Medical Writing Resume Samples
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Medical Writing Resume Samples
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BP
B Powlowski
Buck
Powlowski
61790 Charlotte Avenue
Dallas
TX
+1 (555) 216 4978
61790 Charlotte Avenue
Dallas
TX
Phone
p
+1 (555) 216 4978
Experience
Experience
Boston, MA
Medical Writing Associate
Boston, MA
Bashirian, Johnson and Becker
Boston, MA
Medical Writing Associate
- Knowledge of Good Clinical Practice (GCP), the drug development process, and the AMA Manual of Style helpful
- Uses electronic document management systems (eDMS) to track, route, file, maintain, and archive Medical Writing documentation, including the collection of appendices for clinical study reports
- Acts as resource for Microsoft Word
- Performs high level information searches in the eDMS and various Vertex document repositories and file share areas, and incorporates new insights into internal projects or processes
- Provides troubleshooting and training to all levels on key Medical Writing processes and systems
- Reviews, analyzes, and recommends or takes action based on data gathered from a variety of resource
- May supervise or lead Medical Writing initiatives, including work on SOPs, work instructions, templates, and checklists
Boston, MA
Senior Medical Writing Group Lead
Boston, MA
Wiza, Gerlach and Turcotte
Boston, MA
Senior Medical Writing Group Lead
- Recruit medical writers, manage performance, set direction, align and motivate team members to achieve set goals and objectives
- Facilitate harmonization of technical documentation (templates) within Clinical Development and integrate medical writing processes across franchises
- Establish templates to ensure consistency of quality documentation
- Typically manage medical writers (5-10) to meet resource demands of Navigator
- Provide writing support for additional regulatory documents (eg, Pediatric Investigation Plans or Waivers, CERs, technical reports, Clinical Expert Reports, and Company Core Data Sheets)
- Facilitate workflow and timely completion of Investigator’s Brochure
- Ensure quality and timely development of clinical study reports
present
Philadelphia, PA
Associate Principal Medical Writing Operations Specialist
Philadelphia, PA
Abernathy Inc
present
Philadelphia, PA
Associate Principal Medical Writing Operations Specialist
present
- Contributes to resource planning and metrics tracking activities by coordinating data entry and report generation in Medical Writing Document and PDP databases
- Responsible for design and maintenance of Medical Writing ShareNet, TeamNet and iNet sites to promote effective information flow
- Assists in the generation, updating, and maintenance of vendor governance and oversight documentation
- Participates in and may lead departmental and interdepartmental continuous improvement initiatives
- Assumes responsibility for departmental contracts, invoices, purchase orders (PO), and statements of work (SOW). Interact with other departments (e.g., Finance, Procurement) to assure review and finalization of all contracts, SOWs, invoices, and POs
- Assesses, develops, and implements new processes and technologies to increase efficiency of procedures related to document preparation and management
- Participates in and may lead readiness efforts for GCP and pre-approval regulatory inspections and internal process audits
Education
Education
Bachelor’s Degree in Life Sciences
Bachelor’s Degree in Life Sciences
Duke University
Bachelor’s Degree in Life Sciences
Skills
Skills
- Able to adapt to working in a multicultural environment; able to adapt to change
- Strong computer skills; proficiency in MS Office Suite, and Electronic Document Management Systems (EDMS)
- Ability to focus on the details in a document without losing sight of the document messaging
- Demonstrated ability to work without close supervision
- Able to adopt an entrepreneurial and innovative style when necessary
- Able to think independently and apply principles across various situations and appropriately apply judgment to making changes
- Demonstrated ability to multi-task and to respond rapidly to changing priorities and aggressive timelines
- Able to collaborate productively with colleagues and supervisors
- Ability to work under pressure
- Ability to coach, train, and/or mentor more junior colleagues
15 Medical Writing resume templates
Read our complete resume writing guides
1
Medical Writing Group Lead-director Resume Examples & Samples
- 35% Writing, most often the more strategic documents to support the goals of the product(s)/program(s)
- 15% Directing and mentoring MW team members (internal and external) ensuring quality and efficiency in the production of clinical regulatory documents
- 25% Overseeing the medical writing aspects of the program(s), attending strategic meetings, developing timelines, assessing resource needs, collaborating with cross-functional colleagues
- 20% Leading or participating on departmental or cross-functional initiatives including actively participating on the MWLT
- 5% People management activities including performance management, people development, and fostering a BRAVE culture
2
Head of Medical Writing Resume Examples & Samples
- Responsible for all medical writing management across all clinical programs including strategic planning of MW deliverables, negotiating timelines, risk mitigation, managing and coordination of resources (writers, editors, and clinical publishers [internal or contractors])
- Manage the team leads for multiple medical writing teams and the editing/publishing group
- Provide strategic direction to clinical project teams relative to consistency of key messages across documents with a program goals in concordance with regulatory requirement/guidance for submissions
- Collaborate with other functions to ensure alignment of regulatory submission strategy and timelines
