Key Facts

Remote From:

Full time

Senior (5-10 years)

English

Hard Skills

FDA Regulations Regulatory Compliance Medical Writing Cost Benefit Analysis Utilization Management Resource Management Business Development Client Services Comprehensive Planning Online Communication +4 more

Other Skills

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Distributed Team Management
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Quality Control
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Decision Making
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Non-Verbal Communication
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Leadership
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Time Management
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Teamwork
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Strategic Thinking
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Mentorship
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Social Skills

Roles & Responsibilities

Experience managing a team of medical writers in a line-management function for a minimum of 2 years.
A minimum of 8 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.

Requirements:

Provide line management of a group of medical writers and oversee resource allocation and utilization.
Oversee professional development including quarterly meetings and conduct annual and ad-hoc performance reviews for all team members.
Participate in Trilogy management-level activities and contribute to business development (speaking engagements, workshops, and representing Trilogy at client meetings).
Continue writing on client projects with a reduced workload to accommodate management responsibilities.

Trilogy Writing & Consulting

Writing & Editing

About Trilogy Writing & Consulting

At Trilogy, medical writing is our passion. As specialists in clinical regulatory documentation, we provide a service that is more than just writing. Our writers are integral parts of our clients’ teams: proactively planning, coordinating and writing their clinical documents to meet timelines, with a readability that reduces the time for review and approval. We have been helping pharmaceutical companies and clinical research organizations of all sizes, worldwide, to streamline their documentation processes for over 18 years – either as support on a one-off document or the entire clinical development program. We provide our clients with a constructive advice on their projects: we guide our clients’ teams through the writing process and ask them the right questions in order to produce documents that communicate effectively. Our writers are trained to understand that our job is not to produce a data dump: it is to think about the data available and work with the team to pull out the messages and present them as clearly as possible, so that a reviewer can quickly find the information they are looking for and easily understand the story to be told. Our approach to writing clinical documentation ideally results in a minimum of clarifying questions from reviewers, speeding the process of review and ultimately leading to faster approval. Trilogy currently has more than 50 writers, who are located in Trilogy’s 3 offices: Frankfurt in Germany (HQ), Cambridge in the UK, and Durham, North Carolina in the US.

Company type: SME

Industry: Writing & Editing

Founded: 2018

Company size: 51 - 200

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Job description

Trilogy Writing & Consulting, an Indegene company, is currently looking to hire a Medical Writing Manager/Senior Manager, 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 coordination 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).

Applicants must live in Canada and be authorized to work for any employer in Canada (we are unable to sponsor or take over sponsorship of an employment visa at this time); this is a fully remote position. 

Job Overview:

As a Medical Writing Manager/Senior 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 the honeycomb.

Conduct annual and ad-hoc performance reviews for all members of the honeycomb.

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.

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:

Experience managing a team of medical writers in a line-management function for a minimum of 2 years.

A minimum of 8 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 the ability to guide and influence others internally and/or externally, effective decision-making ability, and excellent written and oral communication skills.

Trilogy offers the following:

Competitive base salary (starting from $165,000CAD; 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, illness).

Comprehensive benefit plans that include medical, dental, vision, short- and long-term disability, life insurance with AD&D.

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

Indegene is an Equal Opportunity Employer committed to fostering a culture of inclusion, diversity, and respect. We do not discriminate against any individual
on the basis of
race, color, religion or belief, sex, sexual orientation, gender identity or expression, age, national or ethnic origin, disability, marital or parental status, or any other characteristic protected under applicable laws. All employment decisions, including recruitment, hiring, training, compensation, promotion, and separation, are made based on business needs, individual merit, and qualifications.

It is important to Indegene 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 are protected against unauthorized access and manipulation by technical and organizational measures and are 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, Trilogy Writing & Consulting, LLC in Canada, 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.