Associate Director, Medical Writing

At Proclinical, we are seeking a talented individual to fill the role of Associate Director, Medical Writing based in Philadelphia, PA on behalf of our client. The successful candidate will assume responsibility for efficient preparation of strategically aligned medical writing deliverables in support of the clinical development, safety and regulatory requirements of the relevant clinical program or programs.

Responsibilities

• Interface with Therapeutic Area Heads, Clinical Program Directors, Biostatistics and 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.
• Lead cross-functional teams to develop a messaging strategy across a program of work.
• Analyze 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.
• Critique ability of product strategy to deliver on business objectives or meet regulatory needs, and identify where new, additional or alternative arguments are needed.
• Build convincing clinical or regulatory arguments using logic, analogy and therapeutic area science.
• Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
• Sets program-level standards.
• Liaise with functional groups within and external to R&D to ensure independent and interdependent communication needs and strategies are considered during document development.
• Drive the development, implementation and communication of best practices, SOPs, templates, work instructions, style guides and content guides.
• Prepare medical writing deliverables for assigned clinical program(s).
• Partner with key stakeholders to ensure understanding of program strategy and the nature of medical writing services required to deliver on company objectives.

Skills And Qualifications

• BA/BS or higher and at least 6 years of writing experience in the pharmaceutical industry
• A solid understanding of the clinical development process, including the documents that are required at each stage.
• Knowledge of ICH and CTD guidelines for clinical and regulatory submission documents.
• Ability to think strategically; demonstrated negotiating skills and resourcefulness.
• Demonstrated ability to manage several projects simultaneously.
• High degree of influencing skills in shaping and developing content and wording.
• Successful track record of leading complex clinical/regulatory writing projects.
• Understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards.
• Demonstrated ability to make decisions even in the absence of complete information.
• Excellent written, verbal, and interpersonal communication skills as well as an exceptional command of English.
• Expertise with Microsoft Office suite.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please call George Watson at (+1) 336-842-8682 or upload your resume on our website - www.Proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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