Medical Editor Jobs

Job Title: Medical Writer (clinical) Company: PRA International Location: Lenexa, KS Description: PRA International is one of the world's leading global clinical research organizations, conducting clinical trials in 65 countries across six continents. PRA provides outsourced clinical services across all phases of pharmaceutical and biotech drug development. Through its 30+ years of experience, PRA has developed the operational and therapeutic expertise to provide high quality, global service while maintaining our differentiating PERSONAL ELEMENT of commitment to excellence. We currently have an excellent opportunity for a Medical Writer in our Lenexa, Kansas office. The Medical Writer is responsible for researching, writing and editing clinical reports, summarizing statistical data from clinical studies for submission to FDA / regulatory authorities and for publication and/or presentations. Accountabilities include: Interprets clinical study results, writes, reviews, and edits scientific manuscripts, clinical study reports, protocols, documents for regulatory submissions (e.g. Pre-IND packages, INDs, sections of NDAs/MAAs), investigator brochures, posters, newsletters, or other clinical and regulatory documents Coordinates and leads the writing of documents for regulatory submissions (e.g. Pre-IND packages, INDs, sections of NDAs/MAAs) Reviews and edits analysis plans that have been prepared by a biostatistician Performs on-line literature searches Leads project teams in drafting report specifications, medical writing, and coordination of data analysis Assists in the development of formats and guidelines for clinical documentation Schedules and conducts peer and team quality control review for assigned projects Serves as primary functional representative on project teams Interacts with clients and participates in client meetings as necessary Reviews all relevant documents and interacts with functional leader and project manager to develop a thorough understanding of tasks, priorities, and schedules May assist CRAs, etc. in clinical protocol development Develops and implements training for medical writers; serves as an active mentor to one or more junior staff members and provides formal in-service training as requested by the functional leader If assigned direct reports, schedules and reviews project tasks; provides leadership in the delivery of services to clients; ensures that staff fulfill their responsibilities in accordance with PRA's policies, procedures and SOPs Maintains familiarity with current industry practices and regulatory requirements that affect medical writing Successful candidates will possess: Undergraduate degree in science or a health-related field from an accredited institution or equivalent international education and/or work experience is required An advanced degree (M.S. or Ph.D. or Pharm. D.) from an accredited institution in science or a health-related field, or equivalent experience preferred Experience writing pharmaceutical or health-related documents required. Experience writing clinical study reports, poster presentations, and manuscripts for publication in a scientific journal preferred Knowledge of regulatory submissions requirements, ICH clinical study report writing guidelines preferred Project leadership/management skills preferred Experience using computerized systems (PC-Windows and WORD) Excellent written, oral communication and presentation skills Read, write, and speak fluent English; fluent in host country language PRA International offers a great working environment and excellent career opportunities and benefits. Apply today to find out more information about PRA and the role of the Medical Writer. Qualified applicants will be contacted.

Job Title: Medical Writer Company: PPD Location: Austin, TX Description: The Medical Writer researches, prepares, and coordinates scientific publications. The Medical Writer is responsible for researching, writing, and editing clinical/statistical reports and study protocols, and summarizing data from clinical studies for submission to the Food and Drug Administration (FDA). Education and Experience: BS/BA in a scientific discipline (or licensed certification) with 2+ years relevant writing experience or An advanced degree with 0 to 2 years relevant experience Or equivalent combination of education, training, and experience that provides the individual with the required knowledge, skills, and abilities Ph I experience or Ph Ib/IIa Knowledge, Skills and Abilities: Excellent working knowledge of biomedical and statistical concepts Excellent grammatical, editorial, and proofreading skills Excellent problem solving capabilities and organizational skills Ability to interpret and present extremely complex data in preparing a coherent written document Proficient with Microsoft Word and other applicable software packages Ability to prioritize and be adaptable to changes in work duties, responsibilities and requirements PPD is an Equal Opportunity Employer

Job Title: Medical Writers with Phd (2 needed) Company: Location: Waltham, MA Description: TOP TIER PHARMACEUTICAL COMPANY in BOSTON: Positin #1:Requires a Phd in a scientific discipline and two to tenyears of writing experience, in medical communications, scientific publications, or related field. This position requires adherence to multiple simultaneous timelines and the ability to multitask and handle multiple projects efficiently in a team environment. Reports to the Director of Medical Writing and works within matrix teams with other functional groups. An understanding of ICH guidelines, strong written and verbal communication skills, and proficiency in Microsoft Word is needed and Documentum experience is helpful. Candidate should have the ability to coordinate and prioritize multiple projects in a fast paced environment. Requires Phd and Protocol writing experience (IND and NDA experience writing a plus), Any submission works experience etc.An understanding of ICH guidelines, strong written and verbal communication skills, and proficiency in Microsoft Word is neededExperience in Hemaphilia a REAL PLUS (but not neccessary)

