49 Scientific Writing jobs in the United States

SUMMARY/JOB PURPOSE :

Leads content development for various regulatory and clinical documents to support multiple assets across all phases of asset development. Examples include clinical and nonclinical summaries for IND/NDA/BLA/MAA, briefing documents, regulatory responses, protocols, investigator brochures, clinical study reports, and other types of complex cross-functional documents and reports as needed.

DUTIES/RESPONSIBILITIES:

• Independently leads content development for regulatory and clinical documents by composing (writing), developing, reviewing, and editing content. Integrates various sources of information into a uniform style and presentation for the intended audience.

• Incorporates diverse reviewer feedback while ensuring high quality of content organization, including completeness, clarity, coherence, conciseness, consistency, and accuracy.

• Compiles, analyzes, and summarizes data from statistical tables and additional data from other sources as needed to create descriptive text and in-text tables.

• Assigns and supervises partner regulatory editors for all document tasks unrelated to writing.

• Proposes and manages timelines for the document development process from initiation through approval.

• Oversees the assembly of appendices for regulatory submission documents as needed.

• Serves as the primary writing contact on regular and ad hoc study/program/asset or project teams.

• Provides writing guidance to internal teams based on organizational goals and company policy, with responsibility for results.

• Peer reviews project work and training materials/guidelines drafted by Regulatory Science Communications team members.

• Contributes to SOP and work instruction development and review for the Regulatory Science Communications team.

• Other duties as needed.

SUPERVISORY RESPONSIBILITIES:

• No direct reports.

• Supervises work of junior writers and regulatory editors on document tasks.

• May direct and review the work of contract writers as needed.

• Mentors less experienced writers.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education:

• BS/BA degree in related discipline and a minimum of thirteen years of related experience including industry; or,

• MS/MA degree in related discipline and a minimum of eleven years of related experience including industry; or,

• PhD in related discipline and a minimum of eight years of related experience including industry; or,

• Equivalent combination of education and experience.

• Active AMWA member with certificate or certification preferred; BELS certification a plus.

Experience:

• Experience in Biotech/Pharmaceutical industry is required.

• A minimum of seven years of regulatory/medical/technical writing or equivalent writing experience in the pharmaceutical industry, including experience supervising less experienced writers.

• Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions (e.g., IND/NDA/BLA/MAAs, clinical protocols, CSRs, IBs).

• Experience and use of electronic literature tools to obtain scientific/medical abstracts and publications.

• Familiarity with the therapeutic area of oncology is essential.

• Advanced knowledge of the drug development process and regulatory requirements for documents including applicable regulations, ICH guidelines, and GCP standards.

• Advanced knowledge of AMA style, medical terminology, and clinical data analysis.

• Professional certification (e.g., AMWA, BELS) is beneficial.

Knowledge, Skills and Abilities:

• Develops and manages plans, establishes timelines, and sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high-quality work.

• Applies extensive knowledge of the regulatory framework, industry drivers, and practices to develop innovative approaches and manage complex work.

• Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one-to-one situations and effectively presents information to cross-functional groups of colleagues.

• Strong interpersonal skills and ability to accommodate differing views to influence an agreed-upon resolution.

• Facilitates team alignment and achievement of common objectives. Engages internal and external stakeholders to establish productive collaborative relationships.

• Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing, and applying key information to solve problems. Provides regulatory writing expertise to cross-functional teams. Understands the longer-term consequences of decisions and actions.

• Acts with integrity to build trust and execute on team objectives that contribute to departmental goals.

• Capable of proactively assessing workload, trends, tasks, and priorities for the area of responsibility.

• Plans and executes multiple activities.

• Considers alternative methods and contingency plans to avoid potential issues.

• Designs and implements solutions to address project-level challenges, taking into consideration the broader impact.

• Environment: primarily working indoors.

#LI-MB1

If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.

