Medical Writer Resume Sample

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Breanna Schultz
850 Blaze Expressway,  Boston, MA
+1 (555) 546 4210

Work Experience

Senior Medical Writer
12/2016 - PRESENT
Los Angeles, CA
  • Mentors and leads less experienced medical writers on complex projects, as necessary
  • Compiles, writes, and edits medical writing deliverables, and serves as a medical writer on inter-department and intra-department project teams with minimal supervision. Provides medical writing deliverables covering all phases of clinical research and in various therapeutic areas
  • Experience of coordinating writing activities for regulatory submissions
  • Plan, write, edit, review and coordinate the publication of scientific data through peer-reviewed journals and forums and/or regulatory documents
  • Facilitate trial development and product registration
  • Ensure and coordinate quality checks for accuracy, collates reviewer’s comments, adjusts content of document as required based on internal/external input, and prepares final version
  • Exhibit flexibility in moving across development and preparation of multiple document types
Medical Writer
05/2010 - 08/2016
Boston, MA
  • Excellent customer service skills and strong oral communication skills
  • Prioritize multiple tasks and transition between activities depending upon corporate needs
  • Proficiency in Microsoft Word and Outlook, familiarity with Microsoft Excel
  • Perform all essential job functions under the constraint of tight timelines
  • Demonstrated ability to communicate and write English clearly, concisely, and effectively
  • Well-organized: ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
  • Recent and significant experience in writing of regulatory documents such as Clinical Study Reports, Protocols, Summaries, Overviews
  • Aptitude for compilation, analysis, and presentation of data
  • Independently motivated with good problem-solving ability
Entry Level Medical Writer
03/2006 - 04/2010
Houston, TX
  • Work with teams to ensure smooth and timely development of documents
  • Influence or negotiate change of timelines and content with other team members
  • Effectively collect and evaluate information from multiple sources
  • Five years of experience as a medical writer in a medical education company
  • Excellent writing skills for professional and patient education materials and able to write medical documents independently
  • Perform medical literature research and interpret medical literature independently
  • Knowledge of medicine and disease states
  • Comprehensive understanding of ACCME guidelines
  • Strong familiarity with medical terminology


Grand View University
2002 - 2006
Bachelor's Degree in Life Sciences

Professional Skills

  • Excellent written and oral communication skills. Experience in working working collaborative, cross-functional teams, including project management experience
  • Demonstrated experience in clinical development, strong interpersonal, time management, project management, and technical writing skills highly desirable
  • Demonstrated advanced writing skills , with strong command of English language and grammar
  • Experience working in collaborative, cross-functional team environments; strong project management skills
  • Proven administrative and organizational skills, good computer literacy and experience
  • Experience working with standard document templates/styles to support electronic (eCTD) submissions; strong MS word formatting skills
  • Demonstrated ability to meet project goals within a matrix environment; excellent project management and organizational skills

How to write Medical Writer Resume

Medical Writer role is responsible for interpersonal, medical, scientific, organizational, clinical, word, technical, microsoft, adobe, editing.
To write great resume for medical writer job, your resume must include:

  • Your contact information
  • Work experience
  • Education
  • Skill listing

Contact Information For Medical Writer Resume

The section contact information is important in your medical writer resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:

  • First and last name
  • Email
  • Telephone number

Work Experience in Your Medical Writer Resume

The section work experience is an essential part of your medical writer resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous medical writer responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular medical writer position you're applying to. The work experience section should be the detailed summary of your latest 3 or 4 positions.

Representative Medical Writer resume experience can include:

  • Excellent written and verbal communication skills, data-interpretation skills, strong interpersonal skills, ability to plan and organize
  • Excellent written and verbal communication skills and effective interpersonal skills
  • Strong technical and scientific skills and the ability to effectively communicate these aspects in writing
  • Demonstrate problem-solving and interpersonal skills that facilitate effective interactions within cross-functional teams and with external providers
  • + Excellent writing and editing skills, and a keen attention to detail
  • Excellent computer skills to include MS Word, MS Excel, MS PowerPoint, MS Outlook, and Adobe Acrobat

Education on a Medical Writer Resume

Make sure to make education a priority on your medical writer resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your medical writer experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.

