Job details
Job type full-time
Full job description
Full time position – remote
Company summary
Sio gene therapies is a biopharmaceutical company committed to developing treatments for severe cns diseasesThe company has rapidly built a diverse portfolio of gene therapy candidates with the potential to address debilitating cns genetic diseases for which the unmet medical need is high, the biology for treatment is clear, and for which there are no approved therapiesAdditionally, the company is focused on more common debilitating cns diseases, such as parkinson’s disease.
Developing new genetic treatments for these diseases is challenging workIt takes courage, talent, and dedication to look past the easy answers and uncover new solutions that can make a meaningful impactAt sio we push each other to perform at our very best to make a difference in our patients’ lives.
Overall summary
The sr/director, medical and regulatory writing, is responsible for determining and driving the medical writing strategy for the clinical programs, and for both the authoring of the documents and the provision of managerial oversight of vendor or contract medical writing when neededAs a strategic partner to the rest of the r&d team, the incumbent is accountable for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, safety and regulatory requirements of a clinical program
He / she will mitigate risk associated with medical writing and disclosure processes by establishing and maintaining best practices and sopsThis will be an individual contributor role and reports to the vp, regulatory affairs.
Primary responsibilities
Responsible for authoring, aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan).
Builds convincing clinical or regulatory arguments using logic, analogy and therapeutic area science.
Coordinate timelines and processes for preparation, review and qc, approval of regulatory submissions
Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents.
Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
Sets program-level standards (eg, style convention)
Liaises with functional groups within and external to r&d to ensure independent and interdependent communication needs and strategies are considered during document development (eg, communicating data in a csr and regulatory documents to support nda and advisory committee positioning)
Accountable for medical writing deliverable quality and ensures work on assigned projects adheres to industry / international standards
Drives the development, implementation and communication of best practices, sops, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.
Program forecasting and budgeting in resource planning
Building and maintaining collaborative relationships with medical writing partner(s) (cro, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship (defines the scope of work to be outsourced, and is responsible for medical writing vendor
Requirements
Scientific degree with post graduate training in biomedical science is desirable in one of the disciplines related to drug development or business
5+ years of writing experience in the pharmaceutical industry
Exceptional english language skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
Understanding of statistical principles and medical terminology across a range of therapeutic areas
Thorough understanding of basic science and demonstrated ability to cogently and succinctly explain complex scientific concepts
Must have experience in writing clinical study reports (csrs), protocols and investigator brochures (ibs), scientific advice documents, ind/bla briefing documents, and all key regulatory submissions (ind/nda/bla)..
A solid understanding of the clinical development process, including the documents that are required at each stage.
Expert ms office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
Knowledge of ich and ctd guidelines for clinical and regulatory submission documents
Ability to think strategically; demonstrated negotiating skills and resourcefulness.
Demonstrated ability to manage several projects simultaneously.
Strong influencing skills, able to lead without formal authority.
Demonstrated ability to make decisions even in the absence of complete information.
Experience and insight on external clinical publication practices and standards (icmje, ama, gpp).
Excellent organizational and time management skills.
Attention to detail.
This is an exciting time to join the field of gene therapy in general, and to become a part of sio gene therapies’ fast-growing dedicated teamSio gene therapies is a publicly traded companyWe offer an exciting, meaningful and collaborative fast-paced environment with a foundation of sound and rigorous scienceCompetitive compensation and benefits package can be expected.
All interested applicants should send a cover letter and resume to: hr@siogtx.com
