Post job

Medical writer jobs in Manchester, NH - 86 jobs

All
Medical Writer
Manager, Medical Writing
Grant Writer
Documentation Writer
Senior Medical Writer
Technical Writer
Editor
Senior Technical Writer
  • Principal Medical Writer

    Candel Therapeutics

    Medical writer job in Needham, MA

    Salary: $175-$190k Core hours: Eastern Time Zone Why Work With Us: At Candel, our people drive our success. We value diversity, collaboration, and bold thinking in a supportive, mission-driven environment. We are a high-performing team that shows up for each other and stays focused on making a difference for patients and families. Our leadership is transparent and empowering, and our culture is built on trust, flexibility, and accountability-encouraging ownership and innovation every day. Our Science: Advancing Cancer Immunotherapies Candel is a clinical-stage biopharma company developing off-the-shelf, multimodal immunotherapies that stimulate personalized, systemic anti-tumor responses. Our platforms use genetically modified adenovirus and HSV constructs. With positive Phase 3 results for our lead candidate, it's an exciting time to join us and help bring transformative cancer treatments to patients. Learn more: **************** Position Summary We are seeking an experienced Senior Medical Writer to lead, plan, author, and manage high-quality clinical and regulatory documents for Candel's oncology programs. The role focuses on authorship of BLA components, Clinical Study Reports (CSRs), and Investigator's Brochures (IBs). This position requires hands-on regulatory writing expertise aligned with ICH, FDA, and EMA expectations, strong cross-functional collaboration, and disciplined project management to meet key submission timelines. This role is remote within the U.S., with preference for candidates in Eastern or Central time zones. What You'll Do Regulatory authorship and content development: Serve as an author for BLA clinical modules, including Module 2.5 Clinical Overview, Module 2.7 Clinical Summary, and relevant Module 5 clinical study content Author and update Clinical Study Reports, Investigator's Brochures, and SOPs. Contribute to protocols, protocol amendments, SAP-aligned data displays and appendices, clinical sections of briefing packages, and responses to health-authority queries Document strategy and project management: Develop document strategies, outlines, and timelinea Manage version control and drive document review cycles to audit-ready completion Cross-functional collaboration: Coordinate input from Clinical, Biostatistics, Regulatory, Safety, and CMC functions to ensure accuracy, consistency, and timely delivery Data interpretation and narrative development: Translate complex clinical and statistical results into clear, consistent regulatory narratives aligned with labeling and submission objectives Standards, compliance, and process improvement: Ensure compliance with ICH guidelines, FDA/EMA guidance, company SOPs, and style conventions Contribute to template and process improvements Submission and inspection readiness: Support inspection and submission readiness, including document quality checks, traceability to source data, and comment reconciliation Milestone, risk, and issue management: Track milestones and risks, escalate issues proactively, and drive resolution to maintain delivery commitments What You'll Bring Required (must have all) 7+ years' medical writing in pharma/biotech/CRO with substantial oncology experience Bachelor's degree in life science (advanced degree preferred) Authorship of BLA clinical modules (2.5, 2.7, relevant 5), CSRs, and IBs Contributions to protocols/amendments, SAP-aligned tables/appendices, briefing packages, and health-authority responses Strong knowledge of ICH/FDA/EMA; oncology trial design, endpoints, and evolving regulatory expectations Ability to interpret clinical and statistical results and craft clear, compliant regulatory narratives Exceptional writing, editing, and project management; effective independent and cross-functional execution in fast, deadline-driven settings Ownership of document strategy, outlines and timelines, version control, and end-to-end review to audit-ready quality Direct experience with submission and inspection readiness, including quality control, data traceability, and comment reconciliation Participation in major submissions (BLA/NDA/MAA) through filing and review including assisting with responses to Agency queries. Proficiency with document and workflow systems (e.g., Veeva, eTMF, CTMS, electronic review tools) Proven collaboration with Clinical, Biostatistics, Regulatory, Safety, and CMC; consistent milestone and risk tracking with timely issue resolution Ability to work core Eastern or Central U.S. hours (remote, U.S.-based) Applicants must be legally authorized to work in the United States at the time of hire and throughout employment. We are unable to provide, assume, or sponsor work visas or employment authorization for this role now or in the future.
    $175k-190k yearly Auto-Apply 15d ago
  • Job icon imageJob icon image 2

    Looking for a job?

    Let Zippia find it for you.

