Medical Writing Resume Sample
Trudie Jacobs
608 Halvorson Overpass,
Chicago,
IL
+1 (555) 712 9918
Work Experience
Medical Writing Manager
12/2016
-
PRESENT
Boston, MA
- Experience : 4-8 years in CNS Therapeutics and Phase 1 regulatory medical writing. Experience in writing Phase 1 clinical protocols and CSRs, IBs, PSP and PIPs, and submission documents is highly desirable
- Relevant pharmaceutical industry experience in medical writing, clinical research, quality, or related area such as regulatory or product support
- Experience in quality review of clinical regulatory documents
- Experience in being flexible with changing workload that requires prioritization and planning to support immediate/urgent business needs
- Proficient experience in use of MS Office (e.g., Word, Excel, Outlook, PowerPoint) and Adobe Acrobat
- Assist in preparation of clinical submission documents by incorporating text edits/comments, in-text tables based on statistical outputs (Tables, Figures, and Listings), and project-specific style sheet standards
- Participate in template development for clinical submission documents to ensure regulatory requirements, style requirements, and publishing specifications are met.
- Track project timelines in order to ensure that all QC timelines across a project are met
- Use functions of EDMS and PleaseReview for quality review, electronic formatting, compiling and finalizing of medical writing deliverables
Medical Writing Business Operations
11/2014
-
11/2016
Boston, MA
- Expertise in globalizing functions to operate in a standardized fashion
- Promotes and provides information support in terms of strategic input to GSK Vaccines’ Clinical Development Plans
- 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
Summer Internship Medical Writing
12/2010
-
10/2014
Detroit, MI
- Establishes and maintains all document standards for global submission of clinical study reports and summaries, investigator’s brochures, and module 2 summaries to Regulatory Authorities in accordance with SOPs
- Experience with managing/coordinating contract medical writers and interaction with CRO’s
- Medical Writing and management expertise with a comprehensive understanding of the drug development and reporting process required for study reports, submission documents, and data transparency deliverables across multiple providers
- Proven track record in building and managing a dynamic and high performance medical writing team that is fit-for-purpose and resource efficient
- Extensive knowledge of vendor processes, contracting, and best practices in outsourcing; ability to influence vendor improvements
- Evidence of strong leadership, influencing, negotiation, project management and talent management skills
- Strong strategic experience in developing and implementing new paradigms
Education
Cabrini University
2005 - 2009
Science's Degree in Science
Professional Skills
- Demonstrated leadership capability and strong writing skills
- Demonstrates strong organizational skills and ability to work collaboratively in a cross-functional team environment
- Excellent communication (written and verbal), interpersonal, organizational, time management, and project management/planning skills
- Strong organizational skills, including the ability to lead cross-functional matrix teams
- Hold Strong organizational skills and meticulous attention to detail
- Excellent time management, organization, and project management skills
- Knowledge of management skills and supervising the work of others Mentoring, training and directing others
How to write Medical Writing Resume
Medical Writing role is responsible for organizational, leadership, software, communications, reporting, training, database, design, research, digital.