Job Title: Medical Writer Company: Alpha Consulting Corp. Location: Plainsboro, NJ Description: MEDICAL WRITERREQUIREMENT #6460RECRUITER: MICHELLE ASHENJOB LOCATION: PLAINBORO, NJ AUGUST 5, 2010Project Description:* Extremely strong command of English language, grammar, style, logical progression* Ability to write in a clear, concise, and persuasive manner* Ability not only to write but to edit on all levels, from copy editing to major rewriting* Extremely strong attention to detail; ability to detect inconsistencies* Understanding of model documents (templates) and how to use them correctly* Basic understanding of electronic publishing* Strong Microsoft WORD skills* Strong project management skills; well organized* Ability to interpret clinical data and analyze published literature* Strong understanding of the basics of drug development, clinical study design, and regulations (CFR; FDA and ICH guidances; EU requirements)* Strong understanding of the rationale for running post-marketing clinical and HEOR studies* Strong understanding of scientific principals (eg, experimental design)* Therapeutic expertise in at least one therapeutic area* Ability to work on more than one project at a time* Ability to work with a diverse group of doctors, protocol managers, HEOR scientists, and statisticians to drive projects through to completion PhD/MD/PharmD in a relevant scientific discipline or MS / BS with a minimum of 3 years (MS) to 5 years (BS) in pharmaceutical regulatory documentation, or equivalent, and good understanding of requirements for regulatory submission documents. In addition, (i) demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals, (ii) good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities, (iii) demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team, (iv) working knowledge of a document management system and basic knowledge of document publishing process, (v) analyzed and interpreted complex data from a broad range of scientific disciplines.Coordinate and author regulatory documents (e.g. phase I/II clinical study reports, Investigator*s Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members.2. When assigned as Lead Writer, ability to lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions.3. Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects.4. Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents.5. Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells. 6. Able to collaborate with project team to respond to health authority questions, requests, etc.7. Provide departmental management with adequate information to help assess resource needs. Required Skills: Medical Writing, Superb Communication Skills, Drug Development, Clinical Study Design and Regulations, MS Word This 6+ month position starts ASAP.Please E-MAIL your resume (attachment to email) with rate and availability to Michelle: Register to View

Job Title: Senior Medical Writer Need 3 Company: Sampson Medical Search Location: Boston, MA Description: If you have interest in this opportunity Please send a resume in a word attachment to Register to View Responsibilities The Senior Medical Writer independently plans and prepares a variety of clinical documents necessary for all phases of clinical drug development by organizing, analyzing, and interpreting scientific and statistical data. Such documents include clinical study reports, study protocols, investigator's brochures, and manuscripts. Conducts overall planning of the clinical sections of global submissions. Works with manager to develop timelines and resource plans for the clinical sections of a submission or for implementation of communication strategy. Advises management regarding project resource requirements, and manages project-related activities of resources assigned. Reviews statistical analysis plans and case report forms, as required. Performs quality control (QC) review of clinical study reports and other submissions written by other medical writers. Keeps management informed on progress documents and other project related information, assist management in projecting resources, and perform administrative duties as requested. Works independently with the sponsor representative(s) with regard to document planning, review, revision, and finalization. Documents are to be completed within a time period that supports project needs and deadlines. Furthermore, documents are to be of high quality and scientifically accurate, and are to reflect a consensus among team members that is acceptable to all appropriate reviewers. Documents must meet International Conference on Harmonisation (ICH) guidelines and company document standards. Minimum Requirements Minimum Education: BS/BSc/BA in a science or industry-related discipline. Minimum Work Requirements: Minimum of 5 years of pharmaceuticals, biotech, or CRO medical writing experience. Skills: Working knowledge of ICH and other regulatory guidelines required. The ability to accurately and clearly present clinical data, strong verbal, written, and interpersonal communication skills, and proficiency in Micro Soft Word required. Broad knowledge of global pharmaceutical regulatory requirements required, and experience in clinical research or other areas of the pharmaceutical industry preferred. Excellent regulatory writing skills (e.g., English usage), and a keen attention to detail also are required Reports to: Vice President, Clinical Operations Also need an Associate Medical Writer and a Medical Writer

