Manager, Medical Writing remote jobs - 181 jobs

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.

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

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

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE Why Syneos Health * We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. * We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. * We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong. Job Responsibilities * Develop regulatory documents for submission to regulatory agencies globally including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives. * Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations. * Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents. * Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate. * eCTD submission experience preferred. * We don't need for this person to mentor junior writers, manage external vendors, or participate in the standard operational procedures or other department initiatives. And I don't have a preference for the EU versus US. We have writers located on both sides and work globally as a team. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health. *************************** Additional Information Tasks, duties, and responsibilities as listed in this are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Summary * The Principal Medical Writer is responsible for the development of clinical documents for submissions to regulatory authorities globally. • Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators' Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. • Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. • Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. • Has a broad understanding of clinical research processes and global regulatory document standards. • Mentors less experienced writers.

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

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

Principal Medical Writer At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future. Our Medical Writing team is growing, and we are looking for a Principal Medical Writer. This role is based in the United States. Discover Impactful Work: Lead ambitious initiatives that craft the future of clinical research. Your expertise will enable us to deliver flawless Regulatory Medical Writing documents, such as protocols, CSR, Investigator Brochures, and Marketing Applications, ensuring outstanding quality and compliance. A Day in the Life: Provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. Serves as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. As an essential advisory member of the writing team, may provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development strategy, document types, regulatory requirements, and industry best practices. May assist in program management activities. Identifies and resolves out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications. Keys to Success: Acts with intensity Strong project management skills Excellent interpersonal skills including problem solving and negotiation Able to perform a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task. Education Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred Experience Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years). Experience in managing and directing complex Regulatory medical writing projects required Experience working in the pharmaceutical/CRO industry preferred Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous. Knowledge, Skills, Abilities Significant knowledge of global, regional, national and other document development guidelines Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, marketing application submissions, communications, etc Strong project management skills Excellent interpersonal skills including problem solving and decision-making Strong negotiation skills Excellent oral and written communication skills with strong presentation skills Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook); willingness to utilize technology to support authoring efficiency Benefits We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation! What We Offer: As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a flexible working culture, where PPD clinical research services truly value a work-life balance. We've grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

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

About Us At Prenuvo, we are on a mission to flip the paradigm from reactive “sick-care” to proactive health care. Our award-winning whole body scan is fast (under 1 hour), safe (MRI has no ionizing radiation), and non-invasive (no contrast). Our unique integrated stack of optimized hardware, software, and increasingly AI, coupled with the patient-centric experience across our domestic and global clinics, have allowed us to lead the change against “we caught it too late again". We are looking for a Medical Writer, you will be the primary author of externally published research content representing Prenuvo's clinical and scientific credibility. You will collaborate closely with Prenuvo's Medical Affairs, Scientific, and Communications teams to craft persuasive, referenced, and accessible white papers for publication on Prenuvo's website and social platforms helping strengthen Prenuvo's leadership position in the preventive imaging landscape such as these recent writings found on Prenuvo's company website: Whole-body and brain changes associated with alcohol intake in adults without alcohol use disorder Exercise is related to distinctly larger brain volumes in depressed versus non-depressed populations Beyond BMI: AI-driven insights on body composition's impact on brain health In addition to ongoing research publications, the Medical Writer will lead a focused Medical Affairs initiative to produce a series of evidence-based white papers addressing key evidence gaps surrounding whole-body MRI (WB MRI) and preventive imaging. This role combines scientific rigor, clarity of communication, and efficiency transforming complex medical and imaging evidence into accessible, authoritative materials that reinforce and further strengthen Prenuvo's scientific credibility and clinical integrity. Your writing will shape how Prenuvo's research influences both clinical practice and public understanding of our preventive imaging services. Please note this is a part-time contract role, with the potential to extend or transition into a full-time position. This contract role requires an average of 25 hours per week, with an expected total of approximately 60 hours for the full scope of work. Help reshape the world through proactive healthcare while working with cutting-edge technology and high performing teams with deep expertise - join us to make a difference in people's lives! What You'll Do Research, draft, and edit evidence-based white papers addressing evidence gaps about whole-body MRI and preventive imaging. Conduct and document literature reviews; source, verify, and archive all references in accordance with scientific standards. Translate complex medical and imaging data into clear, credible, and engaging narratives for both professional and public audiences. Incorporate feedback efficiently and deliver 1-2 polished white papers per week ready for online publication. Stay current with emerging research and public discourse on preventive imaging, screening, and brain-body health. Partner with Prenuvo's Clinical Research, HEOR, and Medical Affairs teams to extract insights, validate data, and ensure scientific accuracy. Collaborate with design and communications teams to make findings visually compelling and accessible for web and social channels. Maintain consistent scientific tone, accuracy, and integrity aligned with ICMJE, AMA, and GPP best practices. Uphold Prenuvo's voice as a trusted, evidence-based thought leader in early detection and preventive imaging. What You'll Bring Advanced degree (PhD, MD, PharmD, or MS) in life sciences, neuroscience, biomedical engineering, public health or related field. At least 5 years of experience in medical or scientific writing - ideally within diagnostics, imaging, or healthcare research. Strong portfolio of peer-reviewed publications, white papers, or research summaries for scientific and clinical audiences. Proven ability to translate complex data into clear, engaging scientific narratives. Familiarity with research publication processes, reference management, and data visualization. Ability to work independently, with minimal oversight, in a collaborative and fast-paced environment. Our Values First: we are Pioneers Transforming healthcare requires divergent thinking, bias for action, disciplined experimentation, and consistent grit and determination to maintain momentum. This journey is as challenging as it is rewarding. Second: we are Platform-Builders We're always building foundations that allow us to achieve tomorrow more than we did today. We never lose sight of what's ahead - in a mindset of ownership and duty to our mission. Above all: we are Patients We could all be the next person who walks through our very doors, seeking clarity or peace of mind. We are proud of our impact on our patients' lives, and we won't stop till everyone can benefit from our work. What We Offer An avenue to make a positive impact on people's lives and their health Growth opportunities are at the heart of our people journey, we're doing big things with bright minds - there is no single path to success, it can be shaped along the way Building strong relationships is at the core of everything we do - our team gets together each week to connect, share, and socialize The hourly rate for this role ranges from $100-$175 in local currency, depending upon experience and geographic location We are an equal-opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. As part of the hiring process, successful candidates will undergo a background check in compliance to applicable federal, provincial, and state rules. Please be advised that official communication from our recruitment team will only come from our authorized domain [prenuvo.com]. If you are contacted by a recruiter, please ensure their email address ends *****************. We do not use third-party recruitment services or any other email domains for hiring purposes. If you receive communication that you believe to be fraudulent, please report it immediately to ****************.

