Principal Medical Writer

RESPONSIBILITIES:
?Specifically lead the writing of complex clinical documents (e.g. protocols, protocol amendments, phase II/III clinical study reports, high level summary documents), and certain non-clinical documents (e.g. initial Investigator’s Brochure and safety update reports).
?Organize and lead meetings with study team members to determine timelines and processes for the assigned regulatory documents.
?Ensure key messages within the document and across the program are clear and consistent.
?Adhere to our style guide for formatting and usage.
?Manage documents through the review process (coordinating document review meetings, collate and reconcile comments from various functional groups) and the approval process.
?Provide guidance/solutions for medical writing processes, standards, and innovative initiatives.
?Contribute to generation and maintenance of templates and standard text for clinical documents
?Critically review project specific data, outputs, and shell reports; organize meetings to get team consensus on document planning and maintain decision trail.
?Conduct quality review as necessary for clinical and regulatory documents.
?Extend document support as needed to Regulatory Affairs.
?Provide training and guidance to other medical writers, offering scientific and operational mentorship and coaching in the design, planning, and execution of their assignments.
QUALIFICATIONS:
?Has more than 5 years of Medical Writing experience in a CRO/biopharmaceutical industry.
?B.S. or equivalent degree in life sciences.  Advanced degree (MS or PhD) preferred.
?Must have strong interpersonal skills needed to work in a team environment.  
?Able to work independently; meet deadlines, demonstrate effective use of time, and handle multiple assignments simultaneously.
?Understands clinical drug development process, including clinical trial design, operations, and results analysis.
Knowledge of regulatory guidances relevant to medical writing.
?Strong verbal and written communications skills.  
?Proficient in use of Microsoft Word, Adobe Acrobat, Microsoft PowerPoint, and other standard software used for data analysis and writing of regulatory documents.
?Careful attention to detail and accuracy.
Prior experience of clinical trial disclosure process or oncology therapeutic area is a plus