Senior Manager, Medical Writing - Clinical Trial Services
Location: Houston, Texas US
Job Id: 6596
Position Title: Senior Manager, Medical Writing
The Senior Manager, Medical Writing will be responsible for writing, internal review, and QC of various clinical and regulatory documents and distributing work to agencies, as needed. The successful candidate will work closely with cross-functional teams to ensure these documents are of high quality and completed in a timely fashion compliant with SOPs, ICH/GCP/regulatory guidelines and eCTD requirements. In addition, the successful candidate will be responsible for managing employees and resourcing within the Medical Writing Department.
Essential functions of the job include but are not limited to:
- Planning, writing, editing, reviewing, and/or collaborating on development of timely and high-quality clinical and regulatory documents (e.g., protocols, investigator brochures, clinical study reports, patient narratives, annual safety reports, INDs, eCTD/NDA clinical summaries, briefing books).
- Efficient review and finalization for documents produced internally and/or externally by consultants, contractors, and vendors.
- Collaborating effectively with clients, corporate, and internal project teams/departments to assist with planning resourcing for upcoming project writing deliverables.
- Ensure smooth and effective document management from start to finish (i.e., from template to a final approved version), which may include, but is not limited to: first draft authoring, reference retrieval, generating bibliographies, editing (e.g., following the house/Sponsor style guide), and managing various processes (i.e., reviews, QC, QA, formatting, publishing, document archiving).
- Formulate key messages from clinical study data.
- Perform literature-based research to support writing activities.
- Provide technical assistance in formatting documents.
- QC of documents mentioned above.
- Follow applicable regulations, including, but not limited to, FDA, ICH, and Precision SOPs.
- Develop and maintain medical writing processes, SOPs, templates and outlines for key documents.
- Provide budget input for medical writing tasks
- Manage internal and consultant Medical Writers.
- BS in a scientific or medical discipline with relevant writing expertise.
- 5+ years of experience as a medical writer in the sponsor and/or CRO setting.
- Proficiency with Microsoft Windows, Word, Excel, Adobe Acrobat, and PowerPoint.
- In-depth understanding of regulatory/ICH guidelines and GCPs and clinical trial transparency requirements (i.e. EudraCT, CT.gov).
- Demonstrated ability to work effectively in a fast-paced environment with multiple high priority projects.
- Impeccable attention to detail and ability to complete writing assignments in a timely manner.
- Proven expertise in implementing medical writing processes and standards.
- Experience overseeing the work of contract writers.
- Strong planning and project management skills, along with initiative and ability to be productive with minimal supervision and minimal administrative support.
- Ability to travel, approximately 10% is required.
- Advanced degree (MS/PhD)
- 7+ years of experience as a medical writer in the sponsor and/or CRO setting
- Oncology and/or hematological oncology Experience (especially protocol development)
- Experience in rare disease and pediatric disease
Division: Precision For Medicine
Business Unit: Clinical Solutions
Office Based: Remote
Employment Type: Exempt
Employment Status: Regular Full-time
Work From Home Available:
Country: United States
Community / Marketing Title: Senior Manager, Medical Writing - Clinical Trial Services
Country: United States
Precision Medicine Group is an integrated team of experts in fields from advanced lab sciences to translational informatics, clinical trial delivery, and regulatory affairs, payer insights to marketing communications. Together, we help our pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
EEO Employer Verbiage:
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process, or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com.
Location_formattedLocationLong: Houston, Texas US