Penfield Search Partners
Contact: Allie Spink – aspink@penfieldsearch.com
Required Leadership and Expertise:
- Expert medical writing consultant
- Medical Writing point of contact for one or more assets. May help with prioritizing workload across an asset or group of assets to deliver MW portfolio.
- Lead matrix team in the delivery of high quality, fit-for-purpose clinical and regulatory documents that accurately reflect associated data and are in line with internal standards and global/regional/local regulatory requirements, while demonstrating high performance standards and encouraging similar standards across the matrix teams.
- Drive, promote and implement key organizational process improvement initiatives. Proactively generate ideas for process improvement.
- May contribute to development of training materials for clinical documentation and submission planning.
- Drive quality, efficiency and effective teamwork across all document teams.
- Develop, prioritize and successfully meet deadlines across multiple project teams with attention to detail. Work closely with submissions leads to provide significant contribution to complex clinical submission documents, document strategy and document delivery.
- Promote team effectiveness across assigned projects.
- Possess highly effective communication skills. Capable of clearly presenting ideas and data to a group, including key stakeholders at senior level or external venues.
- Suggest resourcing strategy to meet anticipated deliverables for assigned assets.
- Suggest process improvement, training, quality and compliance through ideas and proactive engagement in the matrix team.
- Strong understanding and ability to incorporate organizational considerations into strategic and operational decisions.
- Demonstrated track record of quality decision making and creative problem resolution that impacts program/project direction.
Strongly Preferred:
- 7-years Regulatory Medical Writing Experience
- Post-graduate degree in life sciences