vaccinated for COVID-19, unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.

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.

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.

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Arrowhead Pharmaceuticals is seeking an experienced Quality Control (QC) professional to lead the QC function supporting the development of high-quality clinical and regulatory documents across our growing RNAi therapeutic pipeline. This role is critical to ensuring that both externally submitted and internally circulated documents meet Arrowhead's standards for accuracy, clarity, compliance, and scientific integrity. The Manager, Medical Writing QC will partner closely with medical writing colleagues and cross-functional subject matter experts to oversee QC activities for Medical Writing deliverables. This role will also coordinate and manage external QC services to ensure efficient, consistent, and high-quality review support across multiple programs. Responsibilities Lead and manage the QC function within Medical Writing, including QC resource allocation, review planning, and oversight of QC timelines across multiple programs and therapeutic areas. Perform QC activities (editing and data verification) for clinical and regulatory documents, including but not limited to clinical study protocols and amendments, Investigator's Brochures (IBs), clinical study reports (CSRs), NDA/MAA components, and briefing books. Collaborate with lead medical writers and subject matter experts to identify and obtain appropriate QC source materials. Manage external QC vendors to ensure consistent, high-quality deliverables when additional support is required. Establish, track, and report QC performance metrics, and recommend process improvements to support Arrowhead's expanding pipeline. Support planning and content development for document kick-off meetings, including slide deck preparation as needed. Assist in the resolution of QC comments to ensure all feedback is addressed accurately and efficiently. Requirements: Bachelor's degree in a medically related or life sciences field with 5 years of relevant QC experience in the pharmaceutical industry, or Master's or doctoral degree with at least 3 years of relevant medical writing or QC experience in the pharmaceutical industry. Exceptional attention to detail, with the ability to identify issues in complex scientific documents Knowledge of clinical research concepts, FDA regulations, and ICH guidelines related to drug development and medical writing Demonstrated experience contributing to successful clinical documents, such as IBs, CSRs, protocols, and protocol amendments Ability to manage multiple priorities while maintaining high-quality standards Proficiency with document management systems and collaboration tools (e.g., Veeva, SharePoint) Familiarity with basic statistical concepts is a plus Prior experience working with cross-functional study teams California pay range $110,000-$150,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Job Description Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing. Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates. Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need. The Position Arrowhead Pharmaceuticals is seeking an experienced Quality Control (QC) professional to lead the QC function supporting the development of high-quality clinical and regulatory documents across our growing RNAi therapeutic pipeline. This role is critical to ensuring that both externally submitted and internally circulated documents meet Arrowhead's standards for accuracy, clarity, compliance, and scientific integrity. The Manager, Medical Writing QC will partner closely with medical writing colleagues and cross-functional subject matter experts to oversee QC activities for Medical Writing deliverables. This role will also coordinate and manage external QC services to ensure efficient, consistent, and high-quality review support across multiple programs. Responsibilities Lead and manage the QC function within Medical Writing, including QC resource allocation, review planning, and oversight of QC timelines across multiple programs and therapeutic areas. Perform QC activities (editing and data verification) for clinical and regulatory documents, including but not limited to clinical study protocols and amendments, Investigator's Brochures (IBs), clinical study reports (CSRs), NDA/MAA components, and briefing books. Collaborate with lead medical writers and subject matter experts to identify and obtain appropriate QC source materials. Manage external QC vendors to ensure consistent, high-quality deliverables when additional support is required. Establish, track, and report QC performance metrics, and recommend process improvements to support Arrowhead's expanding pipeline. Support planning and content development for document kick-off meetings, including slide deck preparation as needed. Assist in the resolution of QC comments to ensure all feedback is addressed accurately and efficiently. Requirements: Bachelor's degree in a medically related or life sciences field with 5 years of relevant QC experience in the pharmaceutical industry, or Master's or doctoral degree with at least 3 years of relevant medical writing or QC experience in the pharmaceutical industry. Exceptional attention to detail, with the ability to identify issues in complex scientific documents Knowledge of clinical research concepts, FDA regulations, and ICH guidelines related to drug development and medical writing Demonstrated experience contributing to successful clinical documents, such as IBs, CSRs, protocols, and protocol amendments Ability to manage multiple priorities while maintaining high-quality standards Proficiency with document management systems and collaboration tools (e.g., Veeva, SharePoint) Familiarity with basic statistical concepts is a plus Prior experience working with cross-functional study teams California pay range $110,000-$150,000 USD Arrowhead provides competitive salaries and an excellent benefit package. All applicants must have authorization to work in the US for a company. California Applicant Privacy Policy

