Senior Medical Writer
Chadds Ford, PA
We are currently searching for a skilled professional to join a well-known client’s team as Senior Medical Writer, in Chadds Ford, PA. The Senior Medical Writer, role will is responsible for the development of clinical documents for worldwide submissions to regulatory authorities. Works directly with multidisciplinary project team members with the goal of independently writing scientifically valid, complete, and consistent documents, such as clinical study reports (CSRs), investigator’s brochures (IBs), and select clinical Module 2 summary documents. The Senior Medical Writer may be responsible for the medical writing activities for one or more compounds and may contribute to major submissions.
- Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives
- Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines and any processes needed for the completion of regulatory documents
- Administrate as appropriate, the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents
- Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate
- Assist in defining and writing standard operating procedures and working practices to allow the effective and efficient preparation of quality documents
- May participate in cross-functional process improvement initiatives
- This position reports to the Head of Medical Writing
- At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development
- Understanding and knowledge of global regulatory requirements
- Understands the clinical research processes and global regulatory document standards.
- Knowledge of the various phases of clinical development required
- Proficiency in organizing and communicating clinical information required
- Strong communication, organizational, time management, and project management skills are required
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment
- Proficient in MS Word
- A Bachelor's degree in life science discipline with Master's degree in life science discipline 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.