Additional details to include:

  • School you graduated from
  • Major/ minor
  • Year of graduation
  • Location of school

These are the four additional pieces of information you should mention when listing your education on your resume.

Professional Skills in Medical Writer Resume

When listing skills on your medical writer resume, remember always to be honest about your level of ability. Include the Skills section after experience.

Present the most important skills in your resume, there's a list of typical medical writer skills:

  • Good interpersonal skills and the ability to operate effectively in an international environment
  • Strong scientific/medical writing skills evidenced by good quality writing of Medical Affairs communications and/or publications in peer-reviewed journals
  • Demonstrated effective presentation, proofreading, and interpersonal, skills and ensure a team-oriented approach
  • Strong project management and organisational skills combined with good understanding of the commercial drivers of the business
  • Strong influencing skills in shaping and developing content and wording; able to lead without formal authority
  • Excellent writing, proofing, and copy editing skills

List of Typical Experience For a Medical Writer Resume


Experience For Senior Medical Writer Resume

  • Excellent editorial (editing and writing) skills, preferably in the area of grant/proposal and manuscript development
  • Good organizational/planning and problem-solving skills at the document level
  • Maintain ability to work effectively in a fast-paced environment with multiple high-priority projects
  • Experience supporting clinical research and report writing or experience writing in a medical/scientific area
  • Document organization, management, and version control skills to include hyperlinking, TOC generation, and field updating
  • Strong reviewing/coaching experience in a medical communications agency
  • Use project management principles to communicate effectively (written and verbal) within the Integrated Product Team (IPT) development framework
  • Basic document preparation skills and capability in the use of relevant software applications, templates, and other electronic formats

Experience For Principal Medical Writer Resume

  • Solid knowledge of the clinical development process and Good Clinical Practices
  • Impeccable communication skills - both written and oral
  • Writing effective promotional copy for digital campaigns (branded and unbranded) targeted to a physician/healthcare professional (HCP) audience
  • The applicant is desired to have experience in writing and reviewing standard operating procedures
  • Clinical research/medical writing experience including writing multiple clinical study reports, and either CTD documents or similar, or study protocols
  • Excellent written English, e.g., organization, syntax, grammar, clarity, focus, messaging that requires minimal editing/rewriting

Experience For Associate Medical Writer Resume

  • Adept at researching, compiling, and analyzing clinical and scientific evidence quickly
  • Ideally, 4 years’ experience in medical writing, including 2 years as medical writing project lead
  • Oncology-focused medical/scientific writing experience in an academic or agency setting
  • Extensive experience in writing and reviewing Clinical Evaluation Reports
  • Collaborate with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence
  • Experience in technical writing in a regulated commercial setting (CRO/biotech industry), preferably medical devices/ IVD diagnostics
  • Medical writing experience in a pharmaceutical/biotechnology or CRO setting

Experience For Lead Medical Writer Resume

  • 3 – 6 years experience working within the biomedical and clinical writing field
  • Proven ability to write clinically sound, balanced copy with marketing finesse, via writing sample
  • Proven track record in writing and publishing clinical papers/abstracts
  • Relevant experience in medical and healthcare writing / editing
  • Clinical trial results presentations for distribution to clinical investigators – contribution to the good working relationship with investigators
  • Experience writing about complex topics for professional audiences
  • Experience writing about science/medicine for multiple (primarily lay) audiences
  • + Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail; ability to work in a fast-paced environment

Experience For Safety Medical Writer Resume

  • Independently interact with clients to obtain necessary and relevant information, and deal with queries through effective decision making.
  • Prioritize workload and to make strategic decisions about what to accomplish when faced with competing needs
  • Participating in Clinical Project Management Training activities, including creating/reviewing training modules
  • Drafting of SRLs (including the PML safety update) – create/update SRLs as needed, formatting new content according to approved templates
  • Delivering quality editorial content to meet customer requirements – including reviewing and editing work to ensure quality standards are sustained
  • Writing, editing and reviewing Risk Benefit Analysis

