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Associate Director, Medical Writing
The Associate Director, Medical Writing, is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the early clinical development requirements of a clinical program. The incumbent will work with the MW program lead to ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation.
This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions as needed. Work from home days possible.
Drives and develops the messaging strategy within the product development program to ensure effective communication (ie, protocols, briefing books, nonclinical [Modules 2.4 and 2.6] and clinical [Modules 2.7.1 and 2.7.2] for IND submissions and marketing applications) underpins successful product development.
- Represents medical writing on the team level to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process.
- Works with the MW program lead to develop a messaging strategy across a program of work.
- Analyzes proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.
- Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
- BA/BS or higher and at least 6 years of writing experience in the pharmaceutical industry; early clinical development experience preferred
- Exceptional written and oral communication skills and ability to write and edit complex material to ensure accuracy, clarity, and effectiveness
- A solid understanding of the clinical development process, with a focus on the early clinical development and non-clinical stages of development.
- Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
- Knowledge of ICH and CTD guidelines for nonclinical, clinical, and regulatory submission documents
Other Valuable Experience:
- Ability to think strategically with demonstrated negotiating skills and resourcefulness.
- Ability to manage several projects simultaneously.
- Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas.
- Strong influencing skills, able to lead without formal authority.
endevis, LLC. and all companies represented are Equal Opportunity Employers and do not discriminate against any employee or applicant for employment because of age, race, color, sex, religion, national origin, sexual orientation, gender identity and/or expression, status as a veteran, and basis of disability or any other federal, state or local protected class.