Senior Medical Writer (Regulatory)

Proclinical is seeking a Senior Medical Writer (Regulatory) for an innovative biotech company located in New Haven, CT.

Must be eligible to work in the US.

Job Responsibilities:

• Medical writing to include but not limited to annual reports, Investigator's Brochures, protocols/amendments, CSRs, manuscripts, regulatory submissions that reference/summarize clinical data.
• Researches, writes and edits pre-clinical and/or clinical reports, summarizing data from pre-clinical and/or clinical studies.
• Prepares clinical reports, summary documents, package inserts and other documents that may be submitted to the Food and Drug Administration and other regulatory authorities worldwide, for publication and/or presentation.
• Assists in the development of formats and guidelines for clinical documentation.
• May prepare scientific manuscripts, abstracts and posters.
• May also support clinical research associates and medical doctors in clinical protocol development.
• Keeps abreast of professional information and technology through conferences.
• Perform literature reviews and solicit input from medical, statistical and operational resources as necessary to support document content.
• May assist other departments (regulatory, research) with writing projects on an ad-hoc basis.
• Ability to assist with other clinical science activities (review of data to ensure cleanliness/appropriateness for analysis, QA of statistical output, and data compilation to support data summaries/presentations) considered a plus.

Skills and Requirements:

• Strong medical writing skills: takes ownership of document, organizes timeline, works with co-authors, resolves discrepancies and edits to achieve consistency, uses precise accurate language and grammar.
• Strong analytical mind, excellent written/verbal communication skills, attention to detail, and organizational skills.
• Knowledge of and experience in clinical development.
• Ability to work independently, prioritize, and multitask to meet timelines under changing conditions.
• Ability to collaborate in a matrixed environment and work as part of a cross-functional team.
• Ability to develop collaborative working relationships with contracted vendors.
• Strong document management skills, including proficiency with MS Word, EndNote, Excel, and PowerPoint.
• BA/BS/RN degree or equivalent in a scientific or health care field required. Advanced degree (MS, MPH, PhD, or PharmD)
• Preferred 3-5 years medical writing responsibilities
• Medical writing experience authoring clinical protocols/amendments, regulatory documents (IND sections, clinical study reports, Investigator's Brochures), as well as scientific publication and presentations.
• Experience in inflammatory/ immunologic diseases preferable.

If you are having difficulty in applying or if you have any questions, please contact Patrick Mooney at +(1) 619-963-2702 or p.mooney@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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