Overview

The Associate Director, Medical Writer at Celldex will lead the development and management of complex clinical and regulatory documents, including protocols, investigator brochures, study reports, and regulatory submissions for our immunology programs. This role requires extensive medical writing expertise, cross-functional project leadership, and the ability to drive timelines and ensure compliance with regulatory standards in a fast-paced clinical development environment

Responsibilities

• 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.
• 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.
• Research and ensure compliance with applicable regulatory guidance, style guidelines and departmental SOPs; remain abreast of professional information and technology.
• Contribute to 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's locations and for business as required

Qualifications

• Completed BA/BS degree is required, with a concentration in a scientific or health care field preferred.
• Must have 5-10 or more years of experience as a medical writer preparing clinical regulatory submission documents.
• Experience in medical writing project leadership roles for complex submissions, preferably within the field of immunology.
• Later phase writing experience (e.g., Phase 3) and BLA/NDA experience in immunology are strongly preferred
• 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.

Compensation

The expected base salary range for this position is $153,616 to $199,501

We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.

Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.

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