Senior Scientific Writer - Otolaryngology
Scientific writer job at Houston Methodist
At Houston Methodist, the Senior Scientific Writer is responsible for functioning as the mentor for junior staff with an extensive knowledge of both medical and technical science while working with scientific and clinical teams to concisely and clearly communicate technical medicine and science in writing, in accordance with regulations, standards and guidelines. This role must also have familiarity with scientific and clinical research and will conduct comprehensive literature searches for writing and editing abstracts, manuscripts, review articles, grant applications, clinical study protocols, investigator brochures, consent forms, presentations and progress reports for both scientific and lay audiences.
Experience with editing and obtaining R01, R03, and/or K awards from NIH preferred.
Requirements:
PEOPLE ESSENTIAL FUNCTIONS
* Subject matter expert responsible for research, writing, and editing of technical documents.
* Mentors and coaches other scientific writers in editing and compiling appendices of documents related to technical reports.
* Works with departments, agencies and sponsors to ensure that specific requirements are met with respect to document content and formatting.
SERVICE ESSENTIAL FUNCTIONS
* Independently creates technical documents (collaborating with the team) based on the strategy provided, and is accountable for the format, content, and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.
* Interprets data and advises faculty as how to best present data considering scientific communications best practices.
* Works with Principal Investigator(s) to develop, present, and bring to final submission high quality, large, multi-disciplinary, and multi-collaborative grant proposals and publications.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
* Prepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills to the preparation of grant proposals, manuscripts, presentations, protocols, and clinical regulatory documentation.
* Prepares technical documents that adhere to regulatory, financial, policy, and legal requirements.
* Assures compliance with Houston Methodist policies, rules, and regulations to meet government, publisher, and sponsor standards and research development best practices.
FINANCE ESSENTIAL FUNCTIONS
* Development of grant application budgets, industry contracts and subcontracts, and other financial documents in compliance with Houston Methodist policies and procedures.
* Contributes to quality improvement and success of grants applications.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
* Finds and implements innovations in scientific writing, grant development and research development to continuously improve best practices.
* Seeks opportunities to for continual professional development.
* Fosters a positive and constructive teaching environment by engaging students and co-workers in learning opportunities that are valuable and in alignment with business objectives.
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
Qualifications:
EDUCATION
* Master's Degree required
* PhD Preferred
WORK EXPERIENCE
* Six years' experience in technical or scientific writing
* Two years with grant applications preferred
LICENSES AND CERTIFICATIONS - REQUIRED
* N/A
KNOWLEDGE, SKILLS, AND ABILITIES
* Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
* Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
* Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
* Ability to write in a clear, concise, and accurate language that can be understood by technical and non-technical audiences
* Ability to understand complex scientific information, theories, and practices.
* Skilled in identifying extramural funding mechanisms for faculty and programs
* Skilled in coordinating strategic writing projects
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
* Uniform No
* Scrubs No
* Business professional Yes
* Other (department approved) No
ON-CALL*
* Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.
* On Call* No
TRAVEL
Travel specifications may vary by department
* May require travel within the Houston Metropolitan area No
* May require travel outside Houston Metropolitan area Yes
Company Profile:
Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care.
Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs.
Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.
Houston Methodist is an Equal Opportunity Employer.
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Senior Scientific Writer - Urology - Kobashi
Scientific writer job at Houston Methodist
At Houston Methodist, the Senior Scientific Writer is responsible for functioning as the mentor for junior staff with an extensive knowledge of both medical and technical science while working with scientific and clinical teams to concisely and clearly communicate technical medicine and science in writing, in accordance with regulations, standards and guidelines. This role must also have familiarity with scientific and clinical research and will conduct comprehensive literature searches for writing and editing abstracts, manuscripts, review articles, grant applications, clinical study protocols, investigator brochures, consent forms, presentations and progress reports for both scientific and lay audiences.
Requirements:
PEOPLE ESSENTIAL FUNCTIONS
* Subject matter expert responsible for research, writing, and editing of technical documents.
* Mentors and coaches other scientific writers in editing and compiling appendices of documents related to technical reports.
* Works with departments, agencies and sponsors to ensure that specific requirements are met with respect to document content and formatting.
SERVICE ESSENTIAL FUNCTIONS
* Independently creates technical documents (collaborating with the team) based on the strategy provided, and is accountable for the format, content, and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.
* Interprets data and advises faculty as how to best present data considering scientific communications best practices.
* Works with Principal Investigator(s) to develop, present, and bring to final submission high quality, large, multi-disciplinary, and multi-collaborative grant proposals and publications.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
* Prepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills to the preparation of grant proposals, manuscripts, presentations, protocols, and clinical regulatory documentation.
* Prepares technical documents that adhere to regulatory, financial, policy, and legal requirements.
* Assures compliance with Houston Methodist policies, rules, and regulations to meet government, publisher, and sponsor standards and research development best practices.
FINANCE ESSENTIAL FUNCTIONS
* Development of grant application budgets, industry contracts and subcontracts, and other financial documents in compliance with Houston Methodist policies and procedures.
* Contributes to quality improvement and success of grants applications.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
* Finds and implements innovations in scientific writing, grant development and research development to continuously improve best practices.
* Seeks opportunities to for continual professional development.
* Fosters a positive and constructive teaching environment by engaging students and co-workers in learning opportunities that are valuable and in alignment with business objectives.
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
Qualifications:
EDUCATION
* Master's Degree required
* PhD Preferred
WORK EXPERIENCE
* Six years' experience in technical or scientific writing
* Two years with grant applications preferred
LICENSES AND CERTIFICATIONS - REQUIRED
* N/A
KNOWLEDGE, SKILLS, AND ABILITIES
* Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
* Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
* Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
* Ability to write in a clear, concise, and accurate language that can be understood by technical and non-technical audiences
* Ability to understand complex scientific information, theories, and practices.
* Skilled in identifying extramural funding mechanisms for faculty and programs
* Skilled in coordinating strategic writing projects
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
* Uniform No
* Scrubs No
* Business professional Yes
* Other (department approved) No
ON-CALL*
* Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.
* On Call* No
TRAVEL
Travel specifications may vary by department
* May require travel within the Houston Metropolitan area No
* May require travel outside Houston Metropolitan area Yes
Company Profile:
Houston Methodist Academic Institute oversees the Education Institute and Research Institute, including 772 faculty and 56,250 learners. The Academic Institute aligns our research and education initiatives in service to the clinical mission, providing solutions that answer the call for new technologies and skills our clinicians need for patient care.
Houston Methodist Education Institute coordinates our primary academic affiliation with Weill Cornell Medicine and other joint programs, including the Engineering Medicine Program at Texas A&M University Intercollegiate School of Engineering Medicine. The Education Institute also oversees continuing medical education and graduate medical education, and supports more than 1,000 trainees in residence for medical, nursing, allied health and research education programs.
Houston Methodist Research Institute supports research programs and infrastructure that enable faculty across the system to bring new scientific discoveries to patients as rapidly as possible through the full cycle of a cure from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research Institute supports more than 1,387 clinical research protocols and $70.3 million in extramurally funded translational research programs.
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Medical Writer, Clinical Development
New York, NY jobs
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X.
About This Role
Axsome Therapeutics is seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols and clinical study reports. This is a key position within the Clinical Development Group with ample opportunity to make real impact.
This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
Job Responsibilities and Duties include, but are not limited to, the following:
* Interpret, analyze, and synthesize complex clinical data and develop high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, and other documents in support of Clinical Development programs
* Attend strategic meetings as applicable
* Closely collaborate with, and apply strategic direction from, project leads and biostatisticians to manage and prioritize assignments and ensure deliverables are completed per time and quality goals
* Develop documents for assigned programs in compliance with company standard operating procedures (SOPs)
* Participate in developing timelines, managing review/approval workflows, and QC/publication readiness
* Lead cross-functional teams to ensure team-wide agreement on documents content
* Oversee outsourced medical writings projects and the associated vendor(s), as applicable
* Ensure compliance and accountability for all regulatory documents prepared by the company
Requirements / Qualifications
* Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 6 years of relevant experience
* Previous experience with preparation and QC of clinical regulatory documents: Protocols, IBs, CSRs, Module 2 Summary Documents, Clinical Overviews and Agency Briefing Document
* A strong working knowledge of pharmaceutical drug development and GxP principles
* Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
Experience, Knowledge and Skills
* Highly knowledgeable in psychiatric and/or neurological disease areas is a plus
* Track record of developing high-quality scientific documents
* Ability to interpret, analyze, and synthesize complex clinical data into compelling and easily understood documents
* Familiarity with the preparation of Statistical Analysis Plans and document data mapping
* Experience with programmed outputs of tables, figures and listings for analysis and communication of clinical data
* Ability to work collaboratively with and coordinate the efforts of team members to resolve comments and complete deliverables
* Excellent interpersonal skills and judgement that facilitates working with cross-functional executive leadership and maintaining the security of proprietary information
* Ability to manage/prioritize multiple projects under general supervision while working in a fast-paced environment
* Flexibility for adapting to rapidly changing deadlines and priorities
* Must be extremely detail oriented
* Able to self-manage effort to maintain alignment with strategy and corporate goals
Salary & Benefits
The anticipated salary range for this role is $140,000 - $175,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
Medical Writer
Largo, FL jobs
Are you passionate about making a difference in the medical device industry? Join our dynamic team at CONMED as a Medical Writer! In this pivotal role, you'll leverage your expertise in global regulations to proactively collect and analyze market and customer feedback on our medical devices. Your work will ensure compliance with Medical Device Regulation (EU 2017/745) and other global standards, driving innovation and excellence in healthcare.
