Current jobs related to Senior Manager/Associate Director Medical Writing - Remote, Oregon - Pfizer
-
Manager, Medical Writing
4 weeks ago
Remote, Oregon, United States Pfizer Full timeJob SummaryThe Medical Writer (Manager) creates documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols, clinical study reports, briefing documents, clinical summaries for marketing applications, and responses to queries from regulatory authorities.Understands the principles of scientific writing,...
-
Senior Director, Development
1 month ago
Remote, Oregon, United States The ALS Association Full timeThe ALS Association is the only nationally affiliated not-for-profit health organization dedicated solely to ALS. The mission of the ALS Association is to find the cause of the disease and discover a cure through global, cutting-edge research. The ALS Association empowers people with Amyotrophic Lateral Sclerosis (ALS) and their families to live fuller lives...
-
Medical/Senior Medical Director
2 months ago
Remote, Oregon, United States Thermo Fisher Scientific Full timeWork ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionOverview:Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team...
-
Product Management Senior Director
1 month ago
Remote, Oregon, United States The Cigna Group Full timeROLE SUMMARY:The Senior Director of Regulated Markets Audit and Clinical Operations provides strategic direction, guidance and management for a team that is responsible for Regulated Markets clinical operations, audit readiness and coverage determination capabilities oversight. This role is responsible for driving line of business (Medicare, Medicaid and...
-
Senior Director Account Management
1 month ago
Remote, Oregon, United States LetsGetChecked Full timeLetsGetChecked is a global healthcare solutions company that provides the tools to manage health from home through health testing, virtual care, genetic sequencing, and medication delivery for a wide range of health and wellness conditions. LetsGetChecked's end-to-end model includes manufacturing, logistics, lab analysis, physician support, and prescription...
-
Senior Director, Applied Science
2 months ago
Remote, Oregon, United States GitHub Full timeSenior Director, Applied ScienceUnited StatesEngineeringExperienced ProfessionalSenior DirectorYes3049Full TimeJob DescriptionAbout GitHubAs the global home for all developers, GitHub is the complete AI-powered developer platform to build, scale, and deliver secure software. Over 100 million people, including developers from 90 of the Fortune 100 companies,...
-
Senior Major Gifts Manager
2 months ago
Remote, Oregon, United States Indivisible Project Full timeReporting to the Director of Major Gifts, the Senior Major Gifts Manager is responsible for creating and implementing strategies to retain existing major gift donors, upgrade their giving, and bringing in new prospects to Indivisible.To be successful in this role, the Senior Major Gifts Manager is expected to be proactive, a strong writer, communicate...
-
Senior Research Director
2 months ago
Remote, Oregon, United States Blue Matter Full timeAs a Senior Research Director / Research Director with the Blue Matter Insights team, you will join a firm with a dynamic and growing team of seasoned market research consultants and have the opportunity to help grow and build the company. Working collaboratively with internal and client team members, your remit is to address critical business issues in...
-
Associate Medical Director, Neurology
1 month ago
Remote, Oregon, United States Thermo Fisher Scientific Full timeWork ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionThis role is open in North America and Latin America, but there is a preference for a North America based candidate, based upon client locations. Overview:Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory...
-
Senior Development Writer
1 month ago
Remote, Oregon, United States Bread & Roses Community Fund Full timeAbout the Role Bread & Roses Community Fund seeks a highly experienced writer/editor to join its expanding development and communications team. The Senior Development Writer will create persuasive cultivation, solicitation, and stewardship materials for a wide range of audiences, including individual donors and institutional funders. This individual will...
-
Director and Senior Counsel
2 months ago
Remote, Oregon, United States Conduent Business Services, LLC Full timeAbout the role:The Senior Counsel, Litigation is an attorney with at least five (5) years of experience in a variety of subject matters at all stages of a dispute. This role will provide counsel across Conduent's businesses, with a concentration on Conduent's Government Payments business. Conduent's Government Payments business is vital in assisting federal...
