Medical writer

• The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development.
• Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonisation (ICH) and other regulatory guidelines, and individual company document standards.
• Works under the direction of Medical Writing management and collaborates with cross-functional internal and external document production teams.

Principal Medical Writer

• Demonstrate understanding for multiple products and disease states
• Interact with internal teams (Account, PM, creative, etc.) and clients on programs to meet strategic objectives.
• Work closely with the Associate Medical Director in managing multiple accounts from a scientific perspective including all scientific and strategic aspects of medical communication tactics, meetings, and programs
• Participate in strategic planning and project meetings with internal and client teams as needed
• Self-educate on innovation in the industry and begin to conceptualize programs for teams
• Develop depth of understanding for assigned products, related medical areas, and competitors on an ongoing basis
• Identify and communicate important updates and medical-regulatory milestones to the team and recommend new business opportunities
• Collaborate with the Editorial team to resolve grammatical or stylistic errors or concerns
• Take a proactive solutions-oriented approach into all assignments

Senior Medical Copywriter

• Partner and collaborate with clinical and regulatory team members in the preparation of clinical protocols and regulatory documents; participate in study results interpretations and manage the document review/approval process to capture comments and resolve conflicts, including running round-table meetings.
• Communicate and coordinate with line-function team members to gather, organize, and compile information towards the development and planning of writing scientific, clinical, and regulatory documents; communicate deliverables needed, writing process and timelines, and hold team members accountable to agreed-upon dates for deliverables.
• Contribute to timeline planning for regulatory and clinical documents authored by Medical Writing.
• Contribute to preparing manuscripts, conference publications, and slides on research discovery results to support Disc publication strategy.
• Perform QC review as Medical Writing line-function representative and for documents written by other Medical Writing team members.
• Ensure applicable guidelines and regulations are followed in the scientific and clinical writing deliverables, including but not limited to the International Conference on Harmonization (ICH), electronic Common Technical Documents (eCTD) guidelines, content, and templates, as well as document-appropriate QC.
• Verify and share literature references to online library, gather and post literature for submissions, search, and order articles as needed.
• Assist with template modification or creation.
• Stay up to date on current industry practices, compliances, regulations, and company standard operating procedures and policies; assist with writing Medical Writing work instructions, guides, and policies.

Medical Writer

• Independently plans and prepares a range of regulatory documents and/or medical communications to support all phases of product development.
• Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with industry guidelines.

Principal Medical Writer – MedPubs Focus

• The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical communications to support all phases of product development.
• Organizing, analyzing, interpreting, and presenting scientific and statistical information in accordance with International Council for Harmonization (ICH) and other regulatory guidelines, and individual company document standards.
• Work closely with client and internal and partner organization teams to lead development of strategies for organizing and preparing regulatory documents.
• Lead a project team, and actively participate in development and writing of high-quality documents (study-level and submission level documents, pharmacovigilance documents).
• Author documents per client specifications, templates, style guides, and other guidance documents.
• Author documents per regulatory authority guidelines and requirements.
• Act as client advisor, working collaboratively and developing a strong relationship of trust built upon consistent and reliable communication; communicate ideas and strategies to produce a successful end result.
• Practice blameless problem solving, taking broad perspectives in resolving issues to prevent negative impact to work.
• Manage budget for a low complexity project, including all contributors (writers, editors).
• Usher documents through the review process, conduct comment resolutions meetings (CRMs) and successfully lead a project team to consensus.
• Maintain collaborative, proactive, and effective communication with both clients and internal teams.
• Lead project-related meetings and teleconferences.
• Provide coaching to junior staff for study level documents as well as submission level documents and ensure all staff comply with company standard operating procedures (SOPs) and training requirements.

