Medical Writing Resume Samples

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B Powlowski

Buck

Powlowski

61790 Charlotte Avenue

Dallas

+1 (555) 216 4978

61790 Charlotte Avenue

Dallas

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

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

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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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

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

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 MicrosoftOffice 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

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

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

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