Head of Medical Writing Anacor Pharmaceuticals, Inc.
Head of Medical writing will manage a Medical Writing group of contract medical writers and develops, manages, and executes medical writing activities for projects in accordance with applicable regulatory and Anacor requirements. Assumes primary responsibility for preparation of clinical documents supporting clinical trial activities (protocols, IBs, CSRs, posters and presentations, etc). Coordinates, edits and evaluates the activities of other contributors (including contract writers and CROs). Maintains timelines and project manages clinical writing activities. Participates on relevant project teams and task forces, provides guidance on issues related to document preparation and production, and project- or therapeutic area-specific guidance relating to content and organization of documents. Responsible for development of associates (development plans, training, coaching and mentoring, as appropriate).
Lead development of all clinical documents (synopses, protocols, amendments, IBs, CSRs etc.). Focus on message-driven, concise clinical documents. Manage cross-function author input and data flow.
Write or coordinate writing and review of CSRs, IBs, narratives, clinical trial protocols, local working instructions, submission documents (ISS, ISE,), IBs, clinical section of the annual IND updates, and other documents as needed. Reviews SAP as needed.
Establish and enforce quality standards for documents. Ensure Quality control review of protocols, amendments, Clinical Study Reports, IBs and all clinical documents for regulatory submission.
Work effectively with other staff in Clinical Operations (e.g., Biostatistics, Data management, Clinical Monitoring), Regulatory Affairs and others in team situations.
Estimate resources needed and communicate with Vice President of Clinical Operations.
Manage external vendors as needed.
Establish target dates for completion of assignments. Communicate proactively with management when timelines are threatened.
Participate in process improvement and training initiatives. Supervise medical writing staff in execution of operational functions, including tracking and coordinating activities. Assist in professional development of medical writing staff.
Follow governmental regulations and company SOPs for document preparation.
College degree plus a minimum of 4-6 years experience in medical writing, preferably in the pharmaceutical industry.
Experience in Clinical Writing required. Evidence of the skills to manage a group of up to 5 medical writers.
Advanced science degree (eg, MS, PhD) or other related qualifications (eg, Pharm D, BSN) desirable.
Must have relevant medical/scientific knowledge, project management skills, analytical skills, knowledge of drug development and regulatory requirements, excellent written communication skills, computer skills, and ability to work as part of a team. The above are necessary to understand the depth and breadth of drug development issues.
Superior computer skills are a must, including high level word processing and graphic presentation capabilities. The ability to design and execute presentations, submission ready documents, and posters needed.
||Palo Alto, CA |