To write great resume for medical writing job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Medical Writing Resume
The section contact information is important in your medical writing 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
- Telephone number
Work Experience in Your Medical Writing Resume
The section work experience is an essential part of your medical writing 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 writing 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 writing position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Medical Writing resume experience can include:
- Strong leadership capabilities including the ability to drive strong followership in reporting line
- Ensures staff is well qualified and encourage further technical and personal skills development to support career progression
- Demonstrated experience presenting to scientific and non-scientific audiences
- Proven track record in building and managing a dynamic and efficient medical writing team that is fit-for-purpose and resource efficient
- Demonstrates proactive thinking and actions
- Possesses a solid understanding of document standards, criteria and conventions
Education on a Medical Writing Resume
Make sure to make education a priority on your medical writing resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your medical writing 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 Writing Resume
When listing skills on your medical writing 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 writing skills:
- Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within cross-functional teams and with external collaborators
- Effectively work in a multi-disciplinary team, build and maintain effective partnerships
- Hold good communication skills
- Excellent time management and document management skills with high proficiency in MS Office and other relevant software and document management systems
- Project management understanding, including decision analytical skills, budgeting, and resource allocation and utilization
- Demonstrated effectiveness in management of projects of increasing scope and complexity
List of Typical Experience For a Medical Writing Resume
1
Experience For Medical Writing Manager Resume
- Excellent oral and written communications skills, attention to detail, and organization skills
- Knowledge of Microsoft Office products; especially advanced Word skills
- Organizational skills, ability to manage multiple projects at short notice
- BS (with 2+ years work experience) or MS in a health/science field with some industry experience
- Strong command of MS Word and Excel. Experience with MS SharePoint is also desired
- Strong communicational skill both written and spoken in English
2
Experience For Head of Medical Writing Resume
- Advanced PowerPoint skills and ability to use standard Field Medical Slide template
- Excellent ability to prioritize
- Clinical development experience
- Solid understanding of publication development activities and GPP3 and ICMJE authorship guidelines
- Experience in working with healthcare/medical professionals
- Medical education experience in a medical device, diagnostics, or biotechnology environment
- Experience as labeling manager
3
Experience For Scientific & Medical Writing Specialist Clinical Evidence Generation Resume
- Demonstrated ability to solve problems and pro-activity
- Effective management of external relationships with business partners (publication governance and contractual agreements)
- Understanding of biotech/pharmaceutical clinical development and regulatory processes
- Assist SME with collecting feedback on draft procedure and collecting documentation of approvals
- Revise/update QDs according to decisions made by working group
- Partners with key functions to lead/support inspection readiness, audits, doing root-cause analysis and authoring CAPAs as needed
- Potentially draft high level messages useful for training and communication on each procedure
- Respond to RFPs through developing the study objectives, design, methodology, timeline, and budget
4
Experience For Medical Writing Business Operations Resume
- Status reporting & associated administration
- Proactively collaborate with other R&D functional groups to assess medical writing needs for projects and plans for appropriate support and resources
- Develops the talent pools and proactively manages succession planning
- Lead proposal development and business development opportunities with clients
- Attend proposal meetings with clients
- Interact with process improvement project teams and business representatives to review/clarify 'to be' processes and obtain additional information to finalize process maps (flowcharts)
- Develop QDs (SOPs, Working Instructions and Supporting Documents; templates, checklists, etc.), using corporate templates and writing rules and according to international regulations
- Good Clinical Practice ICH guidelines
- Manage QD review & approval process, follow up with business representatives and process owners, organize & chair review meetings
5
Experience For Senior Medical Writing Group Lead Resume
- Peer QC of content of QDs. QC compliance of QDs against writing rules/templates and other regulations, links/references, macros and consistency across QD package
- Collects input from stakeholders and consolidates comments, resolving conflicts collaboratively
