The Medical Writer is responsible for the preparation of documents that support the Clinical Research department, study-related documents, presentation, and publication needs associated with Interventional Oncology studies. This person supports the scientific and medical communication needs of BSC medical device clinical trials, registries, and the wider Medical Affairs department.
- The Medical Writer is responsible for clinical content creation including the preparation of clinical study protocols, protocol amendments, consent forms, documents for regulatory submissions, interim study reports, newsletters, presentations, final CSRs and other material based on BSC clinical trials and registries.
- Writes/reviews scientific manuscripts, congress abstracts and scientific meeting presentations aligned with journal and congress guidelines.
- Writes on white space topics or on post hoc analyses which answer key clinical questions within and outside the United States.
- Clinical content preparation for study investigator meetings, interim data analyses and other interim external and internal meetings regarding clinical studies.
- May create symposia (non-CME), speaker’s decks, post-meeting slide decks, topical slide decks and other Medical Education modules- as needed.
- Interacts extensively with internal medical monitors, clinical research scientists, clinical trial managers, statisticians, other medical writers as part of publication teams. Develops relationships/partnerships with study investigators. Interacts externally with journals, conference organizers, and freelance/contract medical writers. Interacts with other groups as needed to ensure that clinical data is represented accurately and correctly in any published literature, slide sets, and other materials prepared by these groups. Organizes, conducts, and leads document production meetings and other meetings as necessary.
- Helps review documents related to BSC medical device clinical trials and registries to ensure appropriate evaluation and presentation of data, methodology, interpretation, and documentation.
- Degree in the Life Sciences required (Advanced preferred).
- Experience working within Medical Device or Pharmaceutical Industry in Medical Writing and/or Clinical Research with a focus on Medical Writing.
- Extensive experience in writing Clinical Research documents (e.g. protocols, consent forms, protocol amendments, CSRs, interim study reports, regulatory submission documents) and writing, editing and submitting publications to journals and congresses.
- Therapeutic area knowledge in oncology is highly desired.
- Excellent written, analytical, verbal, and communication skills.
- Ability to manage multiple projects and product responsibilities, work independently and self-motivated to meet deliverables on time and with quality deliverable.
- Ability to work effectively with others in a matrix environment.
- Ability to develop strategic solutions to unique, significant and business issues.
- Demonstration of a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented Boston Scientific quality processes and procedures.