Medical Writing Manager (North America)

Job Description

Job Description

Salary :

Trilogy Writing & Consulting is currently looking to hire a Medical Writing Manager (North America), reporting directly to the Director of Medical Writing, to support our growing company in producing regulatory documentation for the international pharmaceutical industry.

At Trilogy, you will play a pivotal role in delivering comprehensive services to our clients that extend beyond writing.

Our writers are integral members of clinical development teams supporting the writing and coordinating of successful documentation across a broad spectrum of therapeutic areas.

As our company continues to expand, there is room to develop with us and your ideas will form our future together. For further insight into who we are and what we do, please explore our website (www.trilogywriting.com).

Job Overview :

As a Medical Writing Manager, you will :

• Provide line management of a group of medical writers.
• Provide resource oversight and guidance on a weekly basis.
• Oversee professional development including regular (i.e. quarterly) meetings with all members of your team.
• Conduct annual performance reviews for all team members.
• Oversee each employee’s time and utilization.
• Regularly reinforce the company’s values and purpose to maintain a sense of shared values, purpose, mission, and vision.
• Participate in Trilogy management-level activities.
• Participate in business development activities such as giving talks or workshops on behalf of Trilogy, participating in management meetings to discuss strategic developments for the company, or representing Trilogy at meetings with clients and / or at conferences.
• In addition, continue writing on client projects but have a reduced writing workload to accommodate these management activities.

Required experience and qualifications (professional skills) for this role :

• A minimum of 5 years of medical regulatory writing experience in a pharmaceutical, biotech, or CRO environment.
• Demonstrated ability and experience as a Lead Medical Writer on multiple types of regulatory documents / writing projects, including complex, multiple-document projects with global, multinational teams such as submission dossiers or responses to regulatory authorities.
• Experience in management and coordination of project-level activities, including oversight of resources, other writers and QC, as well as use of systematic methods to plan and perform tasks and coordinate people.
• Experience with cost / benefit analyses for decision making (e.g. regarding resource assignment, conflict resolution, etc.)
• Excellent interpersonal skills including ability to guide and influence others internally and / or externally, effective decision-making ability, and excellent written and oral communication skills.
• Demonstration of commitment to quality including attention to detail and organizational skills.

Trilogy offers the following :

• Competitive base salary (starting from $150,000; dependent on experience level and the Company’s compensation practices)
• Annual bonus opportunity dependent on personal and company performance
• A generous allowance of paid time off (vacation, holiday, birthday, illness).
• Comprehensive benefit plans that include medical, dental, vision, short- and long-term disability, life insurance with AD&D
• 401K retirement savings plan with company match
• Full AMWA membership and annual conference attendance paid for by Trilogy
• Continuous personal and professional development opportunities
• Free weekly yoga sessions
• Other fun and exciting events to encourage team bonding and development

Trilogy Writing & Consulting complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state / provincial, and local law.

We passionately believe in creating a supportive environment in which everyone can grow, flourish, and do their best work.

It is important to Trilogy to ensure the highest possible degree of protection for your personal data. All personal data collected and processed within the scope of an application for employment with Trilogy is protected against unauthorized access and manipulation by technical and organizational measures and is not forwarded to third parties.

Your data will be collected for the purpose of filling employment opportunities offered by Trilogy Writing & Consulting GmbH in Germany or its subsidiaries Trilogy Writing & Consulting Ltd in the UK, and Trilogy Writing & Consulting, Inc.

in the USA. By submitting your data with this application, you consent to its use for this purpose within Trilogy. You can revoke this consent at any time without needing to give a reason by informing us of your revocation under jobs@trilogywriting.

com. In the event of revocation, we will delete your personal data immediately.

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