Our client is looking for a highly qualified and skilled professional for the role of Medical Writer in Bridgewater, New Jersey. The purpose of the position is to prepare corporate, US and EU labeling (prescribing information and patient information) documents for developmental, mature and marketed products assigned to obtain company and/or agency approval. If you are someone who wants to be a part of a great organizational culture, and loves the industry, this position is for you!
- Develop labeling for products based on study results.
- Coordinate of labeling review and approval throughout the company.
- Prepare label components for submission to regulatory agencies.
- Participate in labeling negotiations with agencies resulting in product approvals or labeling updates.
- Utilize subject matter expertise in specific labeling regulations (e.g. OTC rules) and review of local labeling to assure compliance with corporate labeling.
- Knowledge of European and US regulations and international regulatory environment
- Knowledge of labeling regulations (US, EU and Global)
- Prior experience as labeling manager
- Minimum of Bachelor’s Degree in Computer Science, Engineering, Business Administration
- Master’s Degree preferred
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.