Associate Manager - Regulatory Solutions

EDUCATION: MBBS/PhD/MDS/BDS/MPharm/PharmD

EXPERIENCE: 10 to 12 years experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5)

ROLE PURPOSE: This role is responsible for handling complex Medical Writing projects and provide review support for medical writing deliverables that support the clinical regulatory writing portfolio along with training the junior writers.
SKILLS:
Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs,) protocols, amendments, ICFs & amendements, and Investigator Brochures (IBs)
Demonstrated excellence in focused/lean writing and editing following defined processes and templates
Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questions
Understanding of clinical development process from program panning to submission, including clinical trial design
Communication skills commensurate with a professional working environment
Effective time management, organizational, and interpersonal skills
People management experience for more than 2 years
Customer focus
Comfortable following directions, templates, and structured processes for delivering documents for review and finalization
Able to work independently while maintaining communication with the Sponsor s MW project manager
Ability to move across Therapeutic Areas to support business continuity and resource needs
Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines
Develop work plan and ensure adherence
Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion
Adherence to processes and Sponsor-defined best practices
Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements

KNOWLEDGE REQUIREMENT:

Scientific Knowledge
Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States
Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries)
Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science
Understanding of medical practices regarding procedures, medications, and treatment for different disease states
Manage messaging for consistency with historical information and in alignment with agreed-upon strategy
Capable of providing insight, alternatives, and suggestions based on previous experiences
Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring
Experience writing protocols, amendments, CSR, and CTD summary documents

Technology Skills
Expert authoring in MS Word, understanding of MS Word functionality
Experience working in document management systems; managing workflows eApproval/signatures
Experience working with Word add-ins that facilitate the management of fonts, styles, references, etc.
Flexibility in adapting to new tools and technology
Capable of training writers/authors on the use of templates, guidelines, and tools

RESPONSIBILITIES:
Without guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission documents (Module 2 summarries), and other regulatory documents on investigational drugs in various stages of clinical development
Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of authoring process
Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines
Develop and maintain project plans & work plan for the team members
People management
Work as an active member of cross-functional teams representing Medical Writing
Coordinate and deliver document kick-off meetings with writers and cross-functional representatives
Ensure adherence to standard content, lean authoring, and messaging across team members
Ensure communication between members remain open and information is disseminated appropriately
Possible participation in the orientation and coaching of junior team members
Conduct appropriate literature searches and screening, as needed
Participate on Medical Writing department initiatives, as appropriate.
Research regulatory requirements to remain current in the regulatory landscape
Share lessons learned and best practices
Ensure compliance with company training and time reporting