This is a REMOTE opportunity.
Key Responsibilities:
* Develop and refine strategies and processes for market and customer feedback collection.
* Assist in creating medical device market research protocols and Case Report Forms.
* Craft and update post-market surveillance plans, Periodic Safety Update Reports, and Post Market Surveillance reports.
* Collaborate with cross-functional teams and surgeons for Post Market Clinical Follow-up studies.
* Keep relevant procedures up-to-date.
What You'll Do:
* Utilize your knowledge of medical devices and In-Vitro Diagnostic products to gather proactive customer feedback per Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Medical Device Regulation (EU 2017/746)
* Create market research protocols, deploy questionnaires, and compile technical reports.
* Review and provide feedback on (Periodic Safety Update Reports) and PMSRs (Post-Market Surveillance Reports)
* Author and update post-market surveillance plans for upcoming and existing medical devices.
* Interface with engineering, medical, safety, regulatory, quality, and manufacturing teams to complete surveillance activities.
* Ensure timely creation of deliverables to prevent project delays.
* Develop proactive customer feedback templates and process workflows.
* Communicate roadblocks and escalate issues promptly to stakeholders.
Qualifications:
* Associate's degree in clinical research, health sciences, or a related field.
* 5+ years of experience with medical devices and/or pharmaceutical industry, preferably in an operating room.
Preferred Skills:
* Experience with medical device complaint investigation, CAPAs, Recalls, or Post Market Surveillance.
* Proficiency in creating PMS plans, PMSRs, or PSURs.
* Strong knowledge of risk management, product design practices, and Good Manufacturing Practices (GMP).
* Understanding of medical device regulations and adverse event reporting.
This position is not eligible for employer-visa sponsorship
Disclosure as required by applicable law, the annual salary range for this position is $68,110- $85,000. The actual compensation may vary based on geographic location, work experience, education, and skill level. The salary range is CONMED's good faith belief at the time of this posting.
This job posting is anticipated to close on January 23, 2025. We may, however, extend this time period, in which case the posting will remain available on careers.conmed.com. Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
* Competitive compensation
* Excellent healthcare including medical, dental, vision and prescription coverage
* Short & long term disability plus life insurance -- cost paid fully by CONMED
* Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
* Employee Stock Purchase Plan -- allows stock purchases at discounted price
* Tuition assistance for undergraduate and graduate level courses
Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.
Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at ************ option #5.
Medical Writer, Clinical Development
Day, NY jobs
Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain's biggest problems so patients and their loved ones can flourish. For more information, please visit us at ************** and follow us on LinkedIn and X.
About This Role
Axsome Therapeutics is seeking a highly collaborative Medical Writer to draft, edit and submit high quality, medically accurate documents including protocols and clinical study reports. This is a key position within the Clinical Development Group with ample opportunity to make real impact.
This role is based at Axsome's HQ in New York City with an on-site requirement of at least three days per week. We are unable to consider candidates who are looking for fully remote roles.
Job Responsibilities and Duties include, but are not limited to, the following:
Interpret, analyze, and synthesize complex clinical data and develop high-quality strategic scientific documents including protocols, amendments, agency briefing books, clinical study reports, and other documents in support of Clinical Development programs
Attend strategic meetings as applicable
Closely collaborate with, and apply strategic direction from, project leads and biostatisticians to manage and prioritize assignments and ensure deliverables are completed per time and quality goals
Develop documents for assigned programs in compliance with company standard operating procedures (SOPs)
Participate in developing timelines, managing review/approval workflows, and QC/publication readiness
Lead cross-functional teams to ensure team-wide agreement on documents content
Oversee outsourced medical writings projects and the associated vendor(s), as applicable
Ensure compliance and accountability for all regulatory documents prepared by the company
Requirements / Qualifications
Advanced scientific or clinical degree (MD, PhD, or PharmD) required and a minimum of 6 years of relevant experience
Previous experience with preparation and QC of clinical regulatory documents: Protocols, IBs, CSRs, Module 2 Summary Documents, Clinical Overviews and Agency Briefing Document
A strong working knowledge of pharmaceutical drug development and GxP principles
Ability to work on site Monday, Tuesday & Thursday. We are unable to consider candidates who are looking for fully remote roles
Experience, Knowledge and Skills
Highly knowledgeable in psychiatric and/or neurological disease areas is a plus
Track record of developing high-quality scientific documents
Ability to interpret, analyze, and synthesize complex clinical data into compelling and easily understood documents
Familiarity with the preparation of Statistical Analysis Plans and document data mapping
Experience with programmed outputs of tables, figures and listings for analysis and communication of clinical data
Ability to work collaboratively with and coordinate the efforts of team members to resolve comments and complete deliverables
Excellent interpersonal skills and judgement that facilitates working with cross-functional executive leadership and maintaining the security of proprietary information
Ability to manage/prioritize multiple projects under general supervision while working in a fast-paced environment
Flexibility for adapting to rapidly changing deadlines and priorities
Must be extremely detail oriented
Able to self-manage effort to maintain alignment with strategy and corporate goals
Salary & Benefits
The anticipated salary range for this role is $140,000 - $175,000. We encourage candidates of all levels to apply as there may be flexibility on final job title and responsibilities. The salary offer will be based on a variety of factors, including experience, qualifications, internal equity and location. Axsome offers a competitive employment package that includes an annual bonus, significant equity and a generous benefits package.
Axsome is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, sexual orientation, gender identity, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.
Axsome Therapeutics does not accept unsolicited resumes from recruiters or third-party recruitment agencies and will not pay placement fees for unsolicited candidates that are sent to hiring managers, the HR team or other Axsome team members. Only approved vendors who have been explicitly asked to support a specific search will receive access to our Applicant Tracking System to submit candidates for consideration.
Auto-ApplyAssociate Scientific Writer - Medical Devices
Rancho Santa Margarita, CA jobs
Applied Medical is a new generation medical device company with a proven business model and commitment to innovation fueled by rapid business growth and expansion. Our company has been developing and manufacturing advanced surgical technologies for over 35 years and has earned a strong reputation for excellence in the healthcare field. Our unique business model, combined with our dedication to delivering the highest quality products, enables team members to contribute in a larger capacity than is possible in typical positions.
Position Description
Collaboration is a fundamental part of our organization's culture and is essential to our continued success. As such, the successful candidate for this position is expected to work fully on-site, enabling them to engage fully with colleagues and contribute to cross-functional initiatives. Therefore, the ability to work collaboratively and contribute to a positive and supportive team environment is a key requirement for this role.
As an Associate Clinical Writer, you will work within the Clinical Affairs team. The Associate Clinical Writer's primary responsibilities are developing and completing scientific protocols and reports, including, but not limited to, Clinical Evaluations and Post Market Clinical Feedback as part of design validations for medical devices to support product registrations internationally. You will conduct reviews of post-market data, such as complaints and feedback, to incorporate relevant data and analysis into reports.
Key Responsibilities:
* Critical Thinking: You will need to be able to critically evaluate scientific literature and research findings and apply this knowledge to your work. This involves asking questions, identifying gaps in the research, and synthesizing information from multiple sources.
* Writing Skills: You will be responsible for conducting thorough literature searches to identify relevant studies, systematic reviews, and meta-analyses that inform your writing. You will also be responsible for creating and maintaining job aids and work instructions for the preparation and maintenance of compliant medical writing deliverables.
* Communication: You will be responsible to manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables. You will also be expected to collaborate with cross-functional teams to develop new and insightful analytics to collect and analyze clinical data.
