Medical Editor Jobs

Job Title: Medical Writer II Company: PAREXEL International Corp. Location: Billerica, MA Description: Perceptive Informatics, the technology subsidiary of PAREXEL International Corporation, is the industry's leading eClinical solutions provider and we help customers accelerate the drug development process through innovation. Our product portfolio is built on leading-edge technology and is combined with extensive medical and clinical expertise as well as a deep understanding of the regulatory environment. Our product design methodology is geared towards aligning with our customers' processes and we're merging the boundaries between products that traditionally have been used in isolation. This results in simplified workflow for customers and represents a radical shift in the way technology is used in clinical trials. Our eClinical solutions help biopharmaceutical companies improve efficiency and productivity, and ultimately reduce the costs associated with clinical research. Perceptive Informatics' products and services include Randomization and Trial Supply Management solutions; Clinical Trial Management Systems (CTMS); Electronic Data Capture (EDC); Interactive Voice Response (IVR)- and device-based electronic patient reported outcomes (ePRO); integration services; and web-based portals, tracking tools and investigator database solutions. Essential FunctionMedical writer to join vibrant team at Perceptive Informatics. Write protocols describing independent imaging reviews. No imaging experience required. Training provided. Lead a team through the development of the document and communicate with clients about the details.Degree in Life Sciences or equivalent. Excellent written and oral communication skills, attention to detail, knowledge of clinical trials, ability to work in a fast paced environment.Under general supervision of the Associate Director, Medical Writing, the Medical Writer II will research, create, edit, and coordinate the production of clinical documents associated with Investigational New Drug (IND) Applications and New Drug Applications (NDAs) suitable for FDA submission. The Medical Writer II may also prepare clinical documents for non-US submissions, with appropriate departmental supervision, and will be responsible for the production of clinical study documentation associated with clinical trials, which may not be submitted to the FDA. Will serve as primary technical contact with client under appropriate departmental supervision.Key Accountabilities' Write documents in support of clinical trials (which are not necessarily part of regulatory submissions) and/or for submission to US FDA and/or other non-US regulatory bodies, including but not limited to independent review charters, reviewer training manuals, imaging Case Report Forms (CRFs), user requirements and other documents required by Perceptive SOPs. ' Serve as the main client contact for charter development.' Attend internal technical team and client team meetings as required.' Write and develop documents or other materials associated with clinical trials for client support, including but not limited to abstracts, posters and manuscripts. ' Lead the project team through the development of charters, imaging CRFs and reviewer manuals.' Serve as Medical Writing representative on assigned Project teams for charter development, reviewer manual development, user requirements and requirement specification development, medical acceptance testing and reviewer training, as required, and any other project team meeting where medical writer support is required. ' Regularly communicate project related issues with the Associate Director, Medical Writing, and the project team, as appropriate.' Coordinate and conduct interdivisional team review and sign-off on document deliverables according to Perceptive guidelines/SOPs, including distributing drafts, chairing round table meetings, incorporating revisions, and completing the sign-off procedures.' Perform quality control review such as copy editing and content editing for other writers, as needed.' Perform literature searches/reviews and research current guidelines and medical criteria as necessary to gather background information and training for development of documents.' Develop training materials for medical, operations, software development, and/or other departments.' Adhere to ICH, FDA or other appropriate regulatory body guidelines with respect to document content and style, and compliance with departmental guidelines and corporate SOPs.' Meet client expectations by following any templates, style guides or SOPs provided by the client for document development (within the appropriate regulatory guidelines).' Keep current with medical, academic, clinical and technological advances through workshops and conferences. ' Assist in