Our client has an opening for a highly qualified and skilled professional for the role of Medical Writer in Princeton, New Jersey. You will ensure communications are complete, well organized and scientifically accurate, and that messaging is consistent throughout all technical documentation. We are looking for a Medical Writer with three years of experience who wants to be a part of a great organizational culture, is organized and loves the industry.
- Proactively manages writing activities ensuring adherence to the medical writing strategy and alignment with business needs
- Contributes to therapeutic project teams as the medical writing expert for regulatory submission documents
- Authors deliverables with consideration for regulatory, corporate, departmental, and quality standards (documents include but are not limited to protocols, clinical study reports, Investigator’s Brochures [IBs], annual reports, HA briefing packages and response documents, and integrated data summary reports)
- Adheres to Medical Writing practices, systems and tools to support clinical studies
- Assures that standardized practices are implemented and maintained across all therapeutic areas
- Ensures medical writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, WPs, policies, guidelines and regulations
- At least 3 years medical writing experience in Pharma, Biotech or CRO
- Demonstrated expertise in writing and developing clinical documents in support of regulatory submissions globally
- Ability to interpret and organize scientific and clinical data
- Experience with ICH and electronic submission guidelines for regulatory reports
- Excellent computer skills including MS Office (Word, Excel, PowerPoint, Outlook)
- Bachelor’s Degree in Life Sciences required
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
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