• Act as the Medical Communications lead for product-specific working groups or projects and support Publications, as needed
• Support other Scientific Communications Leads as needed in work across products
• Create, manage and track strategic scientific communication plans in partnership with a cross-functional team
• Create/review medical and scientific materials for both accuracy and strategic alignment for internal and external customers. Main deliverables include scientific communication platforms, MSL slide decks targeted for HCP and payor audiences, Medical Affairs booth materials, Medicaid Testimonies, and others as needed
• Develop in-depth therapeutic knowledge of disease, epidemiology, product and competitor product information; act as a resource to others external to Medical Affairs
• Partner with Medical Directors to develop and implement product specific strategy and alignment, and ensure accurate representation in scientific communication materials
• Work effectively with a cross-functional team of stakeholders including Compliance, Research and Development (Clinical Development, Clinical Operations, Regulatory Affairs, Nonclinical, etc), Marketing, and individuals external to Alkermes
• Ensure compliance with department and company policies and procedures
• Serve as the subject matter expert for Scientific Communications review processes and the content management and review tool (Veeva Vault), provide guidance from concept/project initiation through publication
• Manage vendor and budget
• Support additional projects or initiatives within the Scientific Communications function

• Knowledge of pharmaceutical industry regulations, guidelines, standards and practices
• Domestic and International travel may be required (10%)
• Ability to work independently in a hybrid working model in our Waltham 3 days/week
• Demonstrates problem solving skills and ability to work in a fast-paced environment with competing priorities
• Exceptional interpersonal skills, experience working in a team with ability to work collaboratively toward a common goal
• Excellent written and verbal communication skills and ability to read, interpret, and convey complex scientific information
• Takes intelligent risk and evaluates impact of decisions
• Analyzes complex situations and data, requiring evaluation of intangible and unclear factors
• Employs strategic thinking to contribute to product, departmental, and organizational plans and goals
• Adapts to unexpected tasks, issues, changes in strategy, or department needs and provides leadership to accomplish goals
• Cultivates and maintains effective relationships across all levels of the organization as well as externally

• Advanced scientific degree preferred (MD, PhD, PharmD)
• Minimum 5 years' experience in Medical Affairs, Clinical Development or related field in the industry with an MD/PhD/PharmD

• Healthcare/scientific related degrees may be accepted
• Experience in the development and review (i.e. Medical, Regulatory, and Legal review) of MSL materials and scientific platforms preferred
• Experience with Veeva Vault

About Acadia Pharmaceuticals

Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding, we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson's disease psychosis, and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer's disease psychosis, and multiple other programs targeting neuro-psychiatric and neuro-rare diseases. For more information, visitAcadia.comand follow us onLinkedInandX.

Please note that this position can be based out of Princeton, NJ, San Diego, CA, or South San Francisco, CA. Acadia's hybrid model requires this role to work in our office on average three days per week.

Position Summary

The Director will play a critical role as Medical Affairs primary point of contact for international partnerships (Named Patient Sales (NPS) program) in assigned geographies outside of North America and Europe for Acadia products, particularly rare diseases franchise. This individual will be managing Medical Affairs initiatives of the international NPS program; ensuring appropriate medical content are shared for scientific exchange as well as for responding to escalated Medical Information inquiries. This multi-skilled role will be a key cross-functional interface between Acadia headquarters and partner markets. The successful candidate will be both strategic and operational and participate in regional/key market activities.

Primary Responsibilities

• Manages Medical Affairs initiatives with partners of the international NPS program; ensuring Medical strategies are shared and discussed for alignment


• Works across matrix teams and regions to ensure relevant insights are considered for overall strategy development


• Coordinates with Learning & Development on training needs (onboarding as well as continued training as new data becomes available)


• Maintains and coordinates transfer of appropriate Medical Content for scientific exchange and for responding to Med Info inquiries for international partnerships


• Manages escalated Med Info inquiries from partner markets and ensures accurate and timely responses


• Coordinates with Medical Affairs colleagues and internal stakeholders in the development, review and approval of Medical Content for partner markets, as needed


