Description
Position Summary:
Cubist is seeking a Senior Manager, Medical Writing to be deeply involved in preparing for; leading and facilitating the medical writing effort for multiple regulatory submissions focusing on clinical documents, such as study reports and integrated summaries. The successful individual will be an experienced medical writer with extensive and broad prior role as a lead writer in a regulatory submission at a mid to large bio-pharmaceutical company. Previous experience preparing and integrating clinical documents prior to a new drug application (or equivalent) is required.
In addition, this person must be a skilled facilitator who can work closely with the clinical/development teams to drive document preparation, lead document review cycles roundtables and ensure that information is accurately shared, evaluated and presented.
Key Responsibilities:
- Research, author, edit, format and quality review clinical documents (i.e. clinical study reports, protocols, investigator brochures)
- Research, author, edit, format and quality review clinical portions of regulatory submissions (i.e. integrated summary of safety, integrated summary of efficacy, clinical overviews and summaries)
- Drive document preparation, lead document review cycles roundtables, and incorporate comments
- Establish metrics/timelines and hold functional groups accountable for delivery of essential documents crucial for the NDA submission
- Contribute to the development of standardized processes for the writing/submission organization (i.e. development of templates, shells, and standard operating procedures etc.)
- Supervise and ensure quality and consistency of work performed by the medical writing team and external vendors
- Mentor junior writers and manage external vendors as appropriate
Minimum Basic Qualifications:
- Master's degree in a life sciences discipline
- Minimum of 5 years experience as a medical writer working in the pharmaceutical/medical industry
- Experience in regulatory submissions, including functioning as a medical writing lead for a regulatory submission
- Knowledge of FDA and ICH guidelines
- Skilled in clinical data interpretation
- Attention to detail
Preferred Qualifications and Experience:
- Advanced scientific degree (MS, PhD, PharmD, MD)
- Project management experience
- Knowledge of the anti-infective therapeutic area
Competencies:
- Demonstrates the ability to communicate clearly, concisely, and effectively to express information in both written and oral context
- Aptitude to compile, analyze, and present data in a concise manner
- Proven capability to focus on delivering excellent results and continually improve performance
- Capability to work on multiple projects and meet deliverable timelines
- Proven ability to drive issues to closure and demonstrate an effectiveness to work co-operatively with others in a team environment
Work Environment:
Physical Demands:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position's essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions .
Cubist is an Equal Opportunity Employer (EOE). M/F/D/V
Headquartered in Lexington, Massachusetts, Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on becoming a leader in the discovery, development and commercialization of novel acute care therapies for use in hospitals and other acute care environments.
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