[Hiring] Associate Director Medical Writing @Aequor

Role Description

The Associate Director is a key leadership position responsible for determining and driving the medical writing strategy for one or more Programs within Clinical Development. You will be accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, safety, and regulatory requirements of clinical programs.

• This role reports to the Director of Medical Writing.

Key accountabilities:

• Maintain a collaborative and strategic partnership with Global Clinical Program Directors and Clinical Safety Physicians to ensure understanding of Clinical Development strategy for the Program.
• Lead cross-functional teams to develop a messaging strategy across a program of work (e.g., building a clinical submission).
• Efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines.
• Resource planning and resource allocation.
• Project Manage Medical Writer(s) within the Program. Coach, train and mentor staff, thereby contributing to successful clinical development, product registration in key regions and commercialization of new compounds, including important lifecycle management work.

• Drive and develop 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.
• Interface 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.
• Analyze 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.
• Understand where all intended messages will be located across individual documents within a clinical program, and ensure alignment of messages across documents.
• Understand issues affecting the design of clinical development strategy.
• 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.
• Cultivate an understanding of modern medical writing processes and solutions.
• Responsible for continual improvement of in-house medical writing.
• Provide expert medical writing support to other CR&D and CSL groups where required.

• In collaboration with Director, Medical Writing and Disclosure, ensure 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.).
• Participate in bid defense, contract development, work alignment and/or operation meetings.

Qualifications

• Bachelor's Degree minimum requirement.
• Post-graduate qualifications, preferred.

Requirements

• A minimum of 5 years medical writing experience within the biopharmaceutical industry or a contract research organization.
• 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 templates.

Competencies

• Ability to think strategically; demonstrated negotiating skills and resourcefulness.
• Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own timelines.
• Strong influencing skills, able to lead without formal authority.
• Strong interpersonal skills; proven track record of staff management and effective leadership.
• Demonstrated ability to drive performance – holds others accountable for high standards.
• Demonstrated ability to manage several projects simultaneously.
• Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas.
• High degree of influencing skills in shaping and developing content and wording.
• Demonstrated ability to work collaboratively; multicultural sensitivity, builds positive and productive relationships.
• Successful track record of leading complex clinical/regulatory writing projects.
• Can manage uncertainty and shifting priorities and timelines.
• Demonstrates learning agility.
• An excellent understanding of all aspects of ICH-GCP; keen insight on external clinical publication practices and standards.
• Excellent organizational and time management skills.
• Attention to detail.