The Senior Medical Writer provides innovative leadership to the cross-functional clinical program team, and drives the provision of medical writing services to a clinical program.
The incumbent is responsible for the efficient preparation of high-quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analyzing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency.
The incumbent will ensure that strategically aligned communication points are conveyed in medical writing deliverables and that the communication points are consistent across program documentation. He / she will mitigate risk associated with medical writing and disclosure processes by establishing and maintaining Best Practices and SOPs.
This role has global responsibilities, including participation in global teams and interaction with regulatory agencies in multiple regions. This role reports to the Director of Medical Writing and Disclosure.
Main Responsibilities and Accountabilities:
Leads the Medical Writing and Disclosure contributions to assigned clinical program(s). Responsible for:
• the efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines
• program forecasting, budgeting, and provides support to MWD management in resource planning
• collaboration and strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinical Safety Physicians to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives
• provides input into medical writing vendor selection, defines the scope of work to be outsourced, and is responsible for medical writing vendor oversight on the outsourced deliverables
Drives and develops the messaging strategy within the therapeutic area to ensure effective communication (i.e., CDP, submissions, briefing books, risk management plans, responses to HA questions) underpins successful clinical development.
• Interfaces with Global Therapeutic Area Heads, Global Clinical Program Directors and Clinical Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process.
• Leads cross-functional teams to develop a messaging strategy across a program of work (e.g., building a clinical submission or a data disclosure plan)
• Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (i.e., regulatory authority) in a compelling fashion with accuracy and consistency.
• Critiques ability of product strategy (e.g., submission plans) to deliver on business objectives or meet regulatory needs, and identify where new, additional or alternative arguments are needed.
Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (i.e., regulatory submission or publication of key journal articles for a publication plan).
• Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents.
• Builds convincing clinical or regulatory arguments using logic, analogy and therapeutic area science.
• Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents.
• Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
• Sets program-level standards (e.g., style convention)
• Accountable for medical writing deliverable quality and ensures work on assigned projects adheres to departmental procedures / practices, and industry / international standards.
• Participates in the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.
R esponsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc.) to ensure an effective, efficient, productive and professional working relationship.
• Participant in bid defense, contract development, work alignment and / or operation meetings.
• Negotiate with partner to determine the timeline that will be used for document delivery.
• Mediate disagreement and conflict among team and partner by negotiating, persuading and facilitating the open exchange of ideas and opinions in order to come to consensus.
Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks.
Responsible for continual improvement of in-house medical writing.
Provides expert medical writing support to other CR&D and CSL groups where required.
Position Qualifications and Experience Requirements:
Post-graduate qualifications (PhD or MD) preferred
• A minimum of 5 years medical writing experience within the biopharmaceutical industry or a contract research organization.
• A solid understanding of the clinical development process, including the documents that are required at each stage.
• Excellent written, verbal and presentation skills.
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
• Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates.
• Prior experience with submissions in Common Technical Document (CTD) format.