Job Title: Assoc Medical Writer - Clinical Research Company: Medtronic Location: Northridge, CA Description: Medtronic Job Details Assoc Medical Writer - Clinical Research Requisition 74225 Category Clinical Studies Business Diabetes Division Diabetes Clinical Location USA-CA-Northridge Relocation Relocation eligibility to be determined Job Type Full Time - Regular Exempt/Non-Exempt Exempt Shift First Travel Percentage 0% Experience Required 1 year Education Required Bachelors Degree Medtronic is an Equal Opportunity/Affirmative Action Employer Position Description Provide day to day support and will be responsible for an array of medical/technical documentation activities associated with Clinical Research organization under the direction of a senior member of the team. The qualified candidate will work directly with other medical/technical writers and biostatistician to prepare, edit, and organize a variety of technical documents. Ensure that content contained in all documentation conforms to company design control and legal requirements. Will interface with Document Control, Research and Development, Marketing, and Program Management where needed to ensure the accuracy, timely review, and dissemination of all cross-functional documentation. Position Responsibilities Help prepare, format, and submit summarizes data from clinical studies for submission to the Food and Drug Administration (FDA). Coordinate, prepare, and submit abstracts for presentation at a variety of annual diabetes meetings Help review and edit protocol produced by members of the Clinical Research staff. Collaborate with Document Control to development and implement systems that ensure the timely release of technical documentation Work with internal and external resources to enhance the access of relevant information to all Clinical Research staff. Efforts may lead to the formation of a library type structure. Responsible for the following: Assisting with writing or substantively rewriting investigator's brochures, final reports, papers for scientific/medical journals, risk/benefit and integrated data summaries, literature summaries, and position papers according to ICH guidelnes. Working with project management to set timelines. Driving timelines for projects. Ensuring high quality with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines. Supporting other medical writers within Clinical and providing help when needed Basic Qualifications Bachelor's Degree 1-2 years of medical writing work experience Independent, critical thinking, deadline and detail oriented, and able to manage multiple projects in a fast-paced environment Proficiency in the use of technical publication tools Extensive knowledge of Microsoft Office and the ability to create documents that seamlessly integrate spreadsheets, images, and text. Strong verbal communication skills - necessary communicate with an array of technologists with widely varying backgrounds Ability to write technical summaries and articles for internal and external publication Ability to present information to senior management Ability to read, analyze, and interpret common scientific and technical journals Ability to work effectively as part of a team Desired/Preferred Qualifications BS in a scientific discipline 3- 5 years of medical writing experience Previous experience within a Clinical Research or Regulatory organization Understanding of diabetes and the medical device management of diabetes Be able to show examples of medical reports, papers, and documents previously created Physical Job Requirements Typical office environment

Job Title: Medical Writer, Manager Company: US Oncology - Corporate Location: The Woodlands, TX Description: SCOPE:Manages writing projects and writers within the Biostatistics and Medical Writing (BMW) group. Provides the project management, resources, and oversight for successful project completion within the allotted timeframe. Prepares, reviews, and edits protocols and informed consents for clinical trial development. Submits documents for IRB review. Prepares abstracts, slides, and posters for scientific presentation. Prepares manuscripts upon study completion and management reports related to clinical research as needed. Supports and adheres to the US Oncology Compliance Program, to include the Code of Ethics and Business Standards.ESSENTIAL DUTIES AND RESPONSIBILITIES:-Maintain the publication calendars with the appropriate BMW-related deadlines for data preparation and writing for abstracts and scientific meeting presentations in conjunction with the BMW director-Manage all protocol writing within the department to keep projects on track-Act as a technical resource for MDs within the USON network with regards to writing related issues-Provide writing project resources, management, and oversight to the Research Group-Draft documents and work with investigators to develop protocols. Prepare protocol documentation inclusive of relevant statistical data with assistance form statisticians-Supervise and ensure the preparation of all required documents (protocols and informed consent forms) for submission to the IRB for review-Prepare and maintain standardized templates to be used in clinical trial protocol development and poster preparation-Oversee the uniformity in format within study documents-Communicate with network physicians and industry representatives throughout protocol development-Prepare abstracts, slides, and posters for presentation at scientific meetings -Supervise and ensure the preparation of manuscripts upon completion of studies-Develop management writing reports to provide timely information to the department-Prepare articles for submission to the USON News and Marketing groups for pre-meeting useRequired Skills: EDUCATION:Masters degree in a life sciences, health or scientific related discipline required. PhD preferred.EXPERIENCE: Minimum 7 years work experience directly related to writing of protocols and other clinical documents (manuscripts, presentations, etc.).KNOWLEDGE, SKILLS AND ABILITIES:-Advanced knowledge of drug development and investigational pharmaceutical research-Knowledge of databases related to medical research.-Knowledge of medical terminology-Advanced analytical skills-Advanced communication and organizational skills-Ability to work well within project oriented teams including physicians, finance, project managers, data reviewers, statisticians, and regulatory staff.-Ability to read, analyze and interpret technical procedures and/or government regulations.-Ability to write reports, business correspondence and procedure manualsPHYSICAL DEMANDS:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. Requires vision and hearing corrected to normal ranges.WORK ENVIRONMENT:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Work is performed in an office environment and requires frequent interaction with corporate and field staff. Work may require travel by air or automobile approximately 5% of the time.*CB*

