Associate Director – Medical Writing

Associate Director – Medical Writing

Requirements

• A minimum of 8 years medical writing experience within the biopharmaceutical industry or a contract research organization.
• A minimum of 3 years in a supervisory role.
• A comprehensive understanding of the clinical development process, including the documents that are required at each stage.
• A comprehensive understanding of medical writing processes, standards and issues.
• Demonstrated track record in cross-functional, multicultural and international clinical trial teams.
• Excellent verbal, written and presentation skills.
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
• Prior experience with submissions in Common Technical Document (CTD) format.
• Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).
• Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and template.

Responsibilities

• Leads the Medical Writing contributions to assigned therapeutic area(s).
• Maintain a collaborative and strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinical Safety Physicians.
• Critiques ability of product strategy (eg, submission plans) to deliver on business objectives or meet regulatory needs, and identify where new or alternative arguments are needed.
• Leads cross-functional teams to develop a messaging strategy across a program of work (eg, building a clinical submission).
• The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines.
• Forecasting, budgeting, resource planning and resource allocation.
• Managing (Senior) Medical Writer(s) within therapeutic area(s). Coach, train and mentor staff.
• Drives and develops the messaging strategy within the therapeutic area to ensure effective communication underpins successful clinical development.
• Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program.
• 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.
• Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience in a compelling fashion with accuracy and consistency.
• Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
• Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards.
• Responsible for the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides.
• 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.
• In collaboration with Director, Medical Writing and Disclosure, ensures appropriate medical writing support for the clinical programs.
• Responsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc).
• Participant in bid defense, contract development, work alignment and / or operation meetings.

Preferred Qualifications

• Post-graduate qualifications (PhD or MD preferred)