Position Requirements
This position requires the following skills and attributes:
* Bachelor's or Advanced degree in a scientific field (MS, Ph.D., MD, or Pharm. D.)
* Experience in conducting focused literature searches on PubMed, Embase or other similar literature databases
* Data mining and analysis
* Ability to formulate reports and present findings
* Effective written and oral communication skills
* Ability to collaborate in a team environment
* Project management and organizational skills
* Strong familiarity with Microsoft Office
Preferred
The following skills and attributes are preferred:
* 1-2 years of experience in the medical device/pharmaceutical field or 1+ years of research with professor
* Ability to understand and interpret results of clinical studies, with a strong understanding of statistics
* Experience performing statistical analysis with statistical programs
* Ability to prioritize and manage multiple projects
* Data analytic publication experience or literature author publication experience
* Please note that this role is internally titled 'Associate Clinical Writer'. Externally, we refer to it as 'Associate Scientific Writer - Medical Devices' to better reflect the role's responsibilities.
Benefits
* Competitive compensation range: $70000 - $80000 / year (California).
* Comprehensive benefits package.
* Training and mentorship opportunities.
* On-campus wellness activities.
* Education reimbursement program.
* 401(k) program with discretionary employer match.
* Generous vacation accrual and paid holiday schedule.
Please note that the compensation range may be adjusted in the future, and bonus and incentive compensation plans may apply.
Our total reward package reflects our commitment to employee growth and well-being, as we invest in your development and offer a range of benefits designed to enhance your career and life.
All compensation and benefits are subject to plan documents and written agreements.
Equal Opportunity Employer
Applied Medical is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (including pregnancy, childbirth, breastfeeding and related medical conditions), or sexual orientation, or any other status protected by federal, state or local laws in the locations where Applied Medical operates.
Auto-ApplySenior Medical Writer, Regulatory Affairs
South San Francisco, CA jobs
Description Sutro Biopharma, Inc. is looking for a Senior Medical Writer who will provide leadership in development and execution of document deliverables intended to support clinical trial applications including Health Authority interactions and filings, protocols, CSRs, INDs/ CTAs, and marketing applications. This successful candidate will be proficient in the principles of scientific writing and will work cross‑functionally, maintaining compliance with global regulatory expectations for document content and advising the project teams accordingly. Experience in oncology drug development is preferred. This role may be performed remotely or onsite, with flexibility based on business needs. Responsibilities:
Independently authors complex documents compliant with relevant internal processes and standards as well as external regulatory guidance.
Collaborates cross-functionally with subject matter experts to ensure clear, factual, effective, and appropriately concise presentation of analyses and associated discussions in assigned documents.
Engages early with project teams and subject matter experts to plan and review tables, listings, and figures for assigned documents.
Collaborates with Medical functions on authoring of documents intended to support clinical trials including (but not limited to) protocols, investigator brochure's, clinical study reports, clinical summaries for marketing applications, and responses to queries from regulatory authorities.
Provide guidance for document development for regulatory writing deliverables, including organization, content, and resource requirements.
Collaborates with the CMC subject matter experts on generation of CMC-focused sections of briefing documents, DMFs, INDs/CTAs, response documents and technical reports, as necessary.
Collaborates with the non-clinical subject matter experts on generation of non-clinical focused sections of INDs/CTAs, and technical reports, as necessary.
Works with Project Management and Regulatory Affairs functions to establish appropriate timelines and identify contingencies for delivery of assigned documents in a timely manner.
Perform internal document reviews, editing, and QC as needed.
Qualifications:
4+ years' experience with PhD, PharmD, or MD; 6+ years with Masters; 8+ years with BS/BA (provided degrees are in relevant fields with 2 years of direct experience in regulatory/clinical writing.
Ability to collaborate successfully with all levels and roles in cross-functional, global teams.
Experience with independently authoring CSRs, protocols and submission documents, such as IND components and/or NDA components (Integrated Summaries and Clinical Summaries).
Collaborative organizational skills; demonstrated ability to prioritize multiple projects and timelines.
Strong analytical skills: ability to understand and interpret complex clinical and scientific data from multiple data sources and formulate those data into a well-thought out and reviewer friendly manner.
Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members.
Knowledge in the 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 consolidate, analyze, interpret, and summarize data from multiple data sources.
Track record of communicating complex information and analyses effectively in writing to a variety of scientific and nonscientific audiences.
Demonstrated proficiency with Microsoft Word (above average knowledge) and other relevant software (eg, PowerPoint, Excel, Adobe Acrobat). Veeva RIM experience preferred.
Strong attention to detail; experience with Quality Control and editing of scientific documents.
Sound exciting? Apply today and join our team!Sutro Biopharma, Inc. encourages all colleagues to be fully vaccinated for COVID-19 prior to the first date of employment. As an equal opportunity employer, we believe in fostering a culture that is inclusive and values diversity in background and opinions. Sutro Biopharma hires extraordinary individuals into every position in the company and is committed to the diversity of our team. Our company progresses without regard of race, ethnicity, gender, sexual orientation, religious belief, age, disability or citizenship status. We are dedicated to creating a safe environment where our employees can grow and succeed together. We look forward to hearing from candidates who are interested in exploring opportunities with Sutro! Our People & Culture team/hiring managers are unable to respond and do not accept solicitations from third-party agencies. The anticipated salary range for fully qualified candidates applying for this role at Sutro Biopharma's California based locations will be $120,000 - $155,000 (not including bonus, equity, and benefits). The final salary offered will be dependent on several factors that include and are not limited to relevant previous experience, job responsibilities and duration of experience, the type and length of experience within the industry and education.
About Sutro Biopharma
Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, transforming what science can do for patients. Dedicated to transforming the lives of cancer patients by creating medicines with improved therapeutic profiles for areas of unmet need. To date, Sutro's platform has led to ADCs, bispecific antibodies, cytokine-based immuno-oncology therapies, and vaccines directed at precedented targets in clinical indications where the current standard of care is suboptimal. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit *****************
Auto-ApplyMedical Writer
Largo, FL jobs
Are you passionate about making a difference in the medical device industry? Join our dynamic team at CONMED as a Medical Writer! In this pivotal role, you'll leverage your expertise in global regulations to proactively collect and analyze market and customer feedback on our medical devices. Your work will ensure compliance with Medical Device Regulation (EU 2017/745) and other global standards, driving innovation and excellence in healthcare.
Key Responsibilities:
* Develop and refine strategies and processes for market and customer feedback collection.
* Assist in creating medical device market research protocols and Case Report Forms.
* Craft and update post-market surveillance plans, Periodic Safety Update Reports, and Post Market Surveillance reports.
* Collaborate with cross-functional teams and surgeons for Post Market Clinical Follow-up studies.
* Keep relevant procedures up-to-date.
What You'll Do:
* Utilize your knowledge of medical devices and In-Vitro Diagnostic products to gather proactive customer feedback per Medical Device Regulation (EU 2017/745) and In-Vitro Diagnostic Medical Device Regulation (EU 2017/746)
* Create market research protocols, deploy questionnaires, and compile technical reports.
* Review and provide feedback on (Periodic Safety Update Reports) and PMSRs (Post-Market Surveillance Reports)
* Author and update post-market surveillance plans for upcoming and existing medical devices.
* Interface with engineering, medical, safety, regulatory, quality, and manufacturing teams to complete surveillance activities.
* Ensure timely creation of deliverables to prevent project delays.
* Develop proactive customer feedback templates and process workflows.
* Communicate roadblocks and escalate issues promptly to stakeholders.
Qualifications:
* Associate's degree in clinical research, health sciences, or a related field.
* 5+ years of experience with medical devices and/or pharmaceutical industry, preferably in an operating room.
Preferred Skills:
* Experience with medical device complaint investigation, CAPAs, Recalls, or Post Market Surveillance.
* Proficiency in creating PMS plans, PMSRs, or PSURs.
* Strong knowledge of risk management, product design practices, and Good Manufacturing Practices (GMP).
* Understanding of medical device regulations and adverse event reporting.
This position is not eligible for employer-visa sponsorship
Disclosure as required by applicable law, the annual salary range for this position is $68,110- $85,000. The actual compensation may vary based on geographic location, work experience, education, and skill level. The salary range is CONMED's good faith belief at the time of this posting.
This job posting is anticipated to close on January 23 2025. We may, however, extend this time period, in which case the posting will remain available on careers.conmed.com. Please submit your application as soon as possible as we will be reviewing applications on a rolling basis as we receive them.
Benefits:
CONMED offers a wide array of benefits to fit your unique needs. Visit our Benefits Page for more information.
