Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. We have built a culture where innovative and talented people thrive—focusing a significant effort on attracting and retaining passionate and motivated employees who want to play a role in helping people with serious health conditions and who see this effort as personally rewarding. In our highly entrepreneurial environment, employees are empowered and the opportunity for professional development occurs every day.

The Associate Director Medical Writing supports Celldex’s 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.

• Will lead teams in the timely delivery of high quality clinical research documents across all phases of clinical drug development. This includes but is not limited to: protocols, clinical study reports, Investigator’s Brochures, and clinical summary modules.
• Uses strong knowledge of regulatory guidance to instruct the project team accordingly to prepare a high-quality, regulatory compliant document.
• Involved in MW process and tool development and training of colleagues
• Assumes a lead role in creation, execution and monitoring of complex documents, project plans, management of timelines, and coordination of review meetings. Plans and coordinates timely review, revision and approval of clinical documents
• Involved in developing style guidelines, department SOPs, and document templates.
• Remains abreast of new regulatory guidance, industry trends, and technology and shares with the department and cross-functionally.
• Leads process improvements related to creation and maintenance of clinical documentation and document management.
• Assist other departments with writing projects on an ad-hoc basis.
• Must be able to work on-site, attend business meetings, or travel between Celldex locations for business as required.

• 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 are strongly preferred.
• Must have 5 or more years of experience as a medical writer preparing clinical regulatory submission documents.
• 3+ years’ experience in leading, developing and managing a team or equivalent vendor oversight.
• Experienced 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.
  
  

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