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Director of Medical Writing will be responsible for helping to develop strategic leadership and management of the medical writing function and involves both a people and project-orientated focus. This position reports to the Executive Director, Medical Writing. Required Skills, Experience and Education: Driving for success in terms of people, projects, and productivity of medical writing, including all deliverables in alignment with corporate goals. Assuring the successful completion of high quality, timely and compliant document deliverables. Developing and implementing remediation plans/actions as needed. Providing medical writing leadership and guidance to full-time and contract medical writers. Assisting the Executive Director, Medical Writing, in developing budget and resource requirements for contract medical writers across multiple programs for each fiscal year. Demonstrating current and applied knowledge and understanding of regulatory requirements and standards to ensure consistent application, adherence, and timely achievement of compliant deliverables. Serving as a primary subject matter expert for the planning, design, and preparation of clinical and regulatory documents. Authoring and reviewing clinical regulatory documents as needed, including assisting teams in responding to regulatory requests. Attracting, hiring, and retaining qualified contract medical writing professionals Providing an atmosphere of training, mentorship, and coaching to align with a strategic view of the role of medical writing in clinical development. Working within the medical writing function and cross-functionally to test and develop policies regarding the use of structure content management and/or generative AI as part of clinical regulatory document processes. Structuring resourcing to ensure an effective and cost-efficient approach to covering portfolio workload and goals while ensuring sustainability and alignment with corporate goals. Providing leadership across the medical writing department through strategic input, continual process improvement, and innovation in the development and implementation of a strategic view of regulatory documents. Collaborating and partnering with cross functional leaders and other staff across project management, regulatory affairs, clinical operations, clinical development, biostatistics, and other functions. Representing the medical writing department externally with academic institutions, industry groups/peers, vendors and other entities to develop expertise and drive industry standards and best practice. Doctoral degree and 5 years of regulatory medical writing experience. Master's degree and 7 years of regulatory medical writing experience. Bachelor's degree and 8 years of regulatory medical writing experience. At least 3 years of experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources. Preferred Skills: Academic preparation in life sciences or pharmacy with at least 8 years of related experience in the pharmaceutical/biotechnology industry. Experience in oncology. Strong understanding of drug development process. Experience with authoring major clinical regulatory documents, including protocols and amendments, study reports, and marketing application summaries. Experience with structured content management and/or generative AI use in the medical writing space preferred but not required. #LI-Hybrid #LI-JC1 The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training. Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status. Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com. Base Pay Salary Range$211,000-$264,000 USD

Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted therapies designed to improve outcomes for cancer patients. We are advancing an innovative portfolio of therapeutics, drawing on leadership that previously played key roles in the design, development, and commercialization of cutting-edge targeted cancer therapies, including antibody-drug conjugate therapies (ADCs). Our most advanced pipeline programs are varegacestat (formerly AL102), a gamma secretase inhibitor which is currently in a Phase 3 trial for treatment of desmoid tumors; IM-1021, a ROR1-targeted ADC which is currently in a Phase 1 trial; and IM-3050, a FAP-targeted radioligand, which recently received IND clearance. Our pipeline also includes IM-1617, IM-1335, and IM-1340, all of which are preclinical ADCs pursuing undisclosed targets with expression in multiple solid tumors. Position Overview The Senior Manager, Medical Writing will be responsible for directly authoring and/or leading the creation of high-quality medical and scientific documents that support the development, regulatory approval, and commercialization for one or more of our products. The role will require close collaboration with internal groups, such Clinical Operations, Clinical Development, Regulatory Affairs, Biometrics, and other stakeholders, to ensure high-quality and on-time deliverables that meet regulatory standards. Candidates should possess strong medical writing and scientific communications experience, with a strong understanding of early and late-stage drug development processes. This position reports to the Head of Medical Writing. Responsibilities Regulatory and Clinical Documents Author and/or manage the preparation of medical writing deliverables such as clinical study protocols, CSRs, IBs, eCTD written/tabular summaries, clinical overviews, briefing packages, Module 2 summaries, and IND enabling documents. Develop submission strategies in collaboration with stakeholders and ensure document preparation, review, and approval follow prescribed processes and conform with appropriate regulatory guidance (i.e., GCP, ICH guidelines, and eCTD requirements). Ensure timely and successful responses to health authority questions and/or requests. Authoring of ICF and other patient facing materials In collaboration with stakeholders, facilitate the redaction of clinical study protocols and other documents that fall within the scope of the implementation of EU-CTR. Publications Author and/or manage the preparation of manuscripts, abstracts, and posters for medical and scientific conferences and journals. Collaborate with subject matter experts and external authors to develop high-quality publications. Ensure publications align with strategic communication plans and company objectives. Process Development In collaboration with internal partners, develop and implement suitable document templates, style standards, and quality control checklists to ensure consistent and high-quality deliverables. Ensure the development and maintenance of relevant SOPs and internal best practices. Innovation and Digital Solutions In collaboration with the Head of Medical Writing, evaluate and drive adoption of innovative approaches medical writing and communication strategies that may assist in document development, review, and/or QC. Qualifications Advanced degree (PhD, PharmD, MD) in a scientific discipline or related field preferred. Other relevant experience will also be considered. A minimum of 6 years of experience in medical writing and scientific communications within the pharmaceutical or biotechnology industry; oncology experience a plus. Knowledge and Skills Knowledge of regulatory requirements and guidelines (e.g., ICH, GCP, FDA, EMA, AMA style guide). Excellent writing, editing, and verbal communication skills. Strong project management skills with the ability to manage multiple projects simultaneously. Proficiency with medical writing software and tools. Exceptional attention to detail and a commitment to excellence. Strong business acumen and a deep knowledge and understanding of the drug development process. Experience managing vendors and contractors a plus. Strategic thinker with strong analytical skills and ability to work in a fast-paced environment. Collaborative and able to build effective working relationships across the organization and with external stakeholders and collaborators. Strong ethical standards and integrity. Washington State Pay Range$168,934-$202,671 USD E/E/O Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. E-Verify Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. Position Overview: Beam is seeking a highly talented and motivated AD/Director to join our growing Medical Writing team. The AD/Director will be responsible for creating, authoring, and leading the management of key documents for regulatory filings and clinical studies, such as clinical protocols and amendments, clinical study reports, investigator's brochures, safety and efficacy summaries, and other documents required for regulatory submissions. Working across functions such as clinical operations, regulatory affairs, medical, biostatistics, and pharmacovigilance, this role will represent Medical Writing on study teams and will report to the VP of Medical Writing. Responsibilities: * Act as lead writer for clinical regulatory documents for the hematology program. * Plan and lead the development of clinical study documents, working with cross-functional colleagues. * Work closely with the regulatory team and other writers on regulatory document submissions. * Assist with developing and maintaining medical writing process documents. * Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor. * Contribute to statistical output plans concerning organization and table layout for specific documents. * Project management, strategic design, planning, team input, and reviews. * Opportunities for management/mentorship of other writers. Qualifications: * Bachelor's degree required; MS, PharmD, or PhD preferred in a life science or health discipline. * 12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry. * A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements. * Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents. * Gene therapy experience is preferred but not required. * Excellent communication skills, both oral and written. * Ability to build strong relationships and work collaboratively across functions. * Effective organizational and meeting skills and attention to detail. * Experience with workflow management within standard document management systems. * Ability to come onsite when needed such as for important meetings and team/company functions. The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data. Beam Pay Range $180,000-$260,000 USD

Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam's suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases. Position Overview: Beam is seeking a highly talented and motivated AD/Director to join our growing Medical Writing team. The AD/Director will be responsible for creating, authoring, and leading the management of key documents for regulatory filings and clinical studies, such as clinical protocols and amendments, clinical study reports, investigator's brochures, safety and efficacy summaries, and other documents required for regulatory submissions. Working across functions such as clinical operations, regulatory affairs, medical, biostatistics, and pharmacovigilance, this role will represent Medical Writing on study teams and will report to the VP of Medical Writing. Responsibilities: Act as lead writer for clinical regulatory documents for the hematology program. Plan and lead the development of clinical study documents, working with cross-functional colleagues. Work closely with the regulatory team and other writers on regulatory document submissions. Assist with developing and maintaining medical writing process documents. Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor. Contribute to statistical output plans concerning organization and table layout for specific documents. Project management, strategic design, planning, team input, and reviews. Opportunities for management/mentorship of other writers. Qualifications: Bachelor's degree required; MS, PharmD, or PhD preferred in a life science or health discipline. 12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry. A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements. Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents. Gene therapy experience is preferred but not required. Excellent communication skills, both oral and written. Ability to build strong relationships and work collaboratively across functions. Effective organizational and meeting skills and attention to detail. Experience with workflow management within standard document management systems. Ability to come onsite when needed such as for important meetings and team/company functions. The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data. Beam Pay Range$180,000-$260,000 USD

Fulcrum Therapeutics is a clinical-stage biopharmaceutical company focused on improving the lives of patients with genetically defined rare diseases in areas of high unmet medical need. Fulcrum's lead program in clinical development is pociredir, a small molecule designed to increase expression of fetal hemoglobin for the treatment of sickle cell disease and other hemoglobinopathies. The company's proprietary product engine identifies drug targets that can modulate gene expression to treat the known root cause of gene mis-expression. Description The Director, Head of Medical Writing, will report to the Head of Regulatory Affairs & Quality Assurance and collaborate cross-functionally with colleagues in Discovery, Clinical Development, Medical Affairs, and Regulatory. This individual will lead the development and delivery of a broad range of clinical and regulatory, documents to support the company's drug development programs. Initially, this role will oversee an outsourced model for medical writing activities. Over time, the Director will be responsible for building and managing an internal medical writing team that is appropriately resourced to meet the evolving needs of the organization. The ideal candidate will combine hands-on writing expertise with strategic leadership to ensure timely delivery of high-quality documents. Responsibilities Strategic Leadership & Operational Execution Develop and implement a scalable, fit-for-purpose medical writing delivery model that balances internal and external resources Lead the planning, preparation, and review of high-quality clinical, regulatory, and publication documents in collaboration with cross-functional teams Ensure consistency, accuracy, and compliance with applicable regulatory and scientific guidelines and standards Serve as a subject matter expert in medical writing and provide direct writing support as needed Document Ownership Clinical Documents: Investigator Brochures Protocol Synopses, Protocols, and Amendments Informed Consent Forms Clinical Study Reports (CSRs), Safety Narratives Regulatory Documents: Annual Reports, Safety Updates Briefing Documents, Regulatory Correspondence Clinical Trial and Marketing Applications in eCTD format, including INDs, CTAs, NDAs/sNDAs, MAAs Qualifications PhD in biological science is preferred Minimum of 10 years of medical writing experience in the biopharmaceutical industry or CRO setting Proven leadership experience managing teams of full-time employees and/or contractors Deep knowledge of GCP, ICH, and CFR regulatory requirements; familiarity with Health Canada, MHRA, PMDA, and EMA guidelines Proficiency in scientific literature research methods; familiarity with AMA, APA, CSE, and Chicago style guides Understanding of publication guidelines including GPP2, ICMJE, and CONSORT Strong technical proficiency with tools such as Adobe Acrobat Pro, Microsoft Office Suite (Word, Excel, PowerPoint, Teams, Project, SharePoint), and EndNote We offer a hybrid work model, with employees expected to be onsite at least 50% of the time. Base Salary Pay Range $175,000 - $191,000 USD

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.

