The Director, Medical Writing will be responsible for leading and managing all efforts in writing and coordinating peer-reviewed scientific publications, clinical protocols and amendments, and other clinical and regulatory documents, including distribution of work to contract medical writers or agencies as needed. This is a manager position with team leadership responsibilities. The Director, Medical Writing will work closely with cross-functional teams to ensure the documents are high quality and completed in a timely fashion compliant with SOPs, Good Publication Practice, ICH/GCP/regulatory guidelines, and company goals. The individual must have the ability to lead a functional team and as an effective and engaged team member in a fast-paced environment. Strong initiative and follow-through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
Essential Duties & Responsibilities
Provide leadership and direction to the Medical Writing group. Manage workload, provide coaching and development, train the staff, and effectively allocate resources. Develop document compliance objectives and operational delivery model. Lead implementation of organizational infrastructure with document writing, review and approval processes and standards.
Ensure smooth and effective document management from start to finish (i.e., generation of a blank document to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., follow house style guide), and managing various processes (e.g., reviews, QC, QA, formatting, publishing, document archiving)
Work closely with internal and external resources to ensure alignment with timelines and data communication plans
Write, manage, and oversee the writing of clinical protocols and amendments
Contribute to the development of other clinical and regulatory documents (e.g., investigator brochures, clinical study reports, INDs, eCTD/NDA clinical summaries, briefing books)
Review, edit, and ensure quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards
Distill large amounts of clinical and scientific data into essential elements for graphical display
Partner with the lead author to oversee document review and comment resolution meetings with cross-functional teams
Formulate key messages from clinical study data
Develop best practices for authoring and reviewing
Perform other duties as assigned.
Core Competencies, Knowledge and Skill Requirements
Strong leadership, planning, and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support
Proven ability to develop and implement medical writing processes and standards
Demonstrated experience in medical writing, editing, and clinical development; previous work on protocols, IBs, CSRs a plus
Demonstrated ability to work effectively in a fast-paced environment with multiple high-priority projects
Exceptional oral and written communication skills
Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues
Flexible; adapts work style to meet organization needs
Strong organizational abilities and experience in a multitasking environment
Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust building behaviors in all dealings is essential and required.
Must have excellent customer-service orientation, high degree of professionalism, and ability to work with limited direction
Daily demonstrates a positive, can-do and service-oriented attitude. Strong oral and written communicator; detail-oriented with a commitment to accuracy.
Self-motivated, with initiative and the ability to take ownership of, and follow-through with, specific tasks
Ability to multi-task and shift priorities quickly while working under tight deadlines
Skilled in developing collaborative internal and external relationships
Required skill in the operation of standard office equipment including: fax machines, copy machines and other equipment as necessary
Strong PC experience and demonstrated proficiency in MS Office (Outlook, Word, Excel, PowerPoint)
Communication & Interpersonal Skills
Excellent verbal and written communication skills, as the position will interface potentially key opinion leaders and employees
Ability to effectively communicate, collaborate and deliver an excellent work product in a fast paced, and rapidly growing dynamic company
Employees across the Roivant companies, visitors
BS, MS, or doctorate in a scientific or medical field
Related graduate degrees are preferred
Minimum of 10 years in the biotechnology/pharmaceutical industry
At least 5 years of experience managing Medical Writing is preferred