Medical Writer (Senior/Principal) – Based in Durham, North Carolina, USA
Our client is looking for new Medical Writers (Senior/Principal) to join their ever-expanding team in Frankfurt. You will be given an opportunity like no other to grow and develop into the best writer you can be. You would be part of a genuine team where quality of life is valued, whether it be company yoga, wine and cheese nights, or the general family-like atmosphere. If this sounds like an opportunity that appeals to you, please have a look at some of the following requirements for the role.
Candidate must have the following writing experience:
- At least 5 years of experience actively writing clinical regulatory documents.
- Worked as the lead writer on >3 of at least 3 of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications.
- Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines.
- Competency in the use of document management systems and associated tools.
In addition to having the above writing experience, applicants must have:
- Diploma/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 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.
As a Senior 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 Trilogy as well as 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.