Principal Medical Writer – Nonclinical Focus

• Analyze and present clinical data for novel therapies
• Work on several projects simultaneously across various disease areas
• Collaborate with project teams and participate in client meetings
• Develop reports, presentations, and other deliverables for clients
• Engage in teleconferences and potentially travel for client engagements

Analyst, Medical Writer

• Provides clinically based, concurrent and retrospective reviews of inpatient medical records.
• Ensures documentation accurately reflects quality of care, severity of illness and risk of mortality to support compliant coding, reimbursement, quality reporting, and denials prevention initiatives.
• Proactively contacts physicians or other clinicians as needed to clarify procedures/diagnoses to ensure proper documentation.
• Performs initial case reviews and follow up reviews.
• Submits compliant provider queries as needed to clarify documentation of relevant diagnoses, procedures, clinical indicators, present-on-admission status, acuity, specificity, and treatment in accordance with ACDIS/AHIMA compliant query guidance and organizational policy.
• Applies knowledge of ICD-10-CM/PCS Official Guidelines for Coding and Reporting, AHA Coding Clinic, MS-DRG/APR-DRG methodology, CC/MCC capture, SOI/ROM, and quality indicators to support an accurate working DRG in collaboration with Coding/HIM.
• Promotes a partnership with Coding/HIM team to ensure the accuracy of principal diagnosis, procedures, and completeness of documentation to determine the working and final DRG, severity of illness and risk of mortality.
• Functions as a liaison between clinical and coding teams.
• Actively engages and participates in delivery of education to providers through extensive interaction one on one.
• Utilizes critical thinking skills and clinical reasoning to identify, clarify, and query accurate representation of documentation to reflect appropriate clinical status of the patient which will translate into quality reporting, physician report cards, reimbursement, public health data, and disease tracking and trending.

Clinical Documentation Specialist

• Review medical records and draft the MSA narrative in preparation for nurse review
• Follow established narrative guidelines and recommend improvements for efficiency
• Proofread narrative for spelling and grammatical accuracy
• Communicate with Medical Analyst and Compliance Advisor on file as required
• Meet daily/monthly production goals and client SLAs for due dates/TAT

• Write for healthcare/pharma advertising campaigns across HCP, patient, caregiver, and DTC audiences
• Translate complex clinical data, mechanism of action, and product information into clear, engaging, on-brand messaging
• Develop copy for a wide range of deliverables, including websites, digital banners, emails, sales materials, patient education, videos, social, and other omnichannel assets
• Partner with an Art Director and broader creative team to develop integrated campaign concepts and executions
• Ensure all copy aligns with brand strategy, marketing objectives, tone of voice, and audience needs
• Work closely with Medical/Scientific leadership to ensure content is accurate, balanced, and compliant
• Participate in strategic planning, internal brainstorms, and client meetings as needed
• Present concepts internally and incorporate feedback thoughtfully and efficiently
• Review and refine copy throughout the agency process for clarity, grammar, consistency, and accuracy
• Collaborate with Editorial to resolve stylistic or grammatical concerns
• Build a strong understanding of assigned brands, disease states, competitors, and the evolving market landscape
• Proactively identify relevant medical, competitive, or regulatory updates that may impact messaging or tactical development
• Bring a solutions-oriented mindset to projects and contribute to the overall quality of the work

Medical Copywriter

• Lead the execution of documents, including project management tasks such as creating, maintaining, and communicating timelines
• Coordinate cross-functional client contributors and stakeholders as well as internal resources to ensure timely completion of documents
• Ensure document development adheres to any relevant client processes, templates, and instructional documents
• Serve as an expert on client document management system and related tools, templates, and procedures to ensure efficient document development
• Lead document message development in collaboration with client
• Interpret data and create shell documents to support authoring
• Plan and lead kickoff meetings
• Facilitate resolution of review feedback including planning and leading comment resolution meetings
• Follow-up with individual team members as needed to resolve outstanding review feedback
• Ensure consistency among client programs in terms of messaging, formatting, and presentation of documents
• Conduct literature searches as needed
• Perform peer QC review as needed
• Contribute to medical writing operational initiatives, if needed

