Associate PrincipalPrincipal Medical Writer

Trilogy Writing & Consulting an Indegene Company is currently hiring Associate Principal/Principal Medical Writers in the United States 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 extend beyond writing. Our writers are integral members of clinical development teams supporting the writing and coordination of successful documentation across a broad spectrum of therapeutic areas. As our company continues to expand there is room to develop with us and your ideas will form our future together. For further insight into who we are and what we do please explore our website ().

Trilogy offers the following:

• Competitive base salary (range:$140000 to $159000 USD; the salary range is an estimate and may vary based on experience level region and the Companys compensation practices)
• Annual bonus opportunity
• A generous allowance of paid time off (vacation holiday birthday illness)
• Comprehensive benefit plans to include medical dental vision disability life insurance with AD&D
• 401K retirement savings plan with company match
• Full AMWA membership and annual conference attendance paid for by Trilogy
• Continuous personal and professional development opportunities
• Free weekly yoga sessions
• Other fun and exciting events that encourage team bonding and development

As an Associate Principal/Principal Medical Writer you will:

• Function as a lead writer to prepare a variety 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 client authoring teams and supported by other writers as appropriate.
• Ensure that all 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 companys clients.
• Be responsible for providing document-specific advice to clients.
• Oversee and coordinate other writers and QC specialists assisting with documents under your responsibility.
• Project manage the timelines and review cycles of your documents.
• Work in the clients regulatory document management systems.

Candidates must have the following:

• At least 5 years of experience of actively writing regulatory documents; experience as a lead writer on CTD documents is required.
• Must have worked as the lead writer on several key regulatory documents such as:Clinical Study Protocols Clinical Study Reports Clinical Summaries in the CTD format Investigator Brochures IMPDs/INDs scientific publications.
• Must have experience as the lead writer with multiple-document projects with global multinational teams including team management project management review management and budget oversight.
• Must be able to manage multiple projects simultaneously.
• Must have in-depth working knowledge of the relevant regulatory guidance (e.g. ICH FDA EMA) for clinical trial conduct including document-specific guidance.
• Experience in multiple therapeutic areas to have confidence to work in these areas without lead-in time.
• Advanced understanding of and ability to apply statistical regulatory and medical communication concepts are needed to independently write complex regulatory documents without supervision.
• 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 Bachelors degree in science/pharmacy (Ph.D. not necessary)
• Fluent written and spoken English skills
• An appreciation for a well-written document and an eye for detail
• Excellent proven interpersonal skills and enjoy proactively participating on a team with diverse personalities
• Flexibility and the ability to stay focused under tight timelines
• Applicants must live in the US and be authorized to work for any employer in the US (we are unable to sponsor or take over sponsorship of an employment visa at this time); may work either fully remotely or a hybrid schedule (in office/remote) from our Durham NC USA office.

Trilogy Writing & Consulting an Indegene Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal state/provincial and local law. We passionately believe in creating a supportive environment in which everyone can grow flourish and do their best work.

It is important to Trilogy to ensure the highest possible degree of protection for your personal data. All personal data collected and processed within 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 third 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 the USA. By submitting your data with this application you consent to its use for this purpose within Trilogy. You can revoke this consent at any time without needing to give a reason by informing us of your revocation under In the event of revocation we will delete your personal data immediately.

Required Experience:

Senior IC