SeniorPrincipal Medical Writer USA

Trilogy Writing & ConsultinganIndegeneCompany ishiringSenior/Principal 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 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 ().
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 visa at this time); may work either fully remotely or a hybrid schedule (in office/remote) from our Durham NC USA office.

You willbe responsible for:

• Preparinga variety of clinical regulatory documents (Clinical Study Protocols Clinical Study Reports Clinical Summaries in the CTD format Investigator Brochures IMPDs/INDs scientific publications) as the lead writer in collaboration with members of client authoring teams and supported by other writers asappropriate.

• Ensuringthat all documents are produced according to agreed timelinesmonitorand manage project budgets adhere to relevant SOPs and meet the requirements of Trilogy as well 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 impact:

As a Senior/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 asappropriate.

• Ensure that all documents are produced according to agreed timelinesmonitorand manage project budgets adhere to relevant SOPs and meet the requirements of Trilogy as well as the companys clients.

• Be responsible forprovidingdocument-specific advice to clients.

• Oversee 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.
  

Qualified 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 actively writing regulatory documents; experience as a lead writer on CTD documents is required for Principal Medical Writer.

• Must have worked as the lead writer 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 Principal Medical Writer 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.

• 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 Principal Medical WriterExperience in multiple therapeutic areas to have confidence to work in these areas without lead-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 Principal Medical Writer levelabilityand willingness to take on any project for which a Lead Writer is needed.

• Competency in the use of document management systems and review tools.

• An appreciation for a well-written document and an eye for details.

• Excellent proven interpersonal skills and enjoy proactivelyparticipatingona team with diverse personalities.

• Flexibility and the ability to stay focused under tight timelines.
  
  

Perks:

• Competitive base salary (range:$120000 to $159000USD; 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 benefitplans toinclude medical dental vision disability lifeinsurance with AD&D.

• 401Kretirement 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 eventsthatencourage team bonding and development

EQUAL OPPORTUNITY

Trilogy Writing & Consulting an Indegene Company is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminateon the basis ofrace religion sex colour age national origin pregnancy sexual orientation physical ability or any other characteristics. All employment decisions from hiring to separation will be based on business requirements candidatesmeritand qualification.

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race colour religion sex national origin gender identity sexual orientation disability status protected veteran status or any other characteristics.

Required Experience:

Staff IC