Senior Principal Clinical Writer

Job Description:At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business. JOB SUMMARY:The Senior Principal Clinical Writer participates in key project decisions for the preparation of all clinical regulatory documents, seeking information from other departments and his or her management as needed. With assistance from management, develops timelines and resource plans for clinical sections of regulatory submissions. In collaboration with the clinical program manager, leads a clinical registration team, preparing one or more regulatory submissions or with minimal supervision leads a project-related team. Participates on all levels of project-related teams as appropriate. Assists management in assessing future workload requirements and assigning internal and external resources to projects. Independently prepares or assists with overseeing the preparation of a variety of clinical documents to support all phases of clinical drug development. Responsible for the quality and timeliness of documents produced for the project, coordinating work done by assigned internal, contract, or freelance writers. Ensures that company messages for the product are developed consistently throughout documents related to the project. Represents the department at meetings, participates in or leads process improvement initiatives, and assists supervisor as needed. May participate in resource forecasting and outsourcing of documents. May be responsible for the supervision of clinical writing or technical staff within the functional group.JOB RESPONSIBILITIES:Responsible for overall planning of clinical regulatory documents or for implementation of a communications strategy. Leads clinical registration team with program manager, including coordination of writers working on multiple documents and review of documents for consistency and messages. Acts as Clinical Writing department contact in providing assistance to clinical submission teams. Works to ensure that documents consistently reflect the key messages for the product.Independently plans and prepares a variety of high-level clinical documents (eg; clinical Common Technical Document [CTD] modules, investigator’s brochures [IBs], or clinical study reports [CSRs]) by organizing, critically examining, and interpreting scientific and statistical data. Document assignments can span a number of projects or therapeutic areas.Mentors other writers, both internal and external, in the preparation of all types of clinical documents (eg, CSRs, Investigational New Drug applications [INDs], IBs, and safety reports). Provides feedback to management on individual performance as appropriate.Works effectively with other writers, communicating project information in a timely manner and ensuring that writers new to a project are provided with sufficient background to work effectively with the clinical teams. Collaborates with other writers in the preparation and review of documents; providing feedback on format and content and guidance in general on team skills and company values.Keeps management and others informed on progress of documents and other project-related information. Responsible for the quality and timeliness of documents produced for the project, coordinating work done by assigned internal, contract, or freelance writers. Assists management with assessment of future workload requirements and collaborates with management in assigning internal and external resources to projects.Keeps abreast of project status, development plans, ongoing or new studies, and scientific developments related to therapeutic areas and competitive products, as well as regulatory guidelines, technologic advances, and industry standards. Participates in document preparation teams for 1 or more projects. Coordinates and conducts document-related meetings, including preparation of premeeting agendas and postmeeting minutes. Reviews protocols, statistical analysis plans, and other study-level documents as required, to ensure that data relevant to company messages for the product are appropriately collected and displayed for use in clinical documents. Coordinates preparation of clinical sections of INDs, Investigational Medicinal Product Dossiers (IMPDs), IBs, and Clinical Trial Notifications (CTNs), participates in safety review teams, and ensures compliance with safety reporting requirements for a project or group of projects.Represents the department on clinical and interdepartmental project teams and process improvement committees. Establishes and maintains professional and productive working relationships within the Global Clinical Team (GCT) and without. Works proactively with the clinical program manager, clinical team leader, or others, including regulatory affairs representatives, to identify issues and collaborates with others in driving forward a resolution. Works to ensure that documents are of high quality, scientifically accurate, meet company standards and regulatory requirements or guidelines (eg, standard operating procedures [SOPs] and International Conference on Harmonisation [ICH] and US Food and Drug Administration [FDA] guidances), and reflect a consensus among team members that is acceptable to all appropriate reviewers. Works to ensure that documents are written clearly with appropriate grammar, syntax, medical terminology, style, and format, as determined by department and company guidances.BASIC QUALIFICATIONS:At minimum, MS or MA; PharmD a plus; PhD preferred. BS or BA considered under exceptional circumstances. Degree in science discipline is preferred.Previous experience in medical or clinical writing in a pharmaceutical setting; training in regulatory requirements for clinical documents; technical proficiency in Microsoft Word.BS or BA + 10 years, MS or MA + 7 years, PharmD + 4 years, or PhD (in scientific field) + 4 years of relevant technical or medical writing experience. MS in biomedical writing will be credited as 2 years of relevant experience; PharmD residency will be credited as 1 year of relevant experience.Thorough understanding of global pharmaceutical regulatory requirements and experience in clinical research or other areas of the pharmaceutical industry are required. The ability to accurately and clearly present clinical data and strong verbal, written, and interpersonal communication skills are also required.Relocation is available for this position.Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs.For more information and to apply online, please visit us at: www.wyeth.com/careers Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void.Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.Expected Travel Time: None       www.wyeth.com/careers Wyeth is an equal opportunity employer that shares the vision of a diverse workplace. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void.Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.