  • Principal Medical Writer

    Beone Medicines

    Medical writer job in Cambridge, MA

    BeOne Medicines USA, Inc. seeks Principal Medical Writer in Cambridge, MA: **Job Duties:** Responsible for providing expertise to support the development of high-quality, fit-for-purpose clinical and regulatory documents to facilitate speed of information during development, submission, approval, and life-cycle management of products in BeiGene pipeline. Also responsible for mentoring junior MWs (full-time employees and/or contractors/vendors) as needed. Manage multiple documents at the same time, including the complex documents (eg, those with complex content, urgent timeline, or external collaboration). Contributes to direction and strategy setting (including critically analyzing, synthesizing, and presenting complex information) for document development in collaboration with study team(s). Contribute to the creation and maintenance of document writing template/guidance for the document types listed in the General Description part. Lead part of the maintenance of document writing template/guidance for the document types listed in the General Description part. Identify the questions/issues that require departmental discussion or team discussion with guidance from line manager/mentor. Identify the potential risks and make a mitigation plan with guidance from line manager/mentor. Resolves problems with guidance from line manager/mentor (eg, takes concrete actions according to the aligned decisions). Understands the role of own documents within the larger dossier and voices out any impact on upstream and downstream processes. Provide technical and operational mentorship to junior MWs (full-time employees and/or contractors/vendors). Understands the global MW scope and works to guide study team(s) and program team(s) within the defined scope and responsibility following established processes. Provides topic sharing on regulatory writing and related knowledge within the department and across the company (and to cross-functional stakeholders with guidance from line manager/mentor). Full-time telecommuting is an option. **Minimum Requirements:** + PhD (or its foreign degree equivalent) in Biotechnology, Engineering (any field), Biochemistry, or a related quantitative discipline, and 2 years of experience in the job offered or in any occupation in related field, OR Master's degree (or its foreign degree equivalent) in Biotechnology, Engineering (any field), Biochemistry, or a related quantitative discipline, and 5 years of progressively responsible experience in the job offered or in any occupation in related field. **Special Skill Requirements:** + Writing clinical study reports; + Writing protocols; + Writing protocol amendments; + Analyzing, Synthesizing, and Presenting Complex Information utilized in Medical Documentation; + Working with regulatory authorities from multiple regions. Any suitable combination of education, training and/or experience is acceptable. Full-time telecommuting is an option. Disregard the below range, the selected candidate will earn a wage of $137,100 - $171,400 per annum. Submit resume with references to: Req.#: L24-150320 at: ATTN: Amy Nobriga, **************************. \#LI-DNI All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
    $137.1k-171.4k yearly Easy Apply 13d ago
  • Medical Writer

    Integrated Resources 4.5company rating

    Medical writer job in Cambridge, MA

    A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. With todays growing demand for talented and well qualified professionals, its more important than ever to partner with a company that employs innovative measures to meet your demands. Our expert team of highly trained counselors work hand in hand with every client forming a partnership of understanding and commitment. Our clients know that they can rely on us for prompt response times and reliable staff to meet their workforce demands. Our employees know that they can trust our support for their career development and personal growth. IRI is proud to be JCAHO Certified by the Joint Commissions of Health, MBE Certified by the State of NJ and the National Minority Supplier Diversity Council (NMSDC) and SBE Certified by the State of NJ. We have been honored by the following: Top 100 Diversity Owned Business in NJ for 2007, 2008 and 2009 Top 500 Privately-Held Business in the US Top 500 Diversity Owned Business in the US Top 100 Subcontinent Asian American Business in the US We have also been listed to the Inc. 5000 List of fastest-growing, privately-held companies in the US in 2007, 2008, 2009 and 2010 and honored as an Emerging Business of the Year finalist by NJ BIZ in 2009. Job Description: In this role, incumbent will be expected to provide Medical Writing leadership for clinical development, registrational, and LCM programs. Serves as lead Medical Writer for key programs. Coordinates medical writing support for programs with internal and contract writers. Additionally, must posess the ability to guide and assists medical writers in the writing of documents that are components of clinical/ regulatory approval applications for new biologics or NME applications. Documents include: Sections of clinical trial applications, Annual Reports, and BLA/NDAs, Protocols and Protocol Amendments, Model Informed Consents, Model Privacy Consents, Investigator Brochures, Clinical Study Reports, and Expert Reports and other documents as appropriate. Additional skills: must be a strong technical leader, manage with excellent scientific, strategic and customer focused leadership. Partner with Clinical Operations and R&D team members to ensure completion of high quality, timely, clinical documentation. Expected Qualification: Masters or PhD in biology or related discipline. Equivalent combination of education and experience considered. 7+ years of related experience in biotech or pharmaceutical environment. Must have strong scientific and operational background. At least 3 years of experience managing staff. Additional InformationAll your information will be kept confidential according to EEO guidelines.
    $82k-116k yearly est. 60d+ ago
  • Senior Medical Writer

    Camp4 Therapeutics 3.9company rating

    Medical writer job in Cambridge, MA

    Senior Medical Writer 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 Senior Medical Writer. 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 medical writers 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
  • Medical Writer III : 4710313

    Artech Information System 4.8company rating

    Medical writer job in Cambridge, MA

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • Work with therapeutic teams to develop and/or edit scientific/clinical documents, including manuscripts, abstracts, posters, and slide presentations • Work effectively with company document management systems and related tools, templates, and procedures in order to ensure efficient internal and external review and approval of documents prior to final submission for publication or presentations at scientific congresses • Ensure a consistent style of writing and presentation of clinical data to maintain quality and ease of review by all contributing authors • Participate and contribute to Medical Affairs Publication Team meetings and to cross-functional working groups as needed to facilitate efficient development and submission of publications • Work with external and internal authors on company-sponsored publications to facilitate writing, review and submission to high-tier journals Skills: • Substantial experience (8-10 years) as a medical writer or equivalent working knowledge of clinical research, study design, and ability to present clinical data objectively in a clear, concise written format • Demonstrated competency in project management and the successful preparation and submission of peer-reviewed manuscripts • Outstanding written and verbal communication and interpersonal skills • Proficient in Word, Excel, PowerPoint, and Acrobat. Datavision expertise a plus • Highly organized, detail-oriented, self-motivated, and able to work independently as well as within cross-functional teams • Ability to manage multiple projects simultaneously, thinks critically, and adheres to deadlines • Demonstrated customer facing skills and capability to collaborate with Key Opinion Leaders on publications and presentations in a credible manner • Ability to interpret and critique scientific and medical literature with respect to scientific and business implications is essential • Experience in Multiple Sclerosis therapeutic or neurology area preferred • Medical writing or publications experience with a pharmaceutical company or medical communications agency preferred Qualifications • Advanced degree (MS, PhD, PharmD) in biomedical sciences is preferred, but not required Additional Information For more information, Please contact Akriti Gupta ************** Morristown, NJ 07960
    $79k-111k yearly est. 1d ago
  • Senior Medical Writer - FSP