development of formats, templates, and general guidelines for clinical documentation and workflow procedures.' Participate in departmental or interdivisional process improvement and training initiatives. Skills' Excellent interpersonal, verbal and written communication skills' Client focused approach to work' A flexible attitude with respect to work assignments and new learning ' Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail' Willingness to work in a matrix environment and to value the importance of teamwork' Excellent written and oral communication and interpersonal skills and knowledge of the drug development process essential; strong word processing skills, familiarity with Microsoft Word for Windows, Excel, PowerPoint' Knowledge of GCP/ICH guidelines and the clinical trials processEducation' Minimum Bachelor's degree in Life Sciences/Health Related SciencesLanguage Skills' Fluent in EnglishMinimum Work Experience' Clinical research/medical writing experience and 1-3 years medical writing experience in a contract research organization, or 2-4 years of experience in a pharmaceutical or biotechnology firm, or equivalent. RESPOND HERE! Respond immediately by accessing the following dedicated online response form which will allow you to cut and paste your resume. This form will go directly and immediately to the hiring authority for this position. Access the online response form at: http://sh.webhire.com/servlet/resp/rf?jobid=2427580&boardid=749 Send this job to a friendView all "PAREXEL" jobs

Job Title: Medical Writer Company: Liberty Personnel Services Inc Location: Morrisville, PA Description: Medical Writer My client a premier medical communications company in the local area is actively seeking an experienced Medical Writer.  This is a position for industry experienced professionals who have 2 or more years of promotional or publication medical writing experience within a medical communications company.     Individuals qualifying for this position will have the following qualifications:  •An advanced degree in the life sciences, PhD, MD or Pharm D degree •Excellent communication skills both written and verbal •Strong time and project management skills •Knowledge of AMA writing style •Hands on Medical writing experience: original and review manuscripts, abstracts, posters, oral presentations, executive summaries, and publication plans •Experience in oncology would be ideal, but experience in other areas will also be considered i.e. (pain management, diabetes, cardio, immunology, and hematology, etc)•Experience with data assimilation: assimilating safety and efficacy data from clinical study reports•Excellent computer skills: Word, PowerPoint, Excel, and other industry software My client provides good health benefits, paid time off, 401k, and strong job stability.  Please send a word copy of your resume to Register to View  today for consideration and more details on the company.  All information is strictly confidential.   Alex Showers Register to View ext 114 Register to View   Key Words: (Medical Writer, Senior Medical Writer, Associate Medical Director, Medical Communications, Medical Education, Oncology, Pain Management, Publication Planning)

Job Title: Sr Medical Writer Company: RCM Technologies Location: Billerica, MA Description: .ugDivBody_hj .ugFrame_hj .ugColWrap_hj .ugHeader_hj .ugLeftWrap_hj .ugLeftCol_hj .ugJobTitleLeft_hj .ugLTable_hj .ugLHead_hj .ugLText_hj .ugMap_hj .ugMapplace_hj .ugRightWrap_hj .ugRightCol_hj .ugRTitle_hj .ugROver_hj .ugBold_hj .ugComLink_hj .ugComLink_hj a:link .ugComLink_hj a:hover .ugRTable_hj .ugRTitle1_hj .ugRtext_hj .ugFooter_hj Job overview Company:  RCM Technologies Job Category:  Pharmaceutical/Biotech Location:  Billerica, MA Position Type:  Full-Time, Contract Experience:  5-10 Years Experience Company overview RCM is a premier single-source provider of business and technology solutions with a strong vertical focus offering an integrated suite of services through a global delivery platform. RCM enables clients to realize the full value of their technology investments through the design, development and implementation of innovative solutions that fuel growth and profitability. Our combination of strong technical expertise and extensive industry knowledge drives RCMs ability to bring effective and efficient solutions to the critical business challenges of our clients resulting in a powerful competitive advantage in existing markets, development of new markets and accelerated delivery of products and services. Company Website Sr Medical Writer Job Description Our client is looking for a Sr Medical Writer.Location: North Ballerica, MA 1 year contract If you are Qualified and Interested, please forward your resume to Register to View with Job# PD-10-00204" in the subject of your email.Local candidates are