Principal Medical Writer

Develops, writes, and edits clinical regulatory and /or scientific writing documents. Performs peer review and editing of clinical regulatory and/or scientific writing documents.
Ensures effective resolutions of issues.
Leads medical writing activities associated with multiple studies and/or of other team members.

Manages resources and resource projections to ensure project teams are consistent with client needs, expectations, and contractual obligations.
Identifies out of scope work to contribute to project profitability and margins.

Provides leadership, training, guidance, and support to medical writing staff.
Participates in business development activities in relation to medical writing domain.

Having wide-ranging experience, uses professional concepts and knowledge of company objectives to resolve complex issues in creative and effective ways.
Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
Exercises judgment in selecting methods, techniques, and evaluation criteria for obtaining results.
Networks with senior leadership outside area of expertise.

Qualifications:
Required:

Master's or post doctoral degree or international equivalent in life sciences
10 to 13 years of relevant experience in Regulatory Medical Writing
Advanced knowledge of pharmacokinetics, pharmacodynamics, and statistical principles
Advanced knowledge of drug development process, clinical research design and methodology

In-depth understanding of ICH GCP guidelines, federal and local regulations
Advanced proofreading, editing and literature search skills
Excellent written and oral communication skills
Excellent attention to detail
Ability to solve complex problems
Advanced ability to effectively manage multiple tasks and projects
Ability to lead and coordinate small teams