- Manage and coordinates work of other writers, editors, and clinical publishers (internal or contractors) as required for timely high quality clinical regulatory submissions. Set and oversee the outourcing strategy for the department
- Serve as lead and/or supporting medical writer on project teams as needed to negotiate and coordinate the clinical document development, review, and revision processes as well as writing, editing, and facilitating completion of all types of clinical documents
- Initiate and lead departmental and cross-functional process improvement initiatives (eg, SOPs, process guides, etc.) as they relate to medical writing functions. Ensure the electronic aspects of the documents or archival processes meet standards. Partners with IS toward staying progressive with current technology in the industry
- 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
- Actively participate on the GCDO leadership team
- BS essential. Master’s degree and/or PHD in the medical or life sciences is preferred
- At least 15+ years Medical Writing experience
- At least 8+ years of pharmaceutical industry drug development experience at a managerial level
- Experience with document management systems
- Experience with implementation of document standards and templates
- Experience with managing/coordinating contract medical writers and interaction with CRO’s
3
Medical Writing Group Lead Resume Examples & Samples
- 35%: Writing, most often the more strategic documents to support the goals of the product(s)/program(s)
- 15%: Directing and mentoring MW team members (internal and external) ensuring quality and efficiency in the production of clinical regulatory documents
- 25%: Overseeing the medical writing aspects of the program(s), attending strategic meetings, developing timelines, assessing resource needs, collaborating with cross-functional colleagues
- 20%: Leading or participating on departmental or cross-functional initiatives including actively participating on the MWLT
- 5%: People management activities including performance management, people development, and fostering a BRAVE culture
4
Medical Writing Group Lead Resume Examples & Samples
- Advanced degree in a relevant scientific/clinical/regulatory field preferred; Bachelor’s degree required
- At least 5 years of direct line management experience
- Global regulatory submission experience required
5
Specialist, Medical Writing Resume Examples & Samples
- Write clinical documents for regulatory submissions, including but not limited to: briefing documents,
- Bachelors degree required. Advanced degree preferred (Ph.D., MD, Sc.D., M.S., M.P.H.)
- Strong verbal, written, and interpersonal communication skills
- Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to
6
Director, Head of Medical Writing, Oncology Resume Examples & Samples
- Execute functional business plans of the clinical regulatory writing portfolio and contribute to the development of the group and the department’s objectives
- Manage priorities and assign internal and external medical writing resources, in alignment with business needs and staff developmental opportunities
- Provide scientific and operational guidance to medical writers, ensuring consistent application of standards and adherence to regulatory requirements and the timely completion of high quality deliverables
- Serve as a primary subject matter expert to therapeutic areas for the planning, design, and preparation of clinical documentation
- Build and foster a medical writing group capable of providing the expertise, organization, operations, capabilities, and behaviors required to deliver success on projects
- Hire appropriate, qualified staff (internal and through functional service providers)
- Manage employee performance and development
- Coach and mentor team members
- Contribute to department management through strategic input, continual process improvement, innovation, collaboration with internal and external stakeholders, and leadership for medical writing processes, standards, and initiatives
- Participate in budgeting, administration, and business objectives for their group
- Minimum of 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- A minimum 10 years of related experience in the pharmaceutical/biotechnology industry in a matrix organization
- Experience in oncology clinical trials
7
THV Senior Specialist, Medical Writing Resume Examples & Samples
- Collaborate with the clinical team to write clinical documents for regulatory submissions, including but not limited to: briefing documents, previous human experience summaries, investigator brochures, study protocols, informed consents, clinical evaluation reports, interim and final clinical study reports for the assigned projects
- Researches, creates, and edits assigned clinical reports, documents and scientific presentations associated with clinical research in cooperation with the Clinical Team, KOLs and physician investigators for the THV Clinical program
- Provide guidance to the Clinical team and participates in the development of the publication and reporting strategy and creation the publication/reporting plans for all clinical studies
- Request and/or conduct literature searches, managing the literature database and prepare literature reviews for external and internal clients
- Evaluate the need for scientific content and assist in the creation of clinical educational materials for the global Sales & Marketing organizations
- Project Lead for medical writing deliverables for assigned clinical studies. This may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues with clinical project managers, field teams, clinical data management and biostatistics group
- Develop/update publication/presentation SOPs, maintain awareness of ICMJE (Intl Committee of Medical Journal Editors) recommendations and ensure compliance with good publication practices (GPP), and miscellaneous administrative tasks
- Advanced degree required (Ph.D., MD, Sc.D., M.S., M.P.H.)
