We are currently searching for a skilled professional to join a well-known client's team as a Contract Medical Writer in New Brunswick, New Jersey. The Medical Writer role will develop, edit, and deliver high quality, strategically aligned clinical and regulatory documents. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.
RESPONSIBILITIES
Plan, prepare, write, review, edit, format, and finalize clinical and regulatory documents
Coordinate the internal review, approval of documents, and deliverables with external vendors
Present scientific concepts and objectives using critical thinking
Assist with gathering documents required for completing a submission
Represent Medical Writing on project teams and advise teams on content/format requirements for various documents
Manage writing activities for document development, timelines, and review/revision responsibilities within the project teams
Maintain knowledge of regulations/developments in medical writing, product areas, current trends, and current literature
Ensure that the trial master file (TMF) is inspection ready at all times for project-related documents
Support the creation and finalization of study document templates and operational guidelines
EXPERIENCE
Minimum of 10 years of experience as a Medical Writer, including editing and document processing experience with skills related to technical software troubleshooting required
Good understanding and interpretation of clinical and scientific data
Knowledge of clinical research and current regulatory requirements and guidelines applicable to GCP/ICH/eCTD compliant documents
Demonstrated experience with NDAs/BLAs with active contribution in planning, preparation, and writing of clinical and regulatory documents
Ability to multitask, deal with competing priorities, and meet aggressive timeline expectations
Experience in working with cross-functional teams
Excellent interpersonal and communication skills
Proficient in Microsoft Office suite of software (Word, Excel, Project, and PowerPoint), Adobe Acrobat, PleaseReview, Veeva Vault, and document management systems applications
Strong scientific, interpretive, organizational, and project management skills
Proven track record to meet and/or exceed customer expectations
Excellent writing skills and careful attention to detail
EDUCATION
Minimum of Bachelor's Degree in a relevant life or health science discipline 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
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.
It is Advanced Group's practice not to discriminate against any employee or applicant because of sex, race, color, age, national origin, religion, gender, gender identity/expression, sexual orientation/sexual preference, pregnancy/maternity, genetic information, marital status, physical/mental disability, medical condition, military/veteran status, or any other basis protected by applicable federal, state, or local law. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter so that we can discuss the appropriate alternatives available.
