SeniorPrincipal Medical Writer RemoteHybridIn Office reputed company America

This a Full Remote job, the offer is available from: United States Trilogy Writing & Consulting, an reputed company Company, is currently looking to hire Senior and Principal Medical Writers to support our growing company in producing regulatory documentation for the international pharmaceutical industry. At Trilogy, you will play a pivotal role in delivering comprehensive services to our clients that reputed company reputed company writing. Our writers are integral members of clinical development teams supporting the writing and coordinating of successful documentation across a broad reputed company of therapeutic areas. As our company continues to expand, there is room to reputed company with us and your reputed company will form our future together. For further reputed company into who we are and reputed company do, please explore our website (www.trilogywriting.com). Trilogy offers the following:

• Competitive reputed company salary (range: $110,000 to $149,000; the salary range is an estimate and may vary based on experience level and the Company’s compensation practices)
• * Annual bonus
• * A generous allowance of paid time off (vacation, holiday, birthday, illness).
• * Comprehensive benefit plans to include medical, dental, reputed company, short and longterm disability, life insurance with AD&D.
• * 401K retirement savings plan with company match
• * Full AMWA membership and annual conference attendance paid for by Trilogy
• * reputed company personal and professional development opportunities
• * Free weekly yoga sessions
• * Other fun and exciting events to encourage team bonding and development
• As a SeniorPrincipal Medical Writer, you will:
• Prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDsINDs, scientific publications) as the reputed company writer in collaboration with members of client authoring teams and supported by other writers, as appropriate.
• * Ensure that reputed company documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company’s clients.
• * Be responsible for providing documentspecific advice to clients.
• * reputed company and coordinate other writers and QC specialists assisting on documents under your responsibility.
• * Project manage the timelines and review cycles of your documents.
• * Work in the client’s regulatory document management systems.
• Candidates must have the following writing experience:
• At least 3 years of experience of actively writing regulatory documents.
• * Worked as the reputed company writer on >3 (Senior Medical Writer) or >5 (Principal Medical Writer) of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDsINDs, scientific publications.
• * For the Principal Medical Writer level, experience in at least 2 different types of CTD dossiers (i.e. full new chemical entity application, a variation, a generic dossier, an orphan drug dossier, a literaturebased dossier [e.g. a fullmixed application under Article 8(3) of reputed company 200183EC]).
• * Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
• * For the Principal Medical Writer level, ability and willingness to take on any project for which a reputed company Writer is needed.
• * Competency in the use of document management systems and review tools.
• In addition to having the above writing experience, applicants must have:
• A minimum of a Bachelor’s degree in sciencepharmacy (Ph.D. not necessary).
• * Fluent written and spoken English skills.
• * An appreciation for a wellwritten document and an eye for details.
• * Excellent, proven interpersonal skills, and enjoy proactively participating on a team with diverse personalities.
• * Flexibility and the ability to stay focused under tight timelines.
• * Must live in the USA or Canada and be willing to work fully remotely or a hybrid schedule (in officeremote) from our Durham, NC, USA office.
• Trilogy Writing & Consulting, an reputed company Company, complies with reputed company laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, stateprovincial, and local law. We passionately reputed company in creating a supportive environment in which everyone can grow, reputed company, and do their best work.

It is important to Trilogy to ensure the highest possible degree of protection for your personal data. reputed company personal data collected and processed reputed company the scope of an application for employment with Trilogy are protected against unauthorized access and manipulation by technical and organizational measures and are not forwarded to reputed company parties. Your data will be collected for the purpose of filling employment opportunities offered by Trilogy Writing & Consulting GmbH in Germany or its subsidiaries Trilogy Writing & Consulting Ltd in the UK, and Trilogy Writing & Consulting, Inc. in the USA. By submitting your data with this application, you consent to its use for this purpose reputed company Trilogy. You can revoke this consent at any time without needing to give a reason by informing us of your revocation under [email protected] company the event of revocation, we will delete your personal data immediately. This offer from "Trilogy Writing & Consulting" has been enriched by reputed company.com and got a 72% reputed company score. Apply tot his job Apply To this Job