Medical Writing Manager

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