- Minimum of 5 years’ experience in development of scientific publications as a medical writer for pharmaceutical, CRO, or medical device clients ideally in cardiovascular field,
- Experience as author or contributor or peer-reviewed manuscripts is strongly desired,
- Working knowledge of statistics is required,
- Excellent writing and editing skills, and a keen attention to detail
- Highly proficient in the use of Microsoft Office applications (Word, Excel, PowerPoint) and EndNote
- Strong verbal as well as written communication skills necessary
- Maintain awareness of ICMJE (Intl Committee of Medical Journal Editors) recommendations and ensure compliance with good publication practices (GPP)
- Expertise in conducting focused literature searches on PubMed, MedLine or other similar medical literature databases
8
Associate Principal Medical Writing Operations Specialist Resume Examples & Samples
- Assumes responsibility for departmental contracts, invoices, purchase orders (PO), and statements of work (SOW). Interact with other departments (e.g., Finance, Procurement) to assure review and finalization of all contracts, SOWs, invoices, and POs
- Assists in the generation, updating, and maintenance of vendor governance and oversight documentation
- Contributes to resource planning and metrics tracking activities by coordinating data entry and report generation in Medical Writing Document and PDP databases
- Responsible for design and maintenance of Medical Writing ShareNet, TeamNet and iNet sites to promote effective information flow
- Participates in and may lead departmental and interdepartmental continuous improvement initiatives
- Assesses, develops, and implements new processes and technologies to increase efficiency of procedures related to document preparation and management
- Participates in and may lead readiness efforts for GCP and pre-approval regulatory inspections and internal process audits
- Provides administrative support for all vendor management operations in Global Medical Writing initiation & tracking of work requests and tracking of invoices received
- Communicates accrual information from vendors to Biogen Finance on a monthly basis. Reviews invoices to verify that correct rates and terms have been applied and confers with Medical Writing Managers to confirm that work has been done and is acceptable
- 4+ years medical writing or medical writing operations experience
- 2+ years project management experience with contribution to standards development
9
Medical Writing Operations Specialist Trial Master File Resume Examples & Samples
- Uploads/files/performs quality control on documents to be submitted to the Trial Master File. Includes identification of missing documentation and follow-up with authors or other stakeholders to obtain missing items; performing quality reviews of files and any needed remediation (e.g., follow-up with sources, generating notes to file to explain any discrepancies); and completing file review documentation
- Participates in Inspection Readiness activities as needed
- Responsible for ensuring timely filing of TMF documentation; addressing backlog of unfiled documentation; performing periodic review and remediation of TMF
- Performs document approval and notification processes
- Assists Medical Writing staff with document formatting/troubleshooting/reference management
- 3+ yrs related Document Processing experience
- Knowledge of and direct experience with Trial Master File required
- Quality control experience preferred
- Ability to multitask in a fast-paced environment
10
Medical Writing Specialist Resume Examples & Samples
- Provide support to writing functions to ensure timely, high-quality deliverables in compliance with Standard Operating Procedures (SOPs), FDA, EMEA, ICH, and national and local regulations, as applicable
- Manage and perform quality check of clinical submissions documents which includes data verification, verification of document completeness and consistency within a document and between related documents, spelling and grammar checks (as needed), reference checks, and verification that a document is consistent with company and project-specific writing conventions and styles
- Provide expertise on process, content, checklists, efficiencies, timelines, and interdependencies
- Assist in preparation of clinical submission documents by incorporating text edits/comments, in-text tables based on statistical outputs and project-specific style sheet standards
- Manage and write minor clinical study protocol amendments (as needed) and minor CTD Sections (eg, List of Synopses)
- Participate in template development for clinical submission documents to ensure regulatory requirements, style requirements, and publishing specifications are met
- Such other responsibilities and projects that the company may assign
- Coordinate with other Medical Writing Specialists as needed to maintain consistency across documents within a project and across indications. Identify trends in quality deficiencies and recommend corrective actions
- Act as a Lead Medical Writing Specialist on projects (as assigned). Track project timelines in order to ensure that all QC timelines across a project are met
- A professional certification (eg, AMWA, EMWA, RAPS) is a plus, but not essential
- Three or more years experience in medical or technical writing is a plus
- Demonstrated ability to work without close supervision
- Ability to work within an international team setting
- Demonstrated ability to multi-task and to respond rapidly to changing priorities and aggressive timelines
- Must be detail-oriented, thorough, and methodical
- Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
- Exceptional problem-solving capabilities and organizational skills
- Exceptional proofreading skills
- Ability to focus on the details in a document without losing sight of the document messaging
- Ability to exercise independent judgment in developing methods, techniques, and evaluation criteria for obtaining results
- Intermediate knowledge of medical, pharmaceutical, and clinical research concepts, including a comprehensive understanding of the clinical trial procedures and drug development process