-
Senior Contracts Manager
2 months ago
Remote, Oregon, United States Flexe Full timeFlexe solves the hardest omnichannel logistics problems for the world's largest retailers and brands. Integrating technology, open logistics networks, and elastic economic models allows Flexe customers to move fast, at scale, and with precision. Founded in 2013 and headquartered in Seattle, Flexe brings deep logistics expertise and enterprise-grade...
-
Senior Director, Client Service
3 months ago
Remote, Oregon, United States Bounteous Full timeWe are seeking a Senior Director, Client Service to join our growing Health+ Business Unit. This team member genuinely believes everyone deserves access to quality health and human services, shares our passion for innovation in healthcare, and understands the role digital plays in defining the future of healthcare access, engagement, and outcomes. The ideal...
-
Account Management Director
2 months ago
Remote, Oregon, United States Soda Health Full timeLocation: Remote, USA About Soda Health Soda Health is a healthcare technology company focused on building solutions which eliminate health inequities and create a healthier America. We provide a technology platform to administer benefits personalized to individual needs, delivered more cost-effectively. Our expertise in healthcare, retail and consumer...
-
Fund Accounting Senior Manager
4 weeks ago
Remote, Oregon, United States AngelList Full timeAbout Belltower Fund Group:Belltower was formed in 2019 as AngelList's native fund administrator and completed its journey to become an independent company at the end of 2023. Belltower provides fund administration services to the venture space. Our coverage ranges from syndicates to venture funds to first-of-their-kind rolling funds. Our full-service fund...
-
Senior Research Associate
2 months ago
Remote, Oregon, United States Life Technologies (Thermo Fisher Scientific) Full timeWork ScheduleOtherEnvironmental ConditionsOffice Job Description Company Name: Evidera, Inc. Position Title: Senior Research Associate Location: 7101 Wisconsin Avenue, Suite 1400, Bethesda, MD 20814 Summary of Duties: Conceptualizes, designs, and implements health economic models to conduct cost-effectiveness and budget impact analyses of healthcare...
-
Senior Business Development Director
5 days ago
Remote, Oregon, United States Parsons Corporation Full timeAbout the Role:We are seeking a highly skilled Senior Business Development Director to join our team at Parsons Corporation. As a key member of our Federal Solutions segment, you will play a pivotal role in expanding our market in the Department of State and Federal Civilian sector, focusing on security solutions that safeguard assets and mitigate...
-
Senior Manager, Change Management
4 weeks ago
Remote, Oregon, United States Labcorp Full timeLabcorp is seeking a passionate and results oriented Senior Manager of Change Management to play a critical role in leading and managing strategic change initiatives that support the organization's strategic objectives. Reporting to the Senior Director, HR Transformation, this role will ensure that changes are implemented smoothly and effectively, minimizing...
-
Senior Director, Legal Operations
4 weeks ago
Remote, Oregon, United States Blackline Full timeGet to Know Us:It's fun to work in a company where people truly believe in what they're doingAt BlackLine, we're committed to bringing passion and customer focus to the business of enterprise applications.Since being founded in 2001, BlackLine has become a leading provider of cloud software that automates and controls the entire financial close process. Our...
-
Senior Director, Salesforce Core Cloud
2 months ago
Remote, Oregon, United States Bounteous Full timeBounteous x Accolite makes the future faster for the world's most ambitious brands. Our services span Strategy, Analytics, Digital Engineering, Cloud, Data & AI, Experience Design, and Marketing. We are guided by Co-Innovation, our proven methodology of collaborative partnership. Bounteous x Accolite brings together 5000+ employees spanning North America,...
![Pfizer](https://media.trabajo.org/img/noimg.jpg)
Senior Manager/Associate Director Medical Writing
3 months ago
The Medical Writer (Senior Manager) creates documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols, clinical study reports, briefing documents, clinical summaries for marketing applications, and responses to queries from regulatory authorities.Understands the principles of scientific writing; writing with the audience in mind and conveying messages in a clear and concise manner. Analyzes, interprets, and distills data and other information to create documents.Applies advanced knowledge of relevant regulatory requirements and corporate policies as well as work experience to assess document requirements and identify information gaps or other potential issues. Takes appropriate risks to resolve any identified issues.Is facile with innovative problem solving and peer influence.
