Santa Rosa, CA
Now hiring for a hungry Senior Clinical Medical Writer who has a generous spirit, is committed to creating change and is committed to the pharmaceutical industry. The Senior Clinical Medical Writer is located in Santa Rosa, California, and will be responsible for providing clinical regulatory document support to the clinical teams, ensuring successful preparation of high quality submission-ready documents, global clinical evaluation reports, internal design history file reports, and effective implementation of the clinical writing process.
- Serves as medical writing lead on clinical regulatory documents
- Works closely with the Clinical and Regulatory team(s) on document strategies
- Implements all activities related to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and OUS)
- Coordinates the review, approval, and other appropriate functions involved in the production of clinical regulatory projects
- Arranges and conducts review meetings with the team
- Ensures required documentation is obtained
- Converts relevant data and information into a form that meets clinical regulatory document requirements and internal standard operating procedures
- Explains data in manner consistent with clinical regulatory requirements
- Effectively communicates clinical regulatory document deliverables needed, writing process, and timelines to team members
- Holds team members accountable to agreed-upon project dates and with an appropriate quality level
- Negotiates with cross-functional areas on project outcomes and deliverables to meet conflicting demands
- Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation
- Understands, assimilates, and interprets sources of information with appropriate guidance and direction from development teams
- Interprets and explains data generated, verifies that results are consistent with protocols, challenges conclusions when necessary
- Performs literature searches as needed for drafting document content
- Interprets literature information and makes recommendations for application to clinical regulatory documents
- Works with Clinical Quality throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with team to draft responses
- A minimum of 5 years of experience (Bachelor’s Degree); 4+ years with Masters or 3+ with Doctorate, or Board Certified MD or DVM)
- Knowledgeable of US (e.g. CFR 812) and international regulations (e.g. MedDev Revision 4)
- Bachelors degree
To be a best-fit your strengths must include
- Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology.
- Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines.
- Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure.
- Problem-Solvers. As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
- Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.
- Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.
About Advanced Clinical
Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.
Regarding your application
Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.