Description
The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development.
As a strategic partner to senior clinical leadership, you will be accountable for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program.
You will also be responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analysing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience in a compelling fashion with accuracy and consistency.
Main Responsibilities and Accountabilities
- Leads the Medical Writing contributions to assigned therapeutic area(s).
- Maintains a collaborative and strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinical Safety Physicians to ensure understanding of Clinical Development strategy for the therapeutic area and the nature of medical writing services required to deliver on company objectives.
- Critiques ability of product strategy to deliver on business objectives or meet regulatory needs, and identifies where new or alternative arguments are needed.
- Leads cross-functional teams to develop a messaging strategy across a program of work.
- Ensures the efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines.
- Forecasts, budgets, and allocates resources.
- Manages Senior Medical Writers and Medical Writers within therapeutic area(s), coaching, training and mentoring staff.
Requirements
- Post-graduate qualifications (PhD or MD preferred).
- A minimum of 8 years medical writing experience within the biopharmaceutical industry or a contract research organization.
- A minimum of 3 years in a supervisory role.
- Comprehensive understanding of the clinical development process, including required documents at each stage.
- Comprehensive understanding of medical writing processes, standards and issues.
- Demonstrated track record in cross-functional, multicultural and international clinical trial teams.
- Excellent verbal, written and presentation skills.
- Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
- Prior experience with submissions in Common Technical Document (CTD) format.
- Knowledge of eTechnology related to regulatory submission activities.
- Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.