Medical Writing Manager/Senior Manager - USA
About The Position
Trilogy Writing & Consulting, an Indegene company, is seeking a Medical Writing Manager/Senior Manager to join their growing team. This role reports directly to the Director of Medical Writing and will focus on producing regulatory documentation for the international pharmaceutical industry. The position involves delivering comprehensive services beyond writing, with writers acting as integral members of clinical development teams. The company values employee ideas and offers opportunities for growth and development. The role requires the applicant to live in the USA and be authorized to work for any employer in the USA. The position can be fully remote or hybrid from the Durham, NC, USA office.
Requirements
- 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.
- Must live in the USA.
- Must be authorized to work for any employer in the USA.
Responsibilities
- 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.
- Continue writing on client projects but have a reduced writing workload to accommodate management activities.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