Experience For Clinical Research Medical Writer Resume

  • Writing and reviewing Standard Opeating Procedures
  • Advising and mentoring colleagues and clients on medical writing-related issues
  • Editing and proofreading (specializing in medical content)
  • Reading and summarizing medical literature in the context of preparing peer reviewed journal publications
  • Understanding of medical-marketing strategies including familiarity with the promotional review process

Experience For Clinical Medical Writer Resume

  • Preparing data tables including completing basic statistical analysis in table generation programs
  • Understanding of global regulatory agencies and regulatory processes concerning medical devices
  • Working knowledge of current electronic authoring, document management and electronic regulatory submissions
  • Preparing the study report using details described in the protocol and protocol
  • Working knowledge of MS Office suite and referencing software (ie, Endnote, Refman, etc.)
  • Providing guidance to assigned Project Teams and Project Team members
  • Providing language updates, as required, for all MedComm document templates as needed
  • Updating department SOPs and Work Instructions as needed
  • Leading the MW activities for assigned project(s) including writing key deliverables

Experience For Scribe / Medical Writer Resume

  • Leading or participating on non-project related initiatives
  • Creating, modifying, finalizing and attaching signed final Compliance Reports (CRs) to Final MedComm documents or review Project Team-created CRs
  • Updating the MedComm database every time a document is created, sent out for internal or Sponsor review, finalized, deemed inactive/on-hold, or cancelled
  • Ensuring that records are filed in accordance with site procedures
  • Generate original text and materials by collecting, organizing, interpreting and classifying information for research and reporting purposes
  • Responsible for executing literature searches and for reading, analysing and summarizing medical literature
  • Basic understanding of Medical Writing, including familiarity with writing styles such as American Medical Association
  • Assist in growing and managing the CRD/MW resources including relevant literature, example documents, style guides, and templates

Experience For Senior Medical Writer / Project Manager Resume

  • Flexibility in meeting challenging deadlines and changing requirements
  • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
  • Provides writing and editing support to colleagues during manuscript preparation and submission
  • Conform to house styles and processes (including project tracking, timekeeping)
  • Expertise in copyediting, science and technical writing and writing for the media
  • Support cross-functional coaching, mentoring, and training
  • Perform quality control review such as copy editing, content editing, and number checking for other Medical Writers as required
  • To embrace and promote to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
  • Team Building - Team focused. Encourages and sets an example for cooperation, creating trust and working toward common goals and values

Experience For Contract Medical Writer Resume

  • Liaise with Senior and Scientific Services Directors on junior writers’ training needs and provide coaching and mentoring as required
  • Function as a key contributor in planning & preparation of documents ensuring adherence to GCP, ICH guidelines, and Alkermes SOPs
  • Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)
  • Remain scientifically current in assigned therapeutic areas, including understanding important clinical issues and industry trends
  • Understands and complies with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and SOPs
  • Provides high-quality medical and scientific writing from planning and coordination of literature search through delivery of final drafts
  • Knowledge of global post marketing safety reporting regulations and guidance’s

List of Typical Skills For a Medical Writer Resume


Skills For Senior Medical Writer Resume

  • Strong written and oral communication skills, including solid interpersonal skills that enable positive influencing of others
  • Excellent verbal and written communication skills and be able to demonstrate a high level of accuracy and attention to detail
  • Strong project management and organizational skills and proven ability to meet timelines
  • Experience with effectively managing vendors and contract writers to meet timelines/project objectives
  • Dynamic, self-starter with strong influencing skills and adaptable to change
  • Good problem-solving and analytical skills. Anticipates problems, issues, and delays; proactively looks to minimize the impact to the project
  • Strong organizational and meeting skills
  • Excellent oral communication skills with clients, physician experts, and agency team members

Skills For Principal Medical Writer Resume

  • Strong client management, project management and team leadership skills
  • Excellent interpersonal and team-oriented skills
  • Excellent project/time management and organizational skills to handle multiple tasks and meet deadlines while delivering high quality work
  • Good interpersonal skills with confidence in managing physicians/clients/authors
  • Excellent project/time management and organizational skills and ability to work on own initiative
  • Strong computer skills and general computer literacy
  • Excellent communication skills (English language; written and verbal)
  • Excellent grammatical and communication skills, both written and oral
  • Proven organisation/time management skills and the ability to be proactive and use your initiative to get results