preferred. Job Description:This is a critical function in a group with multiple clinical pipeline products. Responsible for proper strategy for efficient medical writing and clinical document development functions. - Responsible for coordination of medical writing processes, development and review of clinical study protocols, synopsis, study procedure manuals, independent review charters and clinical study reports, etc. - Act as medical writing liaison to work with medical directors, clinical operations, biostatistics and data management and clinical QA and compliance - Manages review process of all clinical documents, coordinates round table discussions if necessary - Helps biostatistics and regulatory affairs groups in regulatory submissions - Provides assistance in preparation of abstracts, manuscripts and other presentations for scientific and sales meetings. Education: Master’s Degree in a Biological or Health-Related Field, PhD Preferred. Experience:1) Min. 5 years of related experience in the life sciences field, including 3 years of in a regulatory environment in the pharmaceutical, biotechnology or CRO industry. 2) Demonstrated proficiency initiating and managing clinical documentation projects. Experience in writing clinical protocols, study report, data monitoring charter, blinded read charters, imaging technical documents, manuscripts and publication materials. 3) Experience in preparation of NDA and IND required. 4) Familiarity with GCP, ICH and FDA regulatory requirements as they apply to clinical trials. Regular interaction with Clinical Operations, Biostatistics and Project Management. 5) Must be able to handle multiple demands and shifting priorities. 6) Excellent written and oral communication skills required.

Job Title: Medical Writer & Researcher/Clinical Affairs Consultant Company: M Squared Inc. Location: San Francisco, CA Description: SituationOur client provides expert and highly specialized advisory and consulting services to senior level executives in the health care, biopharmaceutical and medical device industries. Areas of concentration include clinical trial strategies and design methods to support regulatory applications as well as clinical data interpretation and presentation.Preparation of manuscripts for publication in peer-reviewed medical journals is a specialty of our client. They have authored over 75 publications, book chapters and monographs with a focus around orthopedic and musculoskeletal medical devices with particular emphasis in the spine field.As a result of increased demand of their services, our client needs to add to their team. They have turned to M Squared to provide a senior consultant to expand their firm's capabilities.Value Having an experienced consultant with the right background will enable our client to expand their capacity to provide services to additional customers.ApproachThe M Squared Consultant will provide comprehensive expertise to bio-medical customers of our client, a clinical affairs firm. As a highly experienced clinical affairs strategist and medical writer, the primary responsibility will be to develop high caliber manuscripts for peer-reviewed medical journals as well as clinical reports and dossiers for regulatory and reimbursement reviews. Responsibilities will include clinical writing, guiding customers and putting together plans and assessments.Deliverables will include:* Manuscripts for peer-reviewed medical journals* Clinical reports* Dossiers for regulatory and reimbursement reviews

Job Title: MEDICAL Writer - 3D SIMULATIONS Company: Syandus Location: Exton, PA Description: Syandus brings exciting new advanced learning technology to medicine and medical education based promotional pharmaceutical marketing. Grow with us!  Our simulation-based learning platform creates a win for all:  Doctors improve their practice, patients achieve better outcomes, and aligned pharmaceutical brands gain recognition and access.  We are looking for a creative individual to join our team with hands on experience in developing pharmaceutical medical education content, a life science degree, the technical savvy to work with cutting edge technology and the propensity to think of medical science in terms of processes and systems.   DescriptionDetail oriented individual with a medical science background with the pharmaceutical marketing industry to assist in the development of medical simulations as part of the Syandus team.    