* Competitive compensation
* Excellent healthcare including medical, dental, vision and prescription coverage
* Short & long term disability plus life insurance -- cost paid fully by CONMED
* Retirement Savings Plan (401K) -- CONMED matches your contributions dollar for dollar, with the potential for up to 7% per pay period
* Employee Stock Purchase Plan -- allows stock purchases at discounted price
* Tuition assistance for undergraduate and graduate level courses
Know someone at CONMED? Have them submit you as a referral before applying for this position to be eligible for our Employee Referral Program incentives!
CONMED is an equal opportunity employer and does not discriminate on the basis of any legally protected status or characteristic. Protected veterans and individuals with disabilities are encouraged to apply. The Know Your Rights: Workplace Discrimination is Illegal Poster reaffirms this commitment.
Colorado Residents: In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.
If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at ************ option #5.
Senior Scientific Writer - Neurosurgery -Baskin
Scientific writer job at Houston Methodist
The Houston Methodist Peak Brain & Pituitary Tumor Center seeks a scientific writer. The scientific writer will primarily be responsible for proofreading and editing documents produced by our dynamic organization of researchers to prepare them for publication. In addition to this, they will review, edit, and provide advice on grant submission.
Houston Methodist Standard
PATIENT AGE GROUP(S) AND POPULATION(S) SERVED
Refer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.
HOUSTON METHODIST EXPERIENCE EXPECTATIONS
Provide personalized care and service by consistently demonstrating our I CARE values:
INTEGRITY: We are honest and ethical in all we say and do.
COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
ACCOUNTABILITY: We hold ourselves accountable for all our actions.
RESPECT: We treat every individual as a person of worth, dignity, and value.
EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.
Practices the Caring and Serving Model
Delivers personalized service using HM Service Standards
Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)
Intentionally collaborates with other healthcare professionals involved in patients/customers or employees' experiential journeys to ensure strong communication, ease of access to information, and a seamless experience
Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job
Actively supports the organization's vision, fulfills the mission and abides by the I CARE values
Responsibilities
PEOPLE ESSENTIAL FUNCTIONS
Subject matter expert responsible for research, writing, and editing of technical documents.
Mentors and coaches other scientific writers in editing and compiling appendices of documents related to technical reports.
Works with departments, agencies and sponsors to ensure that specific requirements are met with respect to document content and formatting.
SERVICE ESSENTIAL FUNCTIONS
Independently creates technical documents (collaborating with the team) based on the strategy provided, and is accountable for the format, content, and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.
Interprets data and advises faculty as how to best present data considering scientific communications best practices.
Works with Principal Investigator(s) to develop, present, and bring to final submission high quality, large, multi-disciplinary, and multi-collaborative grant proposals and publications.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
Prepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills to the preparation of grant proposals, manuscripts, presentations, protocols, and clinical regulatory documentation.
Prepares technical documents that adhere to regulatory, financial, policy, and legal requirements.
Assures compliance with Houston Methodist policies, rules, and regulations to meet government, publisher, and sponsor standards and research development best practices.
FINANCE ESSENTIAL FUNCTIONS
Development of grant application budgets, industry contracts and subcontracts, and other financial documents in compliance with Houston Methodist policies and procedures.
Contributes to quality improvement and success of grants applications.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
Finds and implements innovations in scientific writing, grant development and research development to continuously improve best practices.
Seeks opportunities to for continual professional development.
Fosters a positive and constructive teaching environment by engaging students and co-workers in learning opportunities that are valuable and in alignment with business objectives.
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises.
Qualifications
EDUCATION
Master's Degree required
PhD Preferred
WORK EXPERIENCE
Six years' experience in technical or scientific writing
Two years with grant applications preferred
License/Certification
LICENSES AND CERTIFICATIONS - REQUIRED
N/A
KSA/ Supplemental Data
KNOWLEDGE, SKILLS, AND ABILITIES
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
Ability to write in a clear, concise, and accurate language that can be understood by technical and non-technical audiences
Ability to understand complex scientific information, theories, and practices.
Skilled in identifying extramural funding mechanisms for faculty and programs
Skilled in coordinating strategic writing projects
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
Uniform No
Scrubs No
Business professional Yes
Other (department approved) No
ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.
On Call* No
TRAVEL**
**Travel specifications may vary by department**
May require travel within the Houston Metropolitan area No
May require travel outside Houston Metropolitan area Yes
Company Profile
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies, and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.
Auto-ApplyScientific Writer - Urology - Kobashi
Scientific writer job at Houston Methodist
Overview At Houston Methodist, the Scientific Writer position is responsible for performing a variety of tasks including preparing laboratory and clinical studies and documents for submission to journals and granting agencies. The position facilitates the gathering of noteworthy achievements in science within the department and helps translate and disseminate that information through feature articles, news releases, newsletters, social media and other communications venues. Houston Methodist Standard PATIENT AGE GROUP(S) AND POPULATION(S) SERVED
Refer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.
HOUSTON METHODIST EXPERIENCE EXPECTATIONS
Provide personalized care and service by consistently demonstrating our I CARE values:
INTEGRITY: We are honest and ethical in all we say and do.
COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
ACCOUNTABILITY: We hold ourselves accountable for all our actions.
RESPECT: We treat every individual as a person of worth, dignity, and value.
EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.
Practices the Caring and Serving Model
Delivers personalized service using HM Service Standards
Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)
Intentionally collaborates with other healthcare professionals involved in patients/customers or employees' experiential journeys to ensure strong communication, ease of access to information, and a seamless experience
Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job
Actively supports the organization's vision, fulfills the mission and abides by the I CARE values
Responsibilities PEOPLE ESSENTIAL FUNCTIONS
Works with principal investigator, provides advice on grantsmanship, editorial support and standardized language for administrative sections; manages scientific writing process.
Promotes a positive work environment and contributes to a dynamic, team focused work unit that actively helps one other to achieve optimal department results. Collaborates with all members of the patient care team by actively communicating and reporting pertinent information as it relates to assigned system(s) in a comprehensive manner.
SERVICE ESSENTIAL FUNCTIONS
Facilitates writing, editing, and preparation of high quality written scientific documents for grant applications, publications, scientific manuscripts for peer review, white papers, protocols, and other scientific or administrative reports.
Assists with preparation of protocols (including amendments and informed consents), reports, and manuscripts for publication.
Provides faculty with full lifecycle support from technical document development to preparation and submission.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
Assures compliance with Houston Methodist polices, rules, and regulations to meet federal, state, and local standards.
Interpreting data and advising sponsors as to how best to present data considering regulatory agency requirements.
Prepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills to the preparation of grant proposals, manuscripts, presentations, protocols, and clinical regulatory documentation.
Assures quality and timely preparation of technical documents.
FINANCE ESSENTIAL FUNCTIONS
Assists with the writing of grant applications, awards, contracts, subcontracts and other agreements.
Submits grant proposals and manuscripts for editing.
Uses resources efficiently; does not waste supplies. Evaluates and reports on inventory levels. Self-motivated to independently manage time effectively and prioritize daily tasks.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
Seeks opportunities to expand learning beyond baseline competencies with a focus on continual development as a writer.
Participates in departmental projects and shared governance activities; manages and leads projects related to optimization of assigned system(s).
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises. Qualifications EDUCATION
Bachelor's degree in relevant field
MS or PhD in biological science field preferred
WORK EXPERIENCE
Three years of experience in science writing/editing
License/Certification LICENSES AND CERTIFICATIONS - REQUIRED
N/A
KSA/ Supplemental Data KNOWLEDGE, SKILLS, AND ABILITIES
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
Ability to write in a scientific or technical field
Knowledgeable in writing/editing biomedical manuscripts
Knowledgeable in grant application processes
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
Uniform No
Scrubs No
Business professional Yes
Other (department approved) No
ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.
On Call* No
TRAVEL**
**Travel specifications may vary by department**
May require travel within the Houston Metropolitan area No
May require travel outside Houston Metropolitan area No
Company Profile
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies, and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.
Auto-ApplySr Scientific Writer
Scientific writer job at Houston Methodist
Overview At Houston Methodist, the Senior Scientific Writer is responsible for functioning as the mentor for junior staff with an extensive knowledge of both medical and technical science while working with scientific and clinical teams to concisely and clearly communicate technical medicine and science in writing, in accordance with regulations, standards and guidelines. This role must also have familiarity with scientific and clinical research and will conduct comprehensive literature searches for writing and editing abstracts, manuscripts, review articles, grant applications, clinical study protocols, investigator brochures, consent forms, presentations and progress reports for both scientific and lay audiences. Houston Methodist Standard PATIENT AGE GROUP(S) AND POPULATION(S) SERVED
Refer to departmental "Scope of Service" and "Provision of Care" plans, as applicable, for description of primary age groups and populations served by this job for the respective HM entity.
