Proclinical is seeking a remote Principal Medical Writer (Regulatory) for a leading research and development company. The Principal Medical Writer is responsible for developing content, writing, editing, quality control, and formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while meeting project timelines.
- Represents medical writing for all clinical studies.
- Work with clinical & regulatory teams to develop content and produce clinical documents (clinical study reports, protocols/protocol amendments, Investigator Brochures, safety updates, briefing documents, clinical summaries of safety and efficacy and clinical sections of INDs, NDAs, MAAs and other regulatory briefings and submissions) within specified timelines.
- Manage and communicate timelines with team members and senior management to ensure milestones are met.
- Provide quality control review checks of assigned regulatory documents.
- Work with teams to develop standardization of templates, processes, and tools (SOPs, best practices, templates, style guide) in accordance with industry regulations.
- Oversee all contract and external medical writing resources.
- Ability to compile, analyze and present complex information and data.
- Keeps teams apprised of project status, challenges, and potential delays.
- Support development of manuscripts, abstracts, publications, and presentations.
Skills And Requirements
- BS/BA in life sciences and 5 years of experience in regulatory writing within the pharmaceutical industry.
- MS/MA in life sciences and 3 years of experience in regulatory writing within the pharmaceutical industry.
- IND/NDA submission experience preferred.
- Experience working with an electronic based document management system.
- Experience partnering with regulatory groups and developing document strategies.
- Ability to communicate with cross– functional team members.
- Strong understanding of the key requirements for regulatory submissions as stipulated in FDA regulations, scientific journal requirements, and ICH guidelines.
- The ability to establish and maintain effective relationships with other management staff, employees, and the general public.
- Expertise in the use of MS Office, specifically Word, PowerPoint, and Excel.
- Proficient in the use of Adobe Acrobat and Pub Med and literature searches.
- Ability to oversee contract medical writers and provide guidance as well as document review for quality control.
- Ability to manage multiple documents and timelines simultaneously.
- Adheres to a high level of ethics and integrity in the representation of all data and facts.
If you are having difficulty in applying or if you have any questions, please contact Patrick Mooney at (+1) 619– 963– 2702 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.
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