Senior Medical Writer jobs at Merit Medical Systems - 106 jobs
Sr Medical Writer
Dexcom 4.7
San Diego, CA jobs
The Company
Dexcom Corporation (NASDAQ DXCM) is a pioneer and global leader in continuous glucose monitoring (CGM). Dexcom began as a small company with a big dream: To forever change how diabetes is managed. To unlock information and insights that drive better health outcomes. Here we are 25 years later, having pioneered an industry. And we're just getting started. We are broadening our vision beyond diabetes to empower people to take control of health. That means personalized, actionable insights aimed at solving important health challenges. To continue what we've started: Improving human health.
We are driven by thousands of ambitious, passionate people worldwide who are willing to fight like warriors to earn the trust of our customers by listening, serving with integrity, thinking big, and being dependable. We've already changed millions of lives and we're ready to change millions more. Our future ambition is to become a leading consumer health technology company while continuing to develop solutions for serious health conditions. We'll get there by constantly reinventing unique biosensing-technology experiences. Though we've come a long way from our small company days, our dreams are bigger than ever. The opportunity to improve health on a global scale stands before us.
Meet the team:
Dexcom Medical Affairs is looking for candidates for the role of Senior Manager Medical Writing and Scientific Communications. This role provides an opportunity to not only write and manage publications based on cutting edge scientific and technological data, but to also assist in building strategic publication plans and associated processes. This is a great opportunity to help shape the development of the medical writing/scientific communications function and work with some outstanding colleagues!
Where you come in:
You will write high-quality scientific publications, including manuscripts, abstracts, posters, and oral presentations, in accordance with company policies and industry guidelines (eg, GPP)
You will contribute to the development and execution of strategic publication plans in line with company objectives and strategy
You will collaborate with cross-functional teams to align publication activities with the broader strategy and ensure consistency in scientific narratives
You will participate in team meetings to provide input on strategic discussions and decisions related to publication planning and execution
You will ensure timely feedback, review cycles, and adherence to deadlines for publications
You will build productive working relationships with internal and external stakeholders, including key opinion leaders
You will assist with tracking for publication-related activities
What makes you successful:
You have an advanced degree in relevant scientific field
You have a minimum of 3 years of experience writing and developing peer-reviewed publications and developing strategic publication plans in the pharma/biotech/device industry or medical communications agency
Previous experience in diabetes highly preferred, experience in devices a plus
CMPP certification is a plus
You bring In-depth knowledge of industry regulations and guidelines governing publications and medical communications
You are proficient in publication management software and referencing tools
You bring strong project management skills with the ability to manage multiple high-priority projects simultaneously
You have excellent written and verbal communication skills.
What you'll get:
A front row seat to life changing CGM technology. Learn about our brave #dexcomwarriors community.
A full and comprehensive benefits program.
Growth opportunities on a global scale.
Access to career development through in-house learning programs and/or qualified tuition reimbursement.
An exciting and innovative, industry-leading organization committed to our employees, customers, and the communities we serve.
Travel Required:
5-15%
Experience and Education Requirements:
Typically requires a Bachelor's degree and a minimum of 5 - 8 years of related experience.
Remote Workplace: Your location will be a home office; you are not required to live within commuting distance of your assigned Dexcom site (typically 75 miles/120km).
If you reside within commuting distance of a Dexcom site (typically 75 miles/120km) a hybrid working environment may be available. Ask about our Flex workplace option.
Please note: The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. Management may, at its discretion, assign or reassign duties and responsibilities to this job at any time. The duties and responsibilities in this job description may be subject to change at any time due to reasonable accommodation or other reasons. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. Dexcom's AAP may be viewed upon request by contacting Talent Acquisition at ****************************.
If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Dexcom Talent Acquisition at ****************************.
Meritain, an Aetna Company, creates and publishes the Machine-Readable Files on behalf of Dexcom. To link to the Machine-Readable Files, please click on the URL provided: ***************************************************** Code=MERITAIN_I&brand Code=MERITAINOVER/machine-readable-transparency-in-coverage?reporting EntityType=TPA_19874&lock=true
To all Staffing and Recruiting Agencies: Our Careers Site is only for individuals seeking a job at Dexcom. Only authorized staffing and recruiting agencies may use this site or to submit profiles, applications or resumes on specific requisitions. Dexcom does not accept unsolicited resumes or applications from agencies. Please do not forward resumes to the Talent Acquisition team, Dexcom employees or any other company location. Dexcom is not responsible for any fees related to unsolicited resumes/applications.
Salary:
$100,700.00 - $167,900.00
$100.7k-167.9k yearly Auto-Apply 7d ago
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Senior Medical Writer
Camp4 Therapeutics 3.9
Cambridge, MA jobs
SeniorMedicalWriter Reports To: Vice President, Regulatory Affairs
Join the Adventure!
We are seeking a highly skilled, detailed-oriented, scientifically driven Medical Writing professional to join our growing biotech team as a SeniorMedicalWriter. This role is responsible for the development of high-quality clinical and regulatory documents and scientific publications. The ideal candidate will bring deep expertise in medical writing and a collaborative mindset to help drive our pipeline forward.
Key Responsibilities
Lead the planning, writing, and review of clinical and regulatory documents including:
Clinical study protocols and amendments
Investigator brochures (IBs)
INDs, NDAs
Safety narratives and annual reports
Develop and write scientific content for peer-reviewed manuscripts, congress abstracts, posters, and slide decks.
Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Preclinical/Research, and CMC to ensure alignment and accuracy of scientific content.
Develop and maintain document templates and style guides in accordance with regulatory and company standards.
Manage timelines and deliverables across multiple projects, ensuring high-quality output under tight deadlines.
Provide strategic input on document content and regulatory strategy.
Maintain up-to-date knowledge of therapeutic area(s), product(s), and relevant literature
Mentor and/or manage junior medicalwriters or contractors.
Qualifications
Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field.
Minimum of 4-6 years of medical writing experience in the biotech/pharmaceutical industry.
Proven track record of authoring and managing regulatory documents for global submissions and scientific documents in peer-reviewed journals.
Strong understanding of clinical research, data interpretation, and regulatory standards.
Deep understanding of ICH guidelines, GCP, and regulatory requirements.
Exceptional writing, editing, and communication skills.
Ability to work independently and collaboratively in a fast-paced environment.
Preferred Qualifications
Experience in rare disease or neurology therapeutic areas.
Prior involvement in NDA/BLA submissions.
Familiarity with EMA and other ex-US regulatory requirements.
Compensation and Benefits At CAMP4 Therapeutics, we offer a competitive and thoughtfully designed total rewards program. The anticipated salary range for this role is $120,000. - $228,000. 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. In addition to base salary, employees are eligible to receive an annual bonus and equity incentive opportunities.
