Principal Medical Writer- Client Embedded
Principal Medical Writer- Client Embedded
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Job Description
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
At Thermo Fisher Scientific you will discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Summarized Purpose:
We are excited to be expanding our Medical Writing FSP Team. WeseekingaPMWdedicated to a client in the FSP space;preferred candidates will have experiencein Structured Content Authoring systems and automation to support delivery.The ideal candidate will beexperienced and highly skilledresponsible for creating reviewing andmanagingclinical regulatory documents. This role requires a strong understanding of scientific concepts exceptional writing skills and the ability to communicate complex information clearly and concisely.
Our client a global mid-sized biotech company focuses on developing innovative treatments for patients with autoimmune diseases. This fast-growing international organization has a strong scientific foundation. If youre looking for a place where your work in partnership with others can have real impactand where youre encouraged challenge yourself and contribute to breakthrough solutions the Principal Medical Writer role could be a great fit.
Key Responsibilities:
Lead the development writing and editing ofcomplexclinical and regulatory documents.
Collaborate with cross-functional teams including clinical development regulatory affairs biostatistics and medical affairs to ensure theaccurateandtimelycompletion of documents.
Ensure documentsalignwith regulatory guidelines company standards and industry best practices.
Provide strategic input and guidance on document content structure and presentation.
Mentor and provide oversight to junior medical writers and ensure high-quality deliverables.
Manage multiple writing projects simultaneously and prioritize tasks effectively.
Stay current with industry trends guidelines and regulatory requirements.
Education and Experience:
Bachelors degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred.
Regulatory writing experience that provides the knowledge skills and abilities to perform the role(comparable to 8 years in core Regulatory Medical Writer role capacity).
Experience working in the pharmaceutical/CRO industry.
Experience in managing and directing complex medical writing projects.
Extensive experience in Phase 3 CSRs and/or protocol development.
EU CTR experience preferred.
Experience working on structured content management system and AI-driven content creation and familiarity with Natural Language Generationpreferred.
Knowledge Skills and Abilities:
Excellent organizational andprogram management skills.
Proven leadership skills to manage and mentor a team of medical writers.
Extensive knowledge ofregulatory guidelinesand drug development processes.
Strong interpersonal and communication skills to build andmaintaineffective working relationships with colleagues and stakeholders.
Understanding of quality control processes to ensure compliance with regulatory requirements and internal standards.
Self-motivated and adaptable.
Excellent judgment; high degree of independence in decision making and problem solving.
Capable of mentoring and leading junior level staff.
What We Offer:
At PPD clinical research services we hire the best develop ourselves and each other and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career and therefore at PPD clinical research services you willbenefitfrom anaward-winning learning and development programme ensuring you reach your potential.
As well as beingrewardeda competitive salary we have an extensive benefits package basedaroundthe health and well-being of our employees. We have aflexible working culture where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment with teams of colleagues eager to shareexpertiseand have fun together. We are a global organization but with a local feel.
Our Mission is to enable our customers to make the world healthier cleaner and safer. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory with PPD part of Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued
Compensation and Benefits
The salary pay range estimated for this position Medical Writing Senior based inMaryland is .This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:
A choice of national medical and dental plans and a national vision plan including health incentive programs
Employee assistance and family support programs including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy
Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan
Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits please visit: Experience:
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Employment Type
Full-Time
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