Senior Manager, Medical Writing

Employment Type

: Full-Time

Industry

: Pharmaceutical/Biotechnology



Loading some great jobs for you...





Position Summary This position is accountable for the timely preparation of high quality, regulatory-compliant clinical document deliverables for Alexion. This position will support the medical writing (WM) activities for one or more clinical programs. This position will function with moderate supervision. The scope of this position includes the writing, document management, and development support for clinical study-related documentation including, but not limited to, clinical study protocols, Investigators Brochures, and clinical study reports; and to collaborate with cross-functional teams to write and development other IND/CTA or global regulatory submission documents. Job Duties & Responsibilities Authors or provides authoring support for clinical documents and other assigned tasks within established timelines, with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Clinical document types include clinical study protocols, clinical study reports, Investigator’s Brochures and updates, and other IND/CTA or global regulatory submission documents Supports development and implementation of strategy for writing and completion of high quality clinical documents Manages the writing and completion of documents and other assigned tasks within established timelines (editing and QC) and with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Actively supports clinical project team(s), alone or in collaboration with other MWs, and takes responsibility for timely and accurate MW deliverables, negotiating timelines as necessary. Participates with other MW team members to develop and support process and standards to be implemented and takes responsibility for execution across cross functional teams. Maintains adherence to uniform processes and standards in partnership with statistical, clinical, regulatory, and pharmacovigilance colleagues. Develops effective collaborations with other functional lines in Alexion. Ensures consistent support and implementation of MW standards. Reviews, edits, and ensures quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensures adherence to standards. Ensures that all activities are conducted in compliance with relevant regulatory requirements. Essential Qualifications MS degree in life sciences or equivalent required 3-5 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge Demonstrated writing capability for scientific or clinical documents, (eg, clinical study protocols and clinical study reports, Investigator’s Brochures Excellent oral, written, and presentation skills Demonstrated project management, problem solving, organizational, and negotiating skills Agile learner and ability to work independently while seeking advice as required Familiarity with global regulatory requirements and ICH/GCP guidelines Ability to establish excellent internal and external relationships, including alliance partners and vendors Thrives in a team-based environment Results- and compliance-driven and sets standard of excellence for self and others Well-developed sense of ethics, responsibility, and respect for others High level of flexibility and ability to innovate and adapt to changing conditions Preferred Qualifications Advanced degree in a relevant scientific/clinical/regulatory field preferred

Launch your career - Create your profile now!

Create your Profile

Loading some great jobs for you...