Our benefits include medical, dental, and vision insurance; life and disability coverage; paid parental leave; a 401(k) plan with company contribution; Employee Stock Purchase Program, Trek Time (flexible time off); tuition assistance; and additional perks that support your well-being and professional growth.
About CAMP4
CAMP4 is developing disease-modifying treatments for a broad range of genetic diseases where amplifying healthy protein may offer therapeutic benefits. Our approach amplifies mRNA by harnessing a fundamental mechanism of how genes are controlled. To amplify mRNA, our therapeutic ASO drug candidates target regulatory RNAs (reg RNAs), which act locally on transcription factors and are the master regulators of gene expression. CAMP4's proprietary RAPTM Platform enables the mapping of reg RNAs and design of optimal chemistry to generate potent therapeutic candidates to address hundreds of genetic diseases across multiple tissues. Learn more about us at *************** and follow us @CAMP4tx.
$120k-228k yearly 60d+ ago
Sr. Medical Writer
Glaukos 4.9
Aliso Viejo, CA jobs
What You'll Do: This role will be responsible for producing high-quality clinical and clinical regulatory documentation that will require a strong understanding of medical and regulatory concepts and terminology as well as the ability to translate complex information into clear and concise documentation. Will work closely and collaborate with project teams spanning multiple departments on Glaukos's current and pipeline of products. The Sr. MedicalWriter will be responsible for engaging with cross-functional stakeholders to extract key information, and synthesize that into a clear, logical presentation. You will ensure that documentation is accurate, complete, meets editorial and client specifications, and adheres to established guidelines and standards.
* Prepares clinical study reports (CSRs) with limited supervisor direction; based on the clinical study protocol and statistical analysis plan, translates clinical result data tables, listings and figures into a report on the study outcomes, completes final check for discrepancies within data, and ensures compliance with relevant regulatory agencies.
* Translate clinical study synopsis into full clinical study protocol, ensuring appropriate level of depth and detail, as well as technical accuracy. Works with other members of the project team to obtain input.
* Interpret data, analyze results, and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
Systematically review reports and clinical data and cross-check information
* Ensure consistency in style, tone, and quality across all documents.
* Develop and maintain standardized templates and style guides for clinical and regulatory documentation.
* Conduct medical and scientific literature database research to support documentation efforts.
* Review, edit, and cross-check documents produced by other team members for clarity, accuracy, and compliance.
* Stay up-to-date with industry trends, regulatory requirements, and best practices in both technical and medical writing.
* Develop and maintain lists of abstract deadlines, key dates, and locations for relevant/major ophthalmology conferences. Coordinate with R&D leadership to prepare conference abstract submissions while ensuring compliance with conference rules and company objectives and strategy.
* Prepare and proof presentations (slide decks and posters) as required for physicians and other key internal stakeholders
* Develop figures for publications and presentations (peer-reviewed publications, presentations, and posters) to align with company strategy
* Support phase I through phase IV studies prior to database lock, identifying any adverse events or protocol deviations and works with cross-functional
* Participate in project meetings and provide updates on the status of writing assignments.
How You'll Get There:
* Bachelor's Degree Required, Master's Degree or PhD Preferred
* 5-8 years of relevant work experience in a clinical or scientific space
* Deep understanding of therapeutic areas (ophthalmology), clinical research, and regulatory requirements
* Fluency in technical and medical terminology
* Experience in pharmaceutical regulatory submissions
* Experience with scientific publications and presentations
* Familiarity with ophthalmic indications and treatments preferred
* Excellent writing, editing, and proofreading skills
* Proficiency in using documentation tools and software such as Microsoft Office Suite, Adobe Acrobat, and content management systems (CMS) Strong organizational and project management skills
* Excellent communication and interpersonal skills
#GKOSUS
$95k-139k yearly est. 13d ago
Senior Technical Writer
GE Healthcare Technologies Inc. 4.2
Cleveland, OH jobs
This position is in GE Healthcare's MIM Software business which makes vendor-neutral imaging software to standardize your workflow and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM to give patients more precise, personalized care.
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As a member of MIM Software's technical content development team, you will assess customers' needs, reduce customer effort, and improve the overall customer experience. By creating easy-to-use and accessible user documentation, the technical content development team aims to provide an effortless experience for MIM's clinical customers, allowing them to spend more time on patient care. You will be responsible for working independently to document and translate product technical information into easily comprehensible language.
Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.
Job Description
What You'll Do:
* Collaborate with cross-functional teams to draft and publish high-quality user manuals and other documentation
* Develop proficiency in creating, editing, or managing additional content types: training videos, LMS/e-learning content, white papers, or translated documentation (coordinating all translations and vendor relationships as required)
* Independently test the software and research the product to inform better content development
* Collaborate with product and clinical science teams to plan product development and support release timelines
* Support quality and regulatory teams with documentation creation and updates, applying knowledge of medical device guidelines
* Collaborate with engineering teams to develop product copy for a clinical audience
* Develop and maintain strong product knowledge for one or more product lines, understanding the competitive landscape
What You'll Need:
* At least 6 years of prior experience in technical writing, preferably in the medical industry or a related area
* Excellent skills in researching, writing, and editing, as well as meticulous organizational and communication skills
* Superior ability to balance multiple priorities and communicate with a diverse group of stakeholders
* Excellent project management skills and ability to lead a writing project: ability to schedule and coordinate work of other writers (taking multiple variables, including other functional areas, into account), accurately estimate scope and time, and create and work to deadlines
* Aptitude to develop clinical and anatomical knowledge and learn on the job
What You'll Get:
* Hybrid work environment so you can work remotely as well as enjoy the office
* Permissive time off
* A 401(k) with a 4% match
* Tuition reimbursement programs
* Relaxed office setting where jeans are the norm
* Free snacks and beverages at the office
* 24-hour access to an in-office fitness center
We will not sponsor individuals for employment visas, now or in the future, for this job opening.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: Yes
$54k-68k yearly est. 36d ago
Senior Medical Writer
Arrowhead Pharmaceuticals 4.6
San Diego, CA jobs
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The SeniorMedicalWriter will collaborate with lead medicalwriters and cross-functional team members to provide authoring support to numerous regulatory documents. The SeniorMedicalWriter will also lead key supportive documents. The SeniorMedicalWriter will author with accuracy and technical competency to ensure delivery of high quality regulatory clinical documents in a timely manner. The SeniorMedicalWriter will demonstrate a high level of flexibility, collaboration skills, and eagerness to learn.
Responsibilities
Contributing author to regulatory documents such as, but not limited to, clinical study protocols and protocol amendments, investigator's brochures (IBs), clinical study reports (CSRs), components of NDA/MAA documents, and briefing books
Lead author of numerous supporting documents such as summary of changes, patient narratives, and IB updates
Assists in planning and content creation for kick off meetings (ie, slide deck authoring)
Collaborates with nonclinical, clinical safety, biometrics, and clinical development personnel to obtain status updates and plan documents
Assists in the review of statistical analysis plans, and mock and draft statistical tables, listings and figures (TLFs)
Participates in regulatory and clinical team strategy meetings to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources
Assists in resolving team and quality control comments to ensure all comments are appropriately addressed
Assists with team training for document processes and software
Supports key pilot programs in medical writing such as new process development
Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in document management system(s).
