Senior Director Medical Writing, Clinical Transparency, and Document Quality
Job Summary - a concise overview of the job
The Senior Director Medical Writing, Clinical Transparency, and Document Quality is a leadership role that will be responsible for developing and implementing medical writing strategies, operational plans and innovative solutions for all medical writing, clinical transparency and document quality control activities. Establishes and directs staff responsible for documents and global Clinical Trial Disclosure and Transparency. Sets standardization requirements in compliance with regulations and ensures adherence to said requirements. Tracks and prioritizes writing projects and activities related to disclosure and transparency. Continually works with management to develop a strategy and refine the direction for the department. Role is responsible for managing internal and external resources, coordinating timelines for production of regulatory submission documents. Ensures that medical writing activities are coordinated with other departments, including R&D Strategy, Clinical Operations, PVRM, Regulatory Affairs, Medical Affairs and other groups. This role coordinates with Regulatory Affairs and Regulatory Operations group on timelines for publishing technical documents and, for certain projects, this individual may assume the writing responsibilities. Regulatory submission documents include, but are not limited to, clinical protocols, clinical study reports, Investigator’s Brochure(s), clinical, preclinical and CMC sections of INDs/CTAs, BLAs, NDAs, ANDAs and Regulatory Authority Briefing Packages. This position will support various writing needs globally across the R&D organization. The individual facilitates comment resolution with contributing authors/reviewers when necessary and is responsible for driving process improvements both within the R&D Operations group and cross-functionally within R&D. Develops and manages interpersonal relationships in working globally with the company leadership, cross-functional teams, and cross-internal company groups to provide medical writing, DQC, and system level support.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.
Oversight of global Clinical Trial Disclosure and Data Transparency and outsourcing of medical writing activities. Direct management of a team of internal and external resources (consultant writers), and coordinating timelines for production of regulatory submission documents.
Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time
% of Time
Management of Medical Writing & Document Quality Control Teams
§ Direct management of internal and external writing, consultant writers and document quality control (DQC) resources on activities that include coordinating contracts, budgets and writing and reviewing assignments.
§ Develop strategies and manage execution of external support for the internal team with Contract Research Organizations (CRO), or other external resources including in various locations globally.
§ Ensures that timing of project deliverables aligns with project timelines.
§ Establishes standard document quality control (DQC) system of review of various regulatory and medical documents and oversees management of the process.
§ Provides support for QC of complex clinical, nonclinical, and regulatory documents.
§ Actively foster a can-do attitude to drive exceptional performance and continuous improvement.
§ Sets the standards for department guidelines, templates, timelines and SOPs, ensuring that they are in compliance with applicable regulatory guidance and industry standards.
Regulatory Submission Documentation
§ Coordinates with cross-functional teams (and/or external consultants, as needed) and directly contributes to preparation of regulatory submission documents including clinical protocols, clinical study reports and narratives, Investigator Brochure(s), integrated summary documents for clinical, preclinical and CMC sections of ANDA, BLAs, INDs, MAAs, and NDAs, Regulatory Authority Briefing Packages, health authority responses, and Plain Language Summaries (PLS).
§ Provides a strong presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice with respect to reporting activities.
§ Ensures development and maintenance of SOPs that document requirements for completion of regulatory submission ready documents and associated writing tools such as templates and style guides.
Study Team Meeting and TA meetings
§ Represents Medical Writing and Clinical Trial Disclosure and Transparency at cross-company and TA meetings.
§ Establishes and manages key timelines and communicates with team stakeholders to maintain awareness of expectations, milestones, and deliverables.
§ Ensures appropriate communication and involvement across functions, therapeutic areas, internal/outsourced Medical Writers and support staff to create clear accountability for high quality, multidisciplinary documents submitted to regulatory agencies worldwide.
§ Provides training and communications to internal stakeholders and providers regarding medical writing process, best practices and process improvements.
§ Responsible for the strategy and content of high-level submission documents.
