Position: Associate Director/Director of Medical Writing #2094
Location: Northern NJ
Compensation: Based on Experience
The role of the Associate Director Medical Writing is to ensure 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. The role is responsible for leading medical writing activities to support US, European and other regulatory submissions. The Associate Director Medical Writing will be accountable for ensuring that deliverables are prepared according to appropriately rigorous and objective medical writing and quality management procedures and processes.
· To prepare documents that are compliant with the Company’s standards and 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 take responsibility for supervision/production, review, and finalization of assigned clinical documents.
· To work with the Head of Medical Writing for regular project updates, strategic planning, production and review of assigned summary documents.
· To take responsibility for ensuring that medical writing deliverables meet the project specifications, and that they are produced within the timelines to defined quality, and content standards.
· To supervise assigned medical writing projects contracted to third party suppliers and ensure that the activities are performed according to the agreed specification and budget.
· To maintain metrics and KPIs for their project and contribute to the process of continuous improvement.
· Follow the Company’s processes and SOPs and discuss any required changes with the Head of Medical Writing 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) Ensure consistency of documents across a given program or therapeutic area
· Coordinate contributions, reviews and approvals with internal stakeholders
· Participate in the Project Team to plan and manage all Medical Writing activities in support of clinical trial execution
· Serve as the representative for Medical Writing within the Team and ensure compliance of documents to company standards and external regulatory guidelines
· Provide Medical Writing project management
· Manage vendors and ensure fulfillment of the contract and scope of work with respect to quality, timelines and cost of deliverables
Clinical Trial Registration:
· Support registration of clinical trials/results on global registries as needed
· Lead or 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.
· Significant experience (> 8 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/preclinical pharmaceutical research and development.
· Authorship of protocols and Clinical Study Reports
· Authorship of summary level documents such as Investigator’s Brochures, Annual Reports, Safety Updates and regulatory submissions (eCTD modules 2.5 and 2.7).
· Experience of clinical trial registry and disclosure activities.
· Experience of managing vendors.
· Experience or training in project management.
· 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.
· Well-developed writing, time management, communication, presentation, analytical and interpersonal skills.
· Proficient in statistics and data interpretation.
· Ability to present information in a clear, accurate, logical and concise manner.
· Proficient in the use of MS Word and Excel.
· Fluent written and spoken English.
· Demonstrable ability to manage complex projects, conflicting priorities and coordinate preparation of multiple documents.
· 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.
· Pro-actively assess risks and escalate.
· Able to perform root cause analysis and implement continuous improvements.
· 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.
· Responsible, flexible and accountable with a business-focused pro-active approach.