Sr. Medical Writer/Manager

SQA Solution Agency - Pleasanton, CA

ContractEstimated: $120,000 - $150,000 a year
EducationSkills

#JOB: Sr. Medical Writer in Pleasanton, CA

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DIRECT APPLY http://careers.renttesters.com/view/position/539618
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We just got in 2 new contract reqs for a Sr. Medical Writer and a Medical Writing Manager at Roche in Pleasanton, CA. It is position number 8521143. The primary focus of the Senior Medical Writer will be on the generation of new scientific content and on the high quality, properly formatted and timely delivery of selected high priority Clinical Study Documents and Scientific Communications. The Senior Medical Writer will conduct literature reviews, perform reference searches, and produce initial drafts of abstracts, posters, manuscript introductions, and/or publications alerts.

Please email your Resume attached as a Word Doc along with your desired Hourly Rate, your current location, visa status and date you are available to start a new position. Please make certain your resume clearly details your experience with the skills required for this requirement. This is a 12+ month​ contract to start and possible extension for long term.

JOB SUMMARY:

The Medical Writer is an integral member of the RMS Medical Writing team that oversees delivery and execution of the following documents:

Clinical Study Documents

Clinical Validation Plans
Protocols
Clinical Study Reports
Instructions for Use and/or Package Inserts

Scientific Communications

Abstracts
Scientific Posters
White Papers
Literature Reviews
Scientific Manuscripts
Publication Alerts

This team will be led by an RMS Medical Writing Manager that will supervise one or more RMS Senior Medical Writers as well as an externally contracted team of medical writers. This team will also be part of a larger collaborative working group of Medical Writers from other parts of the Roche organization to share best practices, harmonize documentation, and provide mentorship. Particular scientific focus areas within molecular diagnostics will be Infectious Diseases, Blood Screening, Oncology and Sequencing.

Successful document completion will require proactive timeline management, cross-functional meeting coordination, effective and assertive communication with subject matter experts (SMEs), comments resolution, attention to detail, quality control, accountability, and strict adherence to RMS SOPs and submission-specific requirements. The Senior Medical Writer will be working closely with both internal (e.g., Medical and Scientific Affairs, Biostatistics, RD, RMS Publications Project Manager, Regulatory, Biostatistics Clinical Operations, etc.) and external SMEs (e.g., customers, KOLs, etc.) that share the responsibility for generating, changing and/or updating scientific content. The Senior Medical Writer will serve as the primary point of contact for most documents.

ESSENTIAL RESPONSIBILITIES:

For selected and high priority documents, oversees and manages the entire document and submission lifecycle. This includes kickoff meetings to define assignment scope (content, quality and timelines) with key stakeholders, document template/shell creation, internal review processes (iterative QC checks, version control, team review and comments resolution, finalization and approvals), and submission (interface with authors, journal editors or scientific conference planning committees, electronic and online portal communications, generation of cover letters and author responses, electronic consolidation of submission documents, etc.)
Responsible for the on-time, properly formatted and high quality delivery of clinical study and scientific communications in accordance with all relevant RMS SOPs/procedures, regulatory requirements, journal/conference submission requirements and quality control systems/procedures.
Conducts literature reviews, perform reference searches, and produces initial drafts of abstracts, posters, manuscript introductions, and/or publications alerts with minimal guidance/direction.
Partners with internal and external SMEs and coordinates cross-functional collaborations/meetings to ensure completeness/accuracy in documentation and meet the defined quality, content and timelines.
Develops scientific posters (using applications such as Microsoft PowerPoint), including the printing and delivery of posters for scientific presentations, in partnership with internal/ external SMEs (see above)
Monitors quality of assigned work and performs consistent, frequent and through quality control checks.
Serves as the primary contact for assigned work and is accountable for ensuring successful completion, including an obligation to report any concerns or completion risks to the RMS Medical Writing Manager or RMS Publications Manager.
Assists RMS Medical Writing Manager with process improvement activities, such as updating RMS SOPs, optimizing document templates, updating publishing standards to support department document workflow, improving quality control (QC), developing technical solutions or monitoring document quality, etc.
Effectively communicates and builds healthy working relationships with other Medical Writing team members and SMEs with whom he/she will work closely.
Actively participates in Medical Writing team meetings and activities.
Successfully completes all assigned curricula and on-the-job training modules.
Performs his/her work in accordance with Roche cultural beliefs and agreed upon Key Performance Indicators (KPIs).
Provides appropriate and transparent notification for work absences to RMS Medical Writing Manager.

The Essential Responsibilities listed above are not intended to be an exhaustive list of all responsibilities, duties and skills. Incumbents may be required to perform other duties as required.

Formal Training/Education:

Required:

Masters degree in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, veterinary medicine, nursing or other related/ relevant fields
English proficiency (both spoken and written)

Preferred:

Doctoral degree (e.g., PhD, PharmD, DVM) in life sciences, pharmacology, biomedical engineering, biostatistics/ epidemiology, clinical research, veterinary medicine, nursing or other related/ relevant fields
English as a primary language

Experience:

Required:

3 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports.
Understanding of regulatory and audit requirements for diagnostics and/or pharmaceuticals with experience working on submissions for new applications to the U.S. Food and Drug Administration (FDA).
Submission and publication management of scientific manuscripts to at least 5 different journals

Preferred

5 years scientific research and/or medical writing experience in pharmaceutical or biotechnology industries with a variety of clinical and regulatory documents, including clinical study protocols and reports.
Supervisory and/or project management experience
Submission and publication management of scientific manuscripts to at least 10 different journals
Experience within vitrodiagnostics,molecular diagnostics and/or Infectious Disease
Knowledge of drug development (e.g., pharmacokinetics, biostatistics, nonclinical and clinical research)

medical writing, medical writer, medical writing manager, scientific writer, science writer, medical content writer, medical content developer, medical literature

Please submit you resume on our job portal by following this link, http://careers.renttesters.com/view/position/539618 for immediate consideration!

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DIRECT APPLY http://careers.renttesters.com/view/position/539618
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Contact Alina Gazarova

Job Type: Contract