HOUSTON METHODIST EXPERIENCE EXPECTATIONS
Provide personalized care and service by consistently demonstrating our I CARE values:
INTEGRITY: We are honest and ethical in all we say and do.
COMPASSION: We embrace the whole person including emotional, ethical, physical, and spiritual needs.
ACCOUNTABILITY: We hold ourselves accountable for all our actions.
RESPECT: We treat every individual as a person of worth, dignity, and value.
EXCELLENCE: We strive to be the best at what we do and a model for others to emulate.
Practices the Caring and Serving Model
Delivers personalized service using HM Service Standards
Provides for exceptional patient/customer experiences by following our Standards of Practice of always using Positive Language (AIDET, Managing Up, Key Words)
Intentionally collaborates with other healthcare professionals involved in patients/customers or employees' experiential journeys to ensure strong communication, ease of access to information, and a seamless experience
Involves patients (customers) in shift/handoff reports by enabling their participation in their plan of care as applicable to the given job
Actively supports the organization's vision, fulfills the mission and abides by the I CARE values
Responsibilities PEOPLE ESSENTIAL FUNCTIONS
Subject matter expert responsible for research, writing, and editing of technical documents.
Mentors and coaches other scientific writers in editing and compiling appendices of documents related to technical reports.
Works with departments, agencies and sponsors to ensure that specific requirements are met with respect to document content and formatting.
SERVICE ESSENTIAL FUNCTIONS
Independently creates technical documents (collaborating with the team) based on the strategy provided, and is accountable for the format, content, and adherence to global and electronic publishing standards of the individual submission documents that he/she is the author of.
Interprets data and advises faculty as how to best present data considering scientific communications best practices.
Works with Principal Investigator(s) to develop, present, and bring to final submission high quality, large, multi-disciplinary, and multi-collaborative grant proposals and publications.
QUALITY/SAFETY ESSENTIAL FUNCTIONS
Prepares moderately complex documents and sections of regulatory submissions and contributes scientific knowledge and analytical skills to the preparation of grant proposals, manuscripts, presentations, protocols, and clinical regulatory documentation.
Prepares technical documents that adhere to regulatory, financial, policy, and legal requirements.
Assures compliance with Houston Methodist policies, rules, and regulations to meet government, publisher, and sponsor standards and research development best practices.
FINANCE ESSENTIAL FUNCTIONS
Development of grant application budgets, industry contracts and subcontracts, and other financial documents in compliance with Houston Methodist policies and procedures.
Contributes to quality improvement and success of grants applications.
GROWTH/INNOVATION ESSENTIAL FUNCTIONS
Finds and implements innovations in scientific writing, grant development and research development to continuously improve best practices.
Seeks opportunities to for continual professional development.
Fosters a positive and constructive teaching environment by engaging students and co-workers in learning opportunities that are valuable and in alignment with business objectives.
This job description is not intended to be all-inclusive; the employee will also perform other reasonably related business/job duties as assigned. Houston Methodist reserves the right to revise job duties and responsibilities as the need arises. Qualifications EDUCATION
Master's Degree required
PhD Preferred
WORK EXPERIENCE
Six years' experience in technical or scientific writing
Two years with grant applications preferred
License/Certification LICENSES AND CERTIFICATIONS - REQUIRED
N/A
KSA/ Supplemental Data KNOWLEDGE, SKILLS, AND ABILITIES
Demonstrates the skills and competencies necessary to safely perform the assigned job, determined through on-going skills, competency assessments, and performance evaluations
Sufficient proficiency in speaking, reading, and writing the English language necessary to perform the essential functions of this job, especially with regard to activities impacting patient or employee safety or security
Ability to effectively communicate with patients, physicians, family members and co-workers in a manner consistent with a customer service focus and application of positive language principles
Ability to write in a clear, concise, and accurate language that can be understood by technical and non-technical audiences
Ability to understand complex scientific information, theories, and practices.
Skilled in identifying extramural funding mechanisms for faculty and programs
Skilled in coordinating strategic writing projects
SUPPLEMENTAL REQUIREMENTS
WORK ATTIRE
Uniform No
Scrubs No
Business professional Yes
Other (department approved) No
ON-CALL*
*Note that employees may be required to be on-call during emergencies (ie. DIsaster, Severe Weather Events, etc) regardless of selection below.
On Call* No
TRAVEL**
**Travel specifications may vary by department**
May require travel within the Houston Metropolitan area No
May require travel outside Houston Metropolitan area Yes
Company Profile
Houston Methodist Research Institute was formed in 2004 to rapidly and efficiently translate discoveries made in the laboratory and the clinic into new diagnostics, therapies, and treatments. The research institute was created to provide the infrastructure and support for these endeavors, and to house the technology and resources needed to make innovative breakthroughs in important areas of human disease. A 540,000 square foot building dedicated to research, the research institute houses over 1,500 staff and trainees, 284 principal investigators and has more than 570 ongoing clinical trials.
Auto-ApplySenior Medical Writer
Millbrae, CA jobs
Eikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of microscopes which enable real time, molecular-resolution measurements of protein movement in living cells, thereby unlocking otherwise intractable classes of proteins as drug targets.
Position
We are seeking an experienced, detail-oriented individual to join our Medical Writing team. In the Senior Medical Writer role, you will be responsible for independently leading document development by authoring and editing of medical and regulatory writing deliverables that support the Eikon clinical portfolio. You will partner with cross functional colleagues within study teams/project teams to prepare high-quality, accurate and fit for use clinical and regulatory documents enabling delivery of Eikon portfolio milestones.
This role will require a minimum of 3 days a week of onsite presence (or more as business needs require) in either of our Jersey City (NJ) or Millbrae (CA) offices to ensure effective management, operational excellence and high-performance delivery of clinical studies and to support the expected significant team growth & collaboration.
About You
You are an experienced, independent, scientifically minded individual with a passion for accurate and concise medical and regulatory writing.
What You'll Do
Independently write clinical and regulatory documents, including (but not limited to): clinical protocols, clinical study reports (CSRs), investigator brochures (IBs), common technical document (CTD) modules (Module 2.7.Xs, 2.5, and Module 5 integrated summaries), briefing documents, posters, abstracts, manuscripts and other documents per company and regulatory guidelines.
Interpret data and apply knowledge of regulatory/compliance/scientific requirements to document preparation.
Independently manage and maintain document lifecycle, including timelines, workflow of writing assignments, review cycle management, and document quality management where appropriate.
Help to iteratively improve medical writing processes as appropriate.
Contribute to document quality control (QC) as needed and help ensure consistency across documents to ensure adherence to company style and regulatory agency expectations.
Take ownership of a given assignment, proactively consulting other cross-functional project team members to align and build consensus on timelines, document interdependencies, organize and drive kick off meetings, comment resolution meetings, and ad-hoc meetings to mitigate risks and resolve project related issues.
Interpret and understand scientific and clinical data, provide input on data, figures, tables, and listings for clear data presentation per the document scope.
Qualifications
Doctoral-level degree in Life Sciences (e.g., Ph.D., M.D., PharmD; preferred), or Master's degree with 3+ years of relevant experience, or Bachelor's degree with 5+ years of relevant experience in regulatory, scientific, or medical writing.
Substantial clinical study protocol writing experience desired.
Excellent communication, presentation, and project management skills.
Ability to independently prepare clinical and regulatory documents (e.g., protocol, CSR, IB, CTD modules) in compliance with company SOPs and international health agencies/regulatory guidelines with a focus objective data presentation in a clear, concise format in keeping with industry guidelines.
Working knowledge of statistical concepts and techniques.
Proven track record of meeting project timelines/deliverables and attention to detail, process, deadlines, and high-quality results.
Strong understanding of federal regulations, GCPs, and ICH guidelines is a plus.
Understanding of clinical development, including study phases, submission processes, and techniques used within a clinical development environment from protocol design through regulatory submission and support for marketed products.
Technical expertise in typical office applications (e.g., Microsoft Office, Adobe Acrobat) shared document systems (e.g., SharePoint, Veeva RIM, PleaseReview), and with specialized software (e.g., GraphPad Prism, PerfectIt, SmartSheet, Endnote).
Familiarity with concepts of structured content management preferred.
Proven ability to work independently in a dynamic, fast-moving environment while striving for excellence in collaboration and innovation, as part of a cross-functional team.