Telix Pharmaceuticals is a dynamic, fast-growing radiopharmaceutical company with offices in Australia (HQ), Belgium, Japan, Switzerland, and the United States. Our mission is to deliver on the promise of precision medicine through targeted radiation. At our core, we exist to create products that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll-out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical-stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix The Medical Writer will contribute to the achievement of Telix's strategic goals by leading and driving the writing process. This role will be responsible for planning and preparing a variety of clinical and regulatory documents necessary for all phases of clinical drug development. This role will provide medical writing support by organizing, analyzing, and interpreting scientific and statistical data. Such documents include all types of regulatory documents, including eCTD summary documents (for INDs/NDAs/BLAs), clinical study reports, clinical study protocol synopses and protocols, Investigator Brochures, patient safety narratives, and briefing books, among others. Key Accountabilities: Lead the compilation, writing, and editing of high-quality regulatory documents and reports (primarily clinically oriented) including CSRs, IBs, safety narratives, safety reports, ISS, ISE, and eCTD summary documents for IND, NDA, MAA, BLA applications and amendments. Interpret data, search and analyze published literature, define problems, establish facts, draw valid scientific conclusions, propose solutions or corrective actions, and compose text accordingly. Work with colleagues, physicians, clinical scientists, and statisticians in a professional and organized manner to complete projects in a timely manner. Collaborate with project teams to respond to heath authority questions and requests. Develop and update pertinent SOPs, processes, templates, style guides, and manuals, as needed. Maintain knowledge to enable ongoing execution of function as medical writing expert. Maintain working knowledge of the Telix clinical development pipeline. Education and Experience: Bachelor of Science a science or related field required; Advance degree preferred 5+ years of experience in regulatory medical writing required Strong understanding of drug development, clinical study design, regulations (CFR, FDA, EMA, and ICH guidelines), and scientific principles. Understanding medical terminology and statistical methodology is a must. Experience writing clinical protocols, Investigator Brochures, clinical study reports, eCTD clinical summaries, and integrated summaries of safety and efficacy. The ability to accurately and clearly present clinical data; strong verbal, written, and interpersonal communication skills; and proficiency in Microsoft Word are required. Strong command of English language, grammar, style, logical progression. Ability to write in a clear, concise, and persuasive manner, as well as to review and edit on all levels, from copy editing to message strengthening to major rewriting. Experience and proficiency with document templates, document toolbars and proper version control. Demonstrated leadership capability. Good team player characteristics. Excellent communication and interpersonal skills. Strong project management skills. Organized and self-motivated. Strong attention to detail. Key Capabilities: Inclusive mindset: Demonstrate an understanding and appreciation for diversity, and actively work to create an inclusive environment where everyone feels valued and respected Creativity and innovation: Possess a willingness to think outside the box and come up with unique and creative solutions to challenges Commitment to excellence: Take pride in your work and consistently strive for excellence in everything you do Results-oriented: Driven to achieve goals and objectives, with a strong focus on delivering measurable results Ethical behavior: Act with integrity and demonstrate a commitment to ethical behavior in all interactions with colleagues and stakeholders Adaptability: Comfortable working in a dynamic environment, able to adjust to changing priorities, and willing to take on new challenges Strong communication skills: Able to communicate effectively with colleagues and stakeholders at all levels, using clear and concise language Collaboration: Work effectively as part of a team, actively sharing knowledge and expertise to achieve common goals Resilience: Demonstrate the ability to bounce back from setbacks and persevere in the face of challenges Continuous learning: Show a commitment to ongoing learning and professional development, continually seeking out opportunities to expand your knowledge and skills At Telix, we believe everyone counts, we strive to be extraordinary, and we pursue our goals with determination and integrity. You will be part of an engaged and supportive group of colleagues who all have a shared purpose: to help people with cancer and rare diseases live longer, better quality lives. Being a Telix employee means being a part of a unique, global, interdisciplinary team working to deliver what's next in precision medicine. We have hybrid and remote employees located all around the world. We offer competitive salaries, annual performance-based bonuses, an equity-based incentive program, generous vacation, paid wellness days and support for learning and development. Telix Pharmaceuticals is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. VIEW OUR PRIVACY POLICY HERE

