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Senior Medical Writer

India-Bangalore
Permanent
Reference: 043841
This vacancy has now expired.
Description

“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.

 

 

 

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