Director, Scientific Writing

Proclinical is currently recruiting for a Director of Scientific Writing with a research company located in San Diego, CA. As the Scientific Writing Director, you will provide leadership, operational oversight, and subject matter expertise to the scientific/medical writing team and oversee the writing services delivered to sponsors, academic partners and other stakeholders.

Job Responsibilities:

• Lead team in the timely delivery of high-quality clinical research documents across all phases of clinical drug and device development that accurately reflect associated data and are in line with the applicable standards and global/regional/local regulatory requirements. This includes but is not restricted to: protocols, investigator brochures, clinical development plans, clinical study reports, Informed Consent Forms, study data analysis and reports.
• Coordinate functional and quality control reviews to ensure high quality of deliverables.
• Ensure timelines and deliverables are met across all regulatory writing projects.
• Support provision of regular progress updates to sponsors and other stakeholders.
• Support transition to Operations team of new study protocols.
• Support corporate public relations by providing editing services for conference, industry papers and presentations.
• Act as primary contact and liaison with external publication executives, illustrators, designers, and editors representing the Scientists/Investigators, Sponsors and/or the corporation with external specialists to select publication content, address content change requests, complete written revisions and/or resolve competing content requirements.
• Lead, drive, promote and implement key process improvement initiatives within the writing group and involving cross functional collaboration.
• Develop and document resourcing strategies to meet team objectives and deliverables; initiate and implement third party resourcing agreements and oversee contract medical writers.
• Motivate, influence, and advocate for medical writers, team members and senior stakeholders to effectively contribute to and review documents.
• Provide ongoing support to staff in the areas of work allocation, resource planning, training and development, process development, expense management, employee engagement and performance management (staff role development, evaluations, performance improvement and lost time management).

Skills and Requirements:

• Undergraduate university degree (Bachelor or Honors Bachelor) and/or a minimum of 8 years related experience and training/continuous ongoing development.
• Master's degree or PhD within a relevant discipline preferred.
• 10+ years industry or consulting experience in Life/Health Science Research or Writing.
• Excellent verbal and written communication skills.
• Proficiency in relevant software such as MS office (Word, Excel and PowerPoint).
• Exceptional organizational skills and attention to detail.
• Enthusiasm to learn and motivation to develop oneself and others.
• Ability to effectively work in a matrix environment and flexibility to adapt to client project needs in a fast-paced, entrepreneurial workplace.

If you are having difficulty in applying or if you have any questions, please contact Oliver Jones at o.jones@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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