At Eikon, employee compensation also includes bonus and equity compensation, in addition to several generous benefit programs, including:
401k plan with company matching
Medical (premiums covered by Eikon at 95%), dental and vision insurance (premiums covered by Eikon at 100%)
Mental health and wellness benefits
Weeklong summer and winter holiday shutdowns
Generous paid time off and holiday policies
Life/AD&D Insurance (premiums covered by Eikon at 100%) and optional supplemental employee-paid life/AD&D policies
Enhanced parental leave benefit
Daily subsidized lunch program when on-site
The expected salary range for this role is $125,000 to $136,800 depending on skills, competency, and the market demand for your expertise.
Eikon is proud to be an equal opportunity employer and will consider all qualified applicants for employment.
We are currently not accepting any new third-party agencies or firms at this time. Please do not forward unsolicited agency resumes to our website, employees or Human Resources. Eikon Therapeutics will not pay fees to any third-party agency or firm associated with unsolicited resumes.
Auto-ApplyPrincipal Clinical Medical Writer
San Rafael, CA jobs
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
Our Culture
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
SUMMARY DESCRIPTION The Principal Clinical Medical Writer has functional oversight responsibilities for medical writing staff and for the medical writing requirements for clinical development programs, including authoring/editing documents.
RESPONSIBILITIES
Oversight responsibilities for Medical Writing staff
Works with the Head of Medical Writing to establish and maintain timelines for program planning.
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (e.g. PBRERs, DSURs)
Drafts and edits documents used in the preparation of regulatory filings (e.g. briefing books, CTD Module 2/Module 5 clinical or integrated summaries).
Manages study team participation in the preparation of such documents, including scheduling and chairing meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Represents CMW at cross-functional team meetings (e.g. study team, development team, other sub-teams).
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned.
SCOPE
This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Clinical Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.
EDUCATION
Masters (MS) or higher degree preferred; scientific focus desirable. Minimum requirement: •At least 8 years of experience as a medical writer in the pharmaceutical industry. Evidence of medical writing career development desirable, e.g. European/American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
EXPERIENCE
Relevant ExperienceFulfills one of the following:· At least 8 years of experience as a medical writer in the pharmaceutical industry. Management· Prior administrative and/or functional management experience as a manager of a medical writer team or department in a clinical development setting preferred but not required· Demonstrated leadership abilities.· Demonstrated ability to plan timelines and resources for multiple documentation projects with shifting priorities.· Experience with delegating and overseeing projects and tasks. Clinical Studies· Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets.· Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.· Advanced applied knowledge of:o documentation required for the conduct of clinical studieso protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)o study results reportingo integrated results reporting· Direct experience with documentation in all phases of drug development. Medical Writing· Writing high-quality documents that support corporate goals and objectives.· Experience writing, reviewing, or editing protocols, clinical study reports, INDs, BLA/NDAs, periodic safety documents, and regulatory briefing books required.· Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.· Ability to interpret and create complex tabular and graphical clinical data presentations.· Ability to interpret basic clinical laboratory tests.· Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Computer/office equipment Skills
Proficient in Microsoft Word (including the use of templates), Microsoft Copilot, Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint.
Experience using document management software (e.g. SharePoint, Veeva)
Experienced with scanners, printers, and copiers.
Regulatory
Ability to plan and manage development of the following documents in context of regulatory requirements and guidances, development program plans, and organizational business needs:
o ‘standalone' regulatory documents (eg, protocols, investigator brochures, clinical study reports, IND annual reports)
Prior familiarity with standard eCTD IND/NDA work, including:
o Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format o Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)
Support project teams by identifying and summarizing relevant regulations and guidelines, including differences between US and EMEA submissions and to provide recommendations for changes in documentation in response to new or modified regulations and guidances.
Project Management
Ability to plan, resource, and assign multiple simultaneous document development projects (standalone and complex dossiers) with shifting priorities.
Ability to keep CMW line management apprised of program document status, to anticipate potential issues within a program, and to raise those issues to CMW line management with proposed mitigations/solutions
Ability to support staff in renegotiating timelines during development as necessary.
Program Management
Capable of managing and maintaining multiple timelines governing multiple projects within a program.
Capable of performing resource assessments (short- and long-term) based on projected project needs within a program.
Capable of anticipating potential issues within a program and raising those issues to CMW line management with proposed mitigations/solutions.
Communication
Capable of well organized, concise and clear written and verbal communication.
Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Auto-ApplyMedical Writer
San Rafael, CA jobs
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
The Medical Writer 1 applies basic to intermediate documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
RESPONSIBILITIES List the major responsibilities of the job.
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.)
Aids in managing study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Assists in developing and reviewing standard processes and templates within Global Medical Writing
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned.
SCOPE Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.
This position progressively develops the medical writing function in alignment with the requirements of clinical development and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.
EDUCATION State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
Bachelor's or higher degree preferred; scientific focus desirable. Minimum requirement: University-level medical or technical writing course(s) or equivalent experience in science/technical writing. Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
EXPERIENCE State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
Relevant ExperienceFulfills one of the following:· Up to 2 years as a medical writer in the pharmaceutical industry· At least 5 years of medical or scientific writing experience as a primary job responsibility Clinical Studies· Familiar with drug development process (discovery to market).· Basic understanding of biostatistical and clinical research concepts.· Basic applied knowledge of:o documentation required for the conduct of clinical studieso protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)o study results reporting Medical Writing· Writing high-quality documents that support corporate goals and objectives.· Experience writing, reviewing, or editing protocols and clinical study reports preferred.· Basic applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.· Ability to interpret basic tabular and graphical clinical data presentations.· Ability to create basic tables using AMA style (eg, Schedule of Events).· Basic to intermediate applied knowledge of basic clinical laboratory tests.· Basic understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Computer/office equipment Skills
Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, and PowerPoint.
Familiar with document management software (eg, LiveLink, SharePoint, Veeva)
Experienced with scanners, printers, and copiers.
Regulatory
Basic knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
Project Management
Capable of working on multiple tasks and shifting priorities.
Good conflict management skills.
Motivated and shows initiative.
Detail oriented.
Communication
Capable of well organized, concise and clear written and verbal communication.
Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
Effective at explaining writing principles to a varied audience both in individual and group settings; basic presentation skills.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Auto-ApplySenior Document Writer - New Group Business
Sacramento, CA jobs
At CVS Health, we're building a world of health around every consumer and surrounding ourselves with dedicated colleagues who are passionate about transforming health care. As the nation's leading health solutions company, we reach millions of Americans through our local presence, digital channels and more than 300,000 purpose-driven colleagues - caring for people where, when and how they choose in a way that is uniquely more connected, more convenient and more compassionate. And we do it all with heart, each and every day.
**Position Summary**
Under general supervision the Senior Document Writer drafts, reviews, and edits medical, dental and vision plan documents. This position will support plan document needs for new business by creating plan documents and summaries of benefits and coverage (SBC's).
**Required Qualifications**
+ 2-4 years with extensive plan writing experience supporting self-funded or fully insured plans.
+ 2-4 years of experience in the health insurance industry.
+ Proficiency with Microsoft Office Word, Excel, SharePoint, and Outlook applications.
+ Must be an independent, critical thinker who is a self-starter and deadline driven.
+ Strong attention to detail and accuracy performing at high levels in a fast paced and constantly changing work environment.
**Preferred Qualifications**
+ Knowledge and experience in medical, dental, and vision benefits.
+ Knowledge and experience with benefit terminology.
+ General understanding of compliance and regulatory issues (ERISA, HIPAA, ACA, COBRA).
+ Organizes time efficiently to ensure that tasks are completed to meet or exceed deadlines.
+ Strong verbal and written communication skills.
**Education**
+ High School Diploma or GED.
**Anticipated Weekly Hours**
40
**Time Type**
Full time
**Pay Range**
The typical pay range for this role is:
$18.50 - $42.35
This pay range represents the base hourly rate or base annual full-time salary for all positions in the job grade within which this position falls. The actual base salary offer will depend on a variety of factors including experience, education, geography and other relevant factors. This position is eligible for a CVS Health bonus, commission or short-term incentive program in addition to the base pay range listed above.
Our people fuel our future. Our teams reflect the customers, patients, members and communities we serve and we are committed to fostering a workplace where every colleague feels valued and that they belong.
**Great benefits for great people**
We take pride in our comprehensive and competitive mix of pay and benefits - investing in the physical, emotional and financial wellness of our colleagues and their families to help them be the healthiest they can be. In addition to our competitive wages, our great benefits include:
+ **Affordable medical plan options,** a **401(k) plan** (including matching company contributions), and an **employee stock purchase plan** .
