Job: Medical Writer, Agility Clinical, Raleigh, NC
Precision for Medicine, Oncology & Rare Disease is not your typical CRO. You will work with leading subject matter experts who understand the rare disease patient mindset. We help translate science into success for rare disease patients with a targeted, patient-centric approach over a wide geographic area. We are specialists who tackle unusual problems in our detailed approach throughout every phase. From the beginning, we have nurtured a culture where patients’ needs and the needs of our valued clients come first.
We welcome your voice and will provide you with the opportunity to truly make a difference on drug development. You will be a member of a close-knit medical writing team that is passionate about saving the lives of patients every single day.
You are meticulous when writing, reviewing, and finalizing documents.
Teamwork is your way of working with your clients and your internal team.
You establish clear objectives, organize ideas, and embrace creativity.
You clearly articulate key messages from clinical study data.
You are technically savvy, a formatting master
You have excellent writing skills - logical and succinct, with accurate data interpretation and representation.
You are energized by participating in the fast-paced development of drugs, devices, and biologics to improve the lives patients with oncology and rare diseases.
You are sought out by others - highly organized and dedicated
What You Can Expect Day-to-Day:
Developing clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, patient narratives, annual safety reports, INDs, eCTD NDA/BLA clinical summaries, briefing books).
Conducting efficient document review and finalization
Planning resourcing for upcoming project writing deliverables with clients, corporate, and internal project teams/departments to assist with
Ensuring smooth and effective document management from start to finish (i.e., from template to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing
Performing literature-based research to support writing activities. Providing technical assistance in formatting documents. Conducting QC of the documents mentioned above. Following applicable regulations, including, but not limited to, FDA, ICH, and Precision SOPs.
Minimum Required: BS in a scientific or medical discipline with relevant writing expertise.
Medical Writers will have proven experience in the sponsor and/or CRO setting to include; 3+ years for Senior and 5+ years for Principal
Proficiency with Microsoft Windows, Word, Excel, Adobe Acrobat, and PowerPoint
Advanced degree (MS/PhD)
Oncology and/or hematological oncology experience (especially protocol development)
Experience in rare disease and pediatric disease
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.