Job Title: Associate Medical Editor
Company: New Horizons Recruiting LLC
Location: Hackensack, NJ
Description:
Associate Medical EditorASSOCIATE MEDICAL EDITOR
Northern New Jersey – Commutable from Manhattan
Our client is a full-service advertising agency with a 10-year history of exceptional interactive, digital expertise. Their innovative approach is matched only by their strong scientific knowledge base & strategic planning capabilities. They combine these attributes to build exciting & multi-dimensional branding campaigns.
Due to their continued growth, they are seeking to bring a talented individual on board as Associate Medical Editor.
You will assist in the development of all forms of interactive & traditional media for pharmaceutical clients.
Depending on your level of experience, your expertise will be sought to perform medical editing (& some writing) & to assist in research of current clinical topics.
To be considered, you must have:
2+ years editorial experience critically editing for key messages, solid science & excellent readability in a medical communication, pharmaceutical, medical publishing or pharmaceutical agency environment (CME experience a plus)
Knowledge of AMA style
Exceptional team skills
Excellent compensation package & room for growth available for qualified candidates.
Interested parties are encouraged to contact:
Marilyn Sundburg
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Phone: Register to View
Key words: medical editing, medical editor, scientific editor, healthcare editor, healthcare education, accreditation, pharmaceutical advertising, medical education, medical affairs, medical communications, healthcare advertising, healthcare communications, interactive media, digital media, pharmaceutical communications, professional communications
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Description:
Sanofi-aventis is facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class R&D organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines.
Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.
Position Summary:
This position is responsible for successful oversight, development, implementation, and completion of protocol and clinical study report writing in time and quality. Responsible for oversight of timely completion of submission of study data to comply with reporting requirements
(e.g. clinicaltrials.gov, etc.).
This position has direct reports (contract staff). Responsible for management of contractor resources and allocation of project work through interactions with internal customers (MD, CTM, etc.). Responsible for providing and ensuring an adequate level of technical competence and training for the activities that staff are delivering.
Role & Responsibilities:
Manages a team of medical writers responsible for the writing and publishing of Clinical Study Reports (CSRs) and Abbreviated CSRs (ACSRs) for US Medical Affairs (USMA) managed Phase IIIb and IV studies. These activities may also provide writing support to the MD and Statistician in the production of Key Results Memos. Responsible for the coordination and prioritization of activities in order to ensure documents are accurately written and approved in a timely manner. Ensures best practices for document generation, management, review and publishing are in place within industry and specific company practices and tools.
Medical Writer activities include:
Gather all necessary data; set timelines and project management schedules.
Get agreement to timelines by USMA and ensure they are met.
Ensures documents are ready for GRESDA storage.
Ensure all the CSR documents are written meet all the sanofi-aventis approved style and format standards.
Ensure technical input or written text for specific sections are obtained from the appropriate functions, eg, pharmacovigilance, biostatistics.
Maintain version control to minimize review errors.
Ensure all CSRs receive proper sign-off and approval as described in the sanofi-aventis SOPs.
Complete a thorough and accurate cross referencing for all CSR sections and collect the appendices.
Convene scientific review teams as necessary to expedite CSR reviews and approvals.
Lead discussions to find resolutions of any conflicting comments. Meet with individual members of teams as needed to complete CSR, eg, biostatisticians, clinical operations, medical director.
Knowledgeable of the current regulatory and industry guidances and sanofi-aventis SOPs for writing CSRs including proper formatting, filing, references, and US and Global review processes. The document must be registration quality and filed in GRESDA.
Coordinate the review processes for the approval teams for each USMA managed study.
Responsible for the CSR to reflect the data as interpreted by the Medical Director for scientific and factual validity and quality.
Ensure all CSRs are filed accurately and in the correct format.
Provide support to the USMA Medical Directors in writing proposed study protocols.
Draft protocols based on the study concept teams input and directions.
Ensure the protocol meets all guidances and regulations for protocol documents.
