Clinical Dev Sr Mgr
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This candidate offers a unique blend of experience and scientific training that is highly suitable for application in a client-service environment. Her experience spans therapeutic areas, product lifecycles, document types, audiences, and geographic territories, giving her unique insight to acquire effective project briefs to facilitate timely document preparation. She has successfully led writing teams by accurately identifying resource needs, assessing potential cross-project efficiencies, and developing accurate project timelines. She effectively manages direct reports to help increase team productivity and encourage professional development. This breadth has given her the insight to find creative, yet compliant approaches to facilitate document completion.
- After taking over the leadership of the medical writing team supporting a product with 5 indications, she led the team’s growth from 3 members to 6. Productivity increased more than linearly, only in part due to the increased headcount. Productivity also increased due to her identification of cross-project and cross-indication efficiencies, and encouragement in more appropriate targeting of publication submissions, thereby minimizing undue rework of documents. As a result, the medical writing team under her leadership was among the most productive teams in the department, while achieving the product team’s goals of publication in prestigious journals and medical conferences.
- Two years ago she was asked to fly to the United States to help drive completion of a response document to the Centers for Medicare and Medicaid Services, the major reimbursement authority in the US. By applying her extensive knowledge of document preparation, she partnered with the clinical and health economic senior executives team to define the document objectives, key messages, supportive data, and appropriate logic flow for arguments, all to help define the outline. As a result, the document was successfully completed and submitted within 3 weeks.
- She has been able to effectively project, and then manage the resources needed to successfully accomplish project plans for products. This included the management of yearly budgets in the high six-figure range, and identifying cost effective and resource efficient means to accomplish planned activities.
- She is also a highly productive writer, having completed over 30 clinical study reports and over 100 manuscript equivalents (a capacity measurement developed for resourcing purposes, using completion of 1 manuscript as reference measure). She has also written documents for reimbursement authorities and clinical societies. Much of this work was accomplished while simultaneously managing a medical writing team.
This candidate is seeking a medical writing group leadership role that brings greater responsibility, challenge, and opportunity than her current employer. Her interest is in a position that focuses on clinical and regulatory documents, and she is interested in international opportunities.
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