Senior Medical Writer
About the role
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“At ICON, it's our People that set us Apart”
Are you passionate about improving
the quality of human life? If so, we invite you to join us in creating a
healthier world tomorrow.
ICON is a global provider of
outsourced development services to the pharmaceutical, biotechnology and
medical device industries. We specialize in the strategic development,
management and analysis of programs that support Clinical Development - from
compound selection to Phase I-IV clinical studies.
We started as a team of 5 members in
1990 & today we are ranking at top 4 worldwide based on revenue of 2015.
Currently we have 12200+ employees across the globe. ICON is a $1.575bn
company having its presence across 89 offices in 37 countries.
Job Title
: Medical Writer
Reporting
to
: Manager
Type of Employment : Full Time
Location
: BANGALORE
Job Summary:
·
You will
independently write, edit and compile documents that are components of
clinical/regulatory marketing approval applications for new biologics, drugs,
or devices
·
You will be responsible for directing other medical writers in the
writing, editing and compilation of documents
·
You will assist in the management of medical writing resources
Key Responsibilities & Duties:
·
As a member of
staff, you will be expected to embrace and contribute to our culture of process
improvement with a focus on streamlining our processes, adding value to our
business and meeting client needs.
·
You will independently
write clinical study reports and other regulatory documents according to ICON
or client-specified formats.
·
You will be
responsible for writing patient narratives independently for serious adverse
events and drop-outs due to non‑serious adverse events.
·
You will have to
independently provide additional writing and editing services (e.g. for
publications) as required.
·
You will need to Advise
on the content and format requirements for clinical reports and regulatory
documents.
·
You will be performing
quality control (review) of documents and assess whether specific project
related documents comply with regulatory requirements, client requests and ICON
SOPs.
·
You will independently
interact with clients to obtain necessary and relevant information and deal
with queries through effective decision making.
·
Maintain
awareness of the contractual and financial aspects of assigned projects and
projects to which oversight responsibilities have been assigned.
·
You will participate
in non-project specific activities, including assistance in maintaining the medical
writing work schedule.
·
You will participate
in the training and supervision of new and junior medical writers.
·
You will assist Business
Development team with the preparation of proposals and cost estimates for medical
writing tasks.
Academic or Trade qualifications:
Life science or writing qualification,
preferably at post-graduate level.
Requirement :
·
To
perform this job successfully, an individual must be able to perform each
essential duty satisfactorily. The requirements listed below are representative
of the knowledge, skill, and/or ability required. Reasonable accommodations may
be made to enable individuals with disabilities to perform the essential
functions.
·
US/LATAM/CAN:
A minimum of 3 years’ medical writing experience in a CRO or pharmaceutical
company.
·
EU/APAC:
Prior relevant experience as a Medical Writer in a CRO or pharmaceutical
company.
·
Ability to
understand and interpret clinical data.
·
Complete
knowledge of the medical writing industry.
·
Excellent writing
and oral communication skills, problem-solving ability, data‑interpretation
skills, strong interpersonal skills, ability to plan and organise, and
management skills.
·
Demonstrate
expertise with grammar, syntax and format.
Benefit Working with ICON:
Other than working with a great team
of smart and energetic people, we also offer a very competitive salary and
benefits package that includes an excellent pension scheme, private health
care, and life assurance and staff recognition schemes. This varies from
country to country so a dedicated recruiter will discuss this with you at
interview stage.
PROCESS
Technical and competency selection:
When you spot an opportunity you’re
interested in and submit an application, one of our Talent Acquisition
Specialists will contact you to evaluate your suitability for this position, as
well as for other openings within the business.
The evaluation will look at your
technical skills and your competencies – for example, delivering excellence.
Interview
After this, we’ll let you know if
we’ll be progressing with your application. If you have been successful at this
stage, we will talk you through a telephone interview. This will then be
followed by an interview with our Hiring Manager, either face to face or
by tele-conference.
Offer
If you’re successful, we will notify
you with details of the offer, talk you through our culture and values, answer
any questions you may have – and above all, welcome you to the ICON team.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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