- Provide input into information letter
- Experience in the pharmaceutical industry, with 3 years of experience in clinical and/or quality operations-related roles (e.g., direct study management, monitoring, project management)
- Supports the full clinical procedure lifecycle for Policies, SOPs, Work Instructions (WIs) and Forms by serving as a SOP Writer
- Works with author and SMEs on to implement agreed up on procedures development applying appropriate document standards and criteria, ensuring terminology consistency across documents
- Translates process maps or other process representations and applies them to SOP procedures wording
- Contributes to the development and maintenance of up-to-date Clinical SOP Writer procedures so that the process is used and consistently applied by all Clinical SOP Writers
6
Experience For Medical Writing Associate Resume
- Experience working in a system for collaborative document development
- Maintains tracking spreadsheets and timelines, as assigned
- Multi-task in a fast-moving environment
- Contributes to the quality and performance of CROs and staff, impacting costs and program success
- Ensures support of Astellas global project team strategies and program success by contributing as a document specialist with advice from more senior staff
- Displays the ability to manage customer expectations
- Familiar with cross-functional customer service techniques
7
Experience For RWE Associate Medical Writing Director Resume
- Directly or indirectly responsible for oversight of MW activities, through CRO alliances and performance management, with budgets up to $1.5M/year per program
- Development and timely execution of the publication plan in collaboration with the company's Global Medical Affairs and Clinical Sciences and external authors/investigators
- Lead global publication planning meetings and coordinate publication efforts globally
- Research, draft, and edit scientific and medical manuscripts, abstracts, posters, and presentations, including oversight of the review process and incorporating author/reviewer comments
- Liaison with marketing and sales to ensure consistency with regard to educational materials, training programs and physician communications
8
Experience For Head, Medical Writing & Statistics Oncology Resume
- Support scientific congress activities including symposia, medical booth materials, and on-site expert meetings
- Lead development of scientific messaging platforms and literature gap analyses to support product and disease area
- Advanced understanding of statistical and clinical research concepts
- Become an internal expert for assigned product- and disease-specific literature and create literature alerts for company-wide dissemination
- Manage agency and/or contract medical writers
- Follow authorship and publication guidelines as stipulated by ICMJE and GPP3
- Assist with maintenance and reconciliation activities within publication development database
- Datavision publication management software proficiency
- Clear, well-organized, and concise communication
9
Experience For Senior Medical Writing Operations Specialist Resume
- Interpret, critically analyze, and communicate complex scientific data
- Perform multiple tasks under tight deadlines and maintain attention to detail
- Responsible for management educational content and materials related to the surgical product lines and associated disease states
- Serve as an acknowledged expert on company's products and related competitive products in all areas relevant to internal and external customers: clinical, scientific, technical and health economics
- Excellent oral and written communications skills as well as presentation skills and have the ability to effectively educate on Company's position to different stakeholders
- Facilitate workflow and timely completion of Investigator’s Brochure
- Position can be remote-based
- Developmental of labeling for these products is based on study results, coordination or labeling review and approval throughout the company, preparation of labeling components for submission to regulatory agencies and participation in labeling negotiations with agencies resulting in product approvals or labeling updates
10
Experience For Senior Associate Medical Writing Resume
- The position also includes subject matter expertise in specific labeling regulations (e.g. OTC rules) and review of local labeling to assure compliance with corporate labeling
- Experience as labeling manager - multiprotocol label switching
- Knowlegdge of labeling regulations (US, EU and Global)
- Prepares regulatory documents including, but not limited to, Common Technical Document (CTD) Module 2 and Module
- Knowledge of European and US regulations and international regulatory environment
List of Typical Skills For a Medical Writing Resume
1
Skills For Medical Writing Manager Resume
- Experience managing multiple, complex projects, and a strong record of developing successful partnerships and meeting customer expectations in global settings
- Strong Leadership in a team environment. Mentoring, training and directing others
- Medical writing experience in a CRO, pharmaceutical, or biotechnology setting
- Proven track record in contributing to matrix teams in planning and production of clinical documents to support regulatory submissions worldwide