Requirements:
Bachelor's degree in medically-related field or life science, with a minimum of 3 years of relevant medical writing experience in the pharmaceutical industry
Master's or doctoral degree with 2 years of relevant medical writing experience in the pharmaceutical industry
Familiarity with basic statistical analysis concepts and techniques is helpful
Knowledge of clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical research, and medical writing standards; and demonstrated ability to interpret and apply these guidelines to document writing.
A demonstrated track record of contribution to successful clinical documents such as IBs, CSRs, protocols, and protocol amendments
Prior experience in interacting with cross-functional study team members is desirable
Proficient in the use of MS Word, Excel, EndNote, Adobe Acrobat, and PowerPoint
California pay range $100,000-$150,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
California Applicant Privacy Policy
$100k-150k yearly Auto-Apply 2d ago
Senior Medical Writer
Biomarin Pharmaceutical 4.6
San Rafael, CA jobs
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
The SeniorMedicalWriter applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
RESPONSIBILITIES List the major responsibilities of the job.
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.)
Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries).
Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Represents Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams).
Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met.
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned.
SCOPE Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.
This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Global Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.
EDUCATION State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
Bachelor's or higher degree required; scientific focus desirable. Minimum requirement: Experience in medical writing. Evidence of medical writing career development desirable, eg, American MedicalWriters Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
EXPERIENCE State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
Relevant ExperienceFulfills one of the following:· Up to 6 years of as a medicalwriter in the pharmaceutical industry· At least 10 years of medical or scientific writing experience as a primary job responsibility Clinical Studies· Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets.· Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.· Intermediate to advanced applied knowledge of:o documentation required for the conduct of clinical studieso protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)o study results reportingo integrated results reporting· Direct experience with documentation in all phases of drug development. Medical Writing· Experience writing, reviewing, or editing protocols and clinical study reports required.· Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred.· Experience writing, reviewing, or editing regulatory briefing books preferred.· Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.· Ability to interpret and create complex tabular and graphical clinical data presentations.· Advanced applied knowledge of basic clinical laboratory tests.· Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Computer/office equipment Skills
Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint.
Experience using document management software (eg, LiveLink, SharePoint, Veeva)
Experienced with scanners, printers, and copiers.
Regulatory
Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
Prior familiarity with standard eCTD IND/NDA work, including:
o Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format o Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE) Project Management
Capable of working on multiple tasks and shifting priorities.
Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.
Capable of representing Global Medical Writing at cross-functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross-functional conflicts.
Good conflict management skills.
Motivated and shows initiative.
Detail oriented.
Communication
Capable of well organized, concise and clear written and verbal communication.
Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
Effective at explaining writing principles to a varied audience both in individual and group settings; intermediate to advanced presentation skills.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
$115k-148k yearly est. Auto-Apply 60d+ ago
Sr. Medical Writer
Glaukos Corporation 4.9
San Clemente, CA jobs
What You'll Do:
This role will be responsible for producing high-quality clinical and clinical regulatory documentation that will require a strong understanding of medical and regulatory concepts and terminology as well as the ability to translate complex information into clear and concise documentation. Will work closely and collaborate with project teams spanning multiple departments on Glaukos's current and pipeline of products. The Sr. MedicalWriter will be responsible for engaging with cross-functional stakeholders to extract key information, and synthesize that into a clear, logical presentation. You will ensure that documentation is accurate, complete, meets editorial and client specifications, and adheres to established guidelines and standards.
Prepares clinical study reports (CSRs) with limited supervisor direction; based on the clinical study protocol and statistical analysis plan, translates clinical result data tables, listings and figures into a report on the study outcomes, completes final check for discrepancies within data, and ensures compliance with relevant regulatory agencies.
Translate clinical study synopsis into full clinical study protocol, ensuring appropriate level of depth and detail, as well as technical accuracy. Works with other members of the project team to obtain input.
Interpret data, analyze results, and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
Systematically review reports and clinical data and cross-check information
Ensure consistency in style, tone, and quality across all documents.
Develop and maintain standardized templates and style guides for clinical and regulatory documentation.
Conduct medical and scientific literature database research to support documentation efforts.
Review, edit, and cross-check documents produced by other team members for clarity, accuracy, and compliance.
Stay up-to-date with industry trends, regulatory requirements, and best practices in both technical and medical writing.
Develop and maintain lists of abstract deadlines, key dates, and locations for relevant/major ophthalmology conferences. Coordinate with R&D leadership to prepare conference abstract submissions while ensuring compliance with conference rules and company objectives and strategy.
Prepare and proof presentations (slide decks and posters) as required for physicians and other key internal stakeholders
Develop figures for publications and presentations (peer-reviewed publications, presentations, and posters) to align with company strategy
Support phase I through phase IV studies prior to database lock, identifying any adverse events or protocol deviations and works with cross-functional
Participate in project meetings and provide updates on the status of writing assignments.
How You'll Get There:
Bachelor's Degree Required, Master's Degree or PhD Preferred
5-8 years of relevant work experience in a clinical or scientific space
Deep understanding of therapeutic areas (ophthalmology), clinical research, and regulatory requirements
Fluency in technical and medical terminology
Experience in pharmaceutical regulatory submissions
Experience with scientific publications and presentations
Familiarity with ophthalmic indications and treatments preferred
Excellent writing, editing, and proofreading skills
Proficiency in using documentation tools and software such as Microsoft Office Suite, Adobe Acrobat, and content management systems (CMS) Strong organizational and project management skills
Excellent communication and interpersonal skills
#GKOSUS
$95k-139k yearly est. Auto-Apply 13d ago
Senior Medical Writer
Eikon Therapeutics, Inc. 4.3
Millbrae, CA jobs
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
We are seeking an experienced, detail-oriented individual to join our Medical Writing team. In the SeniorMedicalWriter role, you will be responsible for independently leading document development by authoring and editing of medical and regulatory writing deliverables that support the Eikon clinical portfolio. You will partner with cross functional colleagues within study teams/project teams to prepare high-quality, accurate and fit for use clinical and regulatory documents enabling delivery of Eikon portfolio milestones.
This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
About You
You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing.
What You'll Do
* Independently write clinical and regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules (Module 2.7.Xs, 2.5, and Module 5 integrated summaries), briefing documents, posters, abstracts, manuscripts and other documents per company and regulatory guidelines.
* Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
* Independently manage and maintain document lifecycle, including timelines, workflow of writing assignments, review cycle management, and document quality management where appropriate.
* Help to iteratively improve medical writing processes as appropriate.
* Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations.