Job Title: Junior Medical Editor - New York City agency Company: Medical Knowledge Group LLC Location: New York, NY Description: Medical Knowledge Group, LLC is comprised of several best-in-class organizations (collectively known as "MKG") dedicated to addressing the unmet educational needs of physicians and other health care professionals. The Comprehensive Technology & Logistics Solutions (CTLS) division is made up of Editorial Services, Meeting & Event Services (MES), Human Resources, Information Technology, Finance, and Visual Alchemy. To learn more about our companies, please visit www.synapseny.com . We are looking for a Junior Medical Editor to join out top-notch team! PLEASE NOTE: You must have 1 year of medical editing experience to qualify for this role. Responsibilities: -Review material (hard copy or electronic media, eg, manuscripts, slide decks, ancillary meeting materials, and Web site copy) to ensure that quality results and standards are met throughout various stages of production -Edit/proofread for grammar, spelling, sentence/paragraph structure, formatting, and adherence to AMA style -Check accuracy of and review styling of references -Take an active role in learning general and specific knowledge for all therapeutic areas -Occasionally assist with fact checking -Execute all aspects of administrative responsibilities (eg, timesheets, Creative Manager, expenses) in an appropriately detailed and timely manner -Participate in Editorial team meetings and status meetings when required -Support medical editors as required -Take initiative to resolve queries -Interact with other departments as needed to perform efficiently and effectively -Be responsive to needs of team and senior management -Assess and anticipate when a piece may take longer than expected Qualifications: -Bachelor's degree in English, communications, health sciences or a related field, or equivalent work experience -1 year of medical editing experience and 2-3 years editing overall. -Must have a working knowledge of AMA style, a strong attention to detail, and excellent interpersonal and communications skills -Must have a working knowledge of Microsoft Office Suite (including Word, PowerPoint, and Excel) -Ability to work independently, proactively, and within tight deadlines Qualified candidates please send resumes to: Register to View EOE

Job Title: Medical Writer Company: BioMarin Pharmaceutical Inc Location: Novato, CA Description: BioMarin Pharmaceutical Inc. At BioMarin, we recognize and value each employee's contribution toward reaching our corporate missionto develop and commercialize innovative biopharmaceuticals for serious diseases and medical conditions. To this end, we strive to provide employees with a work environment that supports their personal and professional growth. We value the spirit of teamwork and collaboration, encourage honest and open communication amongst all employees, and recognize and celebrate the successes that we work so hard to achieve. We hold ourselves to high standards, and we seek employees who expect excellence in themselves and those around them. Today, with four products on the market and many other opportunities in our pipeline, there remains a lot of work to be done. We are committed to maintaining a motivated team and to providing a challenging and rewarding career opportunity for every individual who joins us. EEO/M/F/D/V To apply: Visit www.BMRN.com Job Code 10-0134 SUMMARY The Medical Writer 1 applies basic to intermediate documentation preparation and document project management skills to assist in the development, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications. RESPONSIBILITIES Under the direction of the project lead Medical Writer, prepares and edits documents that meet project timelines and conform to global regulatory submission and internal document standards. Provides peer review and editing support for regulatory documents and may also provide editorial or review support for other types of documents, such as manuscripts or presentations, CRFs, or study materials. Assists in the preparation and distribution of documentation to the project team members. Adheres to departmental procedures and practices and technical and industry standards during all aspects of work. Works effectively with cross-functional groups within BioMetrics and the document development team. Other tasks as assigned. EDUCATION Bachelor's or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association. EXPERIENCE Relevant Experience Fulfills one of the following: Up to 2 years of as a medical writer in the pharmaceutical industry At least 5 years of medical or scientific writing experience as a primary job responsibility Clinical Studies Familiar with the drug development process (discovery to market), clinical study protocol design and study conduct, and documentation required for the conduct of clinical studies. Familiar with clinical study data collection and results reporting. Medical Writing Intermediate to advanced applied knowledge of routine document content preparation, including the use of style guides, medical dictionaries, and guidance documents that prescribe content. Intermediate to advanced applied knowledge of AMA, CBE, and Chicago Style Manuals. Ability to interpret basic tabular and graphical clinical data presentations. Ability to create basic tables using AMA style (eg, Schedule of Events). Intermediate applied knowledge of basic clinical laboratory tests. Advanced capabilities to research literature and interview subject matter experts to quickly gain familiarity with therapeutic area. Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Basic understanding of biostatistical and clinical research concepts. Experienced with writing, reviewing, or editing protocols, Investigator Brochures, clinical study reports, case report forms, and informed consent forms. Computer/office equipment Skills Proficient in Microsoft Word (including the use of templates), Excel, and PowerPoint. Basic Microsoft Project skills. Experienced with scanners, printers, and copiers. Regulatory Basic knowledge of regulatory requirements and guidances associated with 'standalone' regulatory documents (eg, protocols, investigator brochures, and clinical study reports). Project Management Takes direction well. Capable of working on multiple tasks and shifting priorities. Motivated and shows initiative. Detail oriented. Intermediate applied knowledge of the principles of tracking and accurately compiling reviewer comments. Intermediate applied knowledge of managing document review/development in a team setting. Communication Capable of well organized, concise and clear written and verbal communication. Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements. Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills. To apply: Visit www.BMRN.com Job Code 10-0134