Senior Medical Writer

• The Clinical Documentation Integrity Specialist (CDIS) Lead is an advanced level position for the experienced and proficient CDI Specialist consistently meeting or exceeding all criteria for CDIS advanced performance.
• The CDIS Lead provides support to CDI leadership within a defined scope of facilities and CDI team.
• The CDIS Lead serves as a liaison between senior leadership, medical staff, nursing, coding, case management and quality departments.
• Key Responsibilities: May be assigned special projects related to CDI processes, quality, data analysis, or HIM/CDI performance.
• Assumes responsibility for daily workflow process and adjustments for the CDI team.
• May present CDI performance metrics at facility meetings.
• May present CDI education as needed.
• Will assume operational oversight in the absence of the CDI Director.
• Supports CDI team through multidisciplinary approach in support of program goals.
• Facilitates collaborative efforts between CDI, HIM and Medical Staff providers.
• Facilitates collaborative efforts between CDI and clinical teams such as Quality and Case Management.
• Effectively utilizes leadership abilities and critical thinking skills to identify opportunities for team process and engagement optimization.
• Maintains professional competency in documentation and coding practices by keeping up to date with new coding guidelines, policies/procedures, federal and state reimbursement.

Clinical Documentation Integrity Specialist – Lead

• Assists with the appropriate identification of diagnoses, conditions, and/or procedures that are representative of the patient’s hospital stay and care provided
• Initiates concurrent queries to providers as supported by medical record documentation to improve the accuracy, integrity, and quality of patient data
• Reviews inpatient records to ensure completeness, accuracy, and clinical validation
• Evaluates documentation for assignment of working and possible DRG
• Recognizes opportunities for documentation improvement
• Identifies opportunities to query physicians regarding missing, unclear, or conflicting documentation
• Interacts directly with physicians to request and obtain additional documentation when needed
• Facilitates modifications to physician documentation to reflect the complexity of care of the patient
• Collaborates with and educates members of the patient care team regarding documentation guidelines

Clinical Documentation Specialist I – CDI

• Develop scientific copy for various deliverables on assigned brands and products
• Work independently and collaboratively with medical writers and directors to develop scientifically accurate copy
• Understand medical strategy and content objectives for assigned projects and accounts
• Proactively check-in with senior medical leads on project deliverables and raise questions as needed
• Review current literature for assigned therapeutics areas, including competitor products
• Understand and adhere to AMA/client style guidelines as directed
• Ensure references are accurate and research additional references or source materials as necessary
• Annotate and highlight references for medical review
• Manage workflow for assigned projects and meet associated deadlines
• Communicate with clients and/or KOLs to present scientific projects for review and feedback
• Incorporate and discuss edits requested by clients, KOLs, and/or internal reviewers
• Attend and participate in kickoff, status, and other job-related meetings
• Collaborate with creative and illustrative team members to make scientific data visually compelling and scientifically accurate
• Provide medical guidance to team by maintaining up to date scientific knowledge for assigned brands and products

• Lead end-to-end development of scientific publications, including manuscripts, abstracts, posters, plain language summaries, and congress materials
• Translate publication plans into executable content; identify scientific storylines and recommend approaches to clients and authors
• Ensure compliance with ICMJE, GPP 2022, and journal-specific requirements; serve as a guidelines resource for the wider team
• Translate complex clinical and scientific data into clear, concise, and accurate content for expert audiences — and for lay audiences where required
• Conduct literature reviews and contribute to data interpretation that informs both content and strategy
• Maintain consistency in messaging, tone, and scientific accuracy across deliverables and across an account
• Own author and steering committee engagement, including kickoff meetings, content reviews, and consensus-building across multi-author teams
• Partner with account, strategy, and scientific leads to shape content direction; contribute to scope development and new business work as needed
• Mentor junior writers through structured review, coaching, and onboarding; act as a quality checkpoint on team deliverables
• Build and maintain therapy area expertise; act as a scientific point of contact for an assigned franchise or account
• Apply AI-enabled writing, literature review, and analytics tools thoughtfully and in line with Real Chemistry's responsible-use standards
• Deliver projects on time and to a high standard, proactively managing workload, surfacing risks early, and adapting to changing priorities without compromising quality

Medical writer jobs in Massachusetts

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Principal Medical Writer

Senior Medical Copywriter

Medical Writer

Principal Medical Writer – MedPubs Focus

Principal Medical Writer – Nonclinical Focus

Analyst, Medical Writer

Clinical Documentation Specialist

Medical Writer

Medical Copywriter

Senior Medical Writer

Clinical Documentation Integrity Specialist – Lead

Clinical Documentation Specialist I – CDI

Medical Writer

Senior Medical Writer – Publications