Efficiently research assigned medical simulation topics to support projects Interact with physician thought leaders including setting meetings, agendas, and writing succinct bulleted summaries of meetings  Write bulleted copy for medical simulations  (similar to PowerPoint slides)Verify all textual information and graphics are accurate and correctly referencedVerify that all textual information is in AMA style and in the appropriate form for client  Compile all textual content and screen shots into a provided template for approval  Champion submission of simulation content through review process including electronic submission and appropriate tagging of references Prepare for and participate in client reviewsQualificationsAt least 1-2 years’ experience gained within either the pharmaceutical industry or medical communications environment Proficiency with Acrobat, Microsoft PowerPoint / Word Life-science degree preferred; demonstrated familiarity with medical terminology   Ability to interpret and organize scientific and medical information Proven copyediting and proofreading skillsEffective communication/interpersonal skillsAdditional Plus Ability to grasp concept development process for real-time simulations Ability to take on increasing client facing and project management responsibilities  Engineering background or systems engineering mindset  Keywords:  medical communications, medical education, medical marketing, medical editor, medical writer, copywriter, copyeditor, pharmaceutical marketing, medical communications agency

Job Title: Medical Writer Company: Trans Tech Pharma Location: High Point, NC Description: The Medical Writer is responsible for preparation and coordinating of development of draft and final protocols, protocol amendments, Investigator Brochure, study manuals and Clinical Study Reports for Phase I/II studies as well as interpretation of clinical, pharmacokinetic, pharmacodynamic, and statistical results as appropriate for Phase I/II studies. Duties and Responsibilities: • Writes and coordinates the development of study protocols and protocol amendments • Prepares scientifically valid draft and final CSRs (i.e., interim and abbreviated CSRs to fully integrated CSRs), including the scientific interpretation of data and writing of clinical, pharmacokinetic and pharmacodynamic results, discussion and conclusions, for studies of intermediate complexity• May be a secondary reviewer of data listings and study data as appropriate, prior to database lock, for consistency and scientific integrity. • Participates in the review of the draft and final statistical analysis plan (SAP), in cooperation with the project team. Reviews SAPs to ensure the data presentation and analysis methodology are consistent with the study objectives. • Communicates with internal staff and the external study contact(s) to obtain all relevant information needed to adhere to the project schedule. • summary sections (IND, NDA, etc) and similar medical and regulatory-related documents• Prepare literature reviews and bibliographies. • Writing of clinical development plans to include scientific background and clinical trial strategy. • Responsible for proper strategy for efficient medical writing and clinical document development functions. • Act as medical writing liaison to work with medical directors, clinical operations, biostatistics and data management and clinical QA and compliance • Manages review process of all clinical documents • Helps biostatistics and regulatory affairs groups in regulatory submissions• Provides assistance in preparation of abstracts, manuscripts and other presentations for scientific meetings.• Looks for ways to improve the efficiency and quality of work processes as appropriate. • Must be able to handle multiple demands and shifting priorities. • Detailed knowledge of FDA and ICH guidelines and regulations related to the format, content and integrity of documents. Experience Required:Minimum of 3-5 years professional medical writing experience. Experience in Phase I studies.Education Required: MS degree in Science/Medical field. (PhD preferred.) TransTech Pharma clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of human therapeutics to fill unmet medical needs. Our mission is to utilize our innovative technology to rapidly translate the functional modulation of human proteins into safe and effective medicines. We have a pipeline of small molecule clinical and pre-clinical drug candidates for the treatment of a wide range of human diseases including central nervous system disorders, cardiovascular disorders, type I/II diabetes, obesity, and cancer. We have built our product candidate portfolio through internal discovery. We are advancing our product candidates through in-house research and development efforts. In addition, we have strategic collaborations with leading pharmaceutical and biopharmaceutical companies that have contributed to our portfolio of product candidates. We believe the quality and breadth of our product candidate pipeline, platform technology, scientific team and strategic collaborations will enable us to become a fully integrated pharmaceutical company.   TransTech Pharma is an Equal Opportunity Employer.

