Principal Associate Principal Medical Writer
Principal Associate Principal Medical Writer
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Job Description
TrilogyWriting & ConsultinganIndegeneCompany is currentlyhiringAssociate Principal andPrincipal Medical Writers(F M or D)inthe UK and Europeto 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 andcoordinationof successful documentation across a broad spectrum of therapeutic areas. As our company continues to expand there is room to develop withusand 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.
- Annual bonusopportunity.
- A generous allowance of paid time off.
- Comprehensive benefit plansalignedwithyour region.
- FullEMWA membership and annual conference attendance paid for by Trilogy.
- Continuous personal and professional development opportunities.
- Free weekly yoga sessions.
- Other fun and exciting events thatencourage 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 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 specialistsassistingwithdocuments 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 least5 years of experience of actively writing regulatory documents;experienceas a lead writer onCTDdocumentsis mandatory.
- Must have worked as the lead writeron 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 haveexperienceas the lead writerwithmultiple-document projects with global multinational teams including team management project management review management and budget oversight.
- Must beable to manage multiple projects simultaneously.
- Must have in-depthworking 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 applystatistical regulatory and medical communication conceptsare neededto 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 aBachelors degree in science/pharmacy (Ph.D. not necessary).
- Fluent written and spoken English skills.
- An appreciation for a well-written document and an eye fordetail.
- Excellent proven interpersonal skills and enjoy proactivelyparticipatingon a team with diverse personalities.
- Flexibility and the ability to stay focused under tight timelines.
Trilogy Writing & Consulting anIndegeneCompanycomplies withall laws respecting equal employment opportunity and does not discriminate against applicantswith regard toany 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.
Required Experience:
Senior IC
Employment Type
Full-Time
