Medical Writing Manager
About the role
This vacancy has now expired. Please see similar roles below...
Medical Writing Manager UK or US Home or Office
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?
This is a business management role to provide leadership in ICON Early Phase Scientific Services as well as manage and execute the daily strategic and operational activities of the ICON Early Phase Services Clinical Research and Development department. To lead development of process improvement initiatives, participating in all aspects of new business activities including interactions with potential and current clients both as a representative of IEP Scientific Services and IEP CRD. To develop and conduct trainings, mentoring and, assistance in professional development of CRD staff. To assist in review and interpretation of clinical data, to independently write, edit, compile, and assist in directing other staff in the writing, editing, and compilation of documents that are components of or are related to clinical/regulatory marketing approval applications for new biologics, drugs, or devices..
What you need
- A minimum of 8 years' 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-pharmacodynamic (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/devices a plus. Prefer this experience in a CRO environment and/or Pharmaceutical Company.
- Expertise in pharmaceutical early phase services and associated business activities
- Ability to assess situations with information provided (at times minimal) and develop reasonable solutions, with and without assistance
- Knowledge and ability to effectively communicate with internal and external clients concerning MW processes, requirements, and deliverables (both ICON and industry/regulatory standards)
- Ability to work efficiently without supervision.
- Ability and confidence to make decisions independently.
- Ability to work under pressure.
- Ability to motivate others.
- Excellent written and verbal communication skills, data-interpretation skills, strong interpersonal skills, ability to plan and organize.
- Excellent computer skills to include MS Word, MS Excel, MS PowerPoint, MS Outlook, and Adobe Acrobat.
- Document organization, management, and version control skills to include hyperlinking, TOC generation, and field updating.
Why join us?
On-going development is vital to us, you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely 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/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin
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
Day in the life
Teaser label
Inclusion & BelongingContent type
BlogsPublish date
04/29/2024
Summary
Cultural Fit in the Workplace Finding the perfect cultural fit is crucial when searching for a new employer. It goes beyond just the job description and salary package. Cultural fit refers to how
Teaser label
IndustryContent type
BlogsPublish date
04/29/2024
Summary
Precision medicine is a groundbreaking approach that aims to revolutionise healthcare by tailoring medical treatments to individual patients. Unlike traditional medicine, which adopts a one-size-fi
Teaser label
Our PeopleContent type
BlogsPublish date
04/29/2024
Summary
Deepak is a Clinical Data Management Project Manager at ICON Strategic Solutions, the largest global provider of Functional Service Provision (FSP). He works as a dedicated resource within one of o
Who we are
Similar jobs at ICON
Salary
Location
Mexico, Mexico City
Department
Drug Safety & Pharmacovigilence
Location
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Project Management
Clinical Supplies
Job Type
Permanent
Description
Clinical Supplies Project ManagerICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced s
Reference
JR116640
Expiry date
01/01/0001
Author
Elizabeth DaviesAuthor
Elizabeth DaviesSalary
Location
Ireland, Europe, United Kingdom, South Africa, Poland, Bulgaria, Spain, Germany, Netherlands, Romania, Czech Republic, Slovakia
Department
Biometrics Roles
Location
Any EMEA Location
Bulgaria
Czech Republic
Germany
Ireland
Netherlands
Poland
Romania
South Africa
Spain
UK
Slovakia
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Statistics
Job Type
Permanent
Description
As a Principal Biostatistician you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Reference
2023-104906
Expiry date
01/01/0001
Salary
Location
Argentina
Department
Clinical Monitoring
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
As Clinical Research Associate (CRA), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence. A CRA is a professional who cont
Reference
2023-103904
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Argentina
Department
Clinical Trial Management
Location
Argentina
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
As a Clinical Trial Manager you will play a key role in improving the lives of patients by accelerating the development of our customers drugs and devices through innovative solutions.
Reference
2023-103323
Expiry date
01/01/0001
Author
Tulio SanquizAuthor
Tulio SanquizSalary
Location
Belgium, United Kingdom, Denmark, France, Spain, Germany, Netherlands, Switzerland
Department
Medical Affiars & Medical Writing Roles
Location
Belgium
Denmark
France
Germany
Netherlands
Spain
Switzerland
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Medical Writing
Job Type
Permanent
Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. As principal medical writer, you will be
Reference
2023-103952
Expiry date
01/01/0001
Author
Natalia RothAuthor
Natalia RothSalary
Location
Argentina, Buenos Aires
Location
Buenos Aires
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Early Phase Services
Job Type
Permanent
Description
Senior Clinical Associate - Buenos Aires, Argentina ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research prov
Reference
JR118995
Expiry date
01/01/0001
Author
Elizabeth DaviesAuthor
Elizabeth Davies