Director/Senior Director, Medical Writing

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Director/Senior Director, Medical Writing 4 days ago Be among the first 25 applicants Get AI-powered advice on this job and more exclusive features. The Director/Senior Director of Medical Writing will support Celldex clinical development programs through strategic and efficient management of medical writing projects, medical writing vendors, generation of documents relevant to clinical research, and meeting overall portfolio goals.
Making sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.
Responsibilities
Leads, directs and expands, as needed, the medical writing organization responsible for the generation of clinical regulatory documents including, but not limited to briefing documents, IND annual reports, Investigator's Brochures, clinical protocols and amendments, clinical study reports, scientific manuscripts and abstracts. Coordinates all Medical Writing activities, including planning of resources, oversight of vendor(s), budget, QC activities, and other duties to ensure we maintain cost, quality and time. Assume a lead role in creation, execution and monitoring of complex documents, project plans, management of timelines, and coordination of review meetings. Plan and coordinate timely review, revision and approval of clinical documents. Ensures compliance with applicable regulatory guidance, develops style guidelines, departmental SOPs, and document templates; remain abreast of professional information and technology. Lead process improvements related to creation and maintenance of clinical documentation. Assist other departments with writing projects on an ad-hoc basis. Partial remote work can be accommodated. Must be able to work on-site, attend business meetings, and travel between Celldex locations and for business as required.
Qualifications
Completed BA/BS degree is required, with a concentration in a scientific or health care field preferred. Later phase writing experience (e.g., Phase 3) and BLA/NDA experience in oncology are strongly preferred. Must have 5-10 or more years of experience as a medical writer preparing clinical regulatory submission documents. 3+ year experience in leading, developing and managing a team or equivalent vendor oversight. Experience in medical writing project leadership roles for complex submissions, preferably within the field of immunology. Demonstrated ability to meet project goals within a matrix environment. Lead document writing and related work for clinical development projects. Strong analytical mind, excellent written/verbal communication skills, attention to detail, organizational skills, and ability to work independently and as part of a team. Strong document management skills, including proficiency with MS Word, EndNote, and Excel.
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.Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
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Location:
New Haven

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