* Trilogy Writing & Consulting is currently offering a USD/CAD 5,000 sign-on bonus for any candidate who applies to us directly (without a recruitment agency being involved). The bonus will be paid in two instalments – the first half will be paid with your first salary payment and the second upon successful completion of your probationary period.
Our medical writing managers will work from our office in Durham, NC, USA or fully/partially remotely in USA or Canada.
Job description and responsibilities
We are looking for an experienced Medical Writing Manager to join our growing team of writers in North America. This role straddles the functions of management and working as a medical writer. As a manager at Trilogy, you will understand the power of emotional intelligence to unlock the potential in your team and know how to inspire and lead by example. You will be responsible for the line management of a small team of medical writers (approximately 6 people), overseeing their professional development, assisting them with resource planning, conducting annual appraisals, and participating in Trilogy management-level activities. This can include business development activities such as conducting workshops on behalf of Trilogy, participating in management meetings, and representing Trilogy at pitch meetings or other client meetings.
In addition, our Medical Writing Managers work on high-level writing projects. As an experienced medical writer, you will take full responsibility for the writing and oversight of typical regulatory documents. These will include complex multiple-document projects, often involving multiple medical writers and QC specialists, and you will have the skill set to provide our clients with expertise in these documents as well as in managing all activities involved in planning, coordinating, and executing these projects. You will need to ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements and its clients.
Candidates must have the following experience:
- At least 2 years management experience including resource planning, line management, and oversight of professional development for individuals within your group.
- Ability to manage people including training, mentoring, supervising work, and motivating employees.
- At least 8 years experience actively writing clinical and nonclinical regulatory documents.
- Proven ability to handle full responsibility for any type of clinical document, including complex, multiple-document projects.
- Worked as the lead writer on more than 5 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical and Nonclinical Summaries in the CTD format, Investigator Brochures, PSURs/DSURs, IMPDs/INDs, RMPs, PIPs, briefing books.
- Experience leading 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 literature-based dossier [e.g. a full-mixed application under Article 8(3) of Directive 2001/83/ECJ]).
- Experience as the lead writer interacting directly with global clients and authors of the documents and coordinating review cycles, meetings, and project timelines and working in client document management systems.
- Competency in the use of document management systems and reviewing tools.
- Masters/Bachelors degree in science/pharmacy (PhD 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.
To apply, please write in English, specifying how you comply with the experience requirements, with your CV to jobs@TrilogyWriting.com
Trilogy Writing & Consulting is an equal opportunity employer. Our company values are based on inclusivity and diversity, and we do not discriminate or allow discrimination on the basis of race, color, religion, sex, age, sexual orientation, gender identity, national origin, citizenship, marital status, disability, or any other characteristic protected by law. We passionately believe in creating a supportive environment in which everyone can grow, flourish, and do their best work.