Proclinical is currently recruiting for a Medical Writer for a leading biotechnology company located remotely. As the Medical Writer, you will provide medical writing for clinical and regulatory documentation required for the conduct and submission of results of clinical trials.
- Prepare clinical documents with supervision.
- Participate on clinical teams (e.g., SMT) with supervision; participates in document-related meetings led by senior writers; reviews clinical data reports as needed.
- Interact with other medical writers and document quality reviewers and has limited interaction with cross-functional teams (e.g., SMT), in order to create/author/manage documentation required to support clinical trials and regulatory submissions.
- May participate in cross-functional meetings with supervision.
- Failure to meet goals and deadlines may negatively impact study activities.
- Receive direction on document preparation, data review, timeline management, and meeting skills.
- Demonstrate increasing familiarity with internal and external guidelines related to content and format of clinical documents.
- Recognize problems with completing tasks and develops solutions with direction.
- Depend on management to prioritize tasks.
- Provide information to management to facilitate decision making. Decisions affect primarily study activities.
Skills and Requirements:
- Bachelor's required Master's or PhD preferred.
- Life or Health Science discipline.
- 3+ yrs regulatory, scientific, or publication writing experience with Bachelor's 2+ yrs regulatory, scientific, or publication writing experience with Master's 0-1 yr regulatory, scientific, or publication writing experience with PhD.
- Good written and oral communication skills.
- Good organizational and meeting skills. Solid understanding of scientific and/or clinical research.
- Ability to interpret data. Familiarity with standard clinical document types.
If you are having difficulty in applying or if you have any questions, please contact Mary Jacobs at (+1) 312-291-4181 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.