Job Title: Senior Medical Writer Company: Infinity Pharmaceuticals Location: Cambridge, MA Description: Infinity Pharmaceuticals, Inc. is an innovative drug discovery company focused on discovering and developing novel small molecules as cancer therapeutics. Founded in 2001, the company currently has four drug candidates in clinical trials and is aggressively pursuing a robust pipeline of early discovery projects. Infinity is a small but fully integrated drug discovery company with capabilities ranging from early discovery to clinical sciences. Through a series of strategic alliances, Infinity is in a position to independently fund the development and commercialization of its drug candidates. Infinity Pharmaceuticals is currently seeking a Senior Medical Writer (contract) who will be responsible for ensuring the preparation of clinical documents for timely, consistent and accurate reporting in accordance with ICH guidelines, applicable regulatory requirements, Good Clinical Practices (GCPs) and standard operating procedures (SOPs). Responsibilities: Write and/or edit clinical protocols, clinical study reports, investigator's brochures, and other regulatory documents, including: Developing and maintaining timelines for document generation, revision, and completion Preparing documents, coordinating and managing review cycles, and incorporating comments, as appropriate Leading discussions on document finalization Drive the clinical study report writing process by conducting the following activities or ensuring the following activities have been accomplished: Identify report contributors and their responsibilities Develop and maintain timelines Review statistical analysis plans Ensure all possible report activities are completed prior to database lock Review primary statistical output and participate in results review meetings Interpret and summarize clinical data Lead discussions on report finalization Prepare report, manage review cycles, and incorporate comments, as appropriate Manage compilation of report appendices Lead the preparation of briefing documents, INDs, and other major submissions (BLAs, MAAs), as needed. Manage contracted writing projects. Participate in project teams and provide leadership to the project team in the area of clinical document development. Develop and maintain SOPs and writing tools, such as templates and style manuals. Assist in the development of training materials Contribute to the continued development of electronic document strategies (eCTD, CDISC data standards, etc.), document systems, and tools with the Data Management and Regulatory departments. Work effectively with other department members in team situations (Toxicology, Biology, etc.). Prepare, review, and/or edit medical communications documents (manuscripts, abstracts, poster presentations, etc.) Other duties as assigned. Requirements: BS/BA, MS/MPH/MA, or PhD in a scientific or medical discipline or equivalent with a minimum of 3-4 years of medical writing experience in the pharmaceutical/biotechnology industry or CRO environment. Experience writing all types of clinical and regulatory documents, including registration dossiers for worldwide use. Knowledge of FDA and ICH guidelines. Ability to work on multiple projects in a fast-paced environment. Ability to work with complex projects and within cross-functional teams. Excellent grammatical and communication skills, both written and oral. Expertise in MS WORD, including the ability to solve technical problems with MS WORD templates. Expertise in multiple therapeutic areas. (Experience in oncology is preferred, but not required.) Knowledgeable in science and clinical research. Knowledgeable in industry trends for study reports and international dossier preparation, including electronic document submissions (eCTDs). Knowledgeable in nonclinical development including discovery, toxicology, etc.