Scipher Medicine is developing an exciting portfolio of personalized medicine solutions in complex diseases. Most patients who are prescribed blockbuster therapies today don’t respond to the treatment. Scipher's platform identifies which drug will work based on the patient's fundamental disease biology, and not based on symptoms, disease classification, or medical bias. A simple test predicts which drug he/she will respond to, ensuring that most optimal treatment is prescribed from day one. The molecular data generated by our tests is then used to fuel novel target discovery to address a clear unmet medical need in patients who do not respond to any existing therapy.
The Principal Medical Writer will provide strategic authoring expertise and guidance to project teams, outside vendors, and external contacts. The Principal Medical Writer will write, edit, and coordinate content delivery for regulatory and clinical projects while serving as the primary technical contact on documentation issues with internal and external teams and managing the review, approval, and finalization of documents with a focus on quality and regulatory compliance. This person is responsible for providing specialist technical, regulatory, strategic and scientific leadership for a broad portfolio of Medical Writing projects that span all therapeutic areas, the department’s full scope of work and frequently involve cross-functional work for the support of key clinical development pipeline assets. The role may include supervision of a limited number of direct reports.
- Uses leading-edge knowledge of principles, concepts, practices and/or techniques to champion complex projects or programs involving medical writing and related departments/groups.
- Recognized internally and externally as a leading contributor to solution generation and delivery for special projects such as development of best practices for new and evolving documentation, technological advances to increase efficiency, and guidance for integration of acquisitions and working in collaborations.
- Coordinates the efforts of cross-functional teams to produce high-quality, scientifically accurate documents
- Creates and tracks project timelines and content delivery milestones to contribute to overall project management from document development through finalization.
- Authors a variety of clinical documents such as clinical study protocols, clinical study reports and investigator brochures and their amendments, strategic regulatory documents such as briefing packages, agency response documents, and requests for accelerated review, and documents for major submissions.
- Demonstrates thought leadership in medical writing and represents our company as an expert for external collaborations and external meetings/conferences/seminars.
- Mentors more junior medical writers and coordinates the activities of vendor writers.
- Ensures that all regulatory submission documents are fully compliant with internal document standards.
- Works with study teams to ensure that regulatory strategies and key messages are implemented in the documentation and that submission documents are of high quality and compliant with applicable regulatory guidance.
- Maintains awareness of industry standards, regulatory requirements, and departmental guidelines and SOPs. Works cross-functionally to update procedures or practices as needed to remain in compliance and improve efficiency.
- Required to make complex decisions and troubleshoot in ambiguous situations across departments.
- Presents complex ideas, anticipates potential objections and/or persuades/influences others to adapt a different point of view, when appropriate at a professional level.
- Works across departments to test and advance innovative processes and methodologies; encourages curiosity and challenges the status quo to foster innovation.
- As required, demonstrates advanced skills in optimizing technology to support scientific/business processes.
- Uses a high level of judgment to adapt and/or create standard methods and techniques by applying breadth of knowledge and prior work experience. Has high awareness of own limits and proactively consults others to ensure quality of judgment.
Skills and Education:
- Masters Degree or equivalent experience. PhD in a relevant scientific/clinical/regulatory field preferred
- 7-10 years of relevant experience in the experience in life sciences, clinical diagnostics, or genetics industry (dependent upon graduate degree)
- 5+ years of experience in clinical/pharmaceutical development as a medical writer desirable
- Excellent project management, communication, and cross functional relationship-building skills.
- Ability to be successful independently and within a multi-discipline team environment.
- History of publications and/or presentations at industry meetings
- Strong background and working knowledge of statistical methods that apply to all phases of clinical trials and other study designs.
- Working knowledge of medical writing tasks as part of the regulatory submission packages.
- Ability to take appropriate action in all dealings with CRO partners to ensure that best practices are followed.
- Demonstrated ability to remain flexible should priorities change (judgment and decision making) during project execution.
- Expertise lay summaries and systematic literature searching desirable
The applicant must demonstrate:
- Excellent verbal and written communication skills
- Exceptional organizational skills and attention to detail
- Technical skills with relevant software for authoring such as MS Word, EndNote and an abbreviation manager/QC tool is desirable.
The applicant must be able to:
- Manage multiple projects with competing priorities
- Work within a study team with minimal supervision
Other Relevant Information:
- Some domestic and international travel may be required
- Opportunity for remote work