Remote Job

Senior Medical Writer- Regulatory Strategy Writing (US/Canada-Remote)

ICON Strategic Solutions

• 5000 - 6000 USD per Month
• Full Time
• Posted : 3 weeks ago

ICON & You – The Potential of Together

Experienced Senior Medical Writer needed for niche Regulatory Medical Writing role.

ICON plc is looking for a Senior Medical Writer who is experienced in regulatory strategic writing to work with our embedded, FSP model alongside some of the world’s top leading pharmaceutical companies.

As a Senior Regulatory Strategic Medical Writer, you are responsible for providing support to one or more Therapeutic Areas (TA) as designated by the Regulatory Strategic Writing (RSW) leadership. The Medical Writer provides support for the preparation and submission of critical regulatory documents, including briefing books and responses to health authority information requests, using available reference materials. In addition, you are responsible for ensuring the accuracy and quality of submission-ready documents using established Regulatory Strategic Writing (RSW) processes. As the Medical Writer, you partner with the regulatory strategic TA lead, other RSW contributing staff, as well as the Global Regulatory Lead/Area Regulatory Lead to prepare high-quality, accurate and concise documentation supporting the objectives of GRPT teams and leadership.

Responsibilities include but are not limited to:

Preparing, authoring/writing, contributing, editing, and reviewing high-quality, clearly-messaged documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities.

Documents include:

• Protocols
• Protocol Amendments
• Clinical Study Reports (CSR)
• Informed Consents (ICF)
• Investigative Brochures (IB)
• IND/NDA (Heavy submissions writing)

Requirements:

• Bachelor's degree (Science or English) is required; A relevant advanced degree (e.g., MS, PharmD, PhD, MD) is preferred
• American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing
• Minimum of six (6) years of pharmaceutical industry medical and regulatory strategic writing
• High-level content writing experience and experience with clinical development regulatory documents preferred, with working knowledge of statistical concepts and techniques. Excellent written and oral communication skills. Capable of assimilating and interpreting scientific content with adeptness in ability to translate for appropriate audience. Excellent attention to detail and superior ability with respect to consistency, clarity and accuracy.
• Knowledge of US and international regulations, requirements and guidance associated with regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
• Knowledge of Common Technical Document content templates, electronic document management systems and information technology.
• Excellent working knowledge of software programs in Windows environment.

Benefits of Working in ICON:

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position

#LI-JK1

Skills

• Medical Writing
• Clinical Research
• Pharmaceutics
• Content Writing
• Clinical Development