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

About the role: We are seeking a creative, collaborative, and results-oriented individual to join our 10x team as a Scientific Writer. The ideal candidate will have a strong background in sciences with excellent writing skills. This person will be part of the Technical Communications team and will work closely with multiple teams, including R&D, Support, and Marketing, to generate high quality customer facing document portfolios for multiple product lines in a fast-paced environment. The individual will be a highly productive writer, a quick learner, a methodical and organized worker with an unfailing attention to detail. Writing creativity will be required to generate documents that can maximize product performance and enhance customer experience. Developing an understanding of the diverse product portfolios along with user requirements will be key in contributing towards new content presentation styles and formats. Proficiency in content creation and content management tools along with the ability to learn and apply new tools, processes, and standards will be required. Individuals applying for this position must be self-starters, strategic thinkers, action driven, flexible in changing direction and methods, thrive in a fast paced environment, excel at managing multiple priorities, succeed in communicating with all levels within the organization and provide immediate contribution. This is a hybrid position requiring on-site presence ~3 days/week What you will be doing: Write and edit high quality, clear, concise, and consistent customer facing technical and scientific documentation, like protocols, technical notes, user guides, for diverse product portfolios in a fast-paced environment Effectively partner with multiple stakeholders to gather input and implement specific changes in documents Integrate various sources of information into documents with a uniform style and language for compliance with corporate brand standards and legal guidelines Use a content management system to coordinate document review, approval, and release Effectively manage and sustain multiple product document portfolios under tight timelines, with flexibility to shift priorities Develop understanding of product portfolios and end user experience to generate and implement creative document presentation styles and formats, improving user experience Create systems and processes to streamline content creation by minimizing redundancy and enhancing content modularity Minimum Requirements: Master's degree in a life science discipline or an equivalent qualification At least three years of professional writing experience producing clear, concise, and accurate content for targeted audiences Highly organized, with strong time management and project management skills Excellent interpersonal, communication, and relationship-building abilities, with a proven ability to collaborate effectively Working knowledge of common materials, techniques, and methods used in wet-lab environments Proficiency in English, with exceptional grammatical, editorial, and proofreading skills Preferred Skills and Experience: Hands-on experience working in a wet-lab Proficiency in Adobe Suite and MadCap Flare is highly desirable Experience in leveraging AI tools for content generation Experience in single cell genomics and NGS #LI-MH1 #LI-Onsite Below is the base pay range for this full-time position. The actual base pay will depend on several factors unique to each candidate, including one's skills, qualifications, and experience. At 10x, base pay is also just one component of the Company's total compensation package. This role is also eligible for 10x's equity grants, its comprehensive health and retirement benefit programs, and its annual bonus program or sales incentive program. During the hiring process, your 10x recruiter can share more about the Company's total compensation package. Pay Range$138,700-$187,700 USD About 10x Genomics At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world. We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience. Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference. Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law. 10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.

Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Worldwide Research and Development From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases. The Medical Writer 1 applies basic to intermediate documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications. RESPONSIBILITIES List the major responsibilities of the job. * Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports * Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.) * Aids in managing study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes * Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials * Adheres to departmental procedures and practices and technical and industry standards during all aspects of work. * Assists in developing and reviewing standard processes and templates within Global Medical Writing * Works effectively with cross-functional groups within BioMarin * Other tasks as assigned. SCOPE Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc. This position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications. EDUCATION State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc. Bachelor's or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association. EXPERIENCE State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job. Relevant Experience Fulfills one of the following: * Up to 2 years as a medical writer in the pharmaceutical industry * At least 5 years of medical or scientific writing experience as a primary job responsibility Clinical Studies * Familiar with drug development process (discovery to market). * Basic understanding of biostatistical and clinical research concepts. * Basic applied knowledge of: odocumentation required for the conduct of clinical studies oprotocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs) ostudy results reporting Medical Writing * Writing high-quality documents that support corporate goals and objectives. * Experience writing, reviewing, or editing protocols and clinical study reports preferred. * Basic applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content. * Ability to interpret basic tabular and graphical clinical data presentations. * Ability to create basic tables using AMA style (eg, Schedule of Events). * Basic to intermediate applied knowledge of basic clinical laboratory tests. * Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Computer/office equipment Skills * Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, and PowerPoint. * Familiar with document management software (eg, LiveLink, SharePoint, Veeva) * Experienced with scanners, printers, and copiers. Regulatory * Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports). Project Management * Capable of working on multiple tasks and shifting priorities. * Good conflict management skills. * Motivated and shows initiative. * Detail oriented. Communication * Capable of well organized, concise and clear written and verbal communication. * Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements. * Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. The salary range for this position is: $74,100 to $100,000. BioMarin considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For additional benefits information, visit:

