Job Description

Our Client, an industry-unique biotech / pharma client is looking for a Sr. Manager, Medical Writing (RTH) for their NNJ offices.

The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. As the Lead Medical Writer, the incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the compounds' life cycle management, with support from management as needed. The qualified candidate will have proven ability to effectively manage the outsourcing of document preparation when necessary and the associated service providers. Essential Functions Responsibilities Include but are not limited to: Independently preparing PCS, protocols, and protocol amendments often acting as the compound lead Independently preparing all sections of the CSRs, including narratives, working across functional areas to obtain all applicable source material Routinely engaging clinical research and biostatistics to gain comprehensive understanding of study design, objectives and results Providing guidance to other medical writers applying industry and medical writing best practices With minimal supervision, preparing the clinical sections of submissions documents such as briefing books, Global Investigator Brochures (GIB) and annual regulatory reports Contributing to the writing of marketing application submission documents Managing processes for obtaining feedback for improvements for the document standards and structure Providing mgmt. with appropriate information to ensure procurement of adequate and timely resources to complete medical writing deliverables At the Director's discretion, may provide work direction to contractors/consultants Contributing to process improvement within and across functional areas Influencing medical writing strategies and processes within and across functional areas Working with teams to develop project specific metrics compliant with standard project metrics Monitoring and evaluating project metrics, escalating issues as needed Requirements Bachelor's Degree required; an advanced degree is preferred. Minimum of 5-8 years' medical writing experience in assigned therapeutic area, with specific experience with targeted compounds preferred Must have participated in a major marketing application submission Strong critical thinking and problem solving skills Self-motivated with the ability to influence others Ability to multitask Result driven with the ability to demonstrate time management and project planning Advanced working knowledge of MS project and MS Word Experienced in the use of a document management systems For more info on this & other exciting roles please contact me

-- > MARC LEVINE -- > C: 914-262-5142 -- > E: marc.levine@yoh.com #ZIP-SPG

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

Company Description

Investment Management Company