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ICON Strategic Solutions Sr Medical Writer in Boston, Massachusetts

Overview

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

For the expansion of our team, ICON is looking for a Medical Writer, who will be responsible for providing medical writing support for the development of complex clinical documents for regulatory submissions including, but not limited to clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), patient narratives, annual reports, and other key clinical and regulatory documents.

This individual will support the overall strategy for all medical writing processes according to company standards.

Responsibilities

Key Accountabilities/Responsibilities:

The position will have the following key responsibilities:

  • Support the clinical medical writing team, in developing content for a variety of clinical regulatory documents, including clinical protocols, informed consents (ICFs), clinical study reports (CSRs), investigator brochures (IBs), safety narratives, and

eCTD modules

  • Draft and manage documents that are well-organized, accurate, consistent, and comply with applicable company SOPs and regulations

  • Ensures all clinical documents are standardized according to the company style guide and are based on company-approved document templates to ensure quality andconsistency of the portfolio

  • Partner with Quality Assurance (QA) during an audit of clinical trial documents to ensure timely response to findings

  • Collaborate with members of clinical trial teams and other functions within medical writing to ensure project deadlines are met by providing content development support, research, and editing functions for each program

  • Ensure proper development and coaching of junior writers

Qualifications

  • Bachelor’s degree in a scientific, medical or clinical discipline or related field required, PhD preferred

  • Native English speaker preferred

  • Minimum of 5-7 years of pharmaceutical/biotechnology-related medical writing experience required

  • Knowledge of all FDA and ICH guidelines for clinical reporting required

  • eCTD development, publishing, and submission experience preferred

  • Biologic writing experience preferred

  • Basic understanding of drug development, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission

  • Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)

  • Ability to proofread documents for compliance with internal and external guidance documents

  • Ability to approach issues from various perspectives and accurately summarize data to draw a conclusion

  • Ability to work precisely according to procedures and regulations

  • Excellent written and verbal communication skills

  • Ability to prioritize and multi-task successfully in a fast-paced environment

  • Ability to work autonomously, as well as in a team

  • Excellent time management skills and a proven ability to work on multiple projects at any given time

  • Must be proficient in MS Office

  • Experience in electronic publishing format preferred

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, please let us know.

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Posted Date 12 hours ago (11/23/2022 10:26 AM)

ID 2022-96586

Location : Location US-Remote

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