Are you a passionate medical writer that has a focus on quality? Do you want to be part of a friendly, well-respected, established team? Would you like to work within a varied role that enables you to work on multiple projects?
I am working with a client that are offering an opportunity for you to be a part of a team that provides a service to clients of more than just writing. Writers are integral parts of clinical development teams with worldwide pharmaceutical companies. My client assists those teams in writing and coordinating successful documentation across a broad spectrum of therapeutic areas, whether it is for regulatory submission packages or for publication in scientific journals. As a growing company there is room to progress and develop in this position… and your ideas will form part of your future together.
As a Principal Medical Writer, you will
- Prepare a variety of clinical regulatory documents (as described above) as the lead writer 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 the company’s clients.
- Be responsible for providing document-specific advice to clients.
- Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility.
- Project manage the timelines and review cycles of your documents.
- Work in the client’s regulatory document management systems.
Candidate must have the following writing experience:
- At least 10 years’ experience actively writing regulatory documents.
- Worked as the lead writer on at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications, PSUR or DSUR, PBRER, RMP, or PIP.
- Experience in 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/EC]).
- Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
- Ability and willingness to take on any project for which a Lead Writer is needed.
- Competency in the use of document management systems and associated tools.
In addition to having the above writing experience, applicants must have:
- Masters/bachelor’s degree (PhD not necessary).
- Fluent written and spoken English skills.
- An appreciation for a well-written document and an eye for details.
- Excellent, proven interpersonal skills and enjoy proactively participating on a team with diverse personalities.
- Flexibility and the ability to stay focused under tight timelines.