* Take ownership of a given assignment, proactively consulting other cross-functional project team members to align and build consensus on timelines, document interdependencies, organize and drive kick off meetings, comment resolution meetings, and ad-hoc meetings to mitigate risks and resolve project related issues.
* Interpret and understand scientific and clinical data, provide input on data, figures, tables, and listings for clear data presentation per the document scope.
Qualifications
* Doctoral-level degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master's degree with 3+ years of relevant experience, or Bachelor's degree with 5+ years of relevant experience in regulatory, scientific, or medical writing.
* Substantial clinical study protocol writing experience desired.
* Excellent communication, presentation, and project management skills.
* Ability to independently prepare clinical and regulatory documents (e.g., protocol, CSR, IB, CTD modules) in compliance with company SOPs and international health agencies/regulatory guidelines with a focus objective data presentation in a clear, concise format in keeping with industry guidelines.
* Working knowledge of statistical concepts and techniques.
* Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.
* Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus.
* Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
* Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote).
* Familiarity with concepts of structured content management preferred.
* Proven ability to work independently in a dynamic, fast-moving environment while striving for excellence in collaboration and innovation, as part of a cross-functional team.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
* 401k plan with company matching
* Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
* Mental health and wellness benefits
* Weeklong summer and winter holiday shutdowns
* Generous paid time off and holiday policies
* Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
* Enhanced parental leave benefit
* Daily subsidized lunch program when on-site
The expected salary range for this role is $125,000 to $136,800 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
$125k-136.8k yearly Auto-Apply 60d+ ago
Senior Medical Writer
Eikon Therapeutics 4.3
Millbrae, CA jobs
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
We are seeking an experienced, detail-oriented individual to join our Medical Writing team. In the SeniorMedicalWriter role, you will be responsible for independently leading document development by authoring and editing of medical and regulatory writing deliverables that support the Eikon clinical portfolio. You will partner with cross functional colleagues within study teams/project teams to prepare high-quality, accurate and fit for use clinical and regulatory documents enabling delivery of Eikon portfolio milestones.
This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
About You
You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing.
What You'll Do
Independently write clinical and regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules (Module 2.7.Xs, 2.5, and Module 5 integrated summaries), briefing documents, posters, abstracts, manuscripts and other documents per company and regulatory guidelines.
Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
Independently manage and maintain document lifecycle, including timelines, workflow of writing assignments, review cycle management, and document quality management where appropriate.
Help to iteratively improve medical writing processes as appropriate.
Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations.
Take ownership of a given assignment, proactively consulting other cross-functional project team members to align and build consensus on timelines, document interdependencies, organize and drive kick off meetings, comment resolution meetings, and ad-hoc meetings to mitigate risks and resolve project related issues.
Interpret and understand scientific and clinical data, provide input on data, figures, tables, and listings for clear data presentation per the document scope.
Qualifications
Doctoral-level degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master's degree with 3+ years of relevant experience, or Bachelor's degree with 5+ years of relevant experience in regulatory, scientific, or medical writing.
Substantial clinical study protocol writing experience desired.
Excellent communication, presentation, and project management skills.
Ability to independently prepare clinical and regulatory documents (e.g., protocol, CSR, IB, CTD modules) in compliance with company SOPs and international health agencies/regulatory guidelines with a focus objective data presentation in a clear, concise format in keeping with industry guidelines.
Working knowledge of statistical concepts and techniques.
Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.
Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus.
Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote).
Familiarity with concepts of structured content management preferred.
Proven ability to work independently in a dynamic, fast-moving environment while striving for excellence in collaboration and innovation, as part of a cross-functional team.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site
The expected salary range for this role is $125,000 to $136,800 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
$125k-136.8k yearly Auto-Apply 56d ago
Principal Medical Writer
Revolution Medicines 4.6
Redwood City, CA jobs
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Revolution Medicines is seeking a motivated individual with a clinical regulatory writing background to play a critical role in the successful preparation of high-quality, submission-ready clinical research documents. This role is an individual contributor with team leadership responsibilities, reporting to the Executive Director, Medical Writing.
This position is responsible for drafting and managing the content and reviews of clinical regulatory documents for Revolution Medicines products in various drug development phases.
Serves as medical writing lead on complex clinical regulatory documents, including protocols, IBs, CSRs, briefing documents, periodic safety reports, risk management documents, and IND and NDA modules.
Assists in developing and maintaining document templates, department standard processes and work instructions, medicalwriter onboarding materials, and style guide.
Serves as primary medical writing contact for one or more clinical development programs.
Represents medical writing at cross-functional planning meetings.
Effectively communicates deliverables needed, the writing process, and timelines to team members.
Schedules document reviews and manage adjudication meetings.
Holds team members accountable to agreed-upon project dates.
Independently resolves document content issues and questions.
Ensure consistency, clarity, and accuracy both within and across documents.
Recognizes potential scheduling and resource conflicts across projects and provides recommendations to resolve.
Mentors junior and contract medicalwriters on both document and timeline management.
Required Skills, Experience and Education:
8+ years of clinical regulatory writing experience within one or more biopharmaceutical companies, including prior experience working as a medicalwriter for a BLA/NDA/MAA.
Advanced degree in clinical or life sciences, English, journalism, and/or communications.
Proficiency in Microsoft Word, including the use of MS Word styles and templates.
Familiarity with AMA style.
Ability to successfully manage and prioritize writing projects with competing deadlines, to foster collaborative cross-functional relationships, and to drive high-quality regulatory writing projects to successful submission.
Ability to work in a high-pressure environment with short deadlines while remaining calm, focused, professional, diplomatic, and positive.
Preferred Skills:
Experience with oncology therapeutics.
Familiarity with StartingPoint, EndNote, Veeva RIM, and Smartsheet.
Experience performing QC reviews of clinical regulatory documents. #LI-Hybrid #LI-JC1
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
Base Pay Salary Range$211,000-$264,000 USD
$81k-116k yearly est. Auto-Apply 6d ago
Sr Scientific Writer
Houston Methodist 4.5
Houston, MN jobs
At Houston Methodist, the Senior Scientific Writer is responsible for functioning as the mentor for junior staff with an extensive knowledge of both medical and technical science while working with scientific and clinical teams to concisely and clearly communicate technical medicine and science in writing, in accordance with regulations, standards and guidelines. This role must also have familiarity with scientific and clinical research and will conduct comprehensive literature searches for writing and editing abstracts, manuscripts, review articles, grant applications, clinical study protocols, investigator brochures, consent forms, presentations and progress reports for both scientific and lay audiences.
FLSA STATUS
Exempt
QUALIFICATIONS
EDUCATION
* Master's Degree required
* PhD Preferred
EXPERIENCE
* Six years' experience in technical or scientific writing
* Two years with grant applications preferred
SKILLS AND ABILITIES
* Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
* Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
* Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
* Ability to write in a clear, concise, and accurate language that can be understood by technical and non-technical audiences
* Ability to understand complex scientific information, theories, and practices.
