Experienced Medical Writer (Clinical Research/Oncology) – NC Pharma/Remote
Our client, a development-stage biopharmaceutical company located in Research Triangle Park, NC, is actively recruiting for a highly skilled and knowledgeable Medical Writer, with particular expertise in Clinical Research, to join it R&D team.
This is a critical role for the company, and it is prepared to pay top dollar to attract and retain an excellent candidate.
Key Things to Note:
- The company has multiple products in development including two clinical stage oncology therapies as well as an infectious disease product that recently obtained FDA approval. Strong preference for candidates with oncology bkgd.
- This Medical Writer will manage multiple writing projects that will involve many stakeholders, both internal and external. Seek skilled Project Manager who enjoys coordinating the work of others.
- This role will be responsible for authoring, processing, content and planning of documents such as CSRs, protocols, IND/NDA submissions, etc. as well as submission strategy, data collection, etc. Strong clinical research bkgd and content knowledge will be essential.
- This Medical Writer will also be responsible for assurance of consistent scientific message across programs. Seek candidate whose excellent Medical Writing skills are complemental by finetuned Quality Control technique.
- This position can be remote and located anywhere in the United States.
- Collaborate on the scientific aspects of clinical studies within the team environment; address questions regarding scientific and related procedural issues from the team.
- Author clinical submission documents within a team environment. These may include clinical study reports, protocols, IND/NDA/MAA/ex-US submissions, routine updates (e.g., investigator brochure, DSUR) and interactions with health authorities (e.g., briefing documents, response to requests for information).
- Manage the review and approval of clinical submissions documents; notify team of targeted review responsibilities, generate consensus among reviewers, resolve conflicting comments, and facilitate discussions in an efficient manner.
- Oversee preparation of clinical submission documents to health authorities for a project; review and provide feedback on clinical submission documents to maintain consistent content, messaging, and style.
- Ensures documentation follows Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), ICH compliance and Company standards and templates.
Targeted candidate will offer a related degree (advanced degree preferred) and 5+ years of experience in clinical development, Phases I – IV, with particular expertise in Medical Writing. Oncology experience strongly preferred.
Other priorities include:
- Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
- Detailed and experienced-based understanding of applicable regulations, Common Technical Document (CTD) structure and content, including CSR and summary document content.
- Sound knowledge of the International Conference on Harmonization (ICH) guidelines
- Understanding of the regulatory requirements from US and/or EU health authorities and of the submission process, including participation in NDA and/or MAA submissions.
- Keen attention to detail
- Exceptional organizational skills including deadline orientation
Finally, we seek a skilled project manager who can effectively coordinate the efforts of multiple stakeholders in a highly dynamic, sometimes disruptive, fast-paced and deadline-driven setting and lead them to a success project outcome.
This is an immediate need. Please forward resume or CV for prompt consideration.