• Maintains understanding of product knowledge and labeling, associated disease states, relevant literature, treatment guidelines, competitor information, and marketing strategies and tactics for assigned therapeutic area(s)


• Acts as a subject matter expert to the partners to provide timely up-to-date scientific and clinical information necessary to make impactful business decisions


• Contributes to the development, review and implementation of long and short-term strategies to optimize assigned partner markets for future and current products


• Develops and maintains a strong working relationship with the partners, ensuring alignment with program objectives, timelines, and quality standards aligned to global and medical affairs strategy


• Collaborates with local, regional and global cross-functional teams to address program requirements and challenges


• Collaborates learnings and best practices with leadership, headquarters and with partners


• Other responsibilities as assigned

Education/Experience/Skills

• Requires a PharmD, PhD, or MD degree in a scientific discipline. Targeting 7 years of Medical Affairs experience in pharmaceutical/biotech experience required, with 5 years in Medical Affairs/Scientific Communications/Medical Information. An equivalent combination of relevant education and experience may be considered.


• International experience within Medical Affairs/Sci Com/Med Info is preferred.


• Experience with rare disease/neurology is preferred.


• Ability to work across multiple functions, geographies and business cultures.


• Experience in literature searches, literature evaluation, and drug information concepts.


• Experience in developing medical content for scientific exchange and in response to Medical Information requests.


• Experience in MLR and MRC.


• Strong analytical and problem-solving skills.


• Understanding of the legal and regulatory environment of pharmaceutical industry desired.


• Thinks and acts with urgency while considering the broader impact on the organization


• Confidently executes on and communicates decisions and rationale.


• Anticipates risk and implements strategies to avoid potential problems. When appropriate, elevates to supervisor and other appropriate functional leaders as needed.


• Ability to travel, including international travel.

Physical Requirements

This role involves regular standing, walking, sitting, and the use of hands for handling or operating equipment. The employee may also need to reach, climb, balance, stoop, kneel, crouch, and maintain visual, verbal, and auditory communication in a standard office environment and while working independently from remote locations. The employee must occasionally lift and/or move up to 20 pounds. This position requires the ability to travel independently overnight and/or work after hours as required by travel schedules or business needs.

#LI-HYBRID #LI-BG1

In addition to a competitive base salary, this position is also eligible for discretionary bonus and equity awards based on factors such as individual and organizational performance. Actual amounts will vary depending on experience, performance, and location.

Salary Range

$187,000 $233,900 USD

EEO Statement (US-Based Employees): Studies have shown that women and people of color are less likely to apply for jobs unless they believe they meet every one of the qualifications in the exact way they are described in job postings. We are committed to building a diverse, equitable, inclusive, and innovative company, and we are looking for the BEST candidate for the job. That candidate may be one who comes from a less traditional background or may meet the qualifications in a different way. We strongly encourage you to apply, especially if the reason you are the best candidate isn't exactly what we describe here.

It is the policy of Acadia to provide equal employment opportunities to all employees and employment applicants without regard to considerations of race, including related to hairstyle, color, religion or religious creed, sexual orientation, gender, gender identity, gender expression, gender transition, country of origin, ancestry, citizenship, age, physical or mental disability, genetic information, legally-protected medical condition or information, marital status, domestic partner status, family care status, military caregiver status, veteran or military status (including reserve status, National Guard status, and military service or obligation), status as a victim of domestic violence, sexual assault or stalking, enrollment in a public assistance program, or any basis protected under federal, state or local law.

As an equal opportunity employer, Acadia is committed to a diverse workforce. If you are a qualified individual with a disability or a disabled veteran, you have the right to request a reasonable accommodation. Furthermore, you may request additional support if you are unable or limited in your ability to use or access Acadia's career website due to your disability, along with any accommodations throughout the interview process. To request or inquire about your reasonable accommodation, please complete ourReasonable Accommodation Request Formor contact us

Please note that reasonable accommodations granted throughout the recruiting process are not guaranteed to be the same accommodations given if hired. A new request will need to be submitted for any ADA accommodations after starting employment.