Skills For Associate Medical Writer Resume

  • Strong communication skills, proficient command of the English language in both oral and written format, and action orientation to address issues
  • Good interpersonal skills and relates well to both client and internal personnel
  • Apply critical thinking and problem solving skills and use logic and reasoning to support recommendations to the project team
  • Advanced scientific reading, writing, and editing skills
  • Demonstrated experience in identifying new business opportunities for both new and existing clients
  • 3+ yrs regulatory writing experience; Proven record of success in contributing to clinical development programs and submissions
  • Strong ability to manage timelines and assist in driving documents towards completion amongst colleagues with competing priorities
  • Effectively manage medical writing projects to deliver quality products in agreed upon timelines

Skills For Lead Medical Writer Resume

  • Up to 3-5 years of experience in scientific/medical writing, preferably experience with medical devices
  • Proven track record of scientific writing along with a strong scientific background
  • Experience in clinical/pharmaceutical development with directly related medical writing experience
  • Have a good working knowledge of PDF, and Project. Skilled in use of MS WORD. Has used 1 or more EDM systems
  • Extensive clinical regulatory writing skills
  • Extensive progressive experience in medical and/or scientific writing or equivalent education and experience

Skills For Safety Medical Writer Resume

  • Advanced writing competency, positive and proactive communication skills, proficiency with Microsoft Office Suite, and high attention to detail are essential
  • Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)
  • Advanced writing competency, positive and proactive communication skills, and high proficiency with Microsoft Office Suite and Adobe Acrobat
  • Skilled with software applications and document management systems, including experience with document templates
  • Prior medical information and/or medical writing experience
  • Exceptional organizational and project planning skills
  • Experience in medical writing, preferably experience with medical devices

Skills For Clinical Research Medical Writer Resume

  • Proven experience in the preparation of message-driven market access materials including value dossiers, and HTAs is preferable
  • Clinical experience with 5+ years of relevant medical writing experience in biotech, pharmaceutical or clinical research organization
  • Manage/prioritize multiple projects, working in a fast-paced environment. Flexible/willing to adapt to changing deadlines and priorities
  • At Lead Medical Writer level: Ability to effectively communicate in oral presentations
  • Superior language and communication skills with the abilitiy to translate complex scientfic materials into various formats efficiently
  • ≥7 years of solid experience in clinical submission

Skills For Clinical Medical Writer Resume

  • Medical writing experience in a medical communications agency or equivalent combination of education, training and experience
  • Proficient computer and word processing skills
  • Skilled with MS Word and competent in MS Excel and the use of bibliography databases. Experience with Document Management systems
  • High-level content writing experience and experience with all types of clinical publications or clinical regulatory documents required
  • Prior related experience with a B.S. or less than 3 years with M.S
  • Proven experience in medical devices
  • Proven experience of the scientific peer review process
  • Effectively manages medical writing projects to deliver quality products in agreed timelines

Skills For Scribe / Medical Writer Resume

  • Works effectively with colleagues from other departments in team situations
  • Proven writing experience in a medical communications agency or the pharmaceutical/healthcare industry
  • Proven experience and confident in interacting with clients and medical experts, flexible and able to work as part of a team
  • Proven to have extensive writing experience in a medical communications agency or the pharmaceutical/healthcare industry
  • Prior experience within medical writing is advantageous
  • Excellent time and priority management, work efficiently under pressure
  • Writing effective and compelling case study content targeted to a physician/ healthcare professional (HCP) audience across various therapeutic categories
  • Writing effective branded and unbranded promotional copy targeted to a world-wide physician/healthcare professional (HCP) audience

