Associate Director, Medical Writer

Responsibilities

• 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.
• Involves in MW process and tool development and training of colleagues.
• Affords 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.
• Assists other departments with writing projects on an ad-hoc basis.

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 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.

Pay

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.