Job Title: Medical Editor #S128801 Company: The McIntyre Gro Location: Stamford, CT Description: Medical EditorRequirements:Editorial & project management Develop content with faculty and freelance writers & to manage manuscripts, slide kits, CD-ROMs, etc. to final production Ability to be client facing Strong Powerpoint Experience in the Healthcare industry Ability to travel

Job Title: Senior Medical Writer Company: Human Genome Sciences Location: Baltimore, MD Description: Senior Medical WriterLocationRockville, MDJob ID 2721Employment StatusFull-Time RegularRequired Experience2-5 yearsRequired EducationBachelors Degree or EquivalentRequired TravelNoRelocation AvailableYesSummary/DescriptionHuman Genome Sciences (HGS)is a biopharmaceutical company with approximately 800 employees and world-class R&D and manufacturing facilities based in Rockville, MD. We have three promising products in late-stage development - one, raxibacumab, already commercialized with sales to the U.S, Government and two moving toward commercialization. BENLYSTAT (formerly LymphoStat-B?) has successfully met its primary endpoint in the first of two Phase 3 trials in systemic lupus, and we expect to have results of the second BENLYSTA Phase 3 trial in November 2009. ZALBINT (formerly Albuferon?) has completed Phase 3 development in chronic hepatitis C, and we expect the submission of global marketing applications in fall 2009. We are developing both of these products in collaboration with world leaders in the pharmaceutical industry. Further, in July 2009, we secured a new purchase order for 45,000 doses of raxibacumab, a drug to combat inhalational anthrax, to be delivered to the U.S. Strategic National Stockpile over a three-year period.At HGS, people are the key to our success. We share a passion for scientific and business innovation, creating unique opportunities to contribute to the commercialization phase of our products. At HGS, you will have opportunities to learn and grow; interacting with talent of the highest caliber, and you will be supported by a culture committed to employee and leadership development. We offer a competitive salary and benefits package. HGS is an Equal Opportunity Employer EOE/AA M/F/D/VPlease visitwww.hgsi.comfor further information on our company and to apply on-line for this position.Does the idea of working in a high potential company with an innovative pipeline of drug candidates appeal to you? Are you ready to be immersed in a role that offers challenge, a variety of responsibilities, and a chance to help the company succeed in bringing our first drug to market? We are actively recruiting for a seasoned Senior Medical Writer who can operate independently in a highly energized environment.Responsible for organizing and analyzing clinical trial data, interpreting statistical reports, and writing clinical study reports and comprehensive data summaries for submission to regulatory authorities. Responsible for coordinating team review of these documents. Other responsibilities include writing/editing abstracts, presentations, and clinical trial manuscripts for scientific meetings and publication in peer-reviewed journals. The senior medical writer will provide editing/writing support to the project team as needed for documents such as protocols, Investigator Brochures, and Annual Reports. The senior medical writer will take a lead role in the development of formats and guidelines for clinical documentation. The individual must demonstrate the ability to handle multiple priorities and interface with individuals from various departments.JOB DUTIES:. Write and edit clinical reports, integrated clinical summaries (ISS, ISE), and other regulatory documents. Write and edit manuscripts for scientific journals (may include nonclinical journal articles). Summarize data from clinical studies. Review and edit clinical study tables, listings, and Analytical Plans. Develop and edit clinical document templates that are compatible with ICH guidelines and FDA electronic submissions guidances. Function as a department representative on a therapeutic project team. Keep abreast of professional area through the internet, conferences, and meetings. Manage the work of medical writing contractors and medical writers. Other duties as assignedRequirementsMinimum Qualifications:. Bachelor's Degree in a related science (Biology, Microbiology, Chemistry, etc) with a minimum of 8 years of related medical writer experience, preferably in the pharmaceutical/biotechnology industry. Or, a Master's degree in a related science with at least 3 years of related experience.. Or, a PhD degree in a related science with at least 1 year of related experience. Ability to work within a computerized environment, with basic knowledge of databases and advanced knowledge of word processing.. A solid understanding of scientific/medical terminology and basic statistics. Knowledge of relevant ICH/FDA regulations. Excellent writing, editing, and communication skills. Excellent organizational skills and attention to details. Ability to work effectively on a team and strong interpersonal skills.. Prior supervisory experience preferred