+ **No-cost programs for all colleagues** including wellness screenings, tobacco cessation and weight management programs, confidential counseling and financial coaching.
+ **Benefit solutions that address the different needs and preferences of our colleagues** including paid time off, flexible work schedules, family leave, dependent care resources, colleague assistance programs, tuition assistance, retiree medical access and many other benefits depending on eligibility.
For more information, visit *****************************************
We anticipate the application window for this opening will close on: 12/22/2025
Qualified applicants with arrest or conviction records will be considered for employment in accordance with all federal, state and local laws.
We are an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring, promotion, or any other personnel action based on race, ethnicity, color, national origin, sex/gender, sexual orientation, gender identity or expression, religion, age, disability, protected veteran status, or any other characteristic protected by applicable federal, state, or local law.
Senior Medical Writer
San Rafael, CA jobs
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.
Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
The Senior Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
RESPONSIBILITIES List the major responsibilities of the job.
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.)
Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries).
Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Represents Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams).
Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met.
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
Works effectively with cross-functional groups within BioMarin
Other tasks as assigned.
SCOPE Quantify the scope or impact of the job in terms of revenue, expenses, capital investment, headcount, etc.
This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals. Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Global Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.
EDUCATION State both the minimum and the preferred educational attainment (or equivalent experience), and describe essential and desired subject matter, certifications, special training, etc.
Bachelor's or higher degree required; scientific focus desirable. Minimum requirement: Experience in medical writing. Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.
EXPERIENCE State both the minimum and the preferred number of years of relevant experience, and describe the essential functions of the job.
Relevant ExperienceFulfills one of the following:· Up to 6 years of as a medical writer in the pharmaceutical industry· At least 10 years of medical or scientific writing experience as a primary job responsibility Clinical Studies· Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets.· Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.· Intermediate to advanced applied knowledge of:o documentation required for the conduct of clinical studieso protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)o study results reportingo integrated results reporting· Direct experience with documentation in all phases of drug development. Medical Writing· Experience writing, reviewing, or editing protocols and clinical study reports required.· Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred.· Experience writing, reviewing, or editing regulatory briefing books preferred.· Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.· Ability to interpret and create complex tabular and graphical clinical data presentations.· Advanced applied knowledge of basic clinical laboratory tests.· Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug). Computer/office equipment Skills
Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint.
Experience using document management software (eg, LiveLink, SharePoint, Veeva)
Experienced with scanners, printers, and copiers.
Regulatory
Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
Prior familiarity with standard eCTD IND/NDA work, including:
o Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format o Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE) Project Management
Capable of working on multiple tasks and shifting priorities.
Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.
Capable of representing Global Medical Writing at cross-functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross-functional conflicts.
Good conflict management skills.
Motivated and shows initiative.
Detail oriented.
Communication
Capable of well organized, concise and clear written and verbal communication.
Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
Effective at explaining writing principles to a varied audience both in individual and group settings; intermediate to advanced presentation skills.
Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
Auto-ApplyGrant Writer
Costa Mesa, CA jobs
Grant
Writer
|
Fuel
Purposeful
Research,
and
Shape
the
Future
to
Create
a
Brain
Health
Revolution
Auto-ApplyGrant Writer
Costa Mesa, CA jobs
Grant Writer | Fuel Purposeful Research, and Shape the Future to Create a Brain Health Revolution
Independent Contractor
Remote
Compensation:
Project-based compensation ranging from $70,000.00 To $80,000.00 (estimated, based on workload) annually, plus performance-based bonuses for grant completion and awarded grants.
Job Summary:
Amen Clinics is seeking an experienced Independent Contractor - Grant Writer to partner with us in expanding funding opportunities that support research, education, and clinical innovation. This role will operate on a contract basis and focus on specific projects, providing professional grant writing services with measurable deliverables.
As an Independent Contractor, you will manage your own workflow, tools, and resources, while collaborating as needed with Amen Clinics' leadership to ensure proposals align with organizational goals. This engagement is designed for a results-oriented professional who thrives in an independent setting and brings proven expertise in securing significant grant funding.
Essential Duties and Responsibilities:
- Manage the full lifecycle of grant submissions from concept to submission, including narratives, logic models, budgets, and supporting documentation.
- Track grant deadlines and manage follow-ups including reporting and renewals.
- Research and identify grant opportunities aligned with organizational priorities.
- Craft grant narratives that reflect Amen Clinics' commitment to brain-healthy living, whole-person care and outcomes that change lives.
- Collaborate with leadership, clinicians, educators, and researchers to articulate program needs, budgets, and expected outcomes.
- Write clear, concise, and persuasive content tailored to funder interests.
- Align grant proposals with current Amen Clinics initiatives, including BRIGHT MINDS, brain imaging research, educational curricula, and community outreach ensuring each submission advances our mission of transforming mental health through brain science.
- Ensure all submitted materials meet funder and compliance requirements.
- Maintain organized documentation of all submissions, progress, and outcomes.
- Contribute to strategy for expanding funding portfolio and impact.
Qualifications and Requirements:
- Proven track record of successfully securing six- and seven-figure grants.
- 5+ years of proven success in grant writing for nonprofits, healthcare, or academic institutions.
- Demonstrated ability to manage the full grant lifecycle, including prospect research, proposal strategy, application development, submission, compliance, and post-award reporting.
- Proven track record of maintaining grant calendars, reporting deadlines, and renewal cycles to ensure timely submissions and effective stewardship.
- Strong portfolio of successful six- and seven-figure proposals.
- Skilled in coordinating across departments (finance, research, clinical, and executive leadership) to align project goals, gather supporting data, and ensure all deliverables meet funder requirements.
- Experience developing grant budgets, logic models, and measurable outcomes in collaboration with program and finance teams.
- Strong ability to cultivate and manage funder relationships, including follow-up communications, impact reporting, and renewal discussions.
- Demonstrated success securing funding from government, private foundations, and corporate philanthropy.
- Experience interpreting and responding to NOFOs from federal agencies such as NIH, SAMHSA, HRSA, or the Department of Education.
- Experience drafting scalable proposals, such as those supporting national program expansion, AI-powered platforms, or multi-site clinical studies.
- Proficiency with AI and modern data tools to streamline research, automate opportunity tracking, and optimize lead generation for grants.
- Familiarity with grant management systems for tracking proposals, deadlines, budgets, and outcomes.
- Bachelor's degree in Neuroscience, Public Health, English, Communications, or a related field required; advanced degree (Master's or higher) preferred.
- Experience working with research, clinical, or education teams preferred.
- Excellent writing, research, and storytelling skills, with the ability to translate complex information into compelling, mission-aligned narratives.
- Highly organized, detail-oriented, and able to manage multiple priorities under tight deadlines.
- Self-starter with strong initiative, follow-through, and collaborative spirit.
- Alignment with the brain-healthy principles of Amen Clinics (nutrition, exercise, mental fitness, emotional regulation, and purpose-driven work).
To Apply:
Submit your resume, a cover letter that reflects your alignment with our brain health mission, values and culture, and a writing sample (preferably a successfully funded grant). Apply online.
You are not stuck with the brain you have. You can make it better. And when you help us secure the resources, together we can help millions do just that.
Let's change lives, one brain at a time.
Auto-ApplyGrant Writer
Sacramento, CA jobs
Join Elica's mission and become a part of a team where every day is an opportunity to make a positive impact in your community!
At Elica Health Centers, we share a common goal: provide the best possible patient care to our growing community! Our passion extends throughout Elica, from the exceptional healthcare services we provide to our underserved patients at our Community Health Clinics and state-of-the-art mobile medicine program, Health on Wheels, to our Resource Center where we empower patients and members of the community to connect with resources to help them build healthy and full lives.
WHAT YOU'LL DO
The Grant Writer will conduct ongoing prospect research to identify and help to determine which government and private sector funding programs are most aligned with Elica Health Center's mission and strategic plan. If needed, the Grant Writer will contact potential and current funders to ask them questions which will help Elica to understand their: funding priorities, application process, and methods for selecting grantees. The Grant Writer will present prospect research results to the Community Development Director. The Grant Writer will compile various information from different departments within Elica to answer grant application questions and complete grant narratives. Furthermore, the Grant Writer will gather healthcare-related and social determinants of health data from external sources to help prepare funding applications/proposals.
BENEFITS:
Retirement Savings Made Easy: Enjoy a 403(b) retirement plan with up to 4% employer matching and 100% immediate vesting-start building your future from day one!
Comprehensive Healthcare Options: Choose from two Anthem Blue Cross PPO plans for medical, plus dental and vision coverage for you and your family.
Employer-Funded HRA: Our Health Reimbursement Arrangement helps cover out-of-pocket medical costs, giving you peace of mind.
