Senior Medical Writer & Regulatory Submissions Lead
Alnylam Pharmaceuticals
Alnylam Pharmaceuticals in Cambridge, MA, is seeking a Principal Medical Writer (equivalent to Associate Director) to lead medical writing on multi-disciplinary teams and oversee contract writers on the clinical program. You will develop key clinical documents in accordance with GCP, FDA regulations, and SOPs, coordinate filings, mentor junior staff, and collaborate across functions to ensure timely, high-quality submissions. #J-18808-Ljbffr Alnylam Pharmaceuticals
- Scorpion Therapeutics is seeking a senior statistics leader to drive clinical development... ...programs from study design through regulatory submission. You will collaborate with cross-... ...regulatory readiness. Responsibilities include leading protocol and SAP development, data...SeniorRegulatory
- ...pharmaceutical, biotech, and medical device industries with a... ...approach to complex trial data and regulatory submission challenges. With a global... ...supervision, the Medical Writer will critically evaluate, analyze... ...protocol experience, as lead author, required Experience...SeniorRegulatoryRemote workWorldwide
- Voronoi, Inc. is seeking an experienced Medical Writer with a strong background in oncology... ...Waltham, MA / Cambridge area, supporting regulatory and scientific documents for oncology... ..., and manage sections of regulatory submissions, while mentoring junior writers and aligning...Regulatory
$212k - $333.19k
...lasting impact on patients worldwide.Join Takeda as a Senior Director, Global Regulatory Lead - Oncology, where you will be part of the global regulatory... ...professional and timely manner.Accountable for US FDA submissions and approvals of project(s) of responsibility. May...SeniorRegulatoryMinimum wageLocal areaRemote workWorldwide$212k - $333.19k
...you to shine? Join us as a Senior Director, Global Program Lead- Neuroscience in our... ...to simultaneously driving regulatory approval as well as launch... ...in the context of unmet medical need, competitive landscape... ...through large-scale Phase III/submission projects and global...SeniorRegulatoryMinimum wageWork at officeLocal areaRemote work- Biogen is seeking a Senior Scientist to advance parenteral drug product development, leading sterile formulation efforts and technology transfer. You will work... ...drive process validation, and contribute to regulatory submissions in a fast-paced, matrix environment. The...SeniorRegulatory
- ...Lawyer / Attorney / Counsel - Junior / Senior / Lead Job Openings Lawyer / Attorney /... ...with a specialized vertical in Legal, Regulatory Compliance, and Corporate Governance.... ...record of impactful cases, regulatory submissions, process improvements, policy frameworks...SeniorRegulatoryContract work
- Regeneron is seeking a Senior Toxicologist to lead nonclinical development programs with regulatory oversight and cross‑functional collaboration. The role requires deep... ...and experience coordinating multi‑team studies and regulatory submissions. #J-18808-Ljbffr RegeneronSeniorRegulatory
- Relay Therapeutics is recruiting for an Associate Director/Director, CMC Regulatory in Cambridge, MA. You will lead regulatory CMC strategies for small molecule programs, develop global submission plans, and coordinate cross-functional teams to ensure regulatory success...SeniorRegulatory
- Harvard University’s Office for Sponsored Programs seeks a Senior Manager to lead the proposal review and submission lifecycle, interfacing with sponsors, principal investigators, school and department staff, and central offices across the university. You will partner with...SeniorWork at office
- Beam Therapeutics is seeking a Regulatory Director/Sr. Director Regulatory CMC to lead global regulatory CMC submissions and ensure compliant health authority communications. The role sits within Regulatory and partners with cross-functional teams to shape strategies for...SeniorRegulatory3 days per week1 day per week
$135.62k - $203.44k
...Maryland Reports to: Senior Director, Global Regulatory Strategy About Alexion... ...living with rare diseases. We lead with breakthrough science,... ...rare diseases and unmet medical needs. This individual... ...and execution of regulatory submissions in the US (e.g. INDs, BLAs...SeniorRegulatoryTemporary workWork at office- A clinical-stage biotechnology company is seeking a Medical Writer to lead the development of regulatory and clinical documents. The role requires expertise in medical writing and collaboration with various teams to ensure high-quality documentation. Candidates should...SeniorRegulatory
- Takeda is seeking a Director, Global Regulatory Lead Oncology to set global regulatory strategy and lead major submissions for high-impact oncology programs. You will serve as GRL on GPTs, coordinate with global teams, and ensure FDA submissions and other major filings...Regulatory
$95k - $125k
...storytelling, partnering with leading pharmaceutical and biotech... ...knowledge across therapeutic areas, regulatory standards, and key... ...concepts You are an exceptional writer, able to translate complex data... ...-functional teams, including medical, editorial, and client stakeholders...SeniorRegulatoryLocal area$105k - $140k
