Director, Medical Writing & Regulatory Strategy
$220k - $235kAlkermes
Alkermes, located in Waltham, MA, seeks a Director of Medical Writing to provide strategic leadership in medical writing across clinical programs. This role involves hands-on writing and management of medical writing deliverables, ensuring quality and compliance with regulatory submissions. The ideal candidate will bring over 10 years of experience in medical writing, with a preference for those with supervisory experience. The position maintains a hybrid work environment requiring onsite presence three days per week. The role offers a salary range of $220,000 to $235,000 plus potential performance bonuses. #J-18808-Ljbffr Alkermes
- Responsibilities Drive market access launch strategy as well as development and... ...-through resources) Own the regulatory and legal approval (... ..., Patient Marketing, Medical, Advocacy, Global and U.S. Franchise... ...clearly, orally and in writing, across internal and external...MedicalRegulatory
$129k - $203.1k
...seeking an Associate Director, Data Engineer to join... ...establish DSCS Digital Data Strategy. Design and implement... ...hands‑on experience writing and optimizing queries... ...steps. Knowledge of regulatory expectations relevant... ...benefits include medical, dental, vision healthcare...MedicalRegulatoryFor contractorsLocal area- ...statistical issues in regulatory agency meetings. Leading... .... As an Associate Director, responsible for... ...teams. Interact with Medical Directors, Clinical Scientists... ...Management, Medical Writing, and others to design... ...and development strategies. ~ Excellent influence...MedicalRegulatoryFull time
$195k - $250k
...Summary: The Compensation Director is responsible for... ...business goals and talent strategies. Monitor market trends... ...audits, and regulatory reporting requirements... ...access to market‑leading medical, emotional and mental... ...keyboard, telephone, or writing. The employee is frequently...MedicalRegulatoryTemporary workWork at officeLocal area$225k - $275k
...Biosciences is seeking an experienced and strategic Director, Medical Writing to lead the development of high-quality clinical and regulatory documents that support our advancing... ...to support global regulatory submission strategies and health authority interactions....MedicalRegulatoryLocal area- Job title: Director, US Advertising and Promotion, Global Regulatory Affairs Location: Morristown, NJ /... ...defense, and development strategies for assigned product(s)... ...pharmaceutical or medical device Regulatory Affairs... ...oral communication and writing skills Understanding of...MedicalRegulatory
$222k - $258k
...seeking a proactive and detail-oriented Director, Medical Writing to lead the development of complex,... ...support our clinical development and regulatory submissions. Reporting to the VP,... ...Lead the Medical Writing efforts and strategy for clinical and strategic regulatory...MedicalRegulatoryLocal areaFlexible hours3 days per week$204.4k - $379.6k
...-Hybrid Internal Title: Director Location: Cambridge, MA,... ...innovative drug development strategies for new discoveries and/... .... If, because of a medical condition or disability,... ...Problem Solving Skills, Regulatory Compliance, Report Writing, Strategic Thinking, Team...MedicalRegulatoryFor contractors- ...today and address the medical challenges of tomorrow... ...provide specifications and directors to the HEOR... ...expertise to execute strategies and research activities... ...HEOR. Contribute to the writing and publishing of scientific... .... Monitor scientific, regulatory and reimbursement/...MedicalRegulatoryLocal area
- Takeda is seeking an Associate Medical Director in Cambridge, MA to lead strategy for clinical studies within the Neuroscience Therapeutic Area. This role... ...collaboration with global teams and decision-making impacting regulatory approvals. The ideal candidate holds an MD or...MedicalRegulatory
$220k - $235k
Job Description The Director, Medical Writing provides strategic and operational leadership for medical... ..., fit‑for‑purpose clinical and regulatory documents aligned with program and regulatory... ...accountable for document development strategy, planning, and execution; leads...MedicalRegulatoryWork at officeLocal area3 days per week- Job Title:Senior Director, BiostatisticsTerritory/TA Area:OncologyDivision... ...stakeholders, including regulatory agencies and academic... ...clinicians, regulatory affairs, medical writing, clinical operations,... ...influence product and/or business strategy.Lead and coordinate the...MedicalRegulatory
$200k - $250k
...novel ideas. As an MSAT Director, you will report to... ...the technology transfer strategy in alignment with... ...applicable CMC sections of regulatory documents (IND module... ...problem-solving, technical writing and verbal... ...Hepatitis C infection, medical condition (cancer or a...MedicalRegulatoryWork experience placement- Director, Human Neuron Core BOSTON CHILDREN’S HOSPITAL... ...Hospital and Harvard Medical School is seeking a highly... .... Lead grant writing efforts to secure NIH... ...institutional biosafety, regulatory, and ethical standards... ...and knock‑in/knock‑out strategies. Familiarity with high...MedicalRegulatory
$196.4k - $265.7k