ROLE RESPONSIBILITIES
Independently authors complex documents that are compliant with relevant internal processes and standards as well as external regulatory guidance.Manages all aspects of document development process and leads project teams through process. Collaborates with project teams, subject matter experts, and quality lines to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.Drives decision making about data presentation strategies to support advance planning of documents. Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents.Develops and maintains project timelines. Delivers assigned documents on or before deadline, alerting project teams and line management in a timely manner of any anticipated delays, information gaps, or potential shortcomings in quality.Communicates Medical Writing's position on resource and timeline needs for assigned documents to project team members, negotiating as needed with the team on these matters and keeping line management informed.Aligns with department management to set strategy for meeting department goals.Identifies potential areas for process improvements and possible solutions and communicates these to line management or appropriate functional line.If assigned by manager, serves as the Medical Writing 'point of contact' for all document issues for a given asset or set of assets.Produces documents in conjunction with vendors as needed.
BASIC QUALIFICATIONS
Bachelor's degree, preferably in a life science discipline.BS/BA +7 years, MS/MA +5 years, PhD +2 years of experience in medical writing or related fieldUnderstanding of the role of each member of cross-functional team.Ability to collaborate successfully with all levels and roles in cross-functional, global teams.Ability to manage documents of greater complexity and/or variety.Ability to multi-task and work effectively under pressure, with strong organizational and project management skills.Adapts to change as needed.Ability to communicate with teams to set realistic timeline expectations and then monitor, communicate progress/issues, and deliver against milestones.Ability to identify complex problems that require management or cross-functional input for resolution in timely manner.Develops innovative options to resolve complex problems that impact project completion.Ability to mentor more junior colleagues.Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.Ability to collaborate with cross-functional peers across therapeutic areas for improving a process, not limited to medical writing.Extensive knowledge of the Pfizer Global Style Guide and all relevant SOPs (associated forms and work instructions) and process training that relate to medical writing deliverables and quality review of deliverables.Contributes to improvements in templates, procedures, job aids, and onboarding and training materials for function.Demonstrates knowledge of Pfizer business divisions and interrelationships between them.Engages in continuous learning; shows commitment to being familiar with new regulations and industry standards, new technology, and new processes that impact Medical Writing.Proficiency with global regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety dataComprehensive understanding of the drug development process and how medical writing documents support development at different stages.Comprehensive understanding of medical concepts of the disease and current standard treatments.Analytic skills. Ability to examine data and formulate reasonable hypotheses.Oral presentation skills. Strong oral presentation skills, including ability to present and explain data analyses.Language skills. High fluency in spoken and written English.Knowledge of how to use publicly available databases (eg, PubMed, DailyMed, FDA and EMA sources and guidelines) for literature and information mining to support document content and how to cite such information appropriately.Able to interpret analyses of data supporting regulatory/clinical documents and to summarize in clearly written text with minimal guidance from team members.Participates in discussions of benefit/risk assessment and regulatory impact of documents and analyses.Capable of leading discussions of benefit/risk assessment and regulatory impact of documents and analyses, with guidance.Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel).
PREFERRED QUALIFICATIONS
Advanced degree (MS/MA/PhD) is preferred.Prior experience with document management systems and collaboration software (including cloud-based systems) and co-authoring principles is preferred.
PHYSICAL/MENTAL REQUIREMENTS
Position located at PRD site or remote work location. Primarily an office-based position involving computer work, attending meetings, making presentations, participating in global conference calls that accommodate time zones.Ability to professionally communicate both verbally and in writing in English. Can discuss clinical data succinctly and accurately with cross-functional lines, scientific staff from a range of disciplines, and all levels of management
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Some travel (~5%) across PRD sites for face to face meetings, if necessary. Depending on location may need to accommodate global teleconference calls across different time zones.
#LI-PFE
#LI-Remote
#LI-Remote
The annual base salary for this position ranges from $99,900.00 to $166, In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | ). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
Medical