    Parexel 4.5company rating

    Medical writer job in Concord, NH

    The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include: acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff. **Key Accountabilities** : **Author Clinical Documents** + Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy. + Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. + Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. + Perform literature searches/reviews as necessary to obtain background information and training for development of documents. + Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing. **Quality Control** + Ensure that all work is complete and of high quality prior to team distribution or shipment to client. + Confirm data consistency and integrity across the document. + Prepare documents for publishing readiness, when applicable. + Ensure document structure, content, and style adheres to FDA/EMA or other appropriate regulatory guidelines, and comply with departmental, corporate or client SOPs and style guidelines, as applicable. + Provide suggested alternative content when contributors provide content that does not meet document needs. + Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review. **Document Project Management** + Act in the capacity of project manager/lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues. Project management of contractual and financial aspects may only be performed with the guidance of medical writing management. + Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Distribute final documents to project team and client. + Identify any potential project challenges to departmental line management and project leader, including changes in project plan, timeline or out of scope requests, and suggest possible resolution options. + Attend or lead project team meetings as required. Mediate conflict or disagreement, as well as timeline delays, among team members by negotiating, compromising, and facilitating open exchange of ideas and opinions to come to a consensus. + Supervise collection of documentation by Medical Writing Support Coordinator, Document Specialist, and/or Associate Medical Writer for assembly of project files and client deliverables. Ensure appropriate filing of project documentation with assistance from the Medical Writing Support Coordinator. + Build and maintain collaborative relationships with teams/clients for an efficient, productive, and professional working relationship. **Training/ Compliance** + Attend and complete mandatory, corporate, project-specific, and departmental training as required. + Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department. + Assist in the training/mentoring of new staff as well as less experienced departmental members. **General** + Attend departmental and company meetings as necessary. + Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform. + When requested, assist management with preparation of resourcing estimates for potential new medical writing projects, or review request for proposal packages to determine content and appropriateness of materials required for development of clinical documents. + Initiate and participate in departmental or interdepartmental process improvement and training initiatives, including development of departmental SOPs, templates, and general guidelines for clinical documentation and workflow procedures. **Skills:** + Excellent interpersonal, verbal, and written communication skills. + Ability to consistently produce documents of high quality. + Demonstrates attention to details and proactivity. + Ability to understand all necessary steps in a project, plan ahead, and identify critical paths. + A flexible attitude with respect to work assignments and new learning; readily adapts to changes. + Ability to efficiently manage time spent on tasks and proactively identify deficiency. Manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills. + Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity. + Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned. + Understands and satisfies client needs. + Gains trust and establish a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. + Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy. **Knowledge and Experience** : + Demonstrated understanding of clinical research, the drug development process, and industry guidelines and regulations, e.g., ICH-GCP. + Extensive clinical/scientific writing skills. + Scientific background essential; writing experience includes multiple clinical documents: study reports, study protocols, or CTD documents or similar. + Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel). + Fluent in written and spoken English with appropriate attention to phraseology, grammar, and punctuation. + If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite **Education:** + Bachelor's degree in Life Sciences/Health Related Sciences or equivalent. \#LI-LO1 \#LI-REMOTE EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
    $86k-127k yearly est. 13d ago
  • Senior Manager, Medical Writing

    Maplight Therapeutics

    Medical writer job in Burlington, MA

    Who We Are: MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms. What You'll Do: Reporting to the Head of Medical Writing, the Senior Manager, Medical Writing will be responsible for directly authoring and managing the development of high-quality medical and scientific documents to support the development, regulatory approval, and commercialization for one or more of our products. This role requires close collaboration with cross-functional teams to ensure timely, compliant, and high-standard deliverables that meet global regulatory requirements. The ideal candidate will have extensive experience in medical writing and scientific communications, with a strong understanding of both early- and late-stage drug development processes. Responsibilities: Author and manage regulatory documents for global submissions in accordance with ICH and other international guidelines, internal standards, and project timelines. Lead and coordinate medical writing activities for assigned programs, including internal teams and external vendors, ensuring timely and accurate submissions to regulatory authorities. Provide strategic input on medical writing deliverables, timelines, and processes during cross-functional meetings. Drive process improvements and serve as a subject matter expert on document types, workflows, and technologies. Partner with the Head of Medical Writing to evaluate and implement innovative approaches to document development, review, and quality control. Partner with the Head of Medical Writing to develop and maintain SOPs, templates, and best practices to ensure consistency and efficiency in document preparation. Oversee contract writers as needed, including defining scopes of work and monitoring deliverables and budgets. Apply therapeutic area and product knowledge to ensure scientific accuracy and clarity in all documents. Collaborate with internal stakeholders to establish style standards and quality control measures for high-quality outputs. Qualifications: Advanced degree (PhD, PharmD) in a scientific discipline preferred; Master's degree with at least 5 years of medical writing experience in pharma/biotech required. In-depth knowledge of regulatory requirements and guidelines (ICH, GCP, FDA, EMA) and familiarity with AMA style. Exceptional writing, editing, and verbal communication skills. Strong project management skills with the ability to prioritize and manage multiple projects. Proficiency with medical writing tools and software. Meticulous attention to detail and commitment to quality. Solid understanding of the drug development process and strong business acumen. Experience managing vendors and contractors is a plus. Strategic thinker with analytical skills and ability to thrive in a fast-paced environment. Collaborative team player with strong interpersonal skills and ability to build effective relationships across functions and with external partners. Location: This is a hybrid role with three days per week in-office in Burlington, Massachusetts. Compensation for this role may vary within the above range based on many factors including geographic location, candidate experience, and skills. Additional compensation/benefits include annual bonus opportunity, medical, dental, vision, life and AD&D, short term and long term disability, 401(K) plan with match, stock options, flexible non-accrual paid time off, and parental leave. Salary Range$168,000-$205,000 USD EEOC Statement: MapLight Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.
    $168k-205k yearly Auto-Apply 24d ago
  • Senior Manager, Medical Writing

