COVANCE is a leading global drug development services company and we provide support to the Pharmaceutical and Biotechnology industries.
We are recruiting for our global Medical Writting team in Latin America and are currently seeking to hire a a Senior Medical Writer. This is a permanent, full time position and could be based in any of the following countries in the Latin America Region: Argentina, Brazil, Chile, Colombia, Mexico or Peru.
The opportunity to work within an experienced and highly skilled team.
Covance's ongoing success offers team members unsurpassed growth and career development opportunities.
At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career. This is your chance to become part of a team that helps to bring miracle of medicine to market sooner.
There is no better time to join us!
- Typically minimum 4 years medical writing experience including 2 years as medical writing project lead
- Excellent command of written and spoken Spanish
- Excellent command of written and spoken English
- Excellent written and verbal communication skills
- In-depth knowledge of MS Word
- Excellent organizational and time management ability
- Detailed knowledge of ICH guidelines applicable to medical writing
- Good understanding of medical/scientific terminology and experience in data analysis and interpretation
- Write and coordinate the development of protocols, CSRs or other clinical documents including those of a more complex nature
- Provide support in development of submission level documents under guidance of senior staff
- Oversees management and coordination of complex narrative projects
- Produces scientific papers, abstracts and/or posters, and presentations.
- Responsible for all medical writing aspects of project development and coordination, adherence to timelines and budget
- To prioritize and plan workload to a high standard. Effectively manage multiple assignments in parallel
- Prepare documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
- Review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.
- Act as medical writing contact for major clients and partners
- Keep up to date with developments in Medical Writing
- In consultation with more experienced staff, show initiative and ability to deal with complex project situations
- Inform management of medical writing problems promptly and propose solutions
- Provide advice on Medical Writing issues to project team members (internal and external) and help to resolve problems
- Contribute to Medical Writing initiatives to develop and improve processes
- Mentor and provide guidance and training to other medical writing staff
- Provide peer review and input on deliverables prepared by colleagues
- Provides scientific leadership and support to colleagues in the data management and reporting team
- Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences
- Review Covance SOPs and associated documents
- Represent department in audits and inter-department working groups
- Comply with Covance internal processes and procedures
Performs other duties as assigned by Management
Apply on company website