* Skilled in identifying extramural funding mechanisms for faculty and programs
* Skilled in coordinating strategic writing projects
ESSENTIAL FUNCTIONS
PEOPLE ESSENTIAL FUNCTIONS
* Subject matter expert responsible for research, writing, and editing of technical documents.
* Mentors and coaches other scientific writers in editing and compiling appendices of documents related to technical reports.
* Works with departments, agencies and sponsors to ensure that specific requirements are met with respect to document content and formatting.
SERVICE ESSENTIAL FUNCTIONS
* Independently creates technical documents (collaborating with the team) based on the strategy provided, and is accountable for the format, content, and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.
* Interprets data and advises faculty as how to best present data considering scientific communications best practices.
* Works with Principal Investigator(s) to develop, present, and bring to final submission high quality, large, multi-disciplinary, and multi-collaborative grant proposals and publications.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
* Prepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills to the preparation of grant proposals, manuscripts, presentations, protocols, and clinical regulatory documentation.
* Prepares technical documents that adhere to regulatory, financial, policy, and legal requirements.
* Assures compliance with Houston Methodist policies, rules, and regulations to meet government, publisher, and sponsor standards and research development best practices.
FINANCE ESSENTIAL FUNCTIONS
* Development of grant application budgets, industry contracts and subcontracts, and other financial documents in compliance with Houston Methodist policies and procedures.
* Contributes to quality improvement and success of grants applications.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
* Finds and implements innovations in scientific writing, grant development and research development to continuously improve best practices.
* Seeks opportunities to for continual professional development.
* Fosters a positive and constructive teaching environment by engaging students and co-workers in learning opportunities that are valuable and in alignment with business objectives.
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
* Uniform: No
* Scrubs: No
* Business professional: Yes
* Other (department approved): No
ON-CALLNote that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.
* On Call* No
TRAVELTravel specifications may vary by department
* May require travel within the Houston Metropolitan area No
* May require travel outside Houston Metropolitan area Yes
Company Profile:
Houston Methodist Academic Institute oversees the Education Institute and Research Institute. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports clinical research protocols and extramurally funded translational research programs.
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Houston Methodist Ranked No. 9 on Glassdoor's 2026 Best Places to Work list
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We are honored to share that all seven of our eligible hospitals have been named top performers in the 2025 Bernard A. Birnbaum, MD, Quality Leadership Rankings by Vizient Inc., a trusted national benchmark for hospital performance. This year, five of our hospitals ranked in the top five of their …
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$85k-145k yearly est. 2d ago
Senior Scientific Writer - Otolaryngology
Houston Methodist 4.5
Houston, MN jobs
At Houston Methodist, the Senior Scientific Writer is responsible for functioning as the mentor for junior staff with an extensive knowledge of both medical and technical science while working with scientific and clinical teams to concisely and clearly communicate technical medicine and science in writing, in accordance with regulations, standards and guidelines. This role must also have familiarity with scientific and clinical research and will conduct comprehensive literature searches for writing and editing abstracts, manuscripts, review articles, grant applications, clinical study protocols, investigator brochures, consent forms, presentations and progress reports for both scientific and lay audiences.
FLSA STATUS
Exempt
QUALIFICATIONS
EDUCATION
* Master's Degree required
* PhD Preferred
EXPERIENCE
* Six years' experience in technical or scientific writing
* Two years with grant applications preferred
LICENSES AND CERTIFICATIONS
Required
*
SKILLS AND ABILITIES
* Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
* Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
* Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
* Ability to write in a clear, concise, and accurate language that can be understood by technical and non-technical audiences
* Ability to understand complex scientific information, theories, and practices.
* Skilled in identifying extramural funding mechanisms for faculty and programs
* Skilled in coordinating strategic writing projects
ESSENTIAL FUNCTIONS
PEOPLE ESSENTIAL FUNCTIONS
* Subject matter expert responsible for research, writing, and editing of technical documents.
* Mentors and coaches other scientific writers in editing and compiling appendices of documents related to technical reports.
* Works with departments, agencies and sponsors to ensure that specific requirements are met with respect to document content and formatting.
SERVICE ESSENTIAL FUNCTIONS
* Independently creates technical documents (collaborating with the team) based on the strategy provided, and is accountable for the format, content, and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.
* Interprets data and advises faculty as how to best present data considering scientific communications best practices.
* Works with Principal Investigator(s) to develop, present, and bring to final submission high quality, large, multi-disciplinary, and multi-collaborative grant proposals and publications.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
* Prepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills to the preparation of grant proposals, manuscripts, presentations, protocols, and clinical regulatory documentation.
* Prepares technical documents that adhere to regulatory, financial, policy, and legal requirements.
* Assures compliance with Houston Methodist policies, rules, and regulations to meet government, publisher, and sponsor standards and research development best practices.
FINANCE ESSENTIAL FUNCTIONS
* Development of grant application budgets, industry contracts and subcontracts, and other financial documents in compliance with Houston Methodist policies and procedures.
* Contributes to quality improvement and success of grants applications.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
* Finds and implements innovations in scientific writing, grant development and research development to continuously improve best practices.
* Seeks opportunities to for continual professional development.
* Fosters a positive and constructive teaching environment by engaging students and co-workers in learning opportunities that are valuable and in alignment with business objectives.
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
* Uniform: No
* Scrubs: No
* Business professional: Yes
* Other (department approved): No
ON-CALLNote that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below.
* On Call* No
TRAVELTravel specifications may vary by department
* May require travel within the Houston Metropolitan area No
* May require travel outside Houston Metropolitan area Yes
Company Profile:
Houston Methodist Academic Institute oversees the Education Institute and Research Institute. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports clinical research protocols and extramurally funded translational research programs.
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News from the
Houston Methodist Community
Houston Methodist Ranked No. 9 on Glassdoor's 2026 Best Places to Work list
Houston Methodist has earned a top spot on Glassdoor's 2026 Best Places to Work list, ranking No. 9 out of 100 of the Top 100 U.S. Employers and No. 1 in the health care industry. This national recognition is particularly meaningful because it is based entirely on feedback shared by …
Houston Methodist Named to Forbes Top Hospitals 2026
Forbes has released its inaugural Top Hospitals 2026 list, recognizing the nation's leading acute-care hospitals based on quality, safety and patient experience. We are proud to share that six Houston Methodist hospitals earned a spot among the best: • Houston Methodist Baytown Hospital • Houston Methodist Clear Lake Hospital • …
Houston Methodist Hospitals Recognized in Vizient's 2025 Quality Leadership Rankings
We are honored to share that all seven of our eligible hospitals have been named top performers in the 2025 Bernard A. Birnbaum, MD, Quality Leadership Rankings by Vizient Inc., a trusted national benchmark for hospital performance. This year, five of our hospitals ranked in the top five of their …
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$85k-145k yearly est. 10d ago
Senior / Manager, Medical Writing
Relay Therapeutics 4.6
Cambridge, MA jobs
The Opportunity: The Senior / Manager, Medical Writing is responsible for independently authoring and delivering high-quality routine clinical and regulatory documents and represents Medical Writing as a cross-functional team member for clinical study-level activities. This position will work directly with the Director, Medical Writing.