    Prime Medicine

    Medical writer job in Watertown Town, MA

    Prime Medicine is a leading biotechnology company dedicated to creating and delivering the next generation of gene editing therapies to patients. The Company is leveraging its proprietary Prime Editing platform, a versatile, precise and efficient gene editing technology, to develop a new class of differentiated, one-time, potentially curative genetic therapies. Designed to make only the right edit at the right position within a gene while minimizing unwanted DNA modifications, Prime Editors have the potential to repair almost all types of genetic mutations and work in many different tissues, organs and cell types. Prime Medicine is currently progressing a diversified portfolio of investigational therapeutic programs organized around our core areas of focus: hematology, immunology & oncology, liver and lung. Across each core area, Prime Medicine is focused initially on a set of high value programs, each targeting a disease with well-understood biology and a clearly defined clinical development and regulatory path, and each expected to provide the foundation for expansion into additional opportunities. For more information, please visit ********************** Position Summary Prime Medicine is seeking a Senior Manager, Medical Writing to support the development of high-quality clinical, regulatory, and scientific documents across our gene-editing pipeline. This role will be both hands-on and strategic, contributing directly to authorship while helping to build scalable medical writing processes in a rapidly growing organization. Reporting to the Head of Medical Writing, this individual will partner closely with Clinical Development, Regulatory Affairs, Research, and other cross-functional teams to ensure accurate, consistent, and timely documentation supporting global clinical trials and regulatory submissions. This is an excellent opportunity for an experienced medical writer who thrives in a collaborative, fast-paced biotech environment and wants to grow into increasing leadership responsibility. Key Responsibilities Medical Writing & Content Development Serve as primary author and/or lead writer for key clinical and regulatory documents, including: Clinical Study Protocols and Amendments Investigator's Brochures (IBs) Clinical Study Reports (CSRs) IND/CTA submission documents and briefing packages Critically analyze and interpret nonclinical, clinical, and external literature data to develop clear scientific narratives, conclusions, and messaging. Ensure consistency of content, data interpretation, and scientific positioning across documents and programs. Cross-Functional Collaboration Work closely with Clinical Development, Clinical Operations, Regulatory Affairs, CMC, Nonclinical, and Quality teams to: Drive document timelines Resolve data and messaging questions Ensure regulatory and scientific alignment Lead and participate in cross-functional document review meetings and support responses to health authority questions as needed. Process, Quality & Infrastructure Support the development and maintenance of: Medical writing templates, style guides, and standards Document workflows, timelines, and best practices SOPs and quality control processes Perform or oversee document QC, ensuring accuracy, clarity, formatting consistency, and compliance with internal standards and regulatory expectations. Evaluate and incorporate new writing support tools, including AI tools, to streamline processes and improve writing quality. Contribute to inspection readiness and submission quality initiatives. Leadership & Development (scope dependent on level) May mentor junior writers, contractors, or co-ops as the team grows. Provide guidance on best practices in medical writing, document planning, and scientific storytelling. Required Qualifications Advanced degree or bachelor's/master's degree in life sciences, health sciences, or a related field. ~5+ years of medical writing experience in biotech/pharma OR ~7+ years of writing experience in biotech/pharma or other scientific or academic setting. Includes document ownership and cross-functional leadership Strong experience authoring clinical and regulatory documents (protocols, IBs, CSRs, IND/CTA content). Solid understanding of clinical development and regulatory frameworks (FDA, EMA, ICH). Excellent written, verbal, and organizational skills with strong attention to detail. Proficiency with document authoring tools (e.g., Microsoft Word, Office suite, SharePoint, Adobe). Preferred Qualifications Experience supporting gene editing/therapy or biologics programs. Familiarity with rare disease clinical development. Experience contributing to submissions across multiple development stages. Comfort working in a hands-on, fast-moving biotech environment. The pay range reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, skills, and education. This role is eligible for an annual short-term incentive award (e.g., bonus) and an annual long-term incentive award (e.g., equity). Prime Medicine offers a comprehensive Total Rewards package with robust health, financial, and wellness benefits-including medical, dental, vision, life insurance, a 401(k) match, and equity programs-along with generous paid time off, wellness days, and company-wide recharge breaks. Our commitment to employee well-being reflects our belief that when we care for our people, we strengthen our ability to put patients first and make meaningful impact together. U.S. Pay Range $153,096 - $188,095 USD Prime Medicine is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other classification protected by law.
    $153.1k-188.1k yearly Auto-Apply 21d ago
  • Senior / Manager, Medical Writing

    Relay Therapeutics 4.6company rating

    Medical writer job in Cambridge, MA

    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 medical writer 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
  • Cyber SDC - Endpoint Security Technical Writer - Senior