- Medical Writing experience
- Experience in managing CRO / Partners of the organization
- Experience in a CRO, Pharmaceutical, and/or Biotechnology setting
- Previous experience in any of the following therapeutic area: Oncology, Cardiovascular, and/or Infectious Diseases
2
Skills For Head of Medical Writing Resume
- Experience in managing CRO/Partners of the organization
- Experience working on INDs, BLAs, and other regulatory submission activities
- Strong understanding of drug development, clinical study design, regulations (FDA and EU), ICH and other guidances, and scientific principles
- Experience of working for a large CRO
- Have experience in scientific and/or medical writing
- SOP writing experience
3
Skills For Scientific & Medical Writing Specialist Clinical Evidence Generation Resume
- Previous experience in a Leadership and/or Management role
- Knowledge of, and 3+ years’ direct experience with, Trial Master File required
- Have experience in the analytical evaluation of scientific data
- Preparing meeting minutes/action items from meetings related to investigational new drugs and drug development and distributing these to meeting participants
- Preparing meeting minutes/action items and distributing these to meeting participants
- Coordinating, attending, and, at times, leading conference calls/meetings related to clinical trials
- Preparing, or assisting in the preparation of, medical/scientific/regulatory documents, SOPs, and miscellaneous documents
- Maintaining databases and data entry and mining
- Understanding of project financials and implications
4
Skills For Medical Writing Business Operations Resume
- Maintaining knowledge of published literature in relevant therapeutic areas
- Supervise the work of vendors for medical writing, ensuring work is high quality and developed on time and budget
- Attend team meetings to provide input and aid in troubleshooting/problem-solving
- Participate in brainstorming sessions and strategic publications planning meetings to aid in strategy/goals
- Populates document properties and ensures correct naming conventions are used per the eSubmissions System file naming conventions
- Build and maintain knowledge base in both Medical Writing expertise and therapeutic area understanding to ensure the overall document quality
- Direct, train, and assist other medical writers in the writing and editing and technical aspects of clinical and regulatory document development; and
5
Skills For Senior Medical Writing Group Lead Resume
- Able to manage timelines for document development, review and completion according to expectations
- Detail oriented and dedicated to producing high-quality documents
- Work well in cross-functional team setting and complete projects in an efficient manner
- Ensure publications convey accurate and non-misleading communications of the product
- Ensure developed publications are reviewed and approved according to company SOPs
- Manages and develops the personnel in the roles of Regulatory Consultants and Medical Writing
- Develops, manages, and standardizes the Medical Writing process to include best practices and tools/systems
6
Skills For Medical Writing Associate Resume
- Supervises and provides coaching and assistance Medical Research Managers, Medical Research Scientists, and Medical Research Associates
- Confirms appropriate regulations and quality are being applied in the performance and documentation of regulatory and quality projects
- Maintains a department budget, ensures appropriate billing of Medical Writer and Regulatory services and minimization of costs as much as possible
- Attend advisory boards, roundtables, etc, to record and synthesize meeting into a formal report
- Advanced medical writing for health care professional education
- Accountable for providing services and results on time, accurately and consistent with expectations
- Accurately and timely maintains document tracking for all documents
7
Skills For RWE Associate Medical Writing Director Resume
- Work with key company stakeholders to help integrate nonclinical and clinical trial data into concise and compelling reports
- Meet ICH, GLPs, and GCPs guidelines, develop a writing style guide and template, as needed
- Lead document review and comment resolution meetings with cross-functional teams according to the timeline
- Aligns and implements efficiency initiatives to improve timelines and delivery of authoring documents end to end throughout the development process
- With minimal support, write, review, edit, or otherwise facilitate completion of a range of clinical/regulatory documents
- Assumes role of Lead Writer for one or more compounds. Applies developing knowledge of regulatory medical writing and therapeutic area/investigational product to support pipeline projects
- Responsible for planning, preparation, writing, organization, reviewing, editing, and formatting of specific documents in consultation with the project physician, statistician, and other team members as appropriate
8
Skills For Head, Medical Writing & Statistics Oncology Resume
- Effectively understand and interpret clinical and scientific data and evaluate information from multiple sources. Responsible for cross-functional collaboration with biostatistics, clinical operations, project management, pharmacovigilance, and regulatory