Your Role:
Independently writing and delivering high-quality clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, investigator's brochures, integrated summaries, and sections of regulatory submissions) in partnership with internal cross-functional team members
Coordinating effective document development, review, and approval
Overseeing medical writing vendor writers for individual projects, as needed
Actively contributing to development of processes and procedures to improve departmental and cross-functional workflows
Building relationships and working collaboratively with study team members
Reviewing study and program-level documents for clarity, accuracy, and consistency
Developing in-depth study-level and program knowledge
Contributing scientific knowledge and analytical skills to the production of documents
Participating in developing key messages for clinical regulatory documents
Developing document timelines and communicating with team members to maintain awareness of expectations, milestones, and deliverables
Leading development of clinical trial registry postings for assigned studies
Navigating an electronic document management system and related tools to develop clinical documents
Your Background:
Bachelor's degree in relevant discipline required. PhD in molecular biology, genetics, or a related life sciences field preferred, (or equivalent degree).
3+ years of experience in the pharmaceutical/biotechnology industry as a medicalwriter
Self-motived and nimble with the ability to excel in a fast-paced environment
Excellent written and verbal communication skills
Strong interpersonal skills
Experience producing high-quality scientific/medical documents
Ability to analyze, interpret, and summarize clinical data
Basic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
Strong project management and organizational skills
Initiative and creativity in solving routine problems for individual documents and in identifying process improvements within the Medical Writing department
Attention to detail related to consistency, grammar, syntax, and scientific accuracy
Proficiency in word processing, templates, table/figure creation, and literature searches
Estimated Salary Range: [$107,000 - $179,000].
The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate's education, experience, skills and location.
#JO1
About Relay Therapeutics
Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process.
Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you're excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!
$107k-179k yearly Auto-Apply 5d ago
Senior Scientific Writer - Otolaryngology
Houston Methodist 4.5
Houston, TX jobs
At Houston Methodist, the Senior Scientific Writer is responsible for functioning as the mentor for junior staff with an extensive knowledge of both medical and technical science while working with scientific and clinical teams to concisely and clearly communicate technical medicine and science in writing, in accordance with regulations, standards and guidelines. This role must also have familiarity with scientific and clinical research and will conduct comprehensive literature searches for writing and editing abstracts, manuscripts, review articles, grant applications, clinical study protocols, investigator brochures, consent forms, presentations and progress reports for both scientific and lay audiences.
**FLSA STATUS**
Exempt
**QUALIFICATIONS**
**EDUCATION**
+ Master's Degree required
+ PhD Preferred
**EXPERIENCE**
+ Six years' experience in technical or scientific writing
+ Two years with grant applications preferred
**LICENSES AND CERTIFICATIONS**
**Required**
**SKILLS AND ABILITIES**
+ Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
+ Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
+ Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
+ Ability to write in a clear, concise, and accurate language that can be understood by technical and non-technical audiences
+ Ability to understand complex scientific information, theories, and practices.
+ Skilled in identifying extramural funding mechanisms for faculty and programs
+ Skilled in coordinating strategic writing projects
**ESSENTIAL FUNCTIONS**
**PEOPLE ESSENTIAL FUNCTIONS**
+ Subject matter expert responsible for research, writing, and editing of technical documents.
+ Mentors and coaches other scientific writers in editing and compiling appendices of documents related to technical reports.
+ Works with departments, agencies and sponsors to ensure that specific requirements are met with respect to document content and formatting.
**SERVICE ESSENTIAL FUNCTIONS**
+ Independently creates technical documents (collaborating with the team) based on the strategy provided, and is accountable for the format, content, and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.
+ Interprets data and advises faculty as how to best present data considering scientific communications best practices.
+ Works with Principal Investigator(s) to develop, present, and bring to final submission high quality, large, multi-disciplinary, and multi-collaborative grant proposals and publications.
**QUALITY/SAFETY ESSENTIAL FUNCTIONS**
+ Prepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills to the preparation of grant proposals, manuscripts, presentations, protocols, and clinical regulatory documentation.
+ Prepares technical documents that adhere to regulatory, financial, policy, and legal requirements.
+ Assures compliance with Houston Methodist policies, rules, and regulations to meet government, publisher, and sponsor standards and research development best practices.
**FINANCE ESSENTIAL FUNCTIONS**
+ Development of grant application budgets, industry contracts and subcontracts, and other financial documents in compliance with Houston Methodist policies and procedures.
+ Contributes to quality improvement and success of grants applications.
**GROWTH/INNOVATION ESSENTIAL FUNCTIONS**
+ Finds and implements innovations in scientific writing, grant development and research development to continuously improve best practices.
+ Seeks opportunities to for continual professional development.
+ Fosters a positive and constructive teaching environment by engaging students and co-workers in learning opportunities that are valuable and in alignment with business objectives.
**SUPPLEMENTAL REQUIREMENTS**
**WORK ATTIRE**
+ Uniform: No
+ Scrubs: No
+ Business professional: Yes
+ Other (department approved): No
**ON-CALL***
_*Note that employees may be required to be on-call during emergencies (ie. Disaster, Severe Weather Events, etc) regardless of selection below._
+ On Call* No
**TRAVEL****
_**Travel specifications may vary by department**_
+ May require travel within the Houston Metropolitan area No
+ May require travel outside Houston Metropolitan area Yes
**Company Profile:**
Houston Methodist Academic Institute oversees the Education Institute and Research Institute. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care. Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports trainees in residence for medical, nursing, allied health and research education programs. Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports clinical research protocols and extramurally funded translational research programs.
$74k-125k yearly est. 14d ago
Medical Writer
Biomarin Pharmaceutical 4.6
San Rafael, CA jobs
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
The MedicalWriter 1 applies basic to intermediate documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
RESPONSIBILITIES List the major responsibilities of the job.
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.)
Aids in managing study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Assists in developing and reviewing standard processes and templates within Global Medical Writing
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned.
SCOPE Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.
This position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.
EDUCATION State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
Bachelor's or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Evidence of medical writing career development desirable, eg, American MedicalWriters Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
EXPERIENCE State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
Relevant ExperienceFulfills one of the following:· Up to 2 years as a medicalwriter in the pharmaceutical industry· At least 5 years of medical or scientific writing experience as a primary job responsibility Clinical Studies· Familiar with drug development process (discovery to market).· Basic understanding of biostatistical and clinical research concepts.· Basic applied knowledge of:o documentation required for the conduct of clinical studieso protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)o study results reporting Medical Writing· Writing high-quality documents that support corporate goals and objectives.· Experience writing, reviewing, or editing protocols and clinical study reports preferred.· Basic applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.· Ability to interpret basic tabular and graphical clinical data presentations.· Ability to create basic tables using AMA style (eg, Schedule of Events).· Basic to intermediate applied knowledge of basic clinical laboratory tests.· Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Computer/office equipment Skills
Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, and PowerPoint.
