Principal Medical Writer – Home-Based (US/Canada)

Job title:

Principal Medical Author – House-Primarily based (US/Canada)

Firm

ICON

Job description

OverviewICON plc is a world-leading healthcare intelligence and medical analysis group. We’re proud to foster an inclusive atmosphere driving innovation and excellence, and we welcome you to affix us on our mission to form the way forward for medical improvement.Duties

• Lead, handle, and coordinate all inner and exterior writing actions related to the preparation, compilation, and submission of purposes to regulatory authorities globally.
• Oversee and handle inner and contract medical writing sources as required to make sure well timed completion of assigned tasks.
• Develop regulatory paperwork for submission to regulatory businesses globally, in accordance with ICH and different world pointers, requirements and processes, and AMA Medical Writing types, as relevant, in adherence with research/challenge timelines and company targets.
• Actively take part in research and/or challenge staff conferences to supply enter relating to medical writing deliverables, timelines, and any course of(es) wanted for the completion of regulatory paperwork.
• Administrate as applicable, the receipt, collation, and incorporation of evaluation feedback wanted for the completion of regulatory paperwork.
• Lead or take part in defining and writing normal working procedures and dealing practices which is able to permit the efficient and environment friendly preparation of high quality.
• Lead or take part in cross-functional course of enchancment initiatives.
• Mentor extra junior medical writing employees.

{Qualifications}

• A Bachelor’s diploma in a life science self-discipline, with Grasp’s diploma in life science

self-discipline most popular. * At the very least 6 years writing expertise within the biopharmaceutical/CRO trade required.

• Proficient understanding and information of home and worldwide regulatory necessities required and information of therapeutic areas in all phases of medical improvement desired.
• Proficiency in organizing and speaking medical info obligatory.
• Robust communications, organizational, time administration, and challenge administration expertise are required.
• Proficient in MS Phrase. and expertise with template methods (eg, StartingPoint).
• Expertise with an digital doc administration system (eg, MasterControl,
• Documentum) and use of templates most popular.
• Robust verbal, written, and interpersonal communication expertise wanted to work successfully in a staff atmosphere.

What ICON can give you:Our success will depend on the standard of our individuals. That’s why we’ve made it a precedence to construct a various tradition that rewards excessive efficiency and nurtures expertise.Along with your aggressive wage, ICON presents a spread of extra advantages. Our advantages are designed to be aggressive inside every nation and are targeted on well-being and work life stability alternatives for you and your loved ones.Our advantages examples embody:

• Varied annual depart entitlements
• A variety of medical health insurance choices to go well with you and your loved ones’s wants
• Aggressive retirement planning choices to maximise financial savings and plan with confidence for the years forward
• World Worker Help Programme, TELUS Well being, providing 24-hour entry to a world community of over 80,000 unbiased specialised professionals who’re there to help you and your loved ones’s well-being
• Life assurance
• Versatile country-specific non-obligatory advantages, together with childcare vouchers, bike buy schemes, discounted health club memberships, subsidised journey passes, well being assessments, amongst others

Go to our careers web site to learn extra about the advantages of working at ICON: https://careers.iconplc.com/advantagesICON, together with subsidiaries, is an equal alternative and inclusive employer and is dedicated to offering a office freed from discrimination and harassment. All certified candidates will obtain equal consideration for employment with out regard to race, color, faith, intercourse, sexual orientation, gender identification, nationwide origin, incapacity or protected veteran standing.If, due to a medical situation or incapacity, you want an affordable lodging for any a part of the applying course of, or so as to carry out the important capabilities of a place, please tell us or submit a request . within the position, however not sure in the event you meet all the necessities? We might encourage you to use regardless – there’s each likelihood you’re precisely what we’re on the lookout for right here at ICON whether or not it’s for this or different roles.

Anticipated wage

Location

Canada

Job date

Fri, 08 Mar 2024 08:34:24 GMT

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