    EY 4.7company rating

    Medical writer job in Concord, NH

    At EY, we're all in to shape your future with confidence. We'll help you succeed in a globally connected powerhouse of diverse teams and take your career wherever you want it to go. Join EY and help to build a better working world. **Job Title: Endpoint Security Senior Technical Writer** **Job Description:** We are looking for a dedicated and skilled Senior Technical Writer to join our cybersecurity team. The ideal candidate will be responsible for creating, maintaining, and enhancing documentation that supports the planning, implementation, and operational readiness of multiple endpoint security initiatives. This role requires exceptional writing skills, a strong understanding of cybersecurity concepts, and the ability to collaborate closely with technical subject matter experts to produce clear, accurate, and standardized documentation. **Key Responsibilities:** 1. **Documentation Development:** 1. Develop, revise, and maintain high-quality documentation for cybersecurity technologies, processes, and workflows. 2. Create standard operating procedures (SOPs), implementation guides, engineering runbooks, and architectural overviews. 3. Produce documentation for system requirements, architecture designs, and operational readiness for new and existing solutions. 2. **Content Accuracy & Compliance:** 1. Ensure all documentation reflects current tools, configurations, and organizational standards. 2. Support documentation needs for compliance audits, risk assessments, and onboarding materials. 3. Align outputs with established documentation templates and governance frameworks. 3. **Collaboration & Knowledge Transfer:** 1. Work closely with cybersecurity SMEs, engineering teams, and operations to gather technical details and translate them into clear, user-friendly content. 2. Facilitate knowledge continuity by creating materials that enable smooth handoffs between teams. 4. **Continuous Improvement:** 1. Identify gaps in existing documentation and propose enhancements. 2. Stay informed on cybersecurity trends and incorporate best practices into documentation processes. **Qualifications:** + Strong technical writing skills with demonstrated ability to create clear, concise, and user-focused documentation. + Experience in cybersecurity or IT infrastructure environments, with familiarity in topics such as endpoint protection, SIEM, identity management, and cloud security. + Proficiency in documenting system requirements, architecture diagrams, SOPs, and implementation guides for technical audiences. + Excellent interviewing and collaboration skills to work with subject matter experts, engineers, and project stakeholders. + Familiarity with documentation tools and platforms, such as Confluence, SharePoint, Google Workspace, or equivalent. + Ability to interpret and standardize technical content, applying consistent tone, structure, and formatting across documents. + Understanding of documentation standards and style guides + Version control and change tracking awareness, including using tools like Git, document repositories, or structured file naming/versioning systems. + Experience in the utility sector, with an understanding of industry-specific terminology, operations, or regulatory environments. + Experience developing documentation specific to cybersecurity technologies used to protect systems within the utility vertical. + Experience in creating secure configuration and hardening guides for technologies used in utility environments (e.g., Windows, Linux, firewalls, etc.) + Familiarity with cybersecurity frameworks and standards, including NIST 800-53, NIST Cybersecurity Framework (CSF), ISA/IEC 62443, or ISO/IEC 27001. + Experience documenting critical infrastructure protection strategies, including risk assessments and vulnerability management programs. + Understanding of cybersecurity standards and ability to translate compliance and regulatory language into practical documentation. **What we offer you** At EY, we'll develop you with future-focused skills and equip you with world-class experiences. We'll empower you in a flexible environment, and fuel you and your extraordinary talents in a diverse and inclusive culture of globally connected teams. Learn more . + We offer a comprehensive compensation and benefits package where you'll be rewarded based on your performance and recognized for the value you bring to the business. The base salary range for this job in all geographic locations in the US is $77,500 to $140,900. The base salary range for New York City Metro Area, Washington State and California (excluding Sacramento) is $92,900 to $160,500. Individual salaries within those ranges are determined through a wide variety of factors including but not limited to education, experience, knowledge, skills and geography. In addition, our Total Rewards package includes medical and dental coverage, pension and 401(k) plans, and a wide range of paid time off options. + Join us in our team-led and leader-enabled hybrid model. Our expectation is for most people in external, client serving roles to work together in person 40-60% of the time over the course of an engagement, project or year. + Under our flexible vacation policy, you'll decide how much vacation time you need based on your own personal circumstances. You'll also be granted time off for designated EY Paid Holidays, Winter/Summer breaks, Personal/Family Care, and other leaves of absence when needed to support your physical, financial, and emotional well-being. **Are you ready to shape your future with confidence? Apply today.** EY accepts applications for this position on an on-going basis. For those living in California, please click here for additional information. EY focuses on high-ethical standards and integrity among its employees and expects all candidates to demonstrate these qualities. **EY | Building a better working world** EY is building a better working world by creating new value for clients, people, society and the planet, while building trust in capital markets. Enabled by data, AI and advanced technology, EY teams help clients shape the future with confidence and develop answers for the most pressing issues of today and tomorrow. EY teams work across a full spectrum of services in assurance, consulting, tax, strategy and transactions. Fueled by sector insights, a globally connected, multi-disciplinary network and diverse ecosystem partners, EY teams can provide services in more than 150 countries and territories. EY provides equal employment opportunities to applicants and employees without regard to race, color, religion, age, sex, sexual orientation, gender identity/expression, pregnancy, genetic information, national origin, protected veteran status, disability status, or any other legally protected basis, including arrest and conviction records, in accordance with applicable law. EY is committed to providing reasonable accommodation to qualified individuals with disabilities including veterans with disabilities. If you have a disability and either need assistance applying online or need to request an accommodation during any part of the application process, please call 1-800-EY-HELP3, select Option 2 for candidate related inquiries, then select Option 1 for candidate queries and finally select Option 2 for candidates with an inquiry which will route you to EY's Talent Shared Services Team (TSS) or email the TSS at ************************** .
    $92.9k-160.5k yearly 21d ago
  • Technical Document Writer - Biomanufacturing