Develop protocols that reflect the concept teams needs and potential publications outputs.
Responsible for generating and maintaining a quality system ensuring that all US SOPs and guidances relating to CSRs and the medical writing processes are adhered to and current and define the best industry practices for these activities.
Maintain an up to date reference of all regulations, SOPs, and guidances that affect medical writing, especially for CSRs and Protocols.
Initiate new SOPs or updates when necessary and secure appropriate approvals.
Ensure quality controls are in place in order to ensure the adherence to defined processes and standards and ensure corrective actions are initiated in case of deviation to these standards and processes.
Produce Regulatory filings for area of assignments.
Job Requirements
Education:
Advanced degree in a primary science such as MS, PharmD, PhD, MD.
Experience:
Five or more years hands on experience with medical writing responsibilities in the pharmaceutical industry, academic research or publication vendor. Proven management skills including providing mentoring, medical writing and technical expertise and direction to medical writing personnel.
Professional Skills:
Must be able to demonstrate management competence, analytical inter-personal, planning, problem-solving and project management skills.
Team player able to motivate, organize, manage, and provide direction to teams and individuals.
Excellent networking and communicating skills with multifunctional internal partners.
Ability to work effectively within a matrix organization.
Strong commitment to ethics and patient safety.
Permanently driving for the highest level of quality.
Drive for results.
Ability to make difficult decisions.
Demonstrated excellent scientific writing and editing experience.
Ability to manage vendors/consultants as a resource and maximizing their services.
Strong interpersonal and leadership skills to build successful relationships with global and US medical and marketing managers.
Understand the processes in producing medical research (Phase IIIa through IV) documents.
Proven scientific analytical skills. Understands bio-statistical data / reports.
Some knowledge of Medical Research, Regulatory Affairs, Drug Development and Commercialization, Health economics outcomes, Biostatistics, Pharmacovigilance, Clinical Operations.
Excellent skills using MS Word, PowerPoint, and Document Management systems.
Works well in both cross functional teams and independently to produce expected outcomes.
Demonstrated effective time-management skills; consistently meets established timelines with quality output.
Strong and consistent attention to writing style details.
Successful managerial experience in a similar capacity.
Strong appreciation of and implementation of sanofi-aventis Values.
Language:
English
Sanofi-aventis is an equal opportunity employer that embraces diversity to foster positive, innovative thinking that will benefit people worldwide. Sanofi-aventis is also committed to employing qualified individuals with disabilities and, where warranted, will provide reasonable accommodation to applicants, as well as its employees.
Job Title: Medical Proofreader/Pharm Tech
Company: Aerotek
Location: Poway, CA
Description:
Our client in Poway is seeking a Senior Pharmacy Technician to edit/proofread drug information/documentation. Must have a strong grasp of Pharm Tech also Advanced MS Word. Must be analytical and who can contribute to the team. Administrative skills!!!SKILLS:Must be detailed oriented with strong interpersonal skills with the ability to establish and maintain effective business relationships with all levels of employees and in multiple departments. Strong project management, problem resolution and follow-through skills. Excellent oral and written communication skills and proofreading abilities. Proficiency with personal computers, MS Office and advanced Microsoft Word skills. Minimum typing speed of 55+ wpm. IF INTERESTED and QUALIFIED...please contact Whitney Bice, [email address removed], Register to View Required Skills: Two to five years of related experience, pharm tech experience a plus, MS Word (end notes), MS Word (track changesJoin Aerotek Professional Services. Our customized employment solutions and personalized approach give job seekers access to great opportunities with competitive salaries. Aerotek offers comprehensive benefits that can include medical, dental, optical, and optional 401k. Don't put your career in the hands of just anyone; put it in the hands of a specialist. Launch or rejuvenate your career today with Aerotek Professional Services! Allegis Group and its subsidiaries are equal opportunity employers.
