You will typically support the clinical team in the development of publications (abstracts/posters/orals and manuscripts) based on results from clinical trials. You will be expected to provide writing and editing support for publications to ensure complaint and timely submission of all publicationsEXAMPLE RESPONSIBILITIES:
- Draft and manage the review of abstracts posters, manuscripts, monographs, brochures and oral presentations for external release in coordination with HIV clinical research team
- Apply basic knowledge and understanding of clinical data interpretation and biostatistical principals
- Create timelines and coordinate team activities for document preparation and completion
- Correspond with authors regarding document/presentation review
- Review and amend work in response to feedback
- Conduct reference searches
- Proofread final draft media prior to production
- Collect and submit disclosure forms and other required documentation for scientific conferences or journals
- Prepare submission packages for submission of manuscripts to journals
- Support abstract and poster preparation and submission process
- Participate in and communicate with Publications Planning team
- Provide onsite support at scientific meetings for internal and external speakers when needed
- Ensure approval of all media prior to external release, as required
- Develop, review and produce media associated with HIV Clinical Research expert panels, advisory boards and steering committees
- Manage vendors and independent contract writers working on projects
- Have in-depth knowledge and understanding of industry best practices for publication development including ICMJE and GPP recommendations, and guidelines for reporting clinical research
- Maintain currency of knowledge in HIV therapeutic areas to increase understanding of publication and conference presentation content.
- Establish and maintain HIV Clinical Research style guides and templates to ensure consistent application across all internal and external scientific communication
- All templates and standards created will be consistent with applicable current regulatory and publication guidance
- Excellent technical writing and project management skills.
- Ability to correctly analyze data produced for assigned documents and effectively summarize key points for the individual compound and assimilate the results with an understanding of implications on the broader HIV therapeutic area perspective.
- Ability to assimilate information and understand potential strategic implications within and across HIV therapeutic area.
- Able to proactively identify and problem solve important issues to minimize risks. Is accountable, but appropriately seeks input and direction from Virology Clinical Development team members management for matters of critical importance.
- Excellent verbal communication skills.
- Can effectively communicate with a variety of teams and individuals, including team leadership and members of senior management staff.
- Manage, review and contribute to draft initiative outputs produced by other writers, both internal and external.
We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.Minimum Education & Experience
Knowledge & Other Requirements
- PhD or PharmD in a scientific discipline with 5+ years' experience in the biopharma industry focusing on scientific writing/publication and presentation management
- MS with 9+ years' relevant scientific and/or drug development experience.
- BS or RN with 11+ years' relevant scientific and/or drug development experience.
- Relevant experience in Virology is preferred.
- Experience in the biopharma industry is preferred.
- Significant experience working on and with cross-functional project / program teams in clinical research or development.
- Experience supporting clinical publications and presentations is strongly preferred.
For Colorado Job Applicants:
- Demonstrated ability to be a fast learner.
- Demonstrated ability to be flexible and adaptable to change, to move between projects easily and provide support/expertise where needed.
- Proven analytical abilities as demonstrated through past experience.
- Understands drug development phases and the nature of associated clinical trials across phases.
- Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
- Has advanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
- Strong communication and organizational skills.
- When needed, ability to travel.
The salary range for this position is:
$178,320.00 - $267,480.00
Gilead considers a range of factors, including background and experience, when determining base compensation. These considerations means actual compensation will vary.
Position is also eligible for bonus and benefits. For more information, visit https://www.gilead.com/careers/compensation-benefits-and-wellbeing
For jobs in the United States:
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