Familiar with document management software (eg, LiveLink, SharePoint, Veeva)
Experienced with scanners, printers, and copiers.
Regulatory
Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
Project Management
Capable of working on multiple tasks and shifting priorities.
Good conflict management skills.
Motivated and shows initiative.
Detail oriented.
Communication
Capable of well organized, concise and clear written and verbal communication.
Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
$97k-124k yearly est. Auto-Apply 60d+ ago
Manager, Medical Writing Quality
Arrowhead Pharmaceuticals 4.6
San Diego, CA jobs
Job Description
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
Arrowhead Pharmaceuticals is seeking an experienced Quality Control (QC) professional to lead the QC function supporting the development of high-quality clinical and regulatory documents across our growing RNAi therapeutic pipeline. This role is critical to ensuring that both externally submitted and internally circulated documents meet Arrowhead's standards for accuracy, clarity, compliance, and scientific integrity.
The Manager, Medical Writing QC will partner closely with medical writing colleagues and cross-functional subject matter experts to oversee QC activities for Medical Writing deliverables. This role will also coordinate and manage external QC services to ensure efficient, consistent, and high-quality review support across multiple programs.
Responsibilities
Lead and manage the QC function within Medical Writing, including QC resource allocation, review planning, and oversight of QC timelines across multiple programs and therapeutic areas.
Perform QC activities (editing and data verification) for clinical and regulatory documents, including but not limited to clinical study protocols and amendments, Investigator's Brochures (IBs), clinical study reports (CSRs), NDA/MAA components, and briefing books.
Collaborate with lead medicalwriters and subject matter experts to identify and obtain appropriate QC source materials.
Manage external QC vendors to ensure consistent, high-quality deliverables when additional support is required.
Establish, track, and report QC performance metrics, and recommend process improvements to support Arrowhead's expanding pipeline.
Support planning and content development for document kick-off meetings, including slide deck preparation as needed.
Assist in the resolution of QC comments to ensure all feedback is addressed accurately and efficiently.
Requirements:
Bachelor's degree in a medically related or life sciences field with 5 years of relevant QC experience in the pharmaceutical industry, or Master's or doctoral degree with at least 3 years of relevant medical writing or QC experience in the pharmaceutical industry.
Exceptional attention to detail, with the ability to identify issues in complex scientific documents
Knowledge of clinical research concepts, FDA regulations, and ICH guidelines related to drug development and medical writing
Demonstrated experience contributing to successful clinical documents, such as IBs, CSRs, protocols, and protocol amendments
Ability to manage multiple priorities while maintaining high-quality standards
Proficiency with document management systems and collaboration tools (e.g., Veeva, SharePoint)
Familiarity with basic statistical concepts is a plus
Prior experience working with cross-functional study teams
California pay range $110,000-$150,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
California Applicant Privacy Policy
$110k-150k yearly 8d ago
Manager, Medical Writing Quality
Arrowhead Pharmaceuticals 4.6
San Diego, CA jobs
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
Arrowhead Pharmaceuticals is seeking an experienced Quality Control (QC) professional to lead the QC function supporting the development of high-quality clinical and regulatory documents across our growing RNAi therapeutic pipeline. This role is critical to ensuring that both externally submitted and internally circulated documents meet Arrowhead's standards for accuracy, clarity, compliance, and scientific integrity.
The Manager, Medical Writing QC will partner closely with medical writing colleagues and cross-functional subject matter experts to oversee QC activities for Medical Writing deliverables. This role will also coordinate and manage external QC services to ensure efficient, consistent, and high-quality review support across multiple programs.
Responsibilities
Lead and manage the QC function within Medical Writing, including QC resource allocation, review planning, and oversight of QC timelines across multiple programs and therapeutic areas.
Perform QC activities (editing and data verification) for clinical and regulatory documents, including but not limited to clinical study protocols and amendments, Investigator's Brochures (IBs), clinical study reports (CSRs), NDA/MAA components, and briefing books.
Collaborate with lead medicalwriters and subject matter experts to identify and obtain appropriate QC source materials.
Manage external QC vendors to ensure consistent, high-quality deliverables when additional support is required.
Establish, track, and report QC performance metrics, and recommend process improvements to support Arrowhead's expanding pipeline.
Support planning and content development for document kick-off meetings, including slide deck preparation as needed.
Assist in the resolution of QC comments to ensure all feedback is addressed accurately and efficiently.
Requirements:
Bachelor's degree in a medically related or life sciences field with 5 years of relevant QC experience in the pharmaceutical industry, or Master's or doctoral degree with at least 3 years of relevant medical writing or QC experience in the pharmaceutical industry.
Exceptional attention to detail, with the ability to identify issues in complex scientific documents
Knowledge of clinical research concepts, FDA regulations, and ICH guidelines related to drug development and medical writing
Demonstrated experience contributing to successful clinical documents, such as IBs, CSRs, protocols, and protocol amendments
Ability to manage multiple priorities while maintaining high-quality standards
Proficiency with document management systems and collaboration tools (e.g., Veeva, SharePoint)
Familiarity with basic statistical concepts is a plus
Prior experience working with cross-functional study teams
California pay range $110,000-$150,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
California Applicant Privacy Policy
$110k-150k yearly Auto-Apply 3d ago
Senior Scientific Writer
10X Genomics 4.4
Pleasanton, CA jobs
About the role:
We are seeking a creative, collaborative, and results-oriented individual to join our 10x team as a Scientific Writer. The ideal candidate will have a strong background in sciences with excellent writing skills. This person will be part of the Technical Communications team and will work closely with multiple teams, including R&D, Support, and Marketing, to generate high quality customer facing document portfolios for multiple product lines in a fast-paced environment. The individual will be a highly productive writer, a quick learner, a methodical and organized worker with an unfailing attention to detail. Writing creativity will be required to generate documents that can maximize product performance and enhance customer experience. Developing an understanding of the diverse product portfolios along with user requirements will be key in contributing towards new content presentation styles and formats. Proficiency in content creation and content management tools along with the ability to learn and apply new tools, processes, and standards will be required.
Individuals applying for this position must be self-starters, strategic thinkers, action driven, flexible in changing direction and methods, thrive in a fast paced environment, excel at managing multiple priorities, succeed in communicating with all levels within the organization and provide immediate contribution.
