Location: Boston, MA
or provide authoring support for clinical documents including clinical study protocols and amendments, clinical study reports, Investigator's Brochures and updates, and clinical Common Technical Document components (eg, Module 2 summaries). Contribute to the development of briefing packages, responses to health authority inqueries, pediatric investigational plans, and other IND/CTA or global regulatory submission documents.
Support development and implementation of strategy for writing and completion of high-quality clinical documents. Manage the writing and completion of documents and other assigned tasks (eg, editing and QC) within established timelines. Actively support clinical project
team(s), alone or in collaboration with other MWs, and take responsibility for timely and accurate MW deliverables, negotiating timelines as necessary. Participate with other MW team members to develop and support process and standards to be implemented, and take responsibility for execution across cross functional teams.
Maintain adherence to standard operating procedures and regulatory requirements in partnership with statistical, clinical, regulatory, quality, and drug safety colleagues. Develop effective collaborations with other functional lines in Alexion. Ensure consistent support and implementation of MW standards and compliance with relevant regulatory requirements. Essential
Qualifications At least 3-5 years of clinical regulatory MW experience, including global clinical studies and regulatory submissions.
Will consider fewer years of MW experience combined with other relevant medical industry experience. Demonstrated capability to write clinical study documents (eg, clinical study protocols, clinical study reports, and Investigator's Brochures). Familiarity with global regulatory requirements and ICH/GCP guidelines. Excellent oral, written, and presentation skills; experienced user of MS Office suite. Preferred Qualifications Degree or advanced degree in a relevant scientific/clinical/regulatory field. Agile learner and ability to work independently while seeking advice as required.
High level of flexibility and ability to innovate and adapt to changing conditions. Results- and compliance-driven with high standards of excellence for self and others. Well-developed sense of ethics, responsibility, and respect for others. Demonstrated project management, problem solving, organizational, and negotiating skills. Ability to establish excellent internal and external relationships, including alliance partners and vendors. #LI-Hybrid For more details: jobs-search. org/senior-manager_boston-c434671/senior-manager-medical-writing-boston_i1960820955
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Management & Executive Jobs refer to high-level positions within an organization that involve overseeing operations, making strategic decisions, and leading teams towards achieving business objectives. Individuals in these roles typically have significant experience and expertise in their respective fields. They are responsible for setting goals, developing policies, and ensuring the effective management of resources. Executive roles often include titles such as CEO, CFO, COO, and department heads, among others. Characteristically, these jobs demand strong leadership skills, excellent communication abilities, and a capacity to think critically and solve complex problems.
