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PRIMARY PURPOSE OF POSITION:

Manage the medical and other technical writing needs for Clinical Development. Partner with the appropriate medical monitors and other clinical staff to determine project needs to effectively write, edit, and/or review and QC clinical documents including, but not limited to, clinical study reports, investigator brochures, protocols, integrated regulatory summary documents, standard operating procedures (SOPs), and guideline documents. This position will create documents that effectively and clearly convey clinical and scientific data, ensuring that such documents comply with regulatory guidelines in terms of content, structure, and style.

Evaluate workflow and delivery targets to determine resource needs. Retain appropriate resources and oversee contract medical writers as needed to support program initiatives and meet project deadlines in a timely manner.

This position is equivalent to a manager level and receives assignments in the form of objectives and establishes goals to meet objectives. Incumbent provides guidance to subordinates to achieve goals in accordance with established policies. The work is reviewed and measured based on meeting objectives and schedules. Establishes and recommends changes to policies which affect subordinate organizations.

Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.

MAJOR DUTIES OF POSITION:

Create and update high-quality clinical documents that support clinical program goals and objectives that may include such documents as investigator brochures, protocols, clinical study reports, and safety narratives.

Evaluate and determine workload and retain appropriate contract support to ensure project deadlines are not negatively impacted.

Oversee the work of contract staff to ensure alignment with project deliverables.

Evaluate draft documents and prepare summary of statistical output for accuracy and consistency.

Responsible for researching, writing, editing, and QC of clinical reports

Summarize data from clinical studies for submission to the FDA or other Regulatory Authorities and for publication and/or presentation.

Develop and update SOPs in accordance to technical and industry standards.

Develop and update formats and guidelines for clinical documentation.

Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.

Other duties as assigned.

KNOWLEDGE AND SKILL REQUIREMENTS:

Bachelor degree with at least 8+ years in biotech/pharmaceutical medical writer.

Previous experience managing medical writers is preferred.

Knowledge of, or aptitude for understanding medicine; familiarity with the drug development process and regulatory documentation.

Understand drug development including the various trial phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission.

Knowledge of FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production.

Must be able to gather and synthesize large amounts of data.

Attention to detail and produces accurate work, even when under pressure; check the accuracy of information before using it or passing it on to others

Demonstrated ability to write clear, concise, and effective clinical documents, including the ability to turn data into visuals that convey the key messages and to communicate complex information effectively and accurately.

Understand the role of various documents relevant to drug development in an international environment.

Must have excellent verbal and written communication, interpersonal and training skills.

Excellent organizational, problem solving; excellent writing and editing skills are required.

Proven ability to establish collaborative working relationships in a team environment.

Proficient computer skills, with applications such as MS Office that include Word, PowerPoint, and Outlook. Competency in a software application for managing references.

Must possess the ability to effectively manage multiple projects.

Personal attributes required include:

Flexibility and integrity
Goal oriented and self-starter
Practical approach to problem solving
Demonstrated good judgment and decision-making experience
Collaborative and team-oriented.

A writing assessment will be administered prior to scheduled interviews