    Collabera 4.5company rating

    Medical writer job in Marlborough, MA

    Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Collabera offers a full range of benefits to its employees including paid vacations, holidays, personal days, Medical, Dental and Vision insurance, 401K retirement savings plan, Life Insurance, Disability Insurance. Job Description Description: • We are currently looking for a cGMP Technical Writer who will be responsible for writing, reviewing and driving production and quality documentation to approval. • The Technical Document Writer will be responsible for producing high-quality cGMP documentation that contributes to the overall success of our project goals. • Additional responsibilities might include tracking of the daily, weekly and monthly forecasted documentation priorities required to meet output quotas. Key responsibilities/essential functions: • Originate, revise and maintain Standard Operating Procedures (SOPs), Production Batch Records (PBRs) and Solution Preparation Records. • Compile and draft procedural documentation using standard electronic publishing tools. • Create and maintain templates for cGMP documents. • Collaborate with individuals from various internal functional areas to generate and review new equipment, processing, set-up and operational documents within agreed upon timelines. • Interview subject matter experts to obtain details in order to accurately capture content material. • Demonstrate effective written and verbal communication skills. • Monitor the flow of production documents and adjust workload and resources in an appropriate, organized and efficient manner. • Work with cross-functional teams on the implementation of process improvement initiatives to increase quality in cGMP documentation. • Demonstrate an ability to multi-task and manage multiple projects independently • Maintain a safe work environment for self and staff. Quality Specific Goals: • Aware of and comply with the client Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position. • Complete all planned Quality & Compliance training within the defined deadlines. • Identify and report any quality or compliance concerns and take immediate corrective action as required. • Aware of and comply with Stop Order, Concessions, ESD ECO, Calibration, Preventative Maintenance, Material Identification & Segregation, and Good Documentation Practices, as associated with this job type/position. Training: Aware of and comply with client training requirements. Qualifications Required Qualifications: • 3+ years of previous technical writing experience in a cGMP pharmaceutical environment. • Experience in manufacturing under cGMP guidelines and possess a strong knowledge of cGMP requirements. • Prior experience working in a biotech/pharmaceutical company. • Exceptional written/verbal communication, listening, organizational, interpersonal, research, investigative, and problem-solving skills. • Proven ability to communicate complex ideas in a clear, concise manner. • Working knowledge of MS Office Suite and an Electronic Document Management System (EDMS). • Experience with Document Proficiency in MS Office Products. Preferred Qualifications: • Associates degree in a scientific discipline or equivalent experience. • Cell Culture experience. • Protein Purification experience. • Biological Technical Transfer experience. Additional Information To know more about this position please contact after applying to the position on; Ujjwal Mane *************************** ************
    $72k-96k yearly est. Easy Apply 60d+ ago
  • Grant Writer 2025-26 (independent contractor)

    Community Charter School of Cambridge 3.7company rating

    Medical writer job in Cambridge, MA

    For description, visit HERE: ************* google. com/document/d/17dWbQKKsrVbYu5jl0h52wY4CxYCigHaEqa9mFiHb0SU/edit?usp=sharing
    $42k-51k yearly est. 20d ago
  • Grant Writer/Administrator

    Nanobiosym, Inc.

    Medical writer job in Cambridge, MA

    Nanobiosym is an innovative nanotechnology company in Cambridge, MA, developing novel technologies to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. Nanobiosym was awarded the 2013 X-PRIZE- the first X-PRIZE ever awarded for healthcare. Nanobiosym is seeking an exceptional, highly-motivated grant writer to support Nanobiosym's efforts in developing cutting edge technology from the holistic integration of physics, biomedicine, and nanotechnology. Primary responsibilities for the position include identifying grants and other funding devices from both federal and private organizations to support nanobiophysics research. RESPONSIBILITIES: * Performs research to identify grants and other funding sources from both federal and private organizations. * Oversee the grant writing, budgeting, team identification, collaborator identification and submission process, as well as follow up process until award. * Management and supervision of the grants following submission including: * Participation in internal technical update meetings and reviews * Managing funding agency reports and updates QUALIFICATIONS: * Ph.D (or MS) in Biological Sciences or related field. * Proven successful grant writing experience at a university or in industry * Experience working with NASA, DARPA, NIH, NSF, DOD, BARDA and other federal agencies * Demonstrated examples of innovative thinking * Strong work ethic and ability to generate high quality work under tight deadlines * Flexibility in work schedule * Self-motivated, independent and a driving force of efficient execution * Strong organizational and project management skills Excellent oral and written communication skills
    $54k-78k yearly est. 23d ago
  • Grant Writer/Administrator

