What are the responsibilities and job description for the Associate Director, Medical Writing Science (Temp-to-Perm) position at Lenox Executive Search?
Short-term Contract role with strong potential to extend and/or Convert to Permanent. Hybrid-3X/week onsite work required in Boston. Must have Strategic writing experience and have experience authoring an NDA and/or BLA. Pay rate range $80-$95/hour.
Lenox Executive Search is seeking an experienced AD, Medical Writing Science to fill an 2 month contractual role, with strong potential to convert to permanent or extend, with a global pharmaceutical company in Boston, MA. Must have experience with marketing authorization application regulatory submissions.
REQUIREMENTS for the Associate Director, Medical Writing Science:
- Bachelors degree with 8 years of work experience and 2 years of supervisory/management experience, or the equivalent combination of education and experience. Open to MS and PhD candidates.
- MUST HAVE strategic writing experience
- Experience authoring an NDA and/or a BLA
- Experience with a filing or label expansion
- Experience with marketing authorization application regulatory submissions
- Experience authoring a Briefing Book a big plus!
- Demonstrated aptitude for planning, managing, and optimizing department resources (e.g., staff, technology) to maximize and streamline the advancement of company goals and objectives
- Record of leadership, independence, and ability to solve non-routine, complex problems involving a broad range of issues
- Proven track record of anticipating potential problems and preparing contingency plans as needed
- Understanding of scientific disciplines beyond own specialty area
- Experience managing direct reports and guiding staff development
RESPONSIBILITIES for the Associate Director, Medical Writing Science:
The Associate Director, Medical Writing Science manages the overall operations of a team or major project and implements this through effective leadership. This role provides guidance and leadership for document development for regulatory filings and coordinates the clinical sections of more complex regulatory submissions, including organization, content, and resource requirements. This role applies advanced technical expertise and develops solutions to complex problems, fosters interdisciplinary understanding, and integrates Medical Writing Science department activities with those of other departments.
- Independently authors routine and complex clinical and regulatory documents
- Provides strategic input into program-level plans
- Deep insight into how different functions contribute to the successes of the team
- Aligns, coordinates, and builds consistent information and messages across clinical program(s)
- Provides leadership related to the activities of Medical Writing Science and manages a team
- Participates in developing and implementing goals and initiatives for Medical Writing Science
- Facilitates implementation of new technologies and initiatives related to the preparation of clinical documents
- Proactively anticipates risks, solves complex problems, and seeks out and implements process improvements
Pay: $80.00 - $95.00 per hour
Education:
- Bachelor's (Required)
Experience:
- Medical Writing Science: 8 years (Required)
- Strategic writing: 2 years (Required)
- NDA and/or BLA authoring: 2 years (Required)
- Briefing Book authoring: 1 year (Preferred)
- Leadership: 2 years (Required)
Ability to Commute:
- Boston, MA 02210 (Required)
Work Location: Hybrid remote in Boston, MA 02210
Salary : $80 - $95