Senior Associate, Trial Disclosure
Senior Associate, Trial Disclosure
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Job Description
The Senior Associate Trial Disclosure will be responsible for providing writing support to clinical trial registration and results postings including scientific study results and or protocol/results lay summaries and meeting required deadlines. Also responsible for the planning and execution of clinical drug trial registrations per the applicable regulatory requirements. The Senior Associate Trial Disclosure Associate will also support Agency Disclosure activities companywide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.
Responsibilities
- Completes writing activities to assist in ensuring timely disclosure of accurate consistent aligned and complete information globally.
- Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area.
- Operationalizes changes in regulatory requirements via participation in the development and implementation of Standard Operating Procedures (SOPs)/processes creating efficiency improvements/system automation and communication and training activities.
- Communicates deliverables writing process and timelines effectively across functional areas and within department to accomplish project objectives.
- Coordinates the review approval and other appropriate functions involved with the registration and writing of clinical trial results public postings and Agency Disclosure activities.
- Accountable for completing the assigned studies within established timelines and with an appropriate quality level. Held accountable for driving writing projects and registration activities to timely completion.
- Identifies conflicts and resolves or elevates them to management to ensure resolution.
- Provides writing support for unique registrations to global registries or websites includes non-interventional safety studies
- Writes scientific study results and/or protocol/result lay summaries to registries and websites for multiple therapeutic areas with more complex study designs per global registry requirements
- Supports anonymization of Protected Personal Data (PPD) and redaction of Commercially Confidential Information (CCI) in clinical documents for submission to and public release by regulatory agencies. 6. Supports companywide Redaction/Anonymization of clinical documents for public disclosure and Access To Data processes.
Qualifications :
- Bachelors degree (BA/BS) from an accredited college or university is required preferably in a health or biological science field
- 3-4 years experience in clinical trial registries regulatory agency transparency or drug development with a clinical research quality or regulatory background.
- Relevant industry experience in medical writing in the healthcare industry or academia preferred; American Medical Writing Association (AMWA) certification or other is preferred with a specialty in Editing/Writing or Pharmaceutical. 1-3 years of writing experience preferred.
- Knowledge of generally accepted project management practices. Demonstrated success in managing broad scope projects involving cross-functional teamwork.
- Excellent communication (written and verbal) organization planning execution and team leadership skills are required. Relationship management communication ability influencing skills required.
- Ability to successfully operate in an international environment and experience building effective working relationships across geographic locations.
- Working knowledge of registration / results / lay summary / agency disclosure requirements.
- Experienced in working in Excel Word and other systems
- Ability to assimilate and interpret scientific content and translate information for appropriate audience.
- Superior attention to detail. Ability to independently prioritize daily responsibilities and meet deadlines. Strong working knowledge of global registration / results / lay summary / agency disclosure requirements.
Additional Information :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location and we may ultimately pay more or less than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation holidays sick) medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Yes
Employment Type :
Full-time
Employment Type
Remote