California Applicants: Please see Additional Information for California Residents within our Privacy Policy.

Canadian Applicants: Please see Additional Information for Canadian Residents with in our Privacy Policy.

Applicants in the European Economic Area, Switzerland, the United Kingdom, and Serbia: Please see Additional Information for Individuals in the European Economic Area, Switzerland, the United Kingdom, and Serbia within our Privacy Policy.

Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters): The Talent Acquisition team manages the recruitment and employment process for Acadia Pharmaceuticals Inc. (Acadia). Acadia does not accept resumes from recruiters or search firms without an executed search agreement in place. Resumes sent to Acadia empl

• Hire and lead the project team that implements technology, product, and editorial/production functions
• Engage the HHMI community in the development of the platform and its services
• Align platform product development and services with HHMI open research strategy; track and report on progress and outcomes relative to HHMI stated goals
• Manage the definition and delivery of assigned product development projects, collaborating with relevant stakeholders, UX & design teams, and the technology vendor for the product(s), along with carrying out user testing and feature rollout
• Recommend key roadmap (or section of roadmap) priorities, in consultation with manager and stakeholders
• Collaborate with key team members from across the day-to-day running of the product(s) to improve efficiencies and solve product-related issues
• Communicate internally and contribute to external communication, with non-technical language, as relevant, to ensure product enhancements and success are promoted and understood within the HHMI community and beyond, and that any issues or bugs affecting the use of the product are shared and handled, as appropriate
• Interact regularly with platform users to ensure full understanding of their wants, needs and perspectives
• Establish strong relationships with product stakeholders, promoting the reputation of the product, and the product innovation work.
• Actively engage in emerging technologies, techniques and innovations to drive strategic business decisions.

• MS or equivalent or a combination of education and related experience
• Experience working in Product Management
• Familiarity with academic publishing and the latest tech trends, specifically open source softwares
• Research lab experience preferred

• An understanding of and appreciation for open research policy and practice
• Team management experience both as direct supervisor and matrixed relationships up and down
• Strong knowledge of product management best practices
• Interpersonal and leadership skills to influence and build credibility with project teams and the scientific community
• Strong communication and active listening skills; ability to manage inquiries and inputs from a variety of audiences
• Must be skilled in working collaboratively and effectively with employees at all levels of the organization with the ability to influence others.
• Strong analytical and problem-solving skills
• Ability to handle ambiguity well, and to exercise independent judgment to handle all types of situations
• Problem solving skill of prioritizing and effectively progressing many competing priorities or ideas
• Excellent time-management skills and able to handle projects and responsibilities with competing priorities.

1. PURPOSE AND SCOPE OF POSITION:

The Technical Writing Specialist supports the successful implementation of laboratory equipment and systems at multi-use sites through interaction with internal customers and external service providers. The incumbent in this role, contributes to the completion of milestones associated with facility, utility, and equipment qualification. With minimum supervision and given general instructions, this individual independently carries out routine tasks and functions, and uses basic analytical skills to recognize and solve common problems of limited scope. As a developing team player, the incumbent interacts with their immediate supervisor and personnel within their own work group to achieve team goals while building trust and collaborative relationships outside the immediate organization.

