Principal Medical Writer job in Paramus
|Employer:|| Glenmark Pharmaceuticals Inc., USA|
|Category:||Research and Development|
|State:||New Jersey (NJ)|
Position Summary :
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.
Key Responsibilities :
- 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
- Perform fully documented 100% Quality Control (QC) checks of clinical documents against source documents, according to Glenmark standards and SOPs
Clinical Trial Registration:
- Prepare/review data sets for registration of clinical trials/results on global registries
- Participate in process improvement initiatives to push our business forward
- Contribute to the development/revision of relevant Quality Documents (SOPs, Templates) and processes
- Minimum of BA/BS degree in Life Science/Pharmacy/Medicine. Advanced education/degree in Life Sciences/Healthcare is preferred.
- 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 Investigator's 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