Medical Writer

TSR Consulting Services provides best in class staffing solutions to clients nationwide, by staying true to our relentless focus of exceeding the highest professional IT service business standards. Today, as a NASDAQ company specializing in IT consulting and staff augmentation, TSR continues to expand and transform its services to meet and anticipate its clients and candidates needs. For more than 53 years, TSR's has been a leader in the industry because of our expertise and knowledge of the job market, our compassion and caring of our clients and consultants and our work environment of respect and inclusion. Your career is in good hands with TSR because at the end of the day, if YOU THRIVE, WE THRIVE.

Our client, a leading Pharmaceutical company is hiring a Medical Writer on a contracting basis.

Work Location: Princeton NJ

Summary:

• Good understanding of requirements for regulatory submission documents
• Demonstrated strong writing skills as evidenced by good quality writing in pharmaceutical regulatory documentation and/or publications in peer-reviewed journals
• Good understanding of global pharmaceutical drug development and requirements for submission of regulatory dossiers to global health authorities
• Demonstrated ability to manage timelines and quality of work using strong organizational, communication, facilitation and interpersonal skills in a cross-functional team
• Working knowledge of a document management system and basic knowledge of document publishing process
• Analyzed and interpreted complex data from a broad range of scientific disciplines
• Coordinate and author regulatory documents (e.g. phase I/II clinical study reports, Investigators Brochure) ensuring the coordination and integration of the scientific, medical and regulatory input from development team members

Required Skills:

• Ability to lead other writers, including developing strategies/ plans and managing projects, in order to complete multiple documents for regulatory submissions
• Demonstrate mastery of complex writing assignments (e.g., Phase III CSRs, CSS, CSE, Background Packages, etc.) across therapeutic areas or multiple projects
• Participate in relevant filing subteam(s) and ensure effective planning and management of timelines for all components of assigned documents
• Lead or co-lead (with Doc Lead) teams to define content and data displays for CSR prototypes and shells
• Able to collaborate with project team to respond to health authority questions, requests, etc.7
• Provide departmental management with adequate information to help assess resource needs