Job Title: MEDICAL DIRECTOR / MEDICAL WRITER
Company: New Career Personnel Service
Location: Bedminster, NJ
Description:
MEDICAL EDUCATION COMMUNICATIONS EXPERIENCE REQUIRED
Medical Directors needed to provide strategic support in developing and implementing projects for both continuing medical education and promotion activities.
ALL APPLICANTS MUST HAVE MEDICAL EDUCATION AGENCY OR CLIENT COMMUNICATIONS WRITING EXPERIENCE.
The Medical Director (Medical Writer) will be responsible for counseling clients and developing a medical strategy that is consistent with product marketing goals.
You should possess strong leadership, interpersonal, communication and administrative skills. The candidate should be either an MD, life science PhD, or Pharm D. The candidate should also have a minimum of 2 years pharmaceutical company and/or communications agency experience.
You should possess a high degree of creativity and flexibility and be able to develop and execute medical marketing strategies and quickly chance the course of action based on feedback from peers and market information.
Responsbilities include:
Develop medical strategies for US and Worldwide pharmaceutical clients that can be leveraged for marketing campaigns.
Assess client publication strategies and develop medical positioning for client's products in the assigned disease area.
Review content of journal articles as part of the Brand Team and other communication materials, including promotional pieces.
Interact with agency senior management in defining the development strategy and medical/marketing programs for clients.
Great opportunity for an innovative thinker with superb organizational ability.
Any therapeutic category experience is a plus.
Please forward resume for consideration to Cyndi Finnegan, Executive Recruiter - Register to View New Career Personnel Services, Inc.,
364 Parsippany Road, Suite 12B, Parsippany, NJ 0705 Register to View
New Career Personnel Services is a professional search firm providing quality employees to the professional and consumer pharmaceutical communications industry (domestically and internationally). NCPS has been in operation since 1985.
Job Title: Senior Medical Writer
Company: Medimedia
Location: Yardley, PA
Description:
With over 1,600 employees in offices throughout the U.S. and in Canada, MediMedia offers some of the best-known brands in healthcare communications to both industry professionals and consumers. In addition to its leading consumer health content sources, MediMedia is the pre-eminent provider of solutions for pharmaceutical companies along their entire marketing continuum, targeting physicians, payers and patients with our content and applications.
MediMedia is a dynamic and rapidly growing company committed to providing the healthcare industry with some of the most extensive communications, educational and marketing services available. Visit our online Corporate Career Center at www.medimedia.com/careers.aspx
Yardley, PA - Our Managed Markets Division seeks a Senior Medical Writer to develop business-to-business content consistent with the objectives of client-focused marketing, research, and pharmaceutical programs. This position involves developing content for slide kits, writing symposia and consultant-panel reports, and improving the presentation of market research reports for clients.
The ideal candidate is a self-starter with an ability to write well on numerous levels to meet client expectations and deadlines. Interpersonal skills are crucial, as this position will work closely with clients and in-house editors, sales staff, and researchers. A basic understanding of the financing and political/regulatory environment of health care is helpful. Some travel is required (approx. 10% - 15%).
Minimum requirements:
' Bachelor's degree in Communications, Journalism, or English
' 3 or more years' medical or pharmaceutical writing experience
' Proficient in PowerPoint
' High degree of organization, with an ability to handle multiple projects and deadlines
Requirements
See Above.
Job Title: Children's illustrator/cartoonist needed -
Company: Location: madison, WI
Description:
We need an artist for a project geared towards pre-school aged children! Right now this is only in the concept phase, but we're looking for the right team to build a cast of characters and bring it to life. If you are interested, please reply with a sample of your art, and please let us know of any experience you have in the digital realm.
Location: Madison
Compensation: TBD
Principals only. Recruiters, please don't contact this job poster.
Please, no phone calls about this job!
Please do not contact job poster about other services, products or commercial interests.