Flexible Spending Accounts: Take advantage of two FSA options: Health Care FSA and Dependent Care FSA, tailored to suit your needs.
Security for the Unexpected: We provide company-paid basic Life and AD&D Insurance, with options to enhance coverage.
Enhanced Protection: Explore additional benefits like Hospital Indemnity, Critical Illness, and Accident Insurance, plus ID Theft Protection and Pet Insurance.
Time to Recharge: Enjoy accrued paid time off, paid holidays, and Employee Assistance Plan (EAP) access, which includes counseling, financial, and legal services, along with a vast library of online resources.
Invest in Yourself: Benefit from our Tuition Reimbursement Program for ongoing education and growth, plus CME/CEU and license reimbursements for eligible roles.
This is more than just a benefits package-it's a commitment to your health, well-being, and professional success!
Learn more about Elica's services and mission at our website or check us out on Facebook.
Requirements
WHAT ARE WE LOOKING FOR?
The successful candidate will be willing and able to:
Assist with grant writing, and project management of grant applications to government, corporate, and foundation funders.
Request letters of support (including writing drafts) from other regional Federally Qualified Health Centers (FQHCs), healthcare organizations (e.g.: hospitals; community clinics), and government/community/business leaders for Elica's grant requests, change in-scope applications, etc. to HRSA.
Respond to requests for letters of support from other FQHCs and/or organizations that professionally collaborate with Elica.
If needed, participate in Elica's preparations of applications for certain types of noncontributor income (e.g.: program-related investments; New Markets Tax Credits).
Assist with exploring opportunities for Elica to possibly develop and launch: (a) fundraising collaborations with local/regional affordable housing organizations that are required to offer onsite supportive services (e.g., employment preparation; healthcare) to their low-income residents); (b) an annual campaign targeting middle-income individual donors; (c) a major gifts program targeting high-income donors; (d) a planned giving program targeting middle-income and high-income donors.
Assist with grant reporting and management (e.g.: report scheduling and preparation; tracking results of Elica's programs which have received grants).
Participate in the design and implementation of community outreach strategies.
Possibly represent Elica at select meetings and events (examples of past meetings/events: City of Sacramento Pathways to Health + Home Steering Committee meetings; annual Serotonin Surge charitable events for local community health clinics; Sacramento County Medi-Cal Managed Care Advisory Committee public meetings; Kaiser Permanente semi-annual community needs assessment meetings; etc.).
When appropriate, help to organize and participate in site visits of Elica's operations by business, political and community leaders, and other important stakeholders (e.g.: September 2017 Elica site visit by U.S. Representative Doris Matsui).
If needed, assist with: writing / editing of text for promotional materials (e.g., brochures, portable displays, etc.).
If needed, and as approved by Elica's COO/CFO, participate in specific PTX projects- especially those related to internal and external communications.
Attend all mandatory staff meetings, as well as designated staff meetings that are relevant to Elica's fundraising, community outreach and Practice Transformation (PTX) objectives/activities.
As needed, prepare non-monetary proposals/applications to institutions (e.g.: RFQ proposal to Sacramento Housing and Redevelopment Agency for Elica's acquisition of new Revere Street Clinic within SHRA's Sacramento Promise Zone; RFQ to City of Sacramento's Pathways to Health + Home initiative).
Prepare and submit monthly activity update reports to the CDD for incorporation into the CDD's monthly departmental report to Elica's CEO and COO/CFO.
As needed, participate in On-Site Visit (OSV) audits by the U.S. Health Resources and Services Administration (HRSA).
The successful candidate has:
B.A college degree or higher - preferably with a major/concentration in English, Communications, Nonprofit Management or a similar field of study.
A minimum of 3 to 5 years' experience in fundraising.
Experience in a health care organization is highly desired, but not mandatory.
Exceptional writing skills and broad-based grant writing experience is essential.
Experience in planning, leading, and managing projects, including coordinating with peers to achieve desired outcomes, and tracking and reporting on progress to managers/directors.
Additional Requirements
Must have a current and valid California driver's license and the ability to provide proof of personal auto insurance on the vehicle driven during working hours.
If selected for an employment opportunity with Elica Health Centers, external hires must provide proof of immunizations (Hepatitis B, MMR, Varicella & Tetanus), tuberculosis clearance, and proof of COVID-19 vaccination status* prior to their scheduled start date. Please be advised that this position is subject to criminal background investigation and drug screen.
Physical Requirements and Work Environment
The work environment is characteristic of normal office conditions. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is frequently required to sit; use hands to handle or lift. The employee is occasionally required to stand; walk; and reach with hands and arms. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, distance vision and ability to adjust focus. The employee must also possess hearing and speech to communicate in person and over the phone. The noise level in the work environment is usually quiet.
The employee may be required to run agency related errands and attend off-site meetings; the employee must be able to operate, maneuver and/or control a motor vehicle. In performing the driving responsibilities, the driver may sit for long periods. This requires intense concentration, particularly in poor driving conditions.
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
*Elica Health Centers is a healthcare facility that adheres to the mandates issued by the California Department of Public Health including the recent orders regarding the COVID-19 vaccine. Medical and religious exemptions will be considered.
Philanthropic Grant Writer
Dallas, TX jobs
Interested in a career with both meaning and growth? Whether your abilities are in direct patient care or one of the many other areas of healthcare administration and support, everyone at Parkland works together to fulfill our mission: the health and well-being of individuals and communities entrusted to our care. By joining Parkland, you become part of a diverse healthcare legacy that's served our community for more than 125 years. Put your skills to work with us, seek opportunities to learn and join a talented team where patient care is more than a job. It's our passion.
Primary Purpose
Plans, researches, writes, submits, reports on and tracks successful grant proposals in support of Parkland's philanthropic priorities and ensures updated proposal/case for giving templates are available for the purpose of fundraising.
Minimum Specifications
Education
* Bachelor's degree in a health, business, marketing, social service or a related field.
Experience
* Six years of experience in writing successful grant applications, fundraising or marketing/communications.
Equivalent Education and/or Experience
* May have an equivalent combination of education and experience to substitute for both the education and the experience requirements.
Skills or Special Abilities
* Must have excellent communication skills, both verbal and written.
* Must have excellent organizational skills, including project management and meeting facilitation, and must be able to manage competing priorities and rapidly changing department needs.
* Must have proven research skills and knowledge of fundraising information sources.
* Must have ability to understand, process and execute complex instructions independently.
* Must be proficient in MS Office Word, Excel and fundraising database or relationship management software such as Raiser's Edge.
* Must have strong relationship-building skills.
* Must have understanding of healthcare environment and/or related social services.
* Must be sensitive to political, cultural and legal issues related to hospital system operations and fundraising and be able to function both independently and as part of a cross-functional team.
Responsibilities
* Conducts full range of activities required to prepare, write, submit and manage grant proposals to foundations and corporate sources.
* Works with Prospect Researcher to identify and evaluate foundation and corporate grant opportunities.
* Maintains grants calendar to include new application and reporting deadlines.
* Develops and maintains case for giving to and impact of giving to philanthropic priorities of Parkland. Duties include written materials and current relevant statistics for proposals and stewardship.
* Gathers information, prepares and submits reports to comply with all grant reporting as required by grantors/donors.
* Maintains records in database and paper files.
* Assist Foundation staff and volunteers with writing for proposals, publications and other special projects.
* Serves as liaison and conduit of information both to and from health system departments and external partners.
Job Accountabilities
* Identifies ways to improve work processes and improve customer satisfaction. Makes recommendations to supervisor, implements, and monitors results as appropriate in support of the overall goals of the department and Parkland.
* Stays abreast of the latest developments, advancements, and trends in the field by attending seminars/workshops, reading professional journals, actively participating in professional organizations, and/or maintaining certification or licensure. Integrates knowledge gained into current work practices.
* Maintains knowledge of applicable rules, regulations, policies, laws and guidelines that impact the area. Develops effective internal controls designed to promote adherence with applicable laws, accreditation agency requirements, and federal, state, and private health plans. Seeks advice and guidance as needed to ensure proper understanding.
Parkland Health and Hospital System prohibits discrimination based on age (40 or over), race, color, religion, sex (including pregnancy), sexual orientation, gender identity, gender expression, genetic information, disability, national origin, marital status, political belief, or veteran status. As part of our commitment to our patients and employees' wellness, Parkland Health is a tobacco and smoke-free campus.
Nearest Major Market: Dallas
Nearest Secondary Market: Fort Worth
Job Segment: Healthcare Administration, Patient Care, Healthcare