Principal Medical Writer
Chadds Ford, PA
Our client is looking for a highly qualified and skilled professional for the role of Principal Medical Writer. The Principal Medical Writer will oversee the medical writing activities of multiple compounds and will serve as lead writer on major submissions. This position reports to the Head of Medical Writing.
- Responsible for the development of clinical documents for submissions to regulatory authorities globally.
- Works directly with multidisciplinary project team members with the goal of writing scientifically valid, complete, and consistent documents such as clinical study protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs), clinical Module 2 summary documents, and other regulatory documents
- Lead, manage, and coordinate all internal and external writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally
- Oversee and manage internal and contract medical writing resources as required to ensure timely completion of assigned projects
- 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 process(es) 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
- Lead or participate in defining and writing standard operating procedures and working practices which will allow the effective and efficient preparation of quality
- Lead or participate in cross-functional process improvement initiatives
- Mentor more junior medical writing staff
- At least 6 years writing experience in the biopharmaceutical/CRO industry required
- Broad understanding of clinical research processes and global regulatory document standards
- Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired
- Demonstrates strong interpersonal and organizational skills and can interpret and describe scientific data
- Proficiency in organizing and communicating clinical information necessary
- Strong communications, organizational, time management, and project management skills are required
- Proficient in MS Word. and experience with template systems (eg, StartingPoint)
- Experience with an electronic document management system (eg, MasterControl, Documentum) and use of templates preferred
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment
- A Bachelor's degree in a 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.