Technical Manual Writer Remote Jobs in Raleigh, NC

Trilogy Writing & Consulting, anIndegenecompany,is currently looking to hireaMedical WritingManager/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 andcoordinationof successful documentation across a broad spectrum of therapeutic areas. As our company continues to expand, there is room to develop withusand 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 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 aMedical Writing Manager/Senior Manager, you will:

• Provide line managementofa group ofmedicalwriters.

• Provideresource oversightand guidance on a weekly basis.

• Overseeprofessional development includingregular (i.e.quarterly) meetings with all members of the honeycomb.

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

• Overseeeach employees timeandutilization.

• Regularly reinforce the companys values and purpose tomaintaina sense of shared values, purpose, mission, and vision

• Participate in Trilogy management-levelactivities.

• Participate inbusiness development activities such as giving talks or workshops on behalf of Trilogy,participatingin management meetings to discuss strategic developments for the company,orrepresentingTrilogy at meetings withclients.

• 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 inaline-management functionfor a minimum of 2 years.

• A minimum of8years of medical regulatory writing experiencein a pharmaceutical, biotech, or CRO environment.

• Demonstrated abilityand experience as a Lead Medical Writer on multiple types of regulatory documents/writing projects, including complex, multiple-document projectswith global, multinational teamssuch as submission dossiers or responses to regulatory authorities.

• Experience in managementand coordination ofproject-level activities, including oversight of resources, otherwritersand QC, as well asuse ofsystematic methods to plan and perform tasks and coordinate people.

• Experience with cost/benefit analyses for decision making (e.g.regardingresource assignment, conflict resolution, etc.)

• Excellent interpersonal skills includingabilitytoguide andinfluence others internally and/or externally, effective decision-makingability,and excellent written and oral communication skills.

Trilogy offers the following:

• Competitive base salary (starting from$160,000USD;dependent onexperience level and the Companys compensation practices)

• Annual bonusopportunity dependent on personal and company performance

• A generous allowance of paid time off (vacation, holiday, illness).

• Comprehensive benefit plansthatinclude 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 excitingevents toencourage 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 toIndegeneto 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 jobs@trilogywriting.com.In the event ofrevocation, we willdeleteyour personal dataimmediately.