- Strong computer skills; proficiency in MS Office Suite, and Electronic Document Management Systems (EDMS)
- Ability to travel both domestically and internationally as business necessitates
- Ability to coach, train, and/or mentor more junior colleagues
- Can manage uncertainty and shifting priorities and timelines
- Able to collaborate productively with colleagues and supervisors
- Able to adapt to working in a multicultural environment; able to adapt to change
- Able to think independently and apply principles across various situations and appropriately apply judgment to making changes
- Able to adopt an entrepreneurial and innovative style when necessary
11
Associate Specialist, Medical Writing Resume Examples & Samples
- Good computer skills in Microsoft Office Suite, including Word, Excel, and PowerPoint; publication library software (e.g., EndNote)
- Good editing and proofreading skills
- Good knowledge and understanding of policies, procedures and guidelines relevant in the development of scientific publications and medical writing styles and techniques
- Good knowledge on conducting focused searches on medical literature database (e.g., PubMed, Medline)
- Good knowledge of statistics
- Ability to interact professionally with all organizational levels and functions where assigned
12
Head Global Medical Writing Resume Examples & Samples
- As Head Global Medical Writing you will ensure provision of high-quality, compliant deliverables (e.g., clinical study reports, submission documents etc.) to regulatory authorities worldwide to support product development objectives and the growth of the portfolio
- It is your task to ensure global, regional and local alignment, execution and compliance of Medical Writing activities. Thus you are taking into account the functional role and corporate policies as well as legal and regulatory guidance
- You provide leadership and vision in establishing the strategic direction of Medical Writing functions globally within a complex matrix environment
- Furthermore, you drive consistency and alignment through the sharing of best practices, guidance and standards across the Medical Writing function, including external partners and vendors
13
Medical Writing Mgr Resume Examples & Samples
- Doctorate degree
- One year of publication development experience in a biopharmaceutical setting, preferably in the oncology therapeutic area, or postdoctoral experience in oncology
- Experience preparing clinical manuscripts for publication in peer-reviewed medical journals as well as abstracts, posters, and slide decks for presentation at scientific congresses
- Knowledge of hematology and/or oncology
- Experience working in a matrix team setting
- Experience collaborating with clinical investigator-authors
- Exceptional analytical, communication, organizational, and interpersonal skills
- Apply project management skills to advance numerous projects simultaneously and to deliver high-quality documents rapidly
- Lead and/or facilitate effective team meetings
- Proficient in word processing, including touch-typing, and pertinent software (eg, Microsoft Office, EndNote, Adobe Illustrator)
- Knowledgeable about publication guidelines and best practices
14
Scientific & Medical Writing Specialist Clinical Evidence Generation Resume Examples & Samples
- Minimum level of education: Post-graduate degree in life sciences or medical background or equivalent expertise
- Preferred level of Education: PhD or equivalent
- In addition to experience in writing multiple complex documents in varied disease areas, the job requires a higher level of responsibility in producing high quality documents through coordinating others at a project level
- This role requires good understanding of complex scientific information & skills to communicate information to various target audiences
- Proficiency in basic immunology and area of assigned vaccine project
- Demonstrates advanced knowledge of scientific methodology in the design, conduct and description of clinical research
- Demonstrates expertise in analyzing and describing clinical results
- Excellent organization skills to coordinate and manage geographically dispersed multicultural teams
- Understands the organization of scientific documents
- Possesses advanced knowledge of International Committee for Harmonisation (ICH) / Good Clinical Practice (GCP)/Regulatory requirements
- Possesses advanced knowledge of statistical principles used in clinical research
- Possesses very good computer skills and general computer literacy
- Excellent command over English language (verbal and written)
- Specific Knowledge
- As responsible for Scientific Writing deliverables of assigned projects, oversees, coordinates and/or writes documents to support operational and strategic goals of such as study reports, concept protocols and study protocols clinical summary modules, global epidemiology plans and briefing documents. Ensures a consistently high quality through all documents produced by the team
- Provides knowledge expertise to ensure deliverables (regardless of who writes it) are of consistently high scientific standards, with a logical flow in the presentation and interpretation of information throughout the project (inconsistencies should be escalated so risks may be transparently assessed)
- Promotes and provides information support in terms of strategic input to GSK Vaccines’ Clinical Development Plans
- Leads implementation of continuous improvement through exercises such as lessons learned. This includes implementing best practices of/lessons learned from other writing teams and RDCs
- Overview of project workload to anticipate bottle necks and specific resource issues. Resource gaps (or surplus) are communicated to facilitate even distribution of work throughout the scientific writing function
- Assess and escalate risks to the appropriate level in addition to communicating opportunities the manager
- Resolution of conflicts in priority or opinions from reviewers/approvers to ensure alignment of stakeholder (including the Clinical Research and Development Leader, [CRDL])
