Manager, Medical Writing - Remote - Cure COVID-19!
. Successful candidate will be responsible for managing the life cycle of high-quality and submission-ready clinical, regulatory, statistical, and scientific documents by providing advanced scientific writing oversight, editing and project management expertise to ensure all internal and externally produced documents are to FDA standards and publishing guidelines.
- Manage timely generation of clinical study reports (CSRs), clinical study protocols (CSPs) and amendments, Informed Consent Forms (ICFs), and Investigator Brochures (IBs) and amendments, safety update reports, statistical analysis plans, annual reports for a variety of therapeutic areas, and any other relevant documents needed for IND and BLA submissions.
- Support the development and submission of key scientific manuscripts for publication in scientific journals.
- Collaborate with cross functional leads (e.g., Regulatory Affairs and Operations, Biostatistics, Clinical Development, Preclinical, etc.) to ensure accurate and timely completion/delivery of documents and information for clinical/regulatory submissions and will remain abreast of changing priorities in a dynamic company environment.
- Identify unmet needs of the cross-functional team and provide relevant solutions to ensure successful completion of team goals.
- Work on new protocols and assist with clinical development plan documentation across the nanoparticle platform.
- Project management oversight of outsourcing to ensure projects are completed on time and to specifications, and with accuracy and efficiency.
- Financial oversight of contracts and budget for medical writing work products.
- Establish, own and manage the knowledge management system and accuracy of documents used with external facing audiences (medical, legal, regulatory review and approvals) - MRL Data Repository and QC Process
- Acts as a liaison between company and vendors.
Skills and Requirements:
- 5+ years' medical writing experience.
- Experience in vaccine development
- PhD in relevant scientific field or equivalent years of industry experience.
- Excellent command of the English language, both oral and written, with strong scientific understanding.
- Experience with oversight of outsourcing.
- Evidence of a project management skillset
- Excellent organizational skills and attention to detail.
- Experience managing delivery of multiple CSRs and/or protocols.
- Understanding of statistical concepts and techniques, and immunological detection methods used in vaccine development.
- Strong leadership skills and evidence of past supervisory experience.
- Ability to prioritize tasks and to delegate them when appropriate.
- Evidence of leading interdepartmental teams to complete an assigned project on time, to specifications, and with accuracy and efficiency.
- Past experience with budgets and contracts keeping on time deliveries within budget parameters
- Ability to manage work independently or in a collaborative setting in the context of cross functional teams. Proactively addressing questions, concerns, and/or complaints throughout a project.
- Able to manage multiple priorities and adapt quickly to new situations and new project demands.
- Ability to lead meetings and interactions to ensure timely delivery of key submissions.
- Strong command of FDA regulations, GCP guidelines, and industry recommendations for the conduct and reporting of clinical studies.
- Expert in word processing (MS Word) and excellent working knowledge of software programs in Windows environment such as PowerPoint, Endnote and Adobe Acrobat. In addition, experience with Graphpad Prism is preferred.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call George Watson at (+1) 929-223-4835 or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
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.