The Director, Medical Writing will provide Medical Writing leadership for drug development programs,... ...collaborate with project teams on the strategy and development of clinical documents... ...document submissions to global regulatory agencies, and provide Medical Writing...MedicalRegulatoryFull timeTemporary workLocal areaFlexible hours$252k - $378k
General Summary The Medical Affairs Senior Director provides medical and scientific... ...that scientific and medical strategies are aligned with broader... ...understanding of global medical, regulatory and commercial (including... ...countries Experience in writing or reviewing scientific...MedicalRegulatoryLocal areaRemote workFlexible hours2 days per week$222.3k - $302.9k
...indications with high unmet medical need, including... ...Role We are seeking a Director/Senior Director, CMC,... ...applicable quality and regulatory standards. Evaluate,... ...Author (with Technical Writing) and/or review core CMC... ...in line with company strategy. Act in accordance with...MedicalRegulatoryTemporary workWork at officeRemote workFlexible hours2 days per week- We are seeking an experienced Director of Medical Writing to provide strategic leadership for the medical... ..., and delivery of high-quality regulatory and clinical documents that support global... ...Lead the medical writing strategy for multiple clinical development programs...MedicalRegulatoryContract work
$220k - $260k
...We are seeking an experienced medical writer with deep expertise in clinical and regulatory documents and demonstrated experience... ...scientific and regulatory writing judgment with practical experience... ...writing, including prompt strategies, source document mapping, review...MedicalRegulatory$275k - $300k
Senior Director, Toxicology (CNS Specialist) Centessa... ...program‑level toxicology strategy from target selection... ...to global regulatory submissions. Key Responsibilities... ...and scientific writing skills as applied to study... ...plan, company‑sponsored medical, dental, vision, and...MedicalRegulatoryFull time- ...strategically mindedAssociate Director, Corporate... ...external communications strategy. The Associate Director... ..., and compliance with regulatory and disclosure requirements... ...activities around medical/scientific conference... ...audiences. Excellent writing, editing, and presentation...MedicalRegulatory
$185.37k - $308.95k
...Associate Director, Global Safety Lead Who we are... ...Lead to join our growing Medical Safety and Risk... ...safety and risk management strategy in our rare genetic disease... ...to key clinical and regulatory documents including... ...• Contributes to the writing and/or review of the RMP...MedicalRegulatoryTemporary workRemote workWork from homeFlexible hours3 days per week- Position Summary The Associate Director, Medical Writing provides strategic, operational, and people... ...leads the development of clinical and regulatory documents that support global... ...complex submissions, including document strategy, organization, messaging, timelines,...MedicalRegulatory
$180k - $210k
...Requisition ID: 11932 Role Associate Director, US Corporate Strategy About Servier Servier in the U.S. is... ...senior leaders across Commercial, Medical, Finance, Insights & Analytics, and... ...disease markets, drug development, regulatory processes, and commercial and market...MedicalRegulatoryFull timeContract workTemporary workWork experience placementFlexible hours$169.22k - $253k
...Summary The Associate Director, Materials Science will... ...and material control strategies, and successful technology... ...experience supporting regulatory submissions in a GMP... ...regulatory technical writing. Ability to lead... ...laws. Comprehensive medical, dental, vision, prescription...MedicalRegulatoryTemporary workLocal areaFlexible hours$126k - $190k
...The Associate Director, Safety Scientist plays a leadership... ...with the GPS Medical Director(s) and cross-... ...members within the global regulatory framework. You will... ...MedDRA search strategy Representing GPS in... ...solving and scientific writing and communication skills...MedicalRegulatoryTemporary work$154.4k - $242.55k
...Description The Associate Director, Short Bowel Syndrome... ...to developing strategies that support a trusted... ...change Work with legal, regulatory, and compliance partners... ...external partners, including medical, legal, regulatory,... ...clearly in writing and verbally in a time...MedicalRegulatoryTemporary workLocal area- ...seeking an Associate Director, Global Scientific Communications... ...of high-impact medical content for field... ...that support medical strategy and product understanding... ..., Research, Biostats, Regulatory, Legal, and Corporate... ...communication and medical writing agencies to ensure...MedicalRegulatoryWork at officeLocal area3 days per week
$95k - $135k
...lot to learn, there is room to grow. Our Strategy function is responsible for the success... ...particular focus KOL/Thought Leader engagement, medical affairs, and/or commercial launch Proven... ...and effective communicator, capable of writing and speaking clearly with confidence...MedicalWork experience placementWork at officeLocal areaWork from homeFlexible hours$110k - $140k
...collaborative, high-performing medical communications team... ...disciplines to shape strategy, elevate scientific... ...Associate Scientific Director, you will play a... ...content development, regulatory review, and advisory board... ...in medical/scientific writing and content development...MedicalRegulatory
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