    Nanobiosym

    Medical writer job in Cambridge, MA

    Nanobiosym is an innovative nanotechnology company in Cambridge, MA, developing novel technologies to address a broad range of diseases. Nanobiosym was founded by an MIT/Harvard alum to work at the interface of physics, nanotechnology, and biomedicine. Nanobiosym was awarded the 2013 X-PRIZE- the first X-PRIZE ever awarded for healthcare. Nanobiosym is seeking an exceptional, highly-motivated grant writer to support Nanobiosym's efforts in developing cutting edge technology from the holistic integration of physics, biomedicine, and nanotechnology. Primary responsibilities for the position include identifying grants and other funding devices from both federal and private organizations to support nanobiophysics research. RESPONSIBILITIES: Performs research to identify grants and other funding sources from both federal and private organizations. Oversee the grant writing, budgeting, team identification, collaborator identification and submission process, as well as follow up process until award. Management and supervision of the grants following submission including: Participation in internal technical update meetings and reviews Managing funding agency reports and updates QUALIFICATIONS: Ph.D (or MS) in Biological Sciences or related field. Proven successful grant writing experience at a university or in industry Experience working with NASA, DARPA, NIH, NSF, DOD, BARDA and other federal agencies Demonstrated examples of innovative thinking Strong work ethic and ability to generate high quality work under tight deadlines Flexibility in work schedule Self-motivated, independent and a driving force of efficient execution Strong organizational and project management skills Excellent oral and written communication skills
    $54k-78k yearly est. 60d+ ago
  • Technical Writer

    Us Tech Solutions 4.4company rating

    Medical writer job in Cambridge, MA

    + We are looking for a Technical Writer to make our existing content more complete, organize it in a more friendly way and make implementation and optimization more independently actionable by partners. + The team mission is to be the trusted place where travelers go for the most useful information to make fast, effortless decisions. Our team helps scale the growing Travel ecosystem through high-value services and solutions that empower partners and travelers worldwide. + The contractor will work with program managers, engineers and subject matter experts to gather business requirements and product knowledge, identify gaps and areas for improvement and create required content. **Responsibilities:** + Write, review, publish, and maintain high-quality technical content while adhering to client's documentation standards. + Incorporate feedback from relevant stakeholders (e.g., engineers, product managers, program managers, customers) to align content with user needs and product/program goals + Address primary critical documentation needs as compiled in Documentation Needs Analysis and this component. + Identify and address gaps in help content and assist with content development prioritization. + Expand help content to make it actionable and partners more self-sufficient. + Ensure breadth of features/functionality has been documented with best practices and sample use cases. + Address backlog of outstanding bugs and feature requests filed against the Help Center by internal/external users. **Experience:** + Experience in technical writing, product documentation, or online publishing. + Experience working in collaboration with technical and sales stakeholders on a daily basis. + Must be a self-starter who is able to manage multiple tasks under tight deadlines and work independently. + Ability to quickly grasp and communicate technical concepts. **Desired Skills:** + Experience with travel industry a strong plus. **Education:** + Bachelor's degree or equivalent practical experience. **About US Tech Solutions:** US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit *********************** (********************************** . US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
    $66k-93k yearly est. 60d+ ago
  • Part Time Journal Editor

    Serenagroup 3.4company rating

    Medical writer job in Cambridge, MA

    SerenaGroup Part-Time Journal Editor - Healthcare Salary: $26.50/hour Position Type: Part-Time (25 hours per week) Reports To: Chief Operating Officer About the Role: SerenaGroup is seeking an experienced, detail-oriented Journal Editor to oversee the editorial workflow for our peer-reviewed healthcare journal. In this role, you'll handle everything from screening submissions to coordinating peer review and ensuring the publication of rigorous, evidence-based articles. If you have a background in healthcare, medicine, or biomedical sciences and a passion for advancing clinical knowledge, we'd love to hear from you. Key Responsibilities: Screen and triage incoming manuscripts to assess alignment with our journal's focus and editorial standards Assign submissions to qualified peer reviewers and oversee a double-blind review process Maintain clear, professional communication with authors, reviewers, and editorial board members Evaluate reviewer reports and decide whether to accept, revise, or reject manuscripts Provide actionable editorial feedback to ensure scientific rigor and clinical relevance Uphold publication ethics, including conflict-of-interest and plagiarism checks Ensure published articles meet evidence-based healthcare standards and regulatory requirements Collaborate with the editorial board on emerging topics and special issues Stay up to date with trends and research in healthcare and medicine Coordinate with copy editors, proofreaders, and production staff to prepare articles for publication. Review proofs and approve final versions Promote the journal through networks, conferences, and digital platforms Build relationships with healthcare professionals, researchers, and organizations to promote quality submissions What We're Looking For: Experience in academic publishing, peer review, or editorial work (preferred) Strong writing, editing, and critical appraisal skills Excellent organizational and communication abilities Familiarity with journal management systems (e.g., Editorial Manager, ScholarOne) and publication ethics Attributes: Meticulous attention to detail and accuracy Ability to juggle multiple priorities and meet deadlines Professionalism, discretion, and impartiality in editorial decisions How to Apply: Visit ********************* go to our careers page, and click “Apply.” We look forward to seeing what you can bring to our team. Salary Description $26.50/hour
    $26.5 hourly 6d ago
  • Process Documentation Writer

    Real Staffing

    Medical writer job in Lexington, MA

    Real Staffing Group is a global staffing and recruitment specialist providing contract and permanent talent to a wide range of companies and industries. We take time to understand your career ambitions, working with you and for you at every stage of your job search. By applying our industry knowledge to your specific requirements we aim to supply you with the most effective route to your new career opportunity. To find out more about Real Staffing Group please visit http://www.RealStaffingGroup.com Job Description Responsible for developing procedural documents in collaboration with Subject Matter Experts (SMEs) in Global Drug Safety including: - Meet with the SMEs to determine the process and the status of the existing procedure - Develop plan for the revision to the document - Make requested updates to the procedure - Circulate drafts to the SMEs and stakeholders for review. Incorporate changes. Mediate discussions on conflicting requests. - Review procedures for formatting and grammer errors as well as for clarity and accuracy - Assist SME with collecting feedback on draft procedure and collecting documentation of approvals - Potentially draft high level messages useful for training and communication on each procedure Additional Information All your information will be kept confidential according to EEO guidelines.
    $63k-84k yearly est. 1d ago
  • medical writer