- Promotes knowledge sharing knowledge of the Scientific Writers in the project. Coaches and develops Associate Scientific Writers and Scientific Writers in all areas of accountabilities and ensure their integration into the team / company. Give information on training needs of his/her team to the Manager, Scientific Writing. Provides mentorship which develops skills and strengths of junior/newly hired members of the team as well as Provide feedback/information to his/her team members on projects and specific activities
- Build capability by refining and expanding activities to optimize benefits of co-location or remote working. This may include new areas of regulatory support, or building more robust quality/consistency in a transversal environment. Where the lead writer coordinates other writers, the work assigned should match the capability of the individual, with more experienced writers assigned more complex or novel tasks
- Ensure compliance with legal, quality and other regulatory standards through management monitoring and KPI reporting, proactively escalating risks to facilitate mitigation
15
Director of Medical Writing Resume Examples & Samples
- A doctoral degree in a life sciences discipline (e.g., psychology, biology, neuroscience), or a Master’s degree with 5 years of relevant experience
- A minimum of 10 years of industry experience
- A minimum of 3 years of experience managing direct reports
- Thorough understanding of citation databases such as PubMed; training in research methodology and statistics; familiarity with medical literature and terminology
- Ability to communicate effectively with both clients and team members
- Able to lead and manage complex projects on time and on budget with little supervision
- Experience working with interdisciplinary teams
- Skilled user of Microsoft Office product software (Word, Excel, PowerPoint) and Reference Manager
- Must be detail-oriented, and be able to work in a fast-paced team-oriented environment
16
Senior Associate Medical Writing Resume Examples & Samples
- Experience in understanding and interpreting data/information and its practical application
- Excellent written/oral communication skills and attention to detail in English and Japanese
- Strong Time and project management
- Negotiating skills
- Perseverance with a drive for results
- Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
- Knowledge of management skills and supervising vendors
- Understands the core business process and purpose of the functional area in Amgen's commercialization process
- Strong Leadership in a team environment
- Strong negotiator
- Developing and delegating to direct reports with a drive for results
- Doctorate degree and 2 year of directly related experience
- 5+ years experience in writing clinical and regulatory documents for all phases of regulatory submissions (INDs to NDAs)
17
Summer Internship Medical Writing Resume Examples & Samples
- Under the direction of a medical writer the authoring, editing, revision, and quality control (QC) of clinical documents
- Support medical writers with clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for peer-reviewed journals
- Support with departmental initiatives such as development of standards and assistance with departmental transition to enterprise document management system and clinical/medical library
- Must have strong written and verbal communication skills; experience working with Microsoft Word, Excel, and PowerPoint
- Ability to effectively manage time across multiple projects
- Life Sciences or Health Sciences major preferred
18
Medical Writing Associate Resume Examples & Samples
- QC review
- Uses electronic document management systems (eDMS) to track, route, file, maintain, and archive Medical Writing documentation, including the collection of appendices for clinical study reports
- Acts as resource for Microsoft Word
- Performs high level information searches in the eDMS and various Vertex document repositories and file share areas, and incorporates new insights into internal projects or processes
- Provides troubleshooting and training to all levels on key Medical Writing processes and systems
- Reviews, analyzes, and recommends or takes action based on data gathered from a variety of resource
- May supervise or lead Medical Writing initiatives, including work on SOPs, work instructions, templates, and checklists
- Communicates ideas for new processes and/or business operations for process improvement
- Regularly interacts with a variety of employees internally
- Proficiency in Microsoft Office applications (including Word, PowerPoint, and Excel)
- Aptitude for systems applications, including eDMS, PleaseReview, and EndNote
- Excellent interpersonal, verbal, and written skills
- Attention to detail related to consistency, grammar, syntax, and scientific accuracy
- Aptitude for and interest in science and scientific concepts
- Ability to prioritize and manage multiple projects; adapts to changing priorities
- Demonstrates a thorough understanding of implications and impact of work required for the execution of internal and external communications related to projects
- Consistently displays a high level of business acumen when completing assignments and projects
- Exercises competent discretion and judgment to handle routine and unusual situationCurious and interested in clinical regulatory documents and processes and the biotech/pharmaceutical industries
- Knowledge of Good Clinical Practice (GCP), the drug development process, and the AMA Manual of Style helpful
- B.A. (or equivalent degree) and 2 to 4 years of relevant work experience. No graduate degrees please
19
Medical Writing Program Manager Resume Examples & Samples
- Acts as a primary GMWRL generally for several early-stage development projects and/or acts as a back-up/supporting GMWRL for several early-stage development projects. Examples of back-up/supporting activities are substituting at global project team meetings for primary GMWRL (including strategic sessions if the primary GMWRL is unavailable), and undertaking a GMWRL task/responsibility for a program at the request of the primary GMWRL
- As a document specialist, provides intellectual leadership and contributes document knowledge and expertise to the global project team. (Contribution will be commensurate with experience.)