- Provide support to the publication planning and external presentations for assigned study teams. This includes coordination/writing/interactions required for manuscripts, abstracts, and posters. Performs peer review of publications
- Effectively operate in an environment which requires negotiation, persuasion, collaboration, and analytical judgment
- Excellent written/oral communication skills and attention to detail
- Experience in reading, understanding, and applying regulations to constantly changing environment
- Actively support and participate in clinical project team(s) as an effective representative of Medical Writing
- Contribute to all document creation/review/approval SOPs which are subject to bi-annual review
- Write and speak fluent Japanese and English
- Advanced knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
9
Skills For Senior Medical Writing Operations Specialist Resume
- Oncology, Cardiovascular, and Infectious Diseases knowledge
- Motivated, self-directed, and able to work autonomously with limited guidance
- Proficient in Word, Excel, PowerPoint, the use of templates, email, and internet
- Line management
- Familiarity with Veeva Vault, Salesforce and Box
- Execute functional business plans of the clinical regulatory writing portfolio and contribute to the development of the group and the department’s objectives
- Ensure compliance of clinical documents with national and international regulatory requirements and guidelines and Baxter procedures (as applicable)
- Work closely with cross functional team members
10
Skills For Senior Associate Medical Writing Resume
- Develop knowledge of all therapeutic areas
- Able to apply global regulatory authorities’ regulations and/or guidance
- Direct experience demonstrating knowledge of medical and/or scientific writing within a medical device or related industry, preferably with writing of Clinical Evaluation Reports
- PhD or PharmD with 3+ years of relevant experience
- Build and foster relationships with key business stakeholders and cross-functional team members
- Strong working knowledge of ICH guidelines for Common Technical Documents and Good Clinical Practice, FDA Code of Federal Regulations for New Drug Applications, European requirements for Marketing Authorization Applications, and other regulations governing clinical research and documentation
- Proven track record in writing clinical documents including, but not limited to: clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
List of Typical Responsibilities For a Medical Writing Resume
1
Responsibilities For Medical Writing Manager Resume
- Team player adaptable to change, with excellent organizational skills, quality focused
- Implement a confident and effective leadership and build positive relationship skills with integrity
- Well-developed professional communication skills, including written and interpersonal
- Experience in clinical/pharmaceutical development with directly related medical writing experience
- High level technical, statistical, and computer skills, and the ability to interpret complex clinical data
- Demonstrated record of executing strategically and tactically in a highly matrixed environment working with cross-functional, dynamic teams
- Experience as a major contributor in planning and production of clinical documents for regulatory submissions worldwide
2
Responsibilities For Head of Medical Writing Resume
- Experience in managing external publication vendors and/or freelance medical writers
- Experience as a major contributor in planning and production of clinical dossiers documents for regulatory submissions worldwide
- Scientific and Medical Writing Manager I: Up to 5 years of industry experience
- Scientific and Medical Writing Manager II: ≥ 6 years of industry experience
- A solid scientific academic background, together with a deep understanding of clinical drug development
- Multi-task, deal with competing priorities, meet aggressive timeline expectations
3
Responsibilities For Scientific & Medical Writing Specialist Clinical Evidence Generation Resume
- Experience in medical writing for peer reviewed publications and congress materials (abstracts, posters, presentations)
- Knowledge of good publication practices and industry-standard guidelines (GPP, ICMJE)
- Effectiveness in both oral and written communications
- PhD, MD, PharmD, with 2+ years of Clinical Development/Medical Affairs/Regulatory experience
- Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome)
- Reporting of department metrics relating to quality, timeliness and productivity
- Outstanding knowledge of grammar and usage, medical writing style guidelines (ie, AMA Manual of Style), and promotional activity regulations and specifications
4
Responsibilities For Medical Writing Business Operations Resume
- Understanding of clinical trial design and execution, statistical methods, and clinical trial data reporting requirements
- Understanding of data and disease landscape to enable critical analysis of scientific literature and communicate implications cross-functionally
- Position medical writing as an integral R&D function and keeps Senior Management apprised of Medical Writing contributions and impact
- Oversight of a portfolio of clients including ensuring delivery of projects to a high quality and within timelines and contractual obligations