The Associate Director, Medical Writing Science manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments. This is a hybrid role which allows for 2 days per week remote work and 3 days per week in the Boston Fan Pier office. We offer a full relocation package. Key Duties and Responsibilities: Independently authors routine and complex clinical and regulatory documents Provides strategic input into program-level plans Deep insight into how different functions contribute to the successes of the team Aligns, coordinates, and builds consistent information and messages across clinical program(s) Provides leadership related to the activities of Medical Writing Science and manages a team Participates in developing and implementing goals and initiatives for Medical Writing Science Facilitates implementation of new technologies and initiatives related to the preparation of clinical documents Proactively anticipates risks, solves complex problems, and seeks out and implements process improvements Knowledge and Skills: Demonstrated aptitude for planning, managing, and optimizing department resources (e.g., staff, technology) to maximize and streamline the advancement of company goals and objectives Record of leadership, independence, and ability to solve non-routine, complex problems involving a broad range of issues Proven track record of anticipating potential problems and preparing contingency plans as needed Understanding of scientific disciplines beyond own specialty area Experience managing direct reports and guiding staff development Experience with marketing authorization application regulatory submissions Education and Experience: Bachelor's degree in relevant discipline Ph.D. (or equivalent degree) Typically requires 8 years of work experience and 2 years of supervisory/management experience, or the equivalent combination of education and experience #LI-AR1 #LI-Hybrid Pay Range: $157,600 - $236,400 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more. Flex Designation: Remote-Eligible Flex Eligibility Status: In this Remote-Eligible role, you can choose to be designated as: 1. Remote: work remotely five days per week and come into the office on occasion - you're always welcome on-site; or select 2. Hybrid: work remotely up to two days per week; or select 3. On-Site: work five days per week on-site with ad hoc flexibility. Note: The Flex status for this position is subject to Vertex's Policy on Flex @ Vertex Program and may be changed at any time. #LI-Remote Company Information Vertex is a global biotechnology company that invests in scientific innovation. Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com

Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions. Position Description Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work fully on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role. As an Associate Clinical Writer, you will work within the Clinical Affairs team. The Associate Clinical Writer's primary responsibilities are developing and completing scientific protocols and reports, including, but not limited to, Clinical Evaluations and Post Market Clinical Feedback as part of design validations for medical devices to support product registrations internationally. You will conduct reviews of post-market data, such as complaints and feedback, to incorporate relevant data and analysis into reports. Key Responsibilities: * Critical Thinking: You will need to be able to critically evaluate scientific literature and research findings and apply this knowledge to your work. This involves asking questions, identifying gaps in the research, and synthesizing information from multiple sources. * Writing Skills: You will be responsible for conducting thorough literature searches to identify relevant studies, systematic reviews, and meta-analyses that inform your writing. You will also be responsible for creating and maintaining job aids and work instructions for the preparation and maintenance of compliant medical writing deliverables. * Communication: You will be responsible to manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables. You will also be expected to collaborate with cross-functional teams to develop new and insightful analytics to collect and analyze clinical data. Position Requirements This position requires the following skills and attributes: * Bachelor's or Advanced degree in a scientific field (MS, Ph.D., MD, or Pharm. D.) * Experience in conducting focused literature searches on PubMed, Embase or other similar literature databases * Data mining and analysis * Ability to formulate reports and present findings * Effective written and oral communication skills * Ability to collaborate in a team environment * Project management and organizational skills * Strong familiarity with Microsoft Office Preferred The following skills and attributes are preferred: * 1-2 years of experience in the medical device/pharmaceutical field or 1+ years of research with professor * Ability to understand and interpret results of clinical studies, with a strong understanding of statistics * Experience performing statistical analysis with statistical programs * Ability to prioritize and manage multiple projects * Data analytic publication experience or literature author publication experience * Please note that this role is internally titled 'Associate Clinical Writer'. Externally, we refer to it as 'Associate Scientific Writer - Medical Devices' to better reflect the role's responsibilities. Benefits * Competitive compensation range: $70000 - $80000 / year (California). * Comprehensive benefits package. * Training and mentorship opportunities. * On-campus wellness activities. * Education reimbursement program. * 401(k) program with discretionary employer match. * Generous vacation accrual and paid holiday schedule. Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply. Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life. All compensation and benefits are subject to plan documents and written agreements. Equal Opportunity Employer Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.