The Associate Director, Medical Writing will be responsible for representing Medical Writing in one or more therapeutic areas, overseeing more junior writers working on documents in their therapeutic area, and leading the MedicalWriting effort in a clinical filing. The Associate Director will be responsible for working with more senior members of the Medical Writing staff to help produce department guidelines, templates, standard timelines and SOPs that comply with regulatory guidelines. They will be responsible for ensuring adherence to said guidelines templates, timelines and SOPs for all Medical Writing documents provided for their therapeutic area, and they will be responsible for the management and development of staff including performance management, and training. The individual in this position will work independently writing CSRs, CSPs, CSP amendments, and Clinical Summaries in a variety of therapeutic areas, as well as manage a group of more junior writers.
- Leads all Medical Writing deliverable work for a therapeutic area, compound, or indication
- Working with the clinical team, the Associate Director, Medical Writing will be responsible for writing Clinical Study Protocols (CSPs), Clinical Study Protocol Amendments, Clinical Study Reports (CSRs), Patient Safety Narratives, Clinical Summaries, and other documents, as needed
- Represents Medical Writing at cross-company and TA meetings.
- Schedules and leads meetings
- Participants look to this person for actions and decisions
- Articulates document strategy and timelines
- Identifies the correct parties for a document content decision, and if a discussion is faltering, bring the discussion back on track with minimal fuss.
- Follows a discussion to its conclusion, synthesize the message, and present clear accurate prose quickly.
- Oversees/Leads Regulatory Submission document writing
- Manages processes and organize priorities; Solve problems; Foster collaboration to resolve conflict
- Take ownership for leading, challenging, and developing Medical Writing team
- Collaborates with Management to set the requirements for department guidelines, templates, timelines, and SOPs to ensure compliance with applicable regulatory guidance and industry standards.
- Responsible for the management and development of staff including: performance management, recruiting, coaching, and training.
- Develops and implements continual process improvement in departmental and company procedures
- Strong organization, time management and detail-oriented skills needed to work in a stressful environment under tight deadlines while maintaining focus on quality
- Applies good judgment and demonstrates initiative to resolve issues
- Raises issues/concerns to supervisor, as appropriate
- Good working knowledge of MS Office. Skilled in use of MS Word and Excel.
- Have used 1 or more EDMS systems.
Minimum Years of Experience
- Minimum of 8+ years of industry experience to include a minimum of 6+ years of Medical Writing experience.
- 3+ years of management experience.