- Reviews work and manages/coordinates writing activities for an entire program, contributing to the successful completion of required program documents
- For some of the document types within a program, implements adjustments in specific document content within framework of provided templates in order to fit needs of a specific document/core team requirements (other documents may require advice from senior staff)
- Participates in departmental project activities (up to a total of 3% of time)
- For a Contract Research Organization (CRO) working on a program, collects, monitors and maintains metrics associated with document creation and quality review, including individual performance evaluation, and provides the information to Line Management in order to improve CRO alliance management
- In addition to GMWRL responsibilities, may act as a Document Working Group Facilitator (DWGF; lead medical writer in a working group) for a project not within the scope of program responsibilities as a result of being a recognized expert for the document type
- BA/BS degree; 7+ years relevant experience or 5 years with Master's degree. Preferred: MS/MA/MPH; at least 5 years as writing professional in pharmaceutical industry
- Must have substantive medical writing experience in the therapeutic area of Oncology
- Activities require expert technical skill (e.g., as defined by Drug Information Association Medical Writing Competency Model) including techniques of scientific writing and editing; ability to interpret and communicate clinical and numerical data, and verify consistency in data; comprehend and communicate scientific concepts; interpret and communicate clinical, nonclinical, biopharmaceutics, pharmacology, ADME and CMC data and information
- Activities require advanced document and process experience, and routinely requires highly complex problem solving/issue resolution to achieve corporate objective(s)
- Technical expert on a number of document types. Demonstrated and substantial experience in managing the creation of IND/IMPD or NDA/MAA components
20
Head, Medical Writing & Statistics Oncology Resume Examples & Samples
- Define and maintain the strategic positioning, global organizational structure and functional alignment of the Medical Writing and Statistics- Oncology function within the organization
- Provide the resources and expertise needed to support the Oncology Development project portfolio and deliver all required regulatory documentation on time, of high quality and within budget
- Create and maintain a strong network within the SBU and with P&O functions
- Lead, manage and supervise Statistics, thereby ensuring quality and timely delivery from Statistics to early development activities and clinical development plans, projects and studies from research, phase I-III through registration and launch
- Establish and maintain a process and Information Technology framework within which regulatory clinical documentation activities and deliverables can be conducted and delivered efficiently, effectively, and with high quality and full compliance to regulatory requirements
- Contribute to relevant governance bodies to the overall development strategies for the oncology assets
- Provide subject matter expert input in support of all Oncology Development quality and compliance activities including audits, authority inspections and risk management planning and mitigation
- PhD or MSc. in Biostatistics, Statistics or Mathematics with 12 years of Pharmaceutical Industry experience
- At least six (6) years of experience as Statistician with significant time spent in Oncology
- Experience in leading a statistical function in a global organization
- Demonstrated strong statistical skills and experience in regulatory interactions
- Must provide clear vision, direction and purpose in the different cultures present within the SBU Oncology Development organization
- Must embrace change and be able to work in a changing environment with a focus on continuous improvement
- Strong communication skills to ensure that project plans and status are transparent and that risks, issues and results are clear to all involved parties as a matrix structure
- Demonstrated skills in gathering decision information, negotiation and communicating decisions and actions
- Executes responsibilities with knowledge, accuracy, persistence, resilience and creativity seeking to work both independently and collaboratively
- Fluency in English, both written and verbal
21
RWE Associate Medical Writing Director Resume Examples & Samples
- Lead global MW initiatives for RWE Scientific Affairs or act as a regional representative on a cross-functional initiative
- Design training materials and input into generic training plans. Plan and deliver general training on Medical Writing to other QuintilesIMS groups and externally, as appropriate. Provide senior review and guidance for most documents prepared by junior staff
- Draft new cross-functional SOPs (owned by RWE Scientific Affairs MW). May represent RWE Scientific Affairs MW as reviewer for cross-functional SOPs owned by other operations
- Act as Project Leader for a large stand-alone program, including more than one document type and/or region. Support specific partnership customers and projects where MW is the sought after service. May coordinate Medical Writing activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking
- May act as Lead Medical Writer on any type of writing project to an exemplary standard and can advise others on any type of document. Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with very limited senior support needed. Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery. Identifies project needs, negotiates and tracks project timelines and implements client requests independently. Takes responsibility for planning and organizing workload for assigned projects and tasks. Offers proactive solutions and advice to customers as appropriate to experience
- May review and monitors budget for assigned projects, including out of scope activities, and ensures that revenue is recognised as appropriate. May review and approve costings for majority of projects. Managerial consultation required only in cases of discounts/special rate requests. May independently prepare and presents slides for MW component of any full-service bid defence meeting; may present on MW and discuss proposals at a stand-alone bid defence meeting