Skills For Senior Medical Writer / Project Manager Resume

  • Training and development of less experienced Medical Writers
  • Creating Final Effective documents
  • ≥2 years of experience with scientific research methodology, including designing and conducting experiments, and analyzing and reporting experimental results
  • Previous experience leading and writing submission-level documents, including familiarity with eCTD format and associated guidance
  • Significant experience designing, writing, and editing clinical content for healthcare professionals
  • Experience in managing and directing medical writing projects
  • Skilled at reviewing and editing the work of others
  • > 6 months of experience training or providing constructive feedback on editorial production
  • Experience with analyzing and summarizing scientific data in medical device

Skills For Contract Medical Writer Resume

  • Experience of managing junior Medical Writers/Editors, and reviewing their documentation
  • Experience writing for and submitting to medical/clinical peer reviewed journals
  • 6 – 8 years experience working within the biomedical and clinical writing field
  • Extensive experience in scientific/medical writing, including translations (mainly from English to Japanese)
  • Experience with submitting and working with medical journals
  • Solid understanding of the clinical development process, including the documents that are required at each stage
  • Experience writing and editing clinical regulatory documents
  • Demonstrated high attention to detail, including capacity to catch and resolve issues not caught by more junior level quality checking

List of Typical Responsibilities For a Medical Writer Resume


Responsibilities For Senior Medical Writer Resume

  • With minimal support, write, edit, or otherwise facilitate completion of clinical documents, including clinical study reports, investigators’ brochures, subject narratives, Module 2 summary documents, and other IND/CTA or global regulatory submission documents
  • Contribute to account plans, strategic publication plans and publication programs, where appropriate, by maintaining current awareness of developments in therapeutic area or discipline and the Springer Healthcare product portfolio
  • Present to clients the results of activities, when required, e.g. publication plans, results of competitive intelligence reports, and to contribute to client brainstorming meetings
  • Ensure that projects reflect a thorough understanding of clients’ objectives Maintain broad awareness of developments in relevant therapeutic areas and discipline, editorial issues within publishing and the Springer Healthcare product portfolio
  • Excellent interpersonal skills, analytical and critical thinking

Responsibilities For Principal Medical Writer Resume

  • Effectively manage all assigned publication projects, including projects outsourced to vendors
  • Excellent medical writing capability including writing for an end-user audience
  • ≥ BA/BS and ≥ 5 years’ experience writing a broad range of clinical regulatory documents
  • Solid understanding of FDA regulations and ICH/GCP guidelines
  • Establish and maintain effective working relationships with supervisor and colleagues
  • ≥ BA/BS and ≥ 10 years’ experience writing a broad range of clinical regulatory documents
  • Experience working with content management processes and best practices
  • Helps Clinical Sciences, Medical Affairs, Study Management, and Marketing to devise and implement an effective publication strategy

Responsibilities For Associate Medical Writer Resume

  • Experience in scientific/medical writing
  • Related industry experience (e.g., medical writing, scientific publications, clinical research)
  • PhD with at least 6 years experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry
  • Experience working with pharmaceutical/healthcare industry or academic institution
  • Experience preparing scientific publications (abstracts, posters, manuscripts)
  • Experience with submitting to major medical journals (NEJM, Lancet, etc)
  • PhD in the Life Sciences with at least 6 years experience as a medical writer preparing regulated documents in the pharmaceutical and/or biotech industry

Responsibilities For Lead Medical Writer Resume

  • Excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP)
  • Medical/scientific writing experience in the pharmaceutical/healthcare industry, academia, or other relevant industry
  • Solid understanding of therapeutic area(s)
  • Solid understanding of standard clinical document types
  • Solid understanding of internal and external guidelines related to document preparation
  • Desired experience in scientific literature (participation or leading scientific paper publications)
  • Strong neurology/neuroscience background, ideally including MS
  • Experience with a broad range of various clinical submission tasks including regulatory documents and publications
  • Maintain current awareness of good-publication practices and editorial policies and apply to publishing projects

Responsibilities For Safety Medical Writer Resume

  • Regulatory medical writing experience
  • Medical or scientific writing experience as a primary job responsibility
  • Proofreading and editing of written material
  • Briefing document for the Phase III trial in relapsed refractory multiple myeloma
  • Understanding of human anatomy, physiology, scientific and clinical research methods
  • Willing to take on any task, no matter how small
  • Understanding of the benefits and limitations of different data sources (ie, abstracts vs publications, primary vs tertiary data)
  • Assists in planning and coordinating report-writing activities with dependent staff roles to ensure satisfactory completion of all writing projects

