Senior Associate - Scientific Writing

KNOWLEDGE REQUIREMENT:

Scientific Knowledge
Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States
Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries)
Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science
Understanding of medical practices regarding procedures, medications, and treatment for different disease states
Manage messaging for consistency with historical information and in alignment with agreed-upon strategy
Capable of providing insight, alternatives, and suggestions based on previous experiences
Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring
Experience writing protocols, amendments, CSR, and CTD summary documents

Technology Skills
Expert authoring in MS Word, understanding of MS Word functionality
Experience working in document management systems; managing workflows eApproval/signatures
Experience working with Word add-ins that facilitate the management of fonts, styles, references, etc.
Flexibility in adapting to new tools and technology
Capable of training writers/authors on the use of templates, guidelines, and tools

RESPONSIBILITIES:
Without guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development
Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of authoring process
Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines
Develop and maintain project plans
Work as an active member of cross-functional teams representing Medical Writing
Coordinate and deliver document kick-off meetings with writers and cross-functional representatives
Ensure adherence to standard content, lean authoring, and messaging across team members
Ensure communication between members remain open and information is disseminated appropriately
Possible participation in the orientation and coaching of junior team members
Conduct appropriate literature searches and screening, as needed
Participate on Medical Writing department initiatives, as appropriate.
Research regulatory requirements to remain current in the regulatory landscape
Share lessons learned and best practices
Ensure compliance with company training and time reporting