Job Category: Clinical & Statistics

Sr Mgr/Assoc Dir-Medical Writing (BME)

Job Location: NJ/MA

Senior Manager / Associate Director, Medical Writing (Oncology & Rare Disease) (BME)
NJ/MA

RESPONSIBILITIES:
Produce and update clinical documents in a timely manner for study start, conduct and completion, as well as regulatory submissions according to company standards and procedures with the ultimate aim to gain regulatory approval of therapeutic indications. Coordinate medical writing activities in study teams, including external services. Ensure information sharing among MWs. Submit suggestions for improving or extending the standards of clinical documentation, share experience with other medical writers of accommodating special details of clinical studies not covered by the standards and technical expertise gained with advanced technologies. Review clinical development plans to ensure adequate planning of medical writing activities. Advise team members of regulatory requirements for documentation and propose strategies that provide efficiency gains. Prepare, or coordinate the preparation of, clinical modules for registration dossier, including overall EU or US clinical regulatory documentation using available standards, and ensure consistency across regulatory documents following database changes or modifications to the registration package. Prepare, or coordinate the preparation of, responses regarding company drug submission dossiers to Health Authorities. Review and edit work of contract writers to ensure quality is maintained. Build and sustain rapport with clinical personnel, including internal clients and colleagues. Establish effective cross-functional relationships with local and counterparts in other departments, especially Regulatory Operations. Maintain awareness of current clinical documentation requirements for target regulatory agencies. Notify management of any changes to standards and the impact of these changes on systems/processes. Represent Clinical Documentation as Subject Matter Expert on transversal initiatives concerning content, processes and tools for the implementation of new/updated processes or IT solutions to bring efficiencies, time and/or cost saving. Acts as change agent for the medical writing teams. Share experience with and train other medical writers.

REQUIREMENTS:
An experience as a Medical writer of at least 6 years, or equivalent. Ability to clearly, accurately, and concisely prepare all types of clinical documentation, including major submission and/or complex documents in English. Excellent interpersonal and leadership skills. Ability to work both autonomously and collaboratively with transversal teams in a multicultural, multilingual, and geographically dispersed environment. Must be deadline oriented, possessing a sense of urgency, accuracy, and be meticulous and attentive to detail. Technical comfort with electronic document management and word processing software is required, particularly good Microsoft Word skills. 8. Native English speaker or with proven excellent spoken and written English.
Possesses a solid work ethic, professionalism, organizational ability, and follow-up skills. Advanced scientific degree, Master or Ph.D. in life sciences, PharmD, or medically qualified. Work experience of more than 6 years as a medical writer or equivalent, or presenting relevant specialist qualifications. Experience as Lead Project MW on multiple types of clinical documents. Professional background documenting an excellent understanding of, and experience in, clinical development, including clinical study performance/methodology, basic statistics, and/or the regulatory environment. Specific knowledge of company-targeted therapeutic areas is strongly desirable.

Please contact Bill Emker at bemker@clarkdavis.com

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