This is a hybrid position requiring on-site presence ~3 days/week
What you will be doing:
Write and edit high quality, clear, concise, and consistent customer facing technical and scientific documentation, like protocols, technical notes, user guides, for diverse product portfolios in a fast-paced environment
Effectively partner with multiple stakeholders to gather input and implement specific changes in documents
Integrate various sources of information into documents with a uniform style and language for compliance with corporate brand standards and legal guidelines
Use a content management system to coordinate document review, approval, and release
Effectively manage and sustain multiple product document portfolios under tight timelines, with flexibility to shift priorities
Develop understanding of product portfolios and end user experience to generate and implement creative document presentation styles and formats, improving user experience
Create systems and processes to streamline content creation by minimizing redundancy and enhancing content modularity
Minimum Requirements:
Master's degree in a life science discipline or an equivalent qualification
At least three years of professional writing experience producing clear, concise, and accurate content for targeted audiences
Highly organized, with strong time management and project management skills
Excellent interpersonal, communication, and relationship-building abilities, with a proven ability to collaborate effectively
Working knowledge of common materials, techniques, and methods used in wet-lab environments
Proficiency in English, with exceptional grammatical, editorial, and proofreading skills
Preferred Skills and Experience:
Hands-on experience working in a wet-lab
Proficiency in Adobe Suite and MadCap Flare is highly desirable
Experience in leveraging AI tools for content generation
Experience in single cell genomics and NGS
#LI-MH1 #LI-Onsite
Below is the base pay range for this full-time position. The actual base pay will depend on several factors unique to each candidate, including one's skills, qualifications, and experience. At 10x, base pay is also just one component of the Company's total compensation package. This role is also eligible for 10x's equity grants, its comprehensive health and retirement benefit programs, and its annual bonus program or sales incentive program. During the hiring process, your 10x recruiter can share more about the Company's total compensation package.
Pay Range$138,700-$187,700 USD
About 10x Genomics
At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world.
We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience.
Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference.
Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law.
10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.
$138.7k-187.7k yearly Auto-Apply 15d ago
Manager, Medical Writing Quality
Arrowhead Pharmaceuticals, Inc. 4.6
San Diego, CA jobs
Arrowhead Pharmaceuticals is seeking an experienced Quality Control (QC) professional to lead the QC function supporting the development of high-quality clinical and regulatory documents across our growing RNAi therapeutic pipeline. This role is critical to ensuring that both externally submitted and internally circulated documents meet Arrowhead's standards for accuracy, clarity, compliance, and scientific integrity.
The Manager, Medical Writing QC will partner closely with medical writing colleagues and cross-functional subject matter experts to oversee QC activities for Medical Writing deliverables. This role will also coordinate and manage external QC services to ensure efficient, consistent, and high-quality review support across multiple programs.
Responsibilities
* Lead and manage the QC function within Medical Writing, including QC resource allocation, review planning, and oversight of QC timelines across multiple programs and therapeutic areas.
* Perform QC activities (editing and data verification) for clinical and regulatory documents, including but not limited to clinical study protocols and amendments, Investigator's Brochures (IBs), clinical study reports (CSRs), NDA/MAA components, and briefing books.
* Collaborate with lead medicalwriters and subject matter experts to identify and obtain appropriate QC source materials.
* Manage external QC vendors to ensure consistent, high-quality deliverables when additional support is required.
* Establish, track, and report QC performance metrics, and recommend process improvements to support Arrowhead's expanding pipeline.
* Support planning and content development for document kick-off meetings, including slide deck preparation as needed.
* Assist in the resolution of QC comments to ensure all feedback is addressed accurately and efficiently.
Requirements:
* Bachelor's degree in a medically related or life sciences field with 5 years of relevant QC experience in the pharmaceutical industry, or Master's or doctoral degree with at least 3 years of relevant medical writing or QC experience in the pharmaceutical industry.
* Exceptional attention to detail, with the ability to identify issues in complex scientific documents
* Knowledge of clinical research concepts, FDA regulations, and ICH guidelines related to drug development and medical writing
* Demonstrated experience contributing to successful clinical documents, such as IBs, CSRs, protocols, and protocol amendments
* Ability to manage multiple priorities while maintaining high-quality standards
* Proficiency with document management systems and collaboration tools (e.g., Veeva, SharePoint)
* Familiarity with basic statistical concepts is a plus
* Prior experience working with cross-functional study teams
$69k-129k yearly est. Auto-Apply 38d ago
Associate Scientific Writer - Medical Devices
Applied Medical Distribution Corporation 4.4
Rancho Santa Margarita, CA jobs
Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Position Description
Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work fully on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.
As an Associate Clinical Writer, you will work within the Clinical Affairs team. The Associate Clinical Writer's primary responsibilities are developing and completing scientific protocols and reports, including, but not limited to, Clinical Evaluations and Post Market Clinical Feedback as part of design validations for medical devices to support product registrations internationally. You will conduct reviews of post-market data, such as complaints and feedback, to incorporate relevant data and analysis into reports.
Key Responsibilities:
* Critical Thinking: You will need to be able to critically evaluate scientific literature and research findings and apply this knowledge to your work. This involves asking questions, identifying gaps in the research, and synthesizing information from multiple sources.
* Writing Skills: You will be responsible for conducting thorough literature searches to identify relevant studies, systematic reviews, and meta-analyses that inform your writing. You will also be responsible for creating and maintaining job aids and work instructions for the preparation and maintenance of compliant medical writing deliverables.
* Communication: You will be responsible to manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables. You will also be expected to collaborate with cross-functional teams to develop new and insightful analytics to collect and analyze clinical data.
Position Requirements
This position requires the following skills and attributes:
* Bachelor's or Advanced degree in a scientific field (MS, Ph.D., MD, or Pharm. D.)
* Experience in conducting focused literature searches on PubMed, Embase or other similar literature databases
* Data mining and analysis
* Ability to formulate reports and present findings
* Effective written and oral communication skills
* Ability to collaborate in a team environment
* Project management and organizational skills
* Strong familiarity with Microsoft Office
Preferred
The following skills and attributes are preferred:
* 1-2 years of experience in the medical device/pharmaceutical field or 1+ years of research with professor
* Ability to understand and interpret results of clinical studies, with a strong understanding of statistics
* Experience performing statistical analysis with statistical programs
* Ability to prioritize and manage multiple projects
* Data analytic publication experience or literature author publication experience
* Please note that this role is internally titled 'Associate Clinical Writer'. Externally, we refer to it as 'Associate Scientific Writer - Medical Devices' to better reflect the role's responsibilities.
Benefits
* Competitive compensation range: $70000 - $80000 / year (California).
* Comprehensive benefits package.
* Training and mentorship opportunities.
* On-campus wellness activities.
* Education reimbursement program.
* 401(k) program with discretionary employer match.
* Generous vacation accrual and paid holiday schedule.
Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.
Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.
All compensation and benefits are subject to plan documents and written agreements.
Equal Opportunity Employer
Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.