Job Title: Technical Writer/Trainer
Company: Jeppesen
Location: Englewood, CO
Description:
A leader in aviation and aviation training products is looking for the best to journey with us into the future of navigation! For more than 70 years, Jeppesen, a Boeing subsidiary, has made it possible for pilots and their passengers to safely and efficiently reach their destinations. We are the world’s leading provider of aeronautical data, and are combining our company’s enduring spirit of innovation with a legacy of leadership in aviation to deliver 21st century navigation and optimization solutions. We have now expanded into the Marine and Rail industries, and are rapidly growing on a global scale! At Jeppesen, we believe in a balance between personal growth and professional development. We hire the best to grow our company’s future. Visit our website to learn more about Jeppesen’s pioneering spirit, and to apply for our open positions. SummaryProvides key support to our Global Navigation Services division, which is the core of Jeppesen´s data services, charting and product production. Essential Duties and Responsibilities: · Performs training needs analysis and develops training manuals, aids, workbooks, user and instructor documentation with minimal assistance and re-work. · Displays subject matter expertise in majority of training delivery and development for assigned areas of responsibility. · Develops, maintains and delivers basic through advanced technical training materials related to hardware and software applications and applications training, department work flows, quality systems, and other areas. · Provides knowledge, feedback, and development assistance to other Writers. · Reviews existing user and technical documentation for revision purposes. · Coordinates activities and resources for the facilitation of training courses. · Uses evaluation tools and internal work flow to track training progress. · Documents milestones and reports progress to management. · Recommends improvements to departmental business systems and user documentation for usability and compliance with established standards, and modifies, as needed. · Assists in creating project plans, and schedules. · Provides input to department budget, as requested. Education/Experience: Bachelor’s degree in Technical Communications, or Instructional Design, with an emphasis on technical writing, adult learning, aviation or an aviation-related field, or equivalent combination of education and experience. Minimum of two (2) years technical writing experience; previous instructional design experience highly desired. Minimum of four (4) years of adult education experience, to include previous technical writing experience. Established background in the application of Learning Content Management Systems (LCMS), Xyleme preferred. Experience authoring in markup languages, e.g. XML, HTML. Proven background in database management (user perspective). Well-developed technical research skills. Extensive experience with Navigational Data applications required. Computer savvy, to include MS Office suite (Word, Excel, and PowerPoint). Strong written and oral skills, to include stand-up training/presentation abilities. Customer oriented, with a service delivery focus. Pilot certification with instrument rating highly desired. Jeppesen offers a competitive salary, a comprehensive selection of benefit options, including 401(k) with company match. All job offers are contingent upon successful completion of drug screen and background verification.APPLY NOW***In order to apply for this position, please follow the below link to the Jeppesen website: http://careers.jeppesen.com/JobDescription.asp?JobNumber=592190&lang=en Jeppesen is an Equal Opportunity Employer.
Job Title: Medical Writer III
Company: System One Scientific
Location: Philadelphia, PA
Description:
System One is presently seeking qualified candidates for a Medical Writing III opportunity with their client, a large pharmaceutical company in the Philadelphia area. The incumbent will largely be responsible for the production of aggregate reports.
Duties and Responsibilities Include:
Experience Summary Bridging Reports, and Commented Line Listings
Planning, writing, addressing reviewer comments, and assembly of final document.
Perform peer reviews of written reports and publications for other PVAR group members.
This person will report to Manager or Associate Director, Pharmacovigilance Aggregate Reporting
EXPERIENCE WITH PSUR's AND SAFETY WRITING IS REQUIRED
Job Requirements
Degree in health or biomedical science
Industry writing experience and drug safety experience highly preferred
Project management experience.
Person should be a strong independent worker but also be a valuable contributor in a team/matrix setting.
Job Title: Medical Writing Specialist
Company: MedFocus
Location: Montville, NJ
Description:
MEDICAL WRITING SPECIALIST
COMPANY INFO:
MedFocus offers clinical research contract outsourcing and staffing specifically to the pharmaceutical, biotechnology and medical device industries. We specialize in the nationwide recruitment of clinical trials personnel.
