Overview
We work within a highly entrepreneurial environment where personal effort and contributions are rewarded and where communication and teamwork occur every day. 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.
Responsibilities
In addition to responsibilities listed in overview above:
Qualifications
Education/Experience:
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
Medical Writer/Senior Medical Writer • New Haven , CT, US
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