Medical Writer II

Icon Gaithersburg , MD 20877

Posted 2 months ago

At ICON, it's our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients' lives.

Our 'Own It' culture is driven by four key values that bring us together as individuals and set us apart as an organisation: Accountability & Delivery, Collaboration, Partnership and Integrity.

We want to be the Clinical Research Organisation that delivers excellence to our clients and to patients at every touch-point. In short, to be the partner of choice in drug development.

That's our vision. We're driven by it. And we need talented people who share it.

If you're as driven as we are, join us. You'll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you'll be helping shape an industry.

Write, review, manage, and QC documents for clients including synopses, protocols, clinical study reports, protocol and clinical study report amendments, narratives, investigator brochures, and other regulatory documents as required, to meet scientific and regulatory standards as applicable.

Review for quality as well as interpret, analyze, summarize, and present data for clinical studies from sources such as tables, listings, and figures into clinical study reports and other study summaries as required.

Liaise with other functional groups ( scientific, project management, and publishing staff) to insure timely delivery and quality of writing deliverables.

A minimum of 2 years of relevant experience in clinical pharmacology, early clinical drug development (phase 1-2a), clinical research, regulatory science and preparing applicable clinical research documentation, with a substantial amount of that experience being in healthy volunteer (clinical pharmacology) studies such as: First-in-Human (FIH), Single Ascending Dose (SAD), Multiple Ascending Dose (MAD), Pharmacokinetic (PK), Pharmacokinetic-pharmacodynamics (PK-PD), Bioavailability/Bioequivalence (BA/BE), biosimilar, Food Effect (FE), Drug-Drug Interaction (DDI), Thorough QT (TQT), renal impairment and hepatic impairment, as well as proof-of-concept (POC) and early patient studies.

Most of this experience should be in small molecules, with additional experience in biologics/vaccines/devises a plus. Prefer this experience in a CRO environment and/or Pharmaceutical Company knowledge of clinical trial and drug development processes.

Excellent computer skills to include MS Word, MS Excel, MS PowerPoint, MS Outlook, and Adobe Acrobat.

Bachelor's degree or local equivalent, preferably in a biomedical sciences, plus additional medical and/or relevant scientific education or experience. Advanced degree (Master's, PhD, MD, or local equivalent) a strong plus.

Benefits of Working in ICON:

Our success depends on the quality of our people. That's why we've made it a priority to build a culture that rewards high performance and nurtures talent.

We offer very competitive salary packages. And to keep them competitive, we regularly benchmark them against our competitors. Our annual bonuses reflect delivery of performance goals - both ours and yours.

We also provide a range of health-related benefits to employees and their families and offer competitive retirement plans - and related benefits such as life assurance - so you can save and plan with confidence for the years ahead.

But beyond the competitive salaries and comprehensive benefits, you'll benefit from an environment where you are encouraged to fulfil your sense of purpose and drive lasting change.

ICON is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

icon no score

See how you match
to the job

Find your dream job anywhere
with the LiveCareer app.
Mobile App Icon
Download the
LiveCareer app and find
your dream job anywhere
App Store Icon Google Play Icon

Boost your job search productivity with our
free Chrome Extension!

lc_apply_tool GET EXTENSION

Similar Jobs

Want to see jobs matched to your resume? Upload One Now! Remove
Research Associate II

Seracare Life Sciences Inc

Posted 5 days ago

VIEW JOBS 6/17/2021 12:00:00 AM 2021-09-15T00:00 Research Associate II LGC's Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline - from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC's products to support accurate and reliable diagnostic results. Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and the Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK. Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics. Job Purpose: The Research Associate II position will advance LGC Clinical Diagnostics Division purpose of understanding disease by supporting the manufacture of precision diagnostic products. Support includes independently performing routine and non-routine applications of cellular/molecular genetic technology to quantitate and manipulate genetic material all under GLP/GMP Key Responsibilities * Perform general molecular techniques such as nucleic acid purification, gel-electrophoresis, RNA transcription, cell culture, and bacterial culture. * Perform nucleic acid analysis (RNA/DNA integrity analysis, real time qPCR, digital PCR) and analyze results. * Culture cells using aseptic techniques. Introduce nucleic acids into cultured cells. * Prepare and assess NGS libraries for sequencing. * Organize projects and data using Excel, Word, PowerPoint and a document control system (EtQ). * Work with supervisor to plan and execute experiments and tasks as assigned according to the timelines and ensure documentation meets GLP/GMP requirements. * Record test results and data records, seek appropriate approval and file according to established procedures. * Maintain, calibrate, and operate equipment according to established protocols. Monitor equipment for appropriate operation within set parameters and refer abnormal results to lab management. * Plan for raw material requirements by maintaining appropriate inventory of reagents and ordering reagents as needed through an ERP system (SAP). * Maintain a clean and safe lab environment. Knowledge, Experience and Technical Skills * Critical thinker who can analyze date and respond quickly. * Ability to manage and complete projects as assigned. * Ability to multitask and move from project to project quickly as priorities change. * Team player willing to contribute to other groups as needed. * Ability to be able to work independently with minimal supervision as well as to communicate results and provide status updates to supervisor in a timely fashion. * Strong organizational skills. Engaged and committed team professional who is committed to product development. * Passion for continuous improvement and learning new skills. * Can work on diverse projects, sometime simultaneously, as requested. * Collaborates effectively with others. * Independent thinker and self-learner Education and/or Experience * A recent master's degree in Biochemistry or Molecular Biology or a related field within the last year. * Experience in Molecular Biology techniques such as DNA/RNA Purification and quantitation, PCR (Endpoint or Real time PCR), DNA/RNA electrophoresis. * First-hand experience with aseptic techniques. * Software experience: Excel, Word and PowerPoint. * Analytic skills: Perform preliminary data interpretation/analysis. Follow SOPs Physical Demands The physical demands 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. * Requires prolonged sitting and working at a computer monitor. Repetitive motion using a keyboard for long periods of time. May occasionally be required to lift and move material weighing up to 10 lbs. * Requires moving between lab spaces and standing/sitting at lab benches. Requires repetitive manual pipetting. Work Environment The work environment characteristics 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. * Agreeable work environment typical of an open office setting with some exposure to noise from office machines. Seracare Life Sciences Inc Gaithersburg MD

Medical Writer II