Our client is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials and is seeking to add a Medical Writing Specialist to their team in Montville , NJ.
RESPONSIBILITIES:
- The Medical Writing Specialist is responsible for the tracking, quality control and timely completion of the document components for complex medical writing projects, including Clinical Study Reports (CSRs), protocols, and other regulatory documents.
- Working together with key interface partners (e.g. Study Management, Statistics and Programming) to facilitate the completion of clinical study reports and their appendices. Using project management skills to track, review and ensure timely completion of high quality regulatory documents.
- Checking that study file components (e.g., Investigator CVs, protocol and amendments, sample case report form) needed for CSRs are checked into the electronic archive on a timely basis and meet all global standards and regulatory requirements.
- Acting as a resource on all format and style related issues to ensure consistency within submission related documents prepared by Medical Writing or external partners. Maintaining departmental and project-specific style guides to reflect new agreements and changes due to SOPs and regulatory guidelines.
- Assisting scientific medical writers in the review of protocols and case report forms to ensure that methods are clearly presented, data categories are clear, and terminology is consistent.
- Performing real-time edits to clinical documents during comment review and resolution meetings.
- Proofreading, reformatting and editing document text, as required, to ensure that all documents for a writing project meet all formatting and publishing requirements prior to final QC, compilation, and electronic publishing.
- Managing the review and approval of documents in the document management system using standard procedures.
QUALIFICATIONS:
- Excellence in written and oral communication skills in English.
- Excellent interpersonal skills.
- Familiarity with clinical research, statistics, and regulatory submission requirements preferred.
EDUCATION:
- Bachelor's or Associates degree with strong electronic documentation and word processing skills.
MedFocus offers competitive wage and benefits packages; Health Insurance, Dental Insurance, long term disability, Holiday and Vacation Time, life insurance and 401K may be applicable.
Job Title: Medical Writer
Company: Aerotek Scientific
Location: New Providence, NJ
Description:
The contract medical Writer (MW) works directly with International Project Team (IP) members with the goal of writing scientifically valid, complete and consistent documents such as clinical study protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs) primarily, and select submission documents, Clinical Development Plans and other regulatory documents secondarily, as workload permits. Actively participates in the process to ensure the timely submission of high quality, critical documentation both within and outside the company. Key job Responsibilities:- Prepares regulatory documents on behalf of the company's for the ultimate purpose of regulatory agencies, in accordance to ICH guidelines and CFR as applicable, Eisai standards and processes and AMA Medical Writing styles, adhering to study/project timelines.- Actively participates in study and/or project team meetings to provide input regarding deliverables, timelines and any process(es) needed for the completion of regulatory documents.- Administrates as appropriate, the receipt, collation and incorporation of review comments needed for completion of regulatory documents.Qualifications:- Good organization, time management and attention to detail skills needed to work in a stressful environment under tight deadlines while maintaining focus on details and quality- Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.- Electronic Document Management System (eDMS, eg, Documentum) skills- Applies good judgment and demonstrates initiative to resolve issues- Strong verbal, written and interpersonal communication skills needed to work effectively in a team environment-
Join Aerotek Scientific LLCSM, one of the fastest growing providers of scientific and clinical research services in the nation. Due to our growth, we're constantly on the lookout for qualified professionals to place in contract, contract-to-hire, and permanent placement positions across the scientific and clinical research communities. At Aerotek Scientific, we know it's more than just your day-to-day responsibilities that can make or break a job. It's the support you get. That's the reason Aerotek Scientific offers a variety of benefits including medical, dental, optical, 401k, and many more. Don't put your career in the hands of just anyone, put it in the hands of a specialist. Join the Aerotek Scientific team! Allegis Group and its subsidiaries are equal opportunity employers.
CompetenciesDesired:At least 5 years writing experience in the pharmaceutical industry, Bachelor’s degree in life science discipline
Contact Information
Contact:
Caprio,Victoria
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