Associate Director, Medical Writing

Proclinical is currently recruiting for an Associate Director of Medical Writing for a biopharmaceutical company located in Cambridge, MA. Successful candidate will be responsible for planning and preparing clinical and regulatory documents (protocol, CSR, IB, clinical sections clinical trial and marketing authorization applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations.

Job Responsibilities:

• Work with colleagues from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management in planning and preparation of high quality clinical and regulatory documents, including protocols, study reports, investigator brochures, etc., according to company and agency guidelines in order to support drug development under strict timelines.
• Independently write as well as oversee and manage the work of other medical writers. This includes training and mentoring in addition to participation in assessing workload and managing work assignments.
• Contribute to and/or manage the production of relevant documentation for regulatory submissions.
• Proactively and independently work to ensure continuous improvement, and high standards for quality and productiveness; provide suggestions based on area of expertise and prior experience.
• Lead the Medical Writing team in designing and maintaining templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices.
• Provide leadership in area of expertise.
• Knowledge of the company's financial goals and metrics.
• Collaborate with department management on the departmental budget and planning; authorize payment of work on projects and accountable to ensure successful completion and payment of work.
• Suggest direction and strategic ideas within area of expertise.
• Provide managerial leadership in area of expertise.

Skills and Requirements:

• MS or equivalent in a biological science with 7+ (or BS with 10+) years of medical writing experience in the pharmaceutical industry; specific experience in neuroscience, psychiatry, or related field is ideal.
• Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
• Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
• Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
• Expertise in drug development, clinical research, medical terminology, study design, and the regulatory requirements for clinical and regulatory documents.
• Keen understanding of the requirements for preparation of key clinical and regulatory documents.
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
• Possesses strong written and verbal communication skills.
• Embrace our core values: Put People First, Do Big, Be Accountable, Grow through Learning and Change, and Work Fun.

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) 929-223-4835 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.

Proclinical Staffing is an equal opportunity employer.

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