Senior Medical Writer

Icon Chicago , IL 60602

Posted 4 weeks ago

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:

The primary responsibilities and accountabilities of our Senior Medical Writer are:

  • Responsible for writing and reviewing study documents such as Protocol, Synopsis, Informed Consent, Data Collection Documents and Study Report, etc.

  • Responsible for developing scientific communication such as abstract, poster, manuscript, etc.

  • Responsible for performing quality control for medical writing deliverables

  • Responsible for interpreting statistical results and for soliciting statistician input for developing study reports, abstracts, manuscripts, and other documents as required

  • Participating in the improvement of the quality assurance system

  • Responsible for participating in bid-defence presentations representing medical writing activities

To be successful in the role, you will have:

  • Advanced degree in a scientific discipline, preferably PhD, PharmD or MD

  • 5+ years of professional experience in Medical Writing at a pharmaceutical, biotechnology, CRO or other health care setting

  • Proven knowledge of ICH/GCP and GPP guidelines or other meaningful guidelines or industry standard

  • Outstanding written and verbal interpersonal skills

  • Good computer literacy

  • Ability to work effectively and cooperatively with cross-functional teams

  • A strong desire to be a key part of a global network of services that lead to better outcomes for its clients, its people and for patientsapply now and Own IT@ICON!

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, 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
lc_ad

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
Senior Medical Writer

Orphazyme A/S

Posted 9 months ago

VIEW JOBS 2/3/2021 12:00:00 AM 2021-05-04T00:00 Exciting opportunity within medical writing at an innovative biopharmaceutical company Orphazyme is expanding and therefore looking for a Senior Medical Writer to support their medical writing activities and provide medical writing insights to the development projects. As Senior Medical Writer, you will become part of the Medical Writing team consisting of 3 employees; the Manager of Medical Writing and 2 Senior Medical Writers. You will be responsible for your own projects, e.g. Orphazyme's project in phase II for Gaucher disease, as well as close collaboration within the Medical Writer team on the upcoming submission tasks. With direct report to the Manager of Medical Writing. Your main tasks are: * Support medical writing activities, e.g. clinical dossier, briefing packages, and late-phase clinical trial reports * Preparation or oversight of regulatory clinical documents, e.g. clinical trial protocols, investigator's brochures, responses to authorities, clinical summaries and overviews * Planning and coordination of activities in a cross-functional setting * Provide medical writing support to various regulatory and scientific documents * Review of clinical trial documents, e.g. clinical development plans, statistical analysis plans, protocols, and protocol amendments * Support to other functional areas on communication best practices * Manage stakeholders, e.g. close interaction with medical affairs and CMOs Your qualifications are minimum 3 years of experience as a Medical Writer within the pharmaceutical industry and preferably experience with writing clinical dossiers and briefing packages. Alternatively, you have good knowledge of clinical studies and GCP from another specialized position in the industry. It is crucial that you can drive, manage and write concise and targeted regulatory, scientific documents in collaboration with many stakeholders. Moreover, you must have good analytical skills and the ability to work with large amounts of information. Finally, you must possess excellent communication and collaborative skills. You have a Master's Degree within science including skills within scientific research methods. You are self-driven and able to take responsibility for your own projects. It is crucial that you are proactive and can work independently. You must work in a structured way with an eye for details. Furthermore, you must be flexible and open to challenges. It is important that you thrive in a dynamic and entrepreneurial research environment and are passionate about working in a novel therapeutic area. Orphazyme offers a unique opportunity in a company with an exciting pipeline and a positive and informal environment. Orphazyme is growing rapidly and the rate of change is high and hence the opportunities to contribute and influence are many. Travelling: Limited. Domicile: Ole Maaløes Vej 3, DK-2200 Copenhagen N. Unique Human Capital is handling the recruitment. For more details about the job or the company, please contact CEO Jørn Duhn, Unique Human Capital on M: +45 21 75 19 25 or Senior Research Consultant Elisabeth Haun, Unique Human Capital on M: +45 28 90 33 88. All applications must be in English and are treated confidentially. You can apply directly via this link: https://uhc.dk/en/available-jobs/senior-medical-writer/ Want to Stay Connected? Follow us on Twitter and connect with us on LinkedIn. ORPHAZYME A/S Phone: (+45) 39 17 82 72 If you are calling outside of working hours (Monday-Thursday: 8:00AM - 4:00PM CET, Friday: 8:00AM - 2.00 PM CET) and your call concerns a quality issue/product complaint or a side effect, please call: Phone (+45) 20 83 63 97. E-mail: contact@orphazyme.com Ole Maaløes Vej 3 DK-2200 Copenhagen N Denmark Orphazyme A/S Chicago IL

Senior Medical Writer

Icon