About the RoleThe Senior/Lead Analyst, Private Credit Operations role will be responsible for supporting all operational activities within... ...compliance and trade execution processes.Stay abreast of regulatory requirements and understand investment guidelines across multiple...SeniorRegulatoryLocal areaRemote work$119.7k - $222.3k
...PK Sciences representative to lead the development and use of... ...organization and interactions with regulatory agencies, as... ...experience to be considered for Senior Principal Scientist.Extensive... ...disabilities. If, because of a medical condition or disability, you...SeniorRegulatoryFull time- Sanofi is seeking a Senior Manager of Regulatory Affairs Advertising and Promotion to independently review promotional materials and develop regulatory... ...for campaigns. The role includes serving as regulatory lead for product launches and providing input on labeling and lifecycle...SeniorRegulatory
- ...liver disease, uniting science, medical and commercial excellence to... ...medical innovation? As the Senior Global Medical Affairs Leader... ...Development investment decisions, lead pre-launch scientific efforts... ...healthcare system pathways, regulatory landscapes, market access,...SeniorRegulatoryFull timeWorldwideRelocation package
$110k - $160.91k
...essential. This role is focused on leading and overseeing routing and... ...stakeholder engagement, and regulatory documentation and state... ...Electric Transmission Line Siting Senior Lead, you will serve as a... ...benefits including paid time off, medical/dental/vision insurance, 401(...SeniorRegulatoryFull timeFixed term contractCasual workWork at officeRemote workFlexible hoursShift work- Regeneron Pharmaceuticals, Inc. in New York seeks a Senior Toxicologist to lead nonclinical development programs with guidance from a supervisor... ...ability to independently design, conduct, and interpret regulatory toxicology studies in rodent and non-rodent models,...SeniorRegulatory
- ...seeking a Principal Scientist, Formulations in Watertown, MA to lead the design, early-phase development, and manufacturing scale-up... ...in formulation development, process optimization, and regulatory readiness, ensuring robust, scalable drug products that meet TPPS...SeniorRegulatory
$105.8k - $175k
...good. Your impact We are seeking a Senior Environmental Permitting Lead to drive the successful planning,... ...environmental permitting strategy, regulatory interface, and high-quality technical... ...future. Employees have access to medical, dental, vision, and basic life insurance...SeniorRegulatoryFull timeLocal areaRemote workShift work$212k - $333.19k
...DescriptionAbout the role:The Senior Director, Oncology Search &... ...translating scientific, clinical, regulatory, and competitive insights... ...and a demonstrated ability to lead in a highly matrixed global... ...externally at major scientific, medical, and partnering forums to...SeniorRegulatoryMinimum wageLocal areaRemote work- ...Clinical Development team in Cambridge, MA, is seeking a technical lead to advance AI methods across oncology clinical development. You... ...in late‑stage studies while collaborating with biometrics, regulatory, and study teams. The role requires deep ML expertise, a PhD in...SeniorRegulatory
- ...seeks an Associate Director, Statistical Programming to lead programming activities for clinical trials and NDA submissions. You will ensure SAS programs are developed, validated, and aligned with ICH and regulatory requirements. Role requires SAS expertise, CDISC ADaM/...SeniorRegulatory
- Ipsen is seeking a Senior Medical Information Manager in the U.S. who will lead content development for unsolicited inquiries and oversee MI materials across therapeutic... ..., ensuring scientifically balanced messaging and regulatory compliance. The role emphasizes high-quality...SeniorRegulatory
$195k - $255k
...clients to develop and implement regulatory and analytical strategies to... ...and collaborate with leading academics in our areas of expertise... ...consulting firm).About the Senior Biostatistician Position:Analysis... ...supporting regulatory submissions in a pharmaceutical or biotechnology...SeniorRegulatoryWork experience placementWork at officeLocal areaVisa sponsorship- PROMETRIKA, a full-service CRO, seeks a Manager, Medical Writing to oversee the creation of regulatory documents for global drug development... ...includes writing and editing protocols, CSRs, and submissions, and supervising junior writers and contractors. The candidate should have...SeniorRegulatoryFor contractors
- Judge Group, Inc. is seeking a Senior Principal GMP Compliance Auditor to lead independent GMP audits across pharmaceutical sites, laboratories, suppliers, CMOs, and quality systems. This role focuses on regulatory compliance, inspection readiness, and quality-system effectiveness...SeniorRegulatoryRemote job
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