    Integrated Resources 4.5company rating

    Medical writer job in Cambridge, MA

    Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Job Description Job Title: Writer Location: Cambridge, MA Duration: 3+months (Possibilities of extension) Job Roles & Responsibilities · This Project Manager position supports the Content Development (SRL Writing) work streams. · This role provides operational and project management support to ensure that Standard Response Letters (SRLs) are of high-quality and are delivered on time. · The position is also responsible for drafting SRLs and providing quality reviews as needed, and maintenance of these information assets. · This position works closely with the medical writing vendor and internal stakeholders within or outside of medical affairs. Responsibilities include serving as the point contact interacting with the medical writing vendor, coordinating pertinent work streams, and overseeing outsourced SRLs/FAQs development processes; drafting and/or oversight of the development of Medical Information SRLs for assigned products; coordination of Content Development work-streams within or outside of Global Medical; providing internal Medical Information quality reviews of SRLs as needed; maintenance of SRLs within the database. 1) Vendor Management - manage/oversee SRLs/FAQs development processes. Includes researching scientific literature and internal research documents and data feeding the vendor; tracking SRLs/FAQs development status in Veeva; documenting and reporting KPI metrics; facilitating review and approval processes. 2) Quality Reviewer - serve as MI quality reviewer for SRLs/FAQs as needed and provides guidance on MI formatting, as well as scientific accuracy. 3) Drafting of SRLs (including the PML safety update) - create/update SRLs as needed, formatting new content according to approved templates, coding key metadata for SRL assets into central database, facilitation of internal review and approval process. 4) Maintenance of Information Assets - manage SRLs in Veeva, central database, and shared site with the vendor. 5) SRL Project Planning - provide assistance in annual strategic SRL planning. Own and implement per annual SRL plans. REQUIREMENTS: Advanced medical/scientific training, i.e., MD, PhD, PharmD, Master's level degree, preferably in the life sciences, Bachelor in Nursing, or similar qualifications. • 3+ years Medical Information or relevant experience. • Medical writing and editing capabilities. • Project management experience preferred. • Computer skills and experience in Microsoft Office Suite software, Endnote software, Veeva/Vault, and web based inquiry database. • Organizational skills. • Ability to work independently. • Presentation skills. • Neurology experience preferred. • Pharmaceutical industry experience preferred. • Knowledge of regulatory requirements preferred. Additional Information We do have referral bonus of $500 per candidate, if you refer any of your friends or colleague who are looking out for the same job. Thanks & Regards, Seema Chawhan Clinical Recruiter Integrated Resources, Inc. IT Life Sciences Allied Healthcare CRO Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I DIRECT # - 732-844-8724| LinkedIn: https://in.linkedin.com/in/seemachawhan Gold Seal JCAHO Certified ™ for Health Care Staffing “INC 5000's FASTEST GROWING, PRIVATELY HELD COMPANIES” (8th Year in a Row)
    $82k-116k yearly est. 60d+ ago
  • Medical Writer III

    Artech Information System 4.8company rating

    Medical writer job in Cambridge, MA

    Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost. Job Description • Work with therapeutic teams to develop and/or edit scientific/clinical documents, including manuscripts, abstracts, posters, and slide presentations • Work effectively with company document management systems and related tools, templates, and procedures in order to ensure efficient internal and external review and approval of documents prior to final submission for publication or presentations at scientific congresses • Ensure a consistent style of writing and presentation of clinical data to maintain quality and ease of review by all contributing authors • Participate and contribute to Medical Affairs Publication Team meetings and to cross-functional working groups as needed to facilitate efficient development and submission of publications • Work with external and internal authors on company-sponsored publications to facilitate writing, review and submission to high-tier journals. Skills: • Substantial experience (8-10 years) as a medical writer or equivalent working knowledge of clinical research, study design, and ability to present clinical data objectively in a clear, concise written format • Demonstrated competency in project management and the successful preparation and submission of peer-reviewed manuscripts • Outstanding written and verbal communication and interpersonal skills • Proficient in Word, Excel, PowerPoint, and Acrobat. Datavision expertise a plus • Highly organized, detail-oriented, self-motivated, and able to work independently as well as within cross-functional teams • Ability to manage multiple projects simultaneously, thinks critically, and adheres to deadlines • Demonstrated customer facing skills and capability to collaborate with Key Opinion Leaders on publications and presentations in a credible manner • Ability to interpret and critique scientific and medical literature with respect to scientific and business implications is essential • Experience in Multiple Sclerosis therapeutic or neurology area preferred • Medical writing or publications experience with a pharmaceutical company or medical communications agency preferred Qualifications • Advanced degree (MS, PhD, PharmD) in biomedical sciences is preferred, but not required Additional Information For more information, please contact Akriti Gupta ************** Morristown, NJ 07960
    $79k-111k yearly est. 60d+ ago
  • Senior / Manager, Medical Writing

    Relay Therapeutics, Inc. 4.6company rating

    Medical writer job in Cambridge, MA

    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 medical writer * 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 6d ago

Learn more about medical writer jobs

How much does a medical writer earn in Manchester, NH?

The average medical writer in Manchester, NH earns between $63,000 and $135,000 annually. This compares to the national average medical writer range of $63,000 to $137,000.

Average medical writer salary in Manchester, NH

$92,000
Job type you want
Full Time
Part Time
Internship
Temporary