Glenmark Pharmaceuticals Inc. Paramus , NJ 07652
The role of the Senior Medical Writer is to ensure that all clinical study and submission documents for assigned projects are prepared, reviewed, and approved in a quality, timely, and accurate manner such that the data presented will be appropriate for review by the agencies.
To prepare documents that are compliant with Glenmark standards, ICH, and GCP guidelines and that are approved by the project team, as appropriate.
To plan, schedule and track all assigned medical writing activities in close cooperation with the teams to ensure high quality, timely, and accurate completion of all documents at each point in the document lifecycle.
To work with Medical Writing Management for regular project updates, production and review of assigned documents.
To take responsibility for ensuring that medical writing deliverables meet the project specifications and produced within the timelines to defined quality and content standards.
To maintain metrics and KPIs for their project and contribute to the process of continuous improvement.
Follow the Glenmark processes and SOPs and discuss any required changes with Medical Writing Management in advance or otherwise timely manner.
Ensure documents are prepared to high standards of quality and compliance, and within agreed timelines and cost/resource utilization
Peer review and cross-check of documents produced by Medical Writing (internally or externally) or other departments (e.g., Statistics)
Ensure consistency of documents across a given program or therapeutic area
Support Medical Writing Managers in the preparation of complex documents including summary document
Clinical Trial Registration:
Participate in process improvement initiatives to push our business forward
Contribute to the development/revision of relevant Quality Documents (SOPs, Templates) and processes
Experience (> 2 years) of medical writing, preferably with experience in oncology or respiratory or a demonstrated ability to quickly assimilate new therapeutic areas, coupled with prior experience of clinical/pre-clinical pharmaceutical research and development.
Authorship of Clinical Study Reports required.
Authorship of protocols, preferred
Working knowledge of summary level documents such as Investigators Brochures, Annual Reports, Safety Updates and regulatory submissions (eCTD modules 2.5 and 2.7), preferred
Experience of clinical trial registry and disclosure activities, preferred
Good understanding of GCP, the clinical development process and of ICH guidelines
Able to understand and apply regulatory guidance with respect to regulatory documentation to support clinical development, submissions, product maintenance and disclosure/transparency
Demonstrated aptitude for writing concise, clear and accurate clinical documents for submission to agencies
Proven time management, communication, presentation, analytical, and interpersonal skills
Proficient in statistics and data interpretation
Proficient in the use of MS Word and Excel
Fluent written and spoken English
Ability to plan and prioritize workload and interact with multi-disciplinary teams
Able to mentor and encourage junior team members and to disseminate knowledge to the Medical Writing Team
Ability to use initiative to resolve queries and ability to deal with matters confidently and efficiently
Ability to contribute effectively to a team with all levels of seniority and be pragmatic
Diligent with attention to detail