- May plan and deliver workshops or presentations on Medical Writing topics, e.g. for a conference
- Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of RWE/medical writing
- Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
- Understanding of the time needed to perform routine Medical Writing tasks, agree appropriate timelines, and provide accurate resource estimates and costings. Knowledge and understanding of necessary budget assumptions
- Ability to give a presentation to a project team and/or customer on project-specific topics, with an air of competence and authority
- Demonstrated ability to influence others in global and/or cross-functional or customer discussions. Has earned respect from peers in other operational groups
- Sets a positive example to more junior staff in attitude to customers and colleagues and communication style
- Advanced negotiation skills
- Can identify creative solutions to challenges that are acceptable to QuintilesIMS and customers
- Demonstrated abilities in collaboration with others and independent thought
- Knowledge of regulations relevant to medical writing
- Careful attention to detail and accuracy
22
Senior Medical Writing Operations Specialist Resume Examples & Samples
- Works with Medical Operations management and stakeholders to develop and execute a comprehensive plan for outsourcing TMF activities to master service provider (MSP) vendors. Drafts appropriate statements of work
- Provides TMF training and guidance to staff as needed
- Performs and documents ongoing oversight of TMF vendor activities
- Performs regular TMF file review, completes any needed remediation (e.g., follow-up with sources, generating notes to file to explain any discrepancies), and completes required file review documentation
- Participates in Inspection Readiness activities as a document subject matter expert
- Ensures timely filing of required Medical Writing and CTA 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
- Meets all deliverable timelines
- Knowledge of, and 3+ years’ direct experience with, Trial Master File required
- Exceptional attention to detail required
- Adept in oral and written communication
- Proven ability to multitask in a fast-paced environment
- Ability to prioritize while adhering to project deadlines
- Experience working with clinical research organization (CRO) staff preferred
- Understanding of the Drug Information Association (DIA) TMF Reference Model
- Good understanding of the biotechnology/pharmaceutical industry and the clinical development process, including familiarity with International Conference on Harmonisation (ICH) and Good Clinical Practices (GCP) guidelines
- Direct participation in regulatory agency inspections (including inspection readiness and interview process) preferred
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Senior Medical Writing Group Lead Resume Examples & Samples
- Ensure quality and timely development of clinical study reports
- Responsible for multiple initiatives and training to further promote quality documentation
- Facilitate harmonization of technical documentation (templates) within Clinical Development and integrate medical writing processes across franchises
- Typically manage medical writers (5-10) to meet resource demands of Navigator
- Review protocols and MOPs to assure compliance with external standards
- Facilitate workflow and timely completion of Investigator’s Brochure
- Integration of study reports into submission documents
- Provide writing support for additional regulatory documents (eg, Pediatric Investigation Plans or Waivers, CERs, technical reports, Clinical Expert Reports, and Company Core Data Sheets)
- Ensure compliance to internal and external guidances for technical documentation
- Establish templates to ensure consistency of quality documentation
- Ensure harmonization and transparency of processes for assigned business areas
- Recruit medical writers, manage performance, set direction, align and motivate team members to achieve set goals and objectives
- Knowledge of ophthalmology preferred
- The individual must have strong understanding of study design, analytical and data interpretation, and reporting skills
- In-depth knowledge of clinical regulatory requirements for clinical regulatory documentation
- Minimally 5-10 years medical writing experience or other relevant Pharma/Device industry experience Exhibits skills for supervising medical writers
- Ability to coach, mentor, and lead global cross-functional teams, strong leadership skills and previous line management experience
- Extensive experience of data interpretation and presentation of regulatory documents for clinical development programs
- Expertise in the preparation of documents for submission to health authorities in support of marketing applications
- Excellent knowledge of regulatory document requirements, creation, management and publishing processes and tools
- Experience with matrix management and global environment
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Medical Writing Business Operations Resume Examples & Samples
- Develop and implement a flexible resource model to manage all aspects of the dynamic medical writing workload resourcing. Work with Finance, Procurement, Medical Writing Senior Management and PSRM to develop and execute resourcing strategies adapting to the dynamic business needs and changes across GCTO. Establish and lead resource management for the department, providing planning, coordination, processes, best practices, compliance, communication and other related to ensure the successful alignment and implementation. Ensure appropriate tools and metrics are established to track and measure implementation, continuous improvement and success including periodic reviews and communications
- Serve as liaison for implementing Medical Writing vendor partnerships in conjunction with the PSRM group. Ensure consistency, coordination, accountability, communication, and results/tracking related to Medical Writing operations
- Lead for developing and implementing department communication plan. Work closely with the department leadership to implement and support the development of business and operational Medical Writing communications
