Medical Writer
5 days ago
ABOUT THE COMPANY:
Celegence LLC is a privately owned business based in Chicago, IL, USA, with offices in the UK, EU, and India. We provide customers consulting services and solutions to support their regulatory affairs operations and strategy. Our fully trained resources support companies in their day-to-day operations by ensuring global regulatory compliance, leveraging their expert knowledge, and our technology and automation to improve compliance.
The vision of Celegence is to be the premier niche provider of regulatory services and solutions, to improve outcomes for the life sciences industry. Our primary objective is to provide end-to-end regulatory solutions enabling life science organizations to deliver exceptional patient value.
Qualification(s)
Degree in lifesciences / B.Pharma / M. Pharma
Experience(s)
- 2 to 8 years of prior medical writing experience preferred; Interested in expanding his/her knowledge of drug development as it pertains to medical writing/labelling activities
- Experience in the pharmaceutical or CRO industry preferred
- Experience across multiple therapeutic categories – respiratory, ophthalmic, immunology, autoimmune disorders, cardiovascular disorders, endocrine disorders, gastrointestinal disorders, infectious diseases, neurology, oncology, etc.
Technical Skills
- Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge
- Excellent scientific writing skills and understanding of ICH requirements
- Proficiency with MS Office applications and style guides for writing various document types
Soft Skills
- Excellent English written and verbal communication skills
- Good organizational, interpersonal and communication skills
Competencies
- Good knowledge of industry regulations and compliance requirements applicable to pharma/life sciences
- ICH Guidelines and eCTD knowledge
Personal Traits
- Good planner and Skilled communicator
- Well organized to work independently with minimum oversight
Roles and Responsibilities
- Able to independently author clinical and non-clinical documents such as CSRs, Investigator Brochures (IB), summary of changes (SOC), DSURs / PSURs / PADER/PBRERs, safety narratives, risk management plans (RMP)
- Accountable for writing clinical and non-clinical documents and review processes independently with high level proficiency per client’s needs using client templates, toolbars, and style guides
- Effectively coordinate, collect and evaluate data from multiple sources, functions to create an efficient content writing strategy
- Creates medical writing training exercises; trains new medical writers/associates and new medical writers
- Build scientific-based rationale and ensure data is presented in a clear, complete, accurate and concise manner
- Trains via self-study and self-practice independently and explores advances topics related to medical writing, drug development and/or labelling
- Conducts thorough self-review of deliverables prior to release to client; serves as high level reviewer for documents produced by colleagues
- Excellent understanding of MS Word for advanced writing techniques
- Anticipate and mitigate risks by addressing review comments during document’s lifecycle, including critical review of comments and value-added suggestions
- Independently implements and validates QC findings as per agreed procedure
- Demonstrates strong understanding of ICH or any other guidelines, as applicable to medical writing/labelling activities; Maintaining knowledge of the current regulations and upcoming changes
- Practices good internal and external customer service and responsible for project and stakeholder management
- Able to interact directly and independently with client to coordinate all facets of projects; competent communicator
- Demonstrate extensive knowledge of departmental processes
- Takes initiative to suggest and implement departmental process improvements
- Develops excellent internal and external leadership skills for projects
- Follow processes related to project management as appropriate for medical writing/labelling projects
- Complies with document control procedure
- Complies with record control procedure
- Ensures compliance to applicable IQMS policies and procedures
- Maintain and enhance knowledge of regulatory guidelines and publication guidelines.
CCDS
- Responsible for maintenance of an effective labelling process for the preparation, review and approval of draft and final labels/CCDS
- Strong understanding of different labels and customer expectations for developing different documents
- Proficient with MedDRA coding, literature search and other activities in accordance with all the established SOP’s
- Conduct discussions and meetings with cross functional team for labelling related activities
- Ensure compliance to project related trackers and procedures
- Development and maintenance of a central repository for all labelling components
- Develops regulatory solutions and implements action plans for identified project issues to mitigate risks
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