Medical Writer - Clinical and Regulatory

Job Title: Medical Writer - Clinical and Regulatory

Location: Europe and US

At ICON, it's our people that set us apart.

As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry! Are you one of them?

At ICON, we have an incredible opportunity for an expert Medical Writer to join the team in our UK office.

The Role

This is a rare opportunity to join our friendly global Medical Writing team which sits within ICON's Clinical Research Services group. Our remit is to produce high quality documents supporting clinical studies and regulatory submissions.

Our key department values are:

Passionate about partnership Quality without compromise Flexibility in a dynamic environment

In this role you will have the following responsibilities:

• Preparation and QC of imaging documents including Charters, Imaging Manuals and Training Manuals. This includes:
• Working with internal study teams to determine/clarify project requirements and obtaining necessary information.
• Tracking and recording progress against contracted hours/budget using financial tracking tools and the department's project database. Early flagging to management of projects not on track and facilitation of the Change Order process.
• Attendance at internal and external projects meetings via teleconference/Webex.
• Writing of documents according to agreed contractual obligations and timelines using client or ICON templates and style guides, and adhering to regulatory or other guidance.
• Incorporation of review comments from internal and external reviewers, including management of multiple sets of comments.
• Perform QC of documents written by other writers.
• To keep Medical Writing senior management informed of project status and any issues that affect document quality, timelines, and adherence to contractual obligations.
• Achievement of individual utilization (billability) target.
• Compliance with department systems, e.g., project database, timesheets, training.
• General operational assistance to the Medical Writing team.
• Preparation and QC of other document types, if required.
• Active participation in department initiatives and process improvements.
• Any other task deemed reasonable by department senior management.

What you need

Skills & experience required:

Essential:

• Bachelor's degree in a life science, or equivalent.
• Previous experience as a clinical/regulatory Medical Writer.
• Able to assimilate and summarize large volumes of scientific data accurately, clearly and concisely.
• Proficiency in MS Word, Excel, PowerPoint, Adobe Acrobat and Outlook. Able to rapidly learn to use bespoke in-house and client toolbars.
• Excellent verbal English.
• Excellent written English, e.g., organization, syntax, grammar, clarity, focus, messaging that requires minimal editing/rewriting.
• Excellent attention to detail.

Preferred:

• Knowledge of imaging techniques such as CT, MRI, PET, Echo, X-ray, DxCT.
• Experience of working for a large CRO.
• Familiarity with Veeva Vault, Salesforce and Box.

Competencies:

• Able to recognize, exemplify and promote ICON's OwnIt culture and values of Accountability and Delivery, Integrity, Collaboration and Partnership.
• Proactive, gracious and collaborative communication skills.
• Able to work in a fast-paced, results-driven environment.
• Culturally aware and able to work comfortably within a global team.

Why join us?

Other than working with an outstanding team of ambitious people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.

We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.

Ongoing development is vital to us, and as a Medical Writer, you will have the opportunity to progress your career, with the potential to move into other related areas to improve your skillset. Our benefits package is competitive, our scope is international and we sincerely care about our people and their success.

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/colour/religion/sex/sexual orientation/gender identity/disability/vet/national origin