- Lead for establishment of effective meetings for information sharing, planning and coordination across Medical Writing functions. Serves as Senior Leadership Team (SLT) meeting facilitator. Identifies and prioritizes issues, ensures alignment, and accountability tracking of assignments/projects to satisfactory completion and/or realization
- Works with Head of Medical Writing to standardize and implement department periodic summaries and/or reports. Facilitate and contribute to ad hoc Medical Writing department reports or communications
- Work with Head of Medical Writing to facilitate operational and business strategic mindset within Senior Leadership, including strategic planning approach for meetings, accountability, continual process improvement, innovation, collaboration with internal and external stakeholders, and leadership for medical writing processes, standards, and initiatives
- Works with the Head of Medical Writing to facilitate the change management process within Medical Writing. Establish a framework for providing feedback and addressing risk/developing mitigation plans as needed
- Manage departmental budget to support Head of Medical Writing and Senior Staff
- Position can be remote-based**
- A minimum of 6 years managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- A minimum of 3 years of experience in workload/resources/vendor management
- Must have a demonstrated ability to lead/manage large, complex projects from collecting data and information through analysis to successful implementation
- Ability to prioritize, align and simplify
- Working knowledge of Medical Writing/Documentation core business structure and how own function contributes to and works within the organization
- Business & financial acumen
- Strong leadership, negotiation, influencing and change management skills
- Excellent interpersonal and communication skills with ability to communicate with all levels of the organization
- Effective leadership of non-direct reports with broad responsibilities
- Customer focused with ability to create visible value
- Successful history of working in a fast-paced, team-oriented environment, willing to work beyond their job scope to achieve department and company objectives
- Willing and able to travel Up to 20% as required per this position
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Medical Writing Quality Review Specialist Resume Examples & Samples
- May assist project lead for deliverables requiring document quality review support as a single service
- Serves as a member of the medical writing team for all projects with medical writing deliverables. Provides feedback to the Lead Medical Writer on progress of document quality review
- Monitors document quality review timelines and budgets for assigned projects and updates the Lead Medical Writer, Project Manager, and/or direct supervisor (as appropriate) if deliverables are at risk
- Proofreads/edits assigned documents, applying correct grammar, punctuation, and spelling following American Medical Association (AMA) or various custom style guidelines as well as the established Medical Writing internal checklist for Quality Review (QR)
- Uses advanced functions of many software applications, particularly the MicrosoftOffice suite and Adobe Acrobat, for the quality review and electronic formatting, compiling, and publishing of medical writing deliverables. Typical deliverables include study protocols, clinical study reports, investigator brochures, abstracts/manuscripts, and other regulatory submissions and documents
- Manages assigned QR projects according to medical writing Standard Operating Procedures and client standards, on time and on budget
- Maintains familiarity with current industry practices and regulatory requirements that affect document management and quality review of medical writing deliverables
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Medical Writing Manager Resume Examples & Samples
- Acts as Lead Medical Writer on any type of writing project, with limited guidance from senior staff, and consistent high quality and efficiency. Can use experience and initiative to tackle new/unusual document types and customer requirements
- May provide senior review and guidance for most documents prepared by junior staff. May design training materials and input into generic training plans. May plan and deliver general training on MW to other Quintiles groups and externally, as appropriate
- May act as Project Manager for a small series of stand-alone MW projects (e.g. series of related CSRs). May coordinate MW activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking
- May represent region or site on a MW initiative or cross-functional initiative
- Keeps abreast of current data, trends, MW/regulatory knowledge, developments and advances in area of drug development/MW
- Sets SMART goals and objectives for staff
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AD, Medical Writing Resume Examples & Samples
- Line manager of staff, including Senior MW and Manager levels, who may be office- or home-based. The majority of the writers are office-based in RTP, NC
- Ensures staff have a clear and consistent understanding of the strategy and regional and global objectives; contribute to discussions on how to implement strategy on a regional basis. May set and drive site-specific objectives as appropriate. May participate in global MW management activities
- Provides senior review and guidance for most documents prepared by junior staff. May design training materials and input into generic training plans. May plan and deliver general training on MW to other QuintilesIMS groups and externally, as appropriate
- Review and monitors budget for projects of direct reports and/or departmental budgets, including out of scope activities, and ensures that revenue is recognized as appropriate. May review and approve costings for majority of projects. Independently prepares and presents slides for MW component of any full-service bid defense meeting; may present on MW and discuss proposals at a stand-alone bid defense meeting
- May coordinate MW activities for a series of full-service projects, with attendant focus on efficiencies, consistency, budgetary concerns, client liaison, and tracking
- Keeps abreast of current data, trends, MW and/or technical writing/regulatory knowledge, developments and advances in area of drug development and MW