2. REQUIRED COMPETENCIES:

Knowledge, Skills & Abilities:
• Excellent technical writing skills and proficiency with Microsoft Word formatting functions; ability to efficiently create technically accurate documents for system lifecycle deliverables in alignment with the site validation program; highly attentive to spelling, grammar, punctation, and overall document quality.
• Process oriented with solid critical thinking skills; adaptive and able to develop new/improved strategies, approaches, and procedures.
• Strong understanding of cGXP requirements and good documentation practices relating to systems, equipment and instrumentation within the pharmaceutical industry.
• Experience writing Standard Operating Procedures, Work Instructions/Practices, and Risk Assessments for pharmaceutical production processes and/or manufacturing equipment, systems, utilities, and facilities.
• Preferred experience authoring and executing commissioning/qualification/validation deliverables including plans, system requirements, protocols, traceability matrices, and summary reports.
• Preferred experience writing protocol deviations, investigating out of specification results, performing corrective and preventive actions, and executing change controls.
• Ability to interact effectively with cross-functional groups.
• Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
• Strong written and verbal communication skills, including solid presentation skills. Proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors.
• Strong computer skills in Microsoft Office Suite - Word, Excel, Outlook and Teams, and the ability to learn new software as required. Preferred experience with Blue Mountain Regulatory Asset Manager and Veeva Vault applications.

3. DUTIES AND RESPONSIBILITIES
• Develop written procedures for operation, cleaning, and maintenance of equipment and systems.
• Author risk assessments for equipment, systems, facilities, and utilities.
• Perform gap assessments for revisions to the site validation program and the corresponding impact of those changes to all applicable site level functional areas and relevant procedures.
• Create all documents in compliance with Client standards and policies.
• Provide excellent customer service and support. Maintain a positive relationship with all team members and site customers while promoting a positive team environment.

4) EDUCATION AND EXPERIENCE

a. BA/BS degree, Bachelor of Science degree required
b. Minimum 5 years of experience in technical writing, with 3 years of technical writing experience in the pharmaceutical industry

PubMatic (Nasdaq: PUBM) is an independent technology company maximizing customer value by delivering digital advertising's supply chain of the future.

PubMatic's sell-side platform empowers the world's leading digital content creators across the open internet to control access to their inventory and increase monetization by enabling marketers to drive return on investment and reach addressable audiences across ad formats and devices.

Since 2006, our infrastructure-driven approach has allowed for the efficient processing and utilization of data in real time. By delivering scalable and flexible programmatic innovation, we improve outcomes for our customers while championing a vibrant and transparent digital advertising supply chain.

Associate Director, Technical Writing

About The Role :

Overview: PubMatic is a digital advertising technology company that empowers premium app developers and publishers to maximize their programmatic advertising revenue. We are seeking an experienced Associate Director of Technical Writing to join our team in New York. This position will lead the technical writing team and work cross-functionally with product management, engineering, and customer success teams to develop high-quality developer documentation and product user guides.

What You'll Do:

• Lead the development and execution of content and documentation strategy, ensuring alignment with product and business goals

• Manage and lead a team of technical writers, providing guidance and support for the creation of high-quality technical documentation, including product guides, API documentation, and SDK developer guides.

• Collaborate with cross-functional teams to identify documentation needs and requirements for new and existing products and work closely with product management and engineering teams to ensure documentation accuracy and completeness.

• Develop and maintain documentation processes, tools, and standards to ensure consistency and quality of technical documentation across all products.

• Plan and prioritize documentation projects, ensuring that documentation is delivered on time and within scope.

• Manage our online documentation platform.

• Continuously improve documentation processes and standards based on feedback from internal stakeholders and external customers.

• Leverage AI to scale efficiency and quality

• 7+ years of experience in technical writing, with at least 3 years in a management role.

• Proven track record of managing technical writing teams and delivering high-quality documentation.

• Strong technical writing skills with experience writing user guides, online help, release notes, and other technical documentation.

• Ability to communicate complex technical concepts to non-technical audiences.

• Experience working with cross-functional teams, including product management and engineering.

• Familiarity with industry-standard documentation tools and platforms.

• Experience with Agile development methodologies and tools.

• Excellent project management and prioritization skills.

• Bachelor's degree in Technical Communication, English, Computer Science, or a related field (or equivalent experience)

• Experience in AdTech, MarTech, or enterprise SaaS environments.
• Knowledge of HTML, CSS, JavaScript, or scripting languages to support developer-focused documentation.
• Familiarity with AI-driven documentation tools and automation.