8 Dorchester Rd
Direct Hire - Senior Manager, Medical Writing NEUROSCIENCE
Woodcliff Lake, NJ
The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Neuroscience 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.
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
Job Qualifications - Bachelor's Degree required; an advanced degree is preferred.
- Minimum of 5 years' medical writing experience in CNS, with specific experience with compounds targeted for epilepsy preferred
- 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
- Able to work on site
- Advanced working knowledge of MS project and MS Word
- Experienced in the use of a document management system
- Less than 10% travel
Ascent is a leading national technology consulting and professional services firm that focuses on tactical and strategic consulting. Ascent s fundamental business is providing staffing services to Large Enterprise clients in our core market verticals: Financial Services, Healthcare, and Life Sciences. We focus the majority of our efforts in Staff Augmentation support of Large Enterprise Clients who utilize a Vendor Management System. Ascent works as both a reliable supplier in support of programs, as well as a Strategic Advisor in support of enterprise efforts to establish best in class preferred vendor programs. Ascent was ranked in the 2007 and 2008 Inc. 500 and recognized specifically for its innovative work in staff augmentation support of Large Enterprise preferred vendor accounts.
If you are ready to propel your career to new heights read on. We are looking for talented and dedicated colleagues to join our phenomenal team. At Ascent, we have created an environment where culture, commitment and opportunity converge to yield a truly unique place to work. We know that every employee has something important to say and that every employee is integral to our success. Where else can you walk over to a founder and talk about your ideas to help build our business and have that idea implemented in 48 hours? More importantly, we do everything we can to make sure our employees not only have great jobs, but great lives.
Associated topics: antibody, biomedical, biopharma, cytometry, drug, histologist, injury, metabolism, physiology, therapy
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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