Job Title: Medical Writer Company: Digitas Location: Philadelphia, PA Description: ABOUT DIGITAS HEALTH: Counting as clients many of the world’s leading pharmaceutical, bioscience, and medical device companies, Digitas Health is a next-generation marketing agency that helps build healthcare brands that patients, caregivers, and healthcare professionals feel confident turning to and recommending when they are sick, in need, or helping others. With offices in Philadelphia, New York, Boston and London, Digitas Health is frequently recognized as one of the best places to work by the Business Journals and as having the best work perks by CNN.com. The company is a recent Webby Award winner and the MM&M 2009 Agency of the Year. Digitas Health is a unit of Digitas, leading global digital marketing and media agency. For more information, please visit www.digitashealth.com or follow us on Twitter Register to View Digitas Health is seeking a talented senior Medical Writer. Qualifications: • Masters degree in a biological science (e.g. Masters in Biology) or healthcare-related field (e.g. Masters in Public Health) required; PhD preferred • Relevant writing experience in the healthcare field, such as:     o Healthcare advertising agency (preferred)     o Continuing medical education company     o Medical school or university • Experience with interactive media and multi-media     o Web site development (preferred)     o Interactive programs for medical conventions     o Film/video scripts     o Speaker slide decks     o Core visual aids Requirements • Extensive experience writing in multiple disease categories (e.g. cardiology, psychiatry, endocrinology/diabetes, oncology, neurology) • Working knowledge of biostatistics, clinical trial design, anatomy, physiology, pathology, pharmacology, healthcare economics • Ability to generate approvable product-related claims based on information published in the medical literature on data provided by a pharmaceutical company client • Editorial experience (editing drafts for accuracy, style, consistency with regulatory standards, etc; guiding and mentoring writers) preferred but not required • Understanding of DDMAC guidelines governing the marketing of pharmaceutical products • Demonstrated ability to meet tight deadlines • Ability to collaborate effectively with Art Directors, Creative Directors and others

Job Title: MEDICAL WRITER / MEDICAL DIRECTOR - experienced Company: Location: Philadelphia, PA Description: UBC-Envision Group, a stable and growing company, is seeking experienced medical writers and medical directors to join our outstanding team. Our clients are among the top pharmaceutical companies in the world. We have medical communication offices in Fairfield, CT; Philadelphia, PA; San Francisco, CA; and Horsham, and Hammersmith, United Kingdom (UK). WHAT WE OFFER Team-based and scientifically stimulating environment Easily accessible by train and highway Medical and dental insurance Flexible Spending Accounts, health and dependent care Short and long term disability insurance 401(k) plan with immediate vesting of employer contribution 24 days off plus 7 holidays; time off is immediately available Company provided laptop; you may occasionally telecommute JOB DUTIES Work with pharmaceutical clients, authors, and key opinion leaders Write and edit medical communications and publications including manuscripts, posters, slide kits, and product monographs Work with an account manager to coordinate activities with client and internal teams Help develop publication planning strategy and implementation Ensure your writing and editing are medically and scientifically accurate and meets client objectives, timelines and budgets Develop and edit content with direction and guidance from authors Assist with reference gathering and literature searches Combine review comments into subsequent revisions Circulate drafts for further review and finalization REQUIREMENTS/MUST HAVES PhD in biology, pharmacology, biochemistry, biomedicine, or medically related field (MD or PharmD) Medical writing experience directed to scientists and physicians Experience working with pharmaceutical clients, thought leaders, and authors Superlative communications skills Excellent project management skills Familiarity with writing and publication guidelines, journal requirements, and other publication standards Knowledge of American Medical Association (AMA) guidelines and Good Publication Practice (GPP) for pharmaceutical companies Ability to meet deadlines Team player HOW TO APPLY To apply, please send your curriculum vitae and cover letter to: Register to View -envisiongroup.com. For further information, please visit our website at www.envisionpharma.com.