Principal Medical Writer

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.  

About The Role:

Reporting to Associate Director - Medical Writing, Principal Medical Writer is responsible for developing, writing, editing, and reviewing clinical regulatory and scientific writing documents, provide leadership, training, guidance, and support to medical writing staff, participates in business development activities in relation to medical writing domain.

What You Will Do:

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

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy,  gender identity or gender expression), sexual orientation,  parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.