Medical Writer- Remote opportunities
Job Description
ProPharma are looking for an experienced Medical Writer to join the team to support the our global growth; this is a fully remote role across any of the ProPharma entities. The Medical Writer position is responsible for authoring regulatory writing deliverables that focus on quality, accuracy, and efficiency and for providing regulatory writing support to ProPharma clients.
Essential Functions
- Author (write / edit) high-quality regulatory writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) including but not limited to protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs / CERs, DSURs, and plain language summaries. May participate in authoring more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission-level documents) under the supervision of senior personnel.
- Adhere to established regulatory standards / guidelines including but not limited to: ICH E3 / E6(R2), EU MDR / IVDR, Company standard operating procedures, client standards, and Company- and / or client-approved templates.
- Strive to complete writing deliverables on time and within budget.
- Interact and communicate directly with clients, lead team meetings (e.g., project kickoff, comment review), and manage the deliverable timelines, with support from senior personnel (as needed).
- Interact and collaborate as needed with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables.
- Coordinate QC reviews of documents and maintain audit trails of changes as applicable.
- Review statistical analysis plans and table / figure / listing shells (as applicable) for appropriate content, grammar, format, and consistency.
- If requested by supervisor, perform QC review (e.g., reviews in-text tables against statistical output).
- Assist with project-related administrative tasks (e.g., creating and maintaining timelines, updating deliverable trackers, and hosting internal / client meetings) with support from senior personnel (as needed).
- Maintain familiarity with current industry practices, regulatory requirements, and guidelines related to regulatory writing.
- Understand budget specifications for assigned deliverables, work within the budgeted hours, and communicate out-of-scope tasks to regulatory writing leadership.
Ideal Skills And Requirements
- Knowledge of clinical research principles and the ability to interpret and present clinical data and other complex information.
- Understanding of global regulatory bodies and applicable regulations and guidelines.
- Understanding of regulatory submission requirements and processes.
- Minimum of 3 years of experience writing clinical and regulatory documents for drugs, biologics, medical devices/diagnostics for a CRO, pharmaceutical company, or biotechnology company.
- Experience writing & editing scientific documents or experience in reviewing scientific data preferred.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***