Responsibilities For Clinical Research Medical Writer Resume

  • Leading the MW activities for assigned project(s) including writing key deliverables
  • 85%: Leading the MW activities for assigned project(s) including writing key deliverables
  • Participate in non-project specific activities, including assistance in maintaining the medical writing work schedule.
  • Conducts proofreading, editing, document formatting, reviewer comments integration and document completion / approval activities
  • Bilingual English and one other European language (reading, writing, and speaking in a professional medical communications capacity)

Responsibilities For Clinical Medical Writer Resume

  • Is in charge of creating, writing, and coordinating CTD clinical summaries and overviews in line with Sanofi Pasteur document standards
  • Leading or participating on non-project related initiatives
  • 15%: Leading or participating on non-project related initiatives
  • Responsible for developing scientific projects and content as assigned. This includes writing or editing of pharma training materials, eLearning content, video scripts, magazine articles, and slide presentations across several therapeutic areas
  • Work with Client Services team to respond to RFPs or other business development opportunities, including researching therapeutic areas, proposing curricula, and participating in pitches
  • Work alongside our Instructional Designer to edit or write scientific copy as needed to an appropriate reading and literacy level for a variety of audiences, including scientific liaisons, healthcare professionals, and pharmaceutical representatives
  • Manage external medical writers or thought leader contributors to ensure that content developed is of the highest editorial quality, and in alignment with client expectations and medical/legal/regulatory requirements and processes
  • Independently provide additional writing and editing services (e.g. for publications) as required.
  • In accordance with authors’ direction, provides medical writing and editing expertise for abstracts, posters, oral presentations, and manuscripts

Responsibilities For Scribe / Medical Writer Resume

  • Compiles, writes, and edits medical writing deliverables, covering all phases of clinical research and in various therapeutic areas
  • Develop literature analysis, scientific messaging, publication strategy, and hold publication planning meetings
  • Responsible for developing high-quality clinical regulatory and other supporting documents for pipeline and/or marketed products
  • Competent in searching and synthesizing medical literature relevant to publication projects
  • Be able to identify the correct parties for a document content decision, and if a discussion is faltering, bring it back on track with minimal fuss
  • Provide appropriate input on others’ documents, including review of key contributing documents, such as the SAP
  • Ensure that projects reflect a thorough understanding of clients’ objectives

Responsibilities For Senior Medical Writer / Project Manager Resume

  • With support from senior level writers and/or Medical Writing Group Lead, write, edit, or otherwise facilitate completion of clinical documents, including clinical study reports, investigators’ brochures, subject narratives, and other IND/CTA or global regulatory submission documents
  • Arrange and conduct review meetings with teams and independently resolves document content issues and questions arising from the writing/review process
  • Represent Medical Writing on project teams
  • Develop timelines and communicate writing process and timelines to team members
  • Development and updating of Investigator’s Brochures, Safety Update Reports, and other regulatory documents.
  • Independently write clinical study reports and other regulatory documents according to ICON or client-specified formats.
  • Be responsible for the daily management of assigned medical writing projects.
  • Keep Medical Writing management informed of project status (e.g. in relation to quality, timelines, progress, and problems).

Responsibilities For Contract Medical Writer Resume

  • Participate in the training and supervision of new and junior medical writers.
  • Represent Medical Writing at internal and external meetings.
  • Plan, drive, and co-ordinate preparation of documents to ensure submission according to the submission plan, or as otherwise agreed with Regulatory affairs
  • Expertise in searching medical literature and databases for clinical and technical information
  • Oversees internal quality review processes, including senior scientific review, data verification, and editorial review
  • Upholds industry publication standards, including ICMJE recommendations and GPP3 practices
  • Support a diverse group of internal and external stakeholders and adapt working style to accommodate a variety of personalities and needs
  • Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, and consistency
  • Develops and maintains tools to track document status to ensure reporting requirements are met

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