System Owner – Collaborative Review Software
§ System owner of cloud based real-time document collaboration software for R&D organizations.
§ Responsible for account creation, management, oversight, and training for all internal and external users.
§ Subject matter expert for system implementation and execution options to engage and support other groups
Plain Language Summaries
§ Responsible for coordinating, managing, and scaling-up the end-to-end process of implementing PLS of clinical study results in compliance with procedural documents and local standards and requirements.
§ Development and implementation of process, standards and training of all stakeholders involved in the clinical trial summary (CTS) PLS.
§ Provides guidance and leadership to ensure all PLS activities are performed on time.
Disclosure and Data Transparency
§ Support and lead efforts for Data disclosure/transparency and Data Anonymization (de-identification)
§ Develop anonymization strategy and the creation of a data anonymization plan for the clinical documents from their initial stages, focusing on the balance between scientific value and risk of re-identification.
§ Provide guidance and leadership to Clinical Trial Disclosure staff, providing oversight and ensures alignment of activities that are performed on time and development and implementation of processes, standards and training materials for Disclosure and Transparency activities.
§ Oversees global clinical trial disclosure with regard to clinical trial result postings.
Scientific Communications Support
§ Provides guidance and leadership to DQC staff
§ Supervising the writing of congress presentations and manuscripts as applicable.
§ Facilitates comment resolution with contributing authors/reviewers/ consultant writers when necessary.
§ Provides resource documentation and allocate DQC assignments and staffing in support of all MLRQ project quality reviews.
§ Collaborates with Scientific Communications on an as-needed basis for special projects.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ Advanced scientific degree (PhD, PharmD, or MS) is preferred.
§ At least 10 years of pharmaceutical writing experience.
§ Experience in the following areas of medical writing: briefing books/meeting request, clinical protocols, clinical study reports, Investigator’s Brochure(s), clinical sections of ANDAs, BLAs, INDs, IMPDs and NDAs (ISS/ISE), in particular experienced with submission strategy and content of high-level summary documents, health authority responses, and manuscripts.
§ Experience in data analysis and presentation, statistical analysis, as well as quality control of representative data analyses/displays against raw data.
§ Experience with e-CTD and electronic-Document Management Systems.
§ Experience in SOP and process development with regard to above mentioned activities.
§ Prior experience in a variety of therapeutic areas.
§ Demonstrated supervisory and vendor management experience.
§ Strong project management and organizational skills: Strong organizational/prioritization skills for the management of multiple concurrent projects.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ In depth level of understanding of the drug development process including R&D process and objectives.
§ Must have knowledge of FDA regulations/guidelines and ICH guidelines.
§ Knowledge of e-CTD requirements with respect to structure, format, and content requirements.
§ Knowledge of rules and regulations pertaining clinical trial disclosure.
§ Knowledgeable in preclinical development including discovery, toxicology etc.
§ Excellent skills using MS Word, PowerPoint and Electronic –Document-Management systems (EDMS).
§ Knowledge of AMA Style Guide.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
§ Possess excellent oral and written communication skills to establish and maintain close contacts and good communication with internal and external customers.
§ Must possess leadership skills and must display professionalism to effectively deal with sensitive issues, provide positive interaction and commitments to internal and external departments and partners.
§ Ability to provide direction with cross-functional teams in highly matrixes team environment, collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization.
§ Excellent organizational and problem-solving skills to work independently, identify problems, and aid in their resolution.
§ Must have a vision and leadership ability to deliver results.
§ Must be comfortable with anticipating and managing change.
§ Must have high personal values and ethical standards.
§ Must have a results-oriented work ethic and a positive attitude.
§ Must have ability to work productively in a cross- functional team environment and motivate others.
§ Experienced in resource planning and management experience with virtual teams, employees based in field locations, and functional service providers.
§ Ability to work in with a globally based team.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Ability to work from remote based office as well in office environment.