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

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

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

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

The Medical Writer is responsible for developing and writing content for their assigned account(s) and works in conjunction with all internal teams to ensure that the client vision is achieved and content is accurate. The medical writer is responsible for development of a variety of resources, including, but not limited to, flashcards, leave-behinds, and internal training resources. Essential functions of the job include but are not limited to: (This is NOT meant to be an exhaustive task list) Under direct supervision, develop high quality, medically accurate content in print or digital format for a wide range of medical communication resources Deliver requested projects per established timelines Conduct literature reviews and develop annotations to support promotional claims in a variety of promotional medical education and marketing resources Ensure professional, proactive, and collaborative communication with internal and external stakeholders Ensure a constant high quality of work in line with science, good publication practice, and company rules and policies Work closely with account teams to refine content in keeping with strategic imperatives Communicate medical content with internal team and pharmaceutical clients, as necessary Attend medical, legal, regulatory review meetings, as necessary Participate in all internal team meetings, including project kick-off meetings, weekly status meetings, client meetings, and internal brainstorm/review meetings Contribute ideas for tactical planning within assigned accounts Promote and adhere to Precision Value and Health's workplace values known as PRECISION Principles (Client Service, Purpose, Accountability, Mutual Respect and Collaboration) Required Education: BA/BS in life sciences BA/BS in English combined with 2 years of experience in a pharmaceutical agency, medical communications company or healthcare advertising. Required Experience: Minimum 1 year of medical writing experience in a pharmaceutical agency, medical communications company or healthcare advertising Required Skills: Knowledge of American Medical Association (AMA) style Proficiency in Microsoft Word, Microsoft PowerPoint, and Adobe Acrobat Familiarity with scientific search engines including PubMed and Google Scholar Required Competencies: Strong written and verbal communication High analytical ability Ability to prioritize deadline-sensitive projects and juggle competing client priorities Team- and detail-oriented Preferred Qualifications: Expertise in gathering, evaluating, and summarizing healthcare business and scientific literature and insights data for a variety of managed care audiences Working knowledge of managed markets, healthcare, and the healthcare delivery system; health reform legislation; and/or managed care experience (HMO, MCO, PBM, etc.) Experience supporting pharmaceutical patient support programs - such as patient hubs and financial assistance offerings - tailored towards both healthcare professional and patient audiences. Managed care experience #LI-REMOTE Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.Reasonable estimate of the current range$62,000-$90,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at **************************************. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

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

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

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

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