- Assist in achieving the department's strategic business targets, e.g., sales, revenue, utilization, growth, outward-facing leadership and talent development
- Assistance in resourcing projects and work scheduling
- Wider oversight/coordination responsibilities beyond writing individual documents, e.g., managing large programs of work or client oversight
- Build and lead a high performing medical writing team
5
Responsibilities For Senior Medical Writing Group Lead Resume
- Maintain a proactive approach on initiatives for existing and prospective clients
- Review reporting and analysis plans and provides critical input on the content and display of tables
- Independently write or QC clinical study reports, protocols, narratives and other documents according to ICON or client-specified formats
- To lead department initiatives, as required, e.g., development of a new business area, implementation of process improvements, training
- Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical
6
Responsibilities For Medical Writing Associate Resume
- Collaborates with pre-clinical Subject Matter Experts (SMEs) to incorporate pre-clinical data into clinical and regulatory documents
- Ensures timely filing of required CTA and Medical Writing documents to the TMF in compliance with Biogen procedures and standards, including quality control reviews, identification of missing documentation, and follow-up with authors or other stakeholders to obtain missing items
- Format and copy edit clinical regulatory documents to ensure clarity and compliance with company templates and style standards (eg, clinical study reports, investigator's brochures, clinical summaries and overviews, and other submission-related documents)
- Provide QC support for data check for clinical study reports, investigator's brochures, clinical summary documents, and other documents; prepare and format reference lists
- Draft, address relevant comments and finalize safety narratives for clinical study reports
- Self-motivated and highly organized with the ability to work remotely
7
Responsibilities For RWE Associate Medical Writing Director Resume
- Manage multiple projects on tight timelines
- Prepares technical documents to support both domestic and international regulatory submissions
- Incorporates text, graphs, charts, tables and statistical analysis
- Proofreads, circulates, edits, assembles, inspects and duplicates product submissions
- Assist with development of publications for sponsored clinical trials
- Work with internal stakeholders, external authors and medical writers on congress abstracts, posters, and oral presentations
8
Responsibilities For Head, Medical Writing & Statistics Oncology Resume
- Coordinate project development activities (i.e. project timelines, project status, internal review) and recording of required steps for compliance documentation
- Interpret data tables, summarize complex information, and present data in a clear, concise, and scientifically accurate manner to a range of audiences
- Excellent communication, organizational, negotiation and time management skills with individuals and groups
- Work across multi-disciplinary groups and within a matrix environment
- As a member of the clinical project team, collaborates with global and regional functional line representatives and partner-line and vendor medical writers on assigned projects to provide experienced, high-level support and guidance on the preparation and finalization of clinical regulatory documents
- Establishes therapeutic area (Vaccines) and program-level document processes, standards, and templates. Trains, instructs, and provides guidance on these processes and standards to writers, project team members, and partner-line colleagues
- Reviews draft clinical documents prepared by vendor and partner-line writers
9
Responsibilities For Senior Medical Writing Operations Specialist Resume
- Manages and communicates with internal project team members and management to ensure that client expectations are met
- Assists Associates in troubleshooting project challenges, interacting with dissatisfied clients to address their concerns and determining appropriate corrective action
- Accomplishes Department financial objectives by assisting with forecasting requirements/capacity; preparing annual budgets; scheduling and overseeing expenditures, analyzing variances; and initiating corrective actions
- Maintains qualified staff by recruiting, selecting, orienting, and training Associates, and developing personal growth opportunities via training plans and/or career path planning
- Knowledge of labeling regulations (US, EU and Global)
- Work with multi-functional and culturally diverse teams
10
Responsibilities For Senior Associate Medical Writing Resume
- Write original content for publications/communications activities (primary and review manuscripts, abstracts, posters), slide presentations, meeting summaries, and other materials for HCP and internal audiences
- Interpret and apply clinical data
- Work in conjunction with team members to manage workload and to develop and adhere to attainable timelines for project completion
- Efficiently and accurately collate and incorporate author/client comments
- Participate in author/client teleconferences and answer content-related questions
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