Medical Writing Manager/Senior Manager - USA

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 (


Applicants must live in the USA and be authorized to work for any employer in the USA (we are unable to sponsor or take over sponsorship of an employment visa at this time); may work either fully remotely or a hybrid schedule (in office/remote) from our Durham, NC, USA office.


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 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 $160,000USD; 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 toIndegene 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 notforwardedto 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.Bysubmittingyour 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 View email address on click.appcast.io the event ofrevocation, we willdeleteyour personal dataimmediately.