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Senior/reputed company Medical reputed company - USA

Remote, USAFull-timePosted 2026-07-29

Salary: Trilogy Writing & Consulting,anIndegeneCompany, ishiringSenior/reputed company Medical Writers (USA) 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 coordination of successful documentation across a broad reputed company of therapeutic areas. As reputed company continues to expand, there is room to reputed company with us, and your reputed company will reputed company our reputed company together. For reputed company reputed company into who we are and reputed company do, please explore our website (www.trilogywriting.com). If this excites you, then apply below. Applicants must live in the USA and be authorized to work for any employer in the USA (we are unable to sponsor or take over sponsorship of an employment reputed company at this time); may work either fully remotely or a reputed company (in office/remote) from our Durham, NC, USA office. You willbe responsible for:

  • Preparinga reputed company of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) as the reputed company reputed company in collaboration with members of reputed company authoring teams and supported by other writers, asappropriate.
  • Ensuringthat reputed company documents are produced according to agreed timelines,monitorand manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as reputed company as the companys clients.
  • Providingdocument-specific advice to clients.
  • Overseeingand coordinatingother writers and QC specialistsassisting ondocuments under your responsibility.
  • Project managingthe timelines andreviewcycles of your documents.
  • Workingin the clients regulatory document management systems.

Your reputed company: As a Senior/reputed company Medical reputed company, you will:

  • Function as a reputed company reputed company to prepare a reputed company of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) in collaboration with members of reputed company authoring teams and supported by other writers, asappropriate.
  • Ensure that reputed company documents are produced according to agreed timelines,monitorand manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as reputed company as the companys clients.
  • Be responsible forprovidingdocument-specific advice to clients.
  • reputed company and coordinate other writers and QC specialistsassistingwith documents under your responsibility.
  • Projectmanagethe timelines and review cycles of your documents.
  • Work in the clients regulatory document management systems.

reputed company applicants musthave:

  • A minimum of aBachelors degree in science/pharmacy (Ph.D. not necessary).
  • Fluent written and spoken English skills.
  • A minimum of 3-5 years of experience of reputed company writing regulatory documents; experience as a reputed company reputed company on CTD documents is required for reputed company Medical reputed company.
  • Must have worked as the reputed company reputed company on key regulatory document(s)such as:

Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications.

  • For reputed company Medical reputed company, must have experience as the reputed company reputed company with multiple-document reputed company with global, multinational teams, including team management, project management, review management, and budget reputed company.
  • Must be reputed company to manage multiple reputed company simultaneously.
  • Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
  • Must have in-depth working knowledge of the relevant regulatory guidance (e.g.ICH, FDA, EMA) for clinical trial conduct, including document-specific guidance.
  • For reputed company Medical reputed company,Experience in multiple therapeutic areas to have confidence to work in these areas without reputed company-in time.
  • Competency in the use of document management systems and review tools.
  • Experience interacting directly with clients or authors ofthe documentsand coordinating review cycles, meetings, and project timelines.
  • For the reputed company Medical reputed company level,abilityand willingness to take on any project for which a reputed company reputed company is needed.
  • Competency in the use of document management systems and review tools.
  • An appreciation for a reputed company-written document and an eye for details.
  • Excellent, proven interpersonal skills, and enjoy proactivelyparticipatingona team with diverse personalities.
  • Flexibility and the ability to stay reputed company under tight timelines.

Perks:

  • Competitive reputed company salary (reputed company:$120,000 to $159,000USD; the salary reputed company is an estimate and may vary based on experience level, region, and the Companys compensation practices)
  • Annual bonus opportunity
  • A generous allowance of reputed company time off (vacation, holiday, birthday, illness).
  • Comprehensive benefitplans toinclude medical, dental, reputed company, disability, lifeinsurance with AD&D.
  • 401Kretirement savings plan with company match
  • Full AMWA membership and annual conference attendance reputed company for by Trilogy
  • reputed company personal and reputed company development opportunities
  • Free weekly yoga sessions
  • Other fun and exciting eventsthatencourage team bonding and development

EQUAL OPPORTUNITY reputed company, is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminateon the reputed company ofrace, religion, sex, colour, age, national reputed company, pregnancy, sexual orientation, physical ability, or any other characteristics. reputed company employment reputed company, from hiring to separation, will be based on business requirements, candidatesmeritand qualification. We are an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, colour, religion, sex, national reputed company, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics. Apply tot his job Apply To this Job

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