OVERVIEW
JOB: 509551

We are currently searching for a skilled professional to join a well-known client's team as a Sr. Medical Writer in Watertown, MA working onsite 2-3 days a week, with some flexibility. The Sr. Medical Writer role will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity.

RESPONSIBILITIES

Our client is seeking an experienced Medical Writer (MW) to lead and drive the writing of clinical and regulatory documents across the client's portfolio. The Medical Writer will closely partner with the medical and clinical functions to construct Clinical Protocols and amendments, Investigator's Brochures, Clinical Study Reports as well as the Regulatory Affairs team to support the writing of regulatory applications, designation requests, and meeting packages. The Medical Writer will work directly on program teams to communicate and drive timelines, lead document review discussions, and produce high quality, compliant documents quickly and efficiently as the subject matter expert for clinical development documents. The Medical Writer plays a critical role on the program teams through their ability to effectively communicate scientific information clearly and concisely contributing to the advancement of our portfolio of novel targeted protein degraders.

EXPERIENCE

• Demonstrated successful experience as a lead writer for Clinical Protocols, IBs, CSRs and Briefing Documents.
• Strong knowledge of FDA and ICH guidelines, GCP, and applicable US and international regulatory processes related to document preparation and submissions.
• Ability to develop and implement templates, processes and procedures supporting the MW function.
• Ability to understand, critically analyze, and interpret data and summarize complex results in a clear, concise, and scientifically accurate manner for diverse audiences.
• Well-developed interpersonal skills, with experience interacting with and influencing people, and building strong positive relationships.
• Proficiency in researching and synthesizing scientific literature from various sources.
• Ability to work effectively in a fast-paced, cross-functional team environment, manage multiple projects with competing deadlines, and drive projects to completion.
• Strong organizational skills and ability to prioritize tasks efficiently.
• Excellent attention to detail.
• Excellent written and verbal scientific communication skills.
• Preferred: proven ability to manage and contribute to the writing, editing and publication of scientific manuscripts, posters, and abstracts.

EDUCATION

• BS/BA in the life sciences or related field and at least 10 years of medical regulatory writing in the drug development industry required; a focus on immunology preferred.

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.