Sr. Director/Director, Medical Writing
NKMax America is seeking an experienced and energetic individual to fulfill the role of a Sr. Director/Director, Medical Writing. This successful individual will be responsible for the oversight, development, strategy, and planning of the medical writing discipline. Duties for this position include managing, coordinating, and/or authoring medical writing deliverables (clinical/regulatory) on the document-level (e.g., study protocols, investigator’s brochures, clinical study reports, clinical sections of the regulatory applications), as well as clinical/nonclinical publications (e.g., abstracts, posters, and manuscripts). He/she will contribute to the development and implementation of best practices (departmental processes, standards, document templates, electronic document systems, other tools) as necessary. This position may assume lead writing responsibility on certain projects, as appropriate.
The Sr. Director/Director, Medical Writing is also accountable for the oversight of external medical writing resources (CRO, independent consultants) and will assist with the oversight of QC resources (internal/external) to ensure the timely delivery of high quality documents.
Under direction from the Chief Medical Officer, and in collaboration with the Director, Regulatory Affairs, the Sr. Director/Director, Medical Writing will:
- Maintain oversight of development and preparation of clinical protocols and clinical study reports (Module 5), clinical sections (Module 2) of IND, investigator’s brochures, and/or other documents as clearly defined.
- Assess the feasibility, budget, planning, and identification and qualification of resources including outsourced initiatives.
- Develop and oversee timelines and metrics for document development, revision, and review.
- Lead or oversee discussions for document finalization.
- Oversee document writing tools, systems, and standards used by medical writing, including the oversight and/or training of medical writing templates, tools (e.g., style guides), SOPs, and processes within the function and company.
- Oversee and implement QC review of documents to ensure completeness, compliance, accuracy, and quality of data presentation.
- Provide guidance to project teams and medical writing staff regarding problem resolution related to document development, review, and approval.
- Provide subject matter expertise in the Medical Writing discipline to both internal and external stakeholders.
- Develop, mentor and support Medical Writing staff including training and career development.
- Work effectively with colleagues from other disciplines in a team setting.
*The company reserves the right to add or change duties at any time.
Job Qualifications & Skills
- Minimally a Bachelor’s degree in scientific field or equivalent combination of education and related work experience. Advanced scientific degree is a plus.
- A minimum of 15 years of Medical Writing experience in the pharmaceutical/biotechnology industry or CRO environment.
- Experience writing (and/or managing) clinical-regulatory documents including IND/NDA/BLA/CTA/MAA clinical sections in eCTD format, CSRs, clinical protocols, Investigator’s Brochures.
- Experience leading regulatory submissions and submission writing teams. Proven ability to manage a department including headcount, workload, resource allocation, prioritization, budget, timelines, career development.
- Sound knowledge of clinical research (ICH/GCP), regulatory affairs (FDA/EMA), CTD requirements, medical terminology.
- Exceptional organizational, communication, managerial, interpersonal skills.
- Proven ability to understand and summarize clinical data.
- Expertise in MS Office, other publishing software, document management and document review systems.
- Experience working on complex projects within cross-functional teams and under tight time constraints.
Benefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!