Sr. Medical Writer

SUMMARY OF POSITION:The Senior Medical Writer will be part of the Medical Writing and Publishing Groups, and will assume primary responsibility for the preparation of clinical documents according to global agency guidance, specifications, templates, style guides, and Standard Operating Procedures.ESSENTIAL FUNCTIONS:1.Prepare documents in accordance with applicable US and International regulations under the supervision of the Manager, Medical Writing and Publishing Groups. Documents include but are not limited to: Investigator Brochures, Phase 1 through 4 clinical protocols and amendments, clinical study reports, clinical and nonclinical sections of CTD-formatted applications (Modules 2, 4, and 5), package inserts, Integrated Summary of Safety reports, and Integrated Summary of Efficacy reports.2.Lead review meetings and provide guidance on a wide range of issues related to document preparation and production.3.Participate on functional teams that address requirements or issues related to document preparation and production.4.Liaison with contacts outside of the company. Determine specific needs and organize the assembly of an appropriate response. Effectively communicate issues to other department personnel and company management, as appropriate.5.Write and edit Standard Operating Procedures, as necessary.6.Maintain knowledge of current regional regulations in regard to document format. Assesses impact of regulation changes to current work procedures and SOPs. Update procedures and SOPs as appropriate and train personnel regarding all revisions. DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:•Attend seminars and courses to maintain career growth and to stay updated on changes with Agency guidance and medical writing.•Other duties as assigned with or without accommodation.Requirements: Education required/ preferred: Minimum of a Bachelor degree in life scienceExperience: 5-8 years relevant medical writing/pharmaceutical experience Knowledge of ICH and FDA guidanceProficiency with electronic document editing and management systems Preferred Skills/Qualifications: English proficiency and fluencyAbility to conceptually organize, analyze, and interpret dataExcellent interpersonal, oral, and written communication skillsSkills/Competencies: Must be detail orientedMust be able to adapt to changing priorities and be a fast learnerMust be able to set and manage multiple priorities and projects to compete tasks within established timelinesMust work well under tight and conflicting deadlinesAble to work with multiple groups of people at one timeMust be able to work with minimal supervisionMust be able to prioritize own work effectivelyOther Skills: Strong intrapersonal skills, including ability to remain calm, professional, diplomatic, and positiveAllocate down-time effectivelyTo apply online, please use the following link: Apply To Covidien Click here to see all “Covidien� opportunities Visit our web site to learn more about Covidien EMAIL THIS JOB TO A FRIENDCOVIDIEN, COVIDIEN with Logo and